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Ref: 1112/231012/1/F

®

Cipramil Drops 40mg/ml
(citalopram hydrochloride)
Patient Information Leaflet
Read all of this leaflet carefully before you start taking this medicine
* Keep this leaflet. You may need to read it again.
* If you have further questions, please ask your doctor or pharmacist.
* This medicine has been prescribed for you. Do not pass it on to others. It
may harm them, even if their symptoms are the same as yours.
* If any of the side effects are troubling, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.
Your medicine is called Cipramil Drops 40mg/ml, but will be referred to as
Cipramil throughout this leaflet.
In this leaflet:
1 What Cipramil is and what it is used for
2 Before you take Cipramil
3 How to take Cipramil
4 Possible side effects
5 How to store Cipramil
6 Further information

1

What Cipramil is and what it is used for

How does Cipramil work?
Cipramil is a Selective Serotonin Reuptake Inhibitor (SSRI) and belongs to a
group of medicines known as antidepressants.
These medicines help to correct certain chemical imbalances in the brain
that are causing the symptoms of your illness.
What is Cipramil used for?
Cipramil is used for the treatment of depression and, when you feel better, to
help prevent these symptoms recurring. Cipramil is also used for long-term
treatment to prevent the occurrence of new episodes of depression or if you
have recurrent depression.
Cipramil is also beneficial in relieving symptoms if you tend to suffer from
panic attacks.

2

Before you take Cipramil Drops

Do not take Cipramil
* If you are allergic (hypersensitive) to citalopram, or any of the other
ingredients of Cipramil (see What Cipramil contain, section 6). Consult
your doctor if you think you might be.
* If you are also taking a medicine containing pimozide. Talk to your doctor.
* At the same time as taking medication known as monoamine oxidase
inhibitors (MAOIs). MAOIs include medicines such as phenelzine,
iproniazid, isocarboxazid, nialamide, tranylcypromine and moclobemide
(used for the treatment of depression), selegiline (used in the treatment of
Parkinson’s disease) and linezolid (an antibiotic). Even if you have finished
taking one of the following MAOIs: phenelzine, iproniazid, isocarboxazid,
nialamide or tranylcypromine you will need to wait 2 weeks before you
start taking Cipramil. One day must elapse after you have finished taking
moclobemide. After stopping Cipramil you must allow 1 week before taking
any MAOI.
* if you are born with or have had an episode of abnormal heart rhythm
(seen at ECG; an examination to evaluate how the heart is functioning).
* if you take medicines for heart rhythm problems or that may affect the
heart’s rhythm (see Taking other medicines, below).
Take special care with Cipramil
Please tell your doctor if you have any medical problems, especially if you
have:
* Liver disease
* Kidney disease
* Diabetes (you may need an adjustment of your antidiabetic therapy)
* Epilepsy or a history of seizures or fits
* A bleeding disorder or have ever suffered from bleeding in the stomach or
intestine
* Mania or panic disorder
* Low blood levels of sodium
* ECT (electroconvulsive therapy)
* Problems with your eyes, such as certain kinds of glaucoma
* Suffered or suffer from heart problems or have recently had a heart attack.
* A low resting heart-rate and/or you know that you may have salt
depletion as a result of prolonged severe diarrhoea and vomiting
(being sick) or usage of diuretics (water tablets).
* Experienced a fast or irregular heartbeat, fainting, collapse or dizziness
on standing up which may indicate abnormal functioning of the heart
rate.
Please consult your doctor, even if these statements were applicable to you
at any time in the past.
Some patients with manic-depressive illness may enter into a manic phase.
This is characterized by unusual and rapidly changing ideas, inappropriate
happiness and excessive physical activity. If you experience this, contact
your doctor.
Symptoms such as restlessness or difficulty in sitting or standing still can
also occur during the first weeks of the treatment. Tell your doctor
immediately if you experience these symptoms.
Special information relating to your disease
As with other medicines used to treat depression or related diseases, the
improvement is not achieved immediately. After the start of Cipramil
treatment it may take several weeks before you experience any
improvement. In the beginning of the treatment certain patients may
experience increased anxiety, which will disappear during continued
treatment. Therefore, it is very important that you follow exactly your doctor’s
orders and do not stop the treatment or change the dose without consulting
your doctor.
Thoughts of suicide and worsening of your depression or anxiety
disorder
If you are depressed and/or have anxiety disorders you can sometimes have
thoughts of harming or killing yourself. These may be increased when first
starting antidepressants, since these medicines all take time to work, usually
about two weeks but sometimes longer.
You may be more likely to think like this:
* If you have previously had thoughts about killing or harming yourself.
* If you are a young adult. Information from clinical trials has shown an
increased risk of suicidal behaviour in adults aged less than 25 years with
psychiatric conditions who were treated with an antidepressant.
If you have thoughts of harming or killing yourself at any time, contact your
doctor or go to a hospital straight away.
You may find it helpful to tell a relative or close friend that you are
depressed or have an anxiety disorder, and ask them to read this leaflet. You
might ask them to tell you if they think your depression or anxiety is getting
worse, or if they are worried about changes in your behaviour.
Use in children and adolescents under 18 years of age
Cipramil should normally not be used for children and adolescents under 18
years. Also, you should know that patients under 18 have an increased risk
of side-effects such as suicide attempt, suicidal thoughts and hostility
(predominantly aggression, oppositional behaviour and anger) when they
take this class of medicines. Despite this, your doctor may prescribe
citalopram for patients under 18 because he/she decides that this is in their
best interests. If your doctor has prescribed Cipramil for a patient under 18
and you want to discuss this, please go back to your doctor. You should
inform your doctor if any of the symptoms listed above develop or worsen
when patients under 18 are taking Cipramil. Also, the long-term safety
effects concerning growth, maturation and cognitive and behavioural
development of Cipramil in this age group have not yet been demonstrated.

Taking other medicines
Medicines may affect the action of other medicines and this can sometimes
cause serious adverse reactions.
Please tell your doctor or pharmacist if you are taking or have taken any
other medicines (including those purchased without prescription) during the
last 14 days. This includes other medicines for depression (see Do not take
Cipramil above).
* The herbal remedy St John's wort (Hypericum perforatum). This should
not be taken at the same time as Cipramil.
* Monoamine oxidase inhibitors (MAOIs). These should not be taken at the
same time as Cipramil (see Do not take Cipramil Drops above).
Tell your doctor if you are taking any of the following medicines:
* Linezolid (an antibiotic).
* Sumatriptan (used to treat migraine) or tramadol (a pain killer). If you
feel unwell when using these medicines with Cipramil you should see
your doctor.
* Lithium (used to prevent and treat mania) and tryptophan (an
antidepressant)
* Pimozide (a neuroleptic). This should not be taken at the same time as
Cipramil (see Do not take Cipramil above).
* Imipramine and desipramine (used to treat depression).
* Medicines containing selegiline (used to treat Parkinson’s disease)
* Cimetidine (used to treat stomach ulcers).
* Mefloquine (used to treat malaria).
* Bupropion (used to treat depression).
* Medicines known to affect the blood platelets (e.g. anticoagulant drugs
used to treat or prevent blood clots; aspirin and non-steroidal
anti-inflammatory drugs (NSAIDs) such as ibuprofen and diclofenac used
as painkillers and some antipsychotic drugs and tricyclic antidepressants).
* Metoprolol, a beta blocker used to treat migraine, some heart conditions
and high blood pressure. The effects of either drug could be increased,
decreased or altered.
* Neuroleptics (used in the treatment of schizophrenia).
Do not take Cipramil if you take medicines for heart rhythm problems or
medicines that may affect the heart’s rhythm, e.g. such as Class IA and
III antiarrhythmics, antipsychotics (e.g. fentiazine derivatives, pimozide,
haloperidol), tricyclic antidepressants, certain antimicrobial agents (e.g.
sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, anti-malarial
treatment particularly halofantrine), certain antihistamines (astemizole,
mizolastine). If you have any further questions about this you should speak
to your doctor.
Taking Cipramil with food and drink
Cipramil can be taken with or without food (see section 3 “How to take
Cipramil”).
As with all antidepressants, it is sensible to avoid drinking alcohol whilst
receiving treatment although Cipramil has not been shown to increase the
effects of alcohol.
Pregnancy
Ask your doctor or pharmacist for advice before taking any medicine. If
you are pregnant, think you might be pregnant, or are trying to become
pregnant, tell your doctor. Do not take Cipramil if you are pregnant unless
you and your doctor have discussed the risks and benefits involved.
Make sure your midwife and/or doctor know you are on Cipramil. When
taken during pregnancy, particularly in the last 3 months of pregnancy,
medicines like Cipramil may increase the risk of a serious condition in
babies, called persistent pulmonary hypertension of the newborn (PPHN),
making the baby breathe faster and appear bluish. These symptoms usually
begin during the first 24 hours after the baby is born. If this happens to your
baby you should contact your midwife and/or doctor immediately. Also, if you
take Cipramil during the last 3 months of your pregnancy and until the date
of birth you should be aware that the following effects may be seen in your
newborn: fits, being too hot or cold, feeding difficulties, vomiting, low blood
sugar, stiff or floppy muscles, overactive reflexes, tremor, jitteriness,
irritability, lethargy, constant crying, sleepiness or sleeping difficulties. If your
newborn baby gets any of these symptoms please contact your midwife
and/or doctor immediately.
Breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
If you are breast-feeding, ask your doctor for advice. You should not
breast-feed your baby when taking Cipramil because small amounts of the
medicine can pass into the breast milk.
Fertility
Cipramil has been shown to reduce the quality of sperm in animal studies.
Theoretically, this could affect fertility, but impact on human fertility has not
been observed as yet.
Driving and using machines
Cipramil does not usually affect the ability to carry out normal daily activities.
However, if you feel dizzy or sleepy when you start to take this medicine,
you should be careful when driving, operating machinery or performing jobs
that need you to be alert until these effects wear off.
Important information about some of the ingredients of Cipramil
This medicinal product contains small amounts of ethanol (alcohol), less
than 100 mg in all doses. These drops also contain the preservatives E216
and E218, which may cause allergic reactions (possibly delayed).

3

How to take Cipramil

How much to take
It is important to take your drops as instructed by your doctor. The label will
tell you how many to take and how often. If it does not, or you are not sure,
ask your doctor or pharmacist.
Adults
Depression
The usual dose is 16 mg (8 drops) per day. This may be increased by your
doctor to a maximum of 32 mg (16 drops) per day.
Panic disorder
The starting dose is 8 mg (4 drops) per day for the first week before
increasing the dose to between 16 –24 mg (8 to 12 drops) per day. The dose
may be increased by your doctor to a maximum of 32 mg (16 drops) per day.
Elderly patients (above 65 years of age)
The starting dose should be decreased to half of the recommended dose,
e.g. 8-16 mg per day. Elderly patients should not usually receive more than
16 mg (8 drops) per day.
Children and adolescents (< 18 years)
Cipramil should not be given to children or adolescents under 18 years of
age. For further information, please see section 2, Before you take
Cipramil Drops.
Patients with special risks
Patients with liver complaints should not receive more than 16 mg (8 drops)
per day.
If you have previously taken Cipramil tablets, you will find that the dose of
your medicine in mg given as drops is a bit lower than that of tablets. This is
because your body more easily absorbs the drops than the tablets, so you
do not need as many mg to have the same effect.
The doses of tablets correspond to doses of drops as follows:
Tablets
10 mg
20 mg
30 mg
40 mg

Drops
8 mg (4 drops)
16 mg (8 drops)
24 mg (12 drops)
32 mg (16 drops)

Ref: 1112/231012/1/B

Cipramil® Drops 40mg/ml
(citalopram hydrochloride)
Patient Information Leaflet (continued)
How and when to take Cipramil
The drops are for oral use and can be taken in a drink of water, or orange or
apple juice.
Cipramil is taken every day as one dose at any time of the day.
Duration of treatment
Like other medicines for depression and panic disorder these drops may
take a few weeks before you feel any improvement. Continue to take
Cipramil even if it takes some time before you feel any improvement in your
condition.
The duration of treatment is individual, usually at least 6 months. Continue
to take the drops for as long as your doctor recommends. Do not stop
taking them even if you begin to feel better, unless you are told to do so by
your doctor. The underlying illness may persist for a long time and if you
stop your treatment too soon your symptoms may return.
Patients who have recurrent depression benefit from continued treatment,
sometimes for several years, to prevent the occurrence of new depressive
episodes.
Never change the dose of the medicine without talking to your doctor first.
If you take more Cipramil than you should
If you think that you or anyone else may have taken too many Cipramil
drops, contact your doctor or nearest hospital emergency department
immediately. Do this even if there are no signs of discomfort or poisoning.
Take the Cipramil box/container with you if you go to a doctor or hospital.
Some of the signs of an overdosage could be life-threatening.
Symptoms of overdosage may include:
* Irregular heart beat
* Seizures
* Changes in heart rhythm
* Feeling sick (nausea)
* Vomiting
* Sweating
* Drowsiness
* Unconsciousness
* Fast heart beats
* Tremor
* Changes in blood pressure
* Serotonin syndrome (see Section 4)
* Agitation
* Dizziness
* Enlarged eye pupils
* Bluish skin
* Breathing too quickly
If you forget to take Cipramil
If you forget to take a dose, take the next dose at the usual time. Do not
take a double dose.
Effects when treatment with Cipramil is stopped
Stopping this medicine quickly may cause symptoms such as dizziness,
nausea and numbness or tingling in hands or feet, sleep disturbances
(vivid dreams, nightmares, inability to sleep), feeling anxious, headaches,
feeling or being sick, sweating, feeling restless or agitated, tremor, feeling
confused or disorientated, feeling emotional or irritable, diarrhoea (loose
stools), visual disturbances, fluttering or pounding heartbeat (palpitations).
These are usually non-serious and disappear within a few days. When you
have completed your course of treatment, the dose of Cipramil is usually
reduced gradually over a couple of weeks.
If you have any further questions on the use of this product, ask your
doctor or pharmacist.

4

Possible side effects

Like all medicines, Cipramil can have side effects and some people may
experience unwanted effects (side effects) whilst taking Cipramil. Several of
the effects listed below can also be symptoms of your illness and may
disappear as you start to get better.

* Fast heart beat
* Slow heart beat
* Nettle rash
* Loss of hair
* Rash
* Sensitivity to sunlight
* Difficulties urinating
* Vaginal bleeding
* Swelling of the arms or legs
* Increased weight
Rare (likely to affect up to 1 in every 1000 people)
* Convulsions
* Involuntary movements
* Taste disturbances
* Bleeding
* Hepatitis
Some patient have reported (frequency not known)
* Thoughts of harming or killing themselves
* An increase in bleeding or bruising caused by a decrease in blood platelets
* Rash (hypersensitivity)
* Low potassium levels in the blood (hypokalaemia), which can cause
muscle weakness, twitching or abnormal heart rhythms
* Panic attack
* Grinding teeth
* Restlessness
* Unusual muscle movements or stiffness
* Involuntary movements of the muscles (akathisia)
* Low blood pressure
* Nosebleed
* Bleeding disorders including skin and mucosal bleeding (ecchymosis)
* Sudden swelling of skin or mucosa
* In men, painful erections
* Flow of breast milk in men or in women who are not breast-feeding
(galactorrhoea)
* Abnormal liver function tests
* An increased risk of bone fractures has been observed in patients taking
this type of medicines
SSRIs can, very rarely, increase the risk of bleeding, including stomach or
intestinal bleeding. Let your doctor know if you vomit blood or develop
black or blood stained stools.
Also let your doctor know if you continue to have other symptoms associated
with your depression. This might include hallucinations, anxiety, mania or
confusion.
Any side effects that do occur will usually disappear after a few days. If they
are troublesome or persistent, or if you develop any other unusual side
effects while taking Cipramil, please tell your doctor.
If you notice any other side effects not mentioned in this leaflet please tell
your doctor or pharmacist.

5

How to store Cipramil

Do not use this medicine after the expiry date shown on the carton label.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required.
These measures will help to protect the environment. Only keep this
medicine if your doctor tells you to. If your medicine becomes discoloured or
shows any signs of deterioration, consult your pharmacist (chemist) who will
tell you what to do.

* KEEP OUT OF THE SIGHT AND REACH OF CHILDREN
* Do not store above 25°C.
* Use within 16 weeks after first use.

6

Further information

Serious side effects
Stop taking Cipramil and seek medical advice immediately if you have any
of the following symptoms:
* Difficulty in breathing.
* Swelling of the face, lips, tongue or throat that causes difficulty in
swallowing or breathing.
* Severe itching of the skin (with raised lumps).
* Fast, irregular heartbeat, fainting which could be symptoms of a
life-threatening condition known as torsades de pointes.

What Cipramil Drops contain
Each ml of solution contains 40mg of the active ingredient citalopram.
Cipramil also contains the following inactive ingredients;
methyl-parahydroxybenzoate E218, propyl-parahydroxybenzoate E216,
ethyl alcohol 9% v/v, hydroxyethylcellulose, purified water.

If you notice any of the following you should contact your doctor immediately
as your dose may need to be reduced or stopped:
* You start having fits for the first time or fits that you have suffered from in
the past before become more frequent.
* Your behaviour changes because you feel elated or over excited.
* You experience high fever, agitation, confusion, and trembling or abrupt
contractions of muscles. These may be signs of a rare condition called
serotonin syndrome.
* Tiredness, confusion and twitching of your muscles. These may be signs of
a low blood level of sodium.

Manufacturer and Licence Holder
Cipramil is manufactured by H. Lundbeck A/S Ottiliavej 9, DK-2500 Valby
Denmark and is procured from within the EU and repackaged by the Product
Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road,
East Moons Moat, Redditch, Worcestershire, B98 0RE.

If you have thoughts of harming or killing yourself at any time, contact your
doctor or go to a hospital straight away.
The following side effects are often mild and usually disappear after a few
days’ treatment.
Very common side effects (likely to affect more than 1 in 10 people)

* Sleepiness
* Difficulty in sleeping
* Increased sweating
* Dry mouth (a dry mouth increases the risk of tooth decay, so be sure to
clean your teeth more often than usual)

* Feeling sick (nausea)
Common side effects (likely to affect up to 1 in 10 people)
* Lack of appetite
* Agitation
* Decreased sex drive
* Anxiety
* Nervousness
* Confusion
* Abnormal dreams
* Tremor
* Tingling or numbness in the hands or feet
* Ringing in the ears (tinnitus)
* Yawning
* Diarrhoea
* Vomiting
* Constipation
* Itching
* Pain in muscles and joints
* For men, problems with ejaculation and erection
* For females, failing to reach an orgasm
* Tiredness,
* Prickling of the skin
* Loss of weight
Uncommon (likely to affect up to 1 in every 100 people)
* Bruising easily
* Increased appetite
* Aggression
* Reduced emotions, indifference
* Hallucinations
* Mania
* Fainting
* Large pupils (the dark centre of the eye)

What Cipramil Drops look like and contents of the pack
Cipramil comes in a brown glass bottle containing 15ml clear drops solution
with screw cap and polyethylene dropper.

POM

PL Number: 15184/1112

Cipramil is a registered trademark of H.Lundbeck A/S.
Leaflet revision date:

23/10/12

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.

Ref: 1112/231012/2/F

®

Cipramil Drops 40mg/ml
(citalopram hydrochloride)
Patient Information Leaflet
Read all of this leaflet carefully before you start taking this medicine
* Keep this leaflet. You may need to read it again.
* If you have further questions, please ask your doctor or pharmacist.
* This medicine has been prescribed for you. Do not pass it on to others. It
may harm them, even if their symptoms are the same as yours.
* If any of the side effects are troubling, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.
Your medicine is called Cipramil Drops 40mg/ml, but will be referred to as
Cipramil throughout this leaflet.
In this leaflet:
1 What Cipramil is and what it is used for
2 Before you take Cipramil
3 How to take Cipramil

Taking other medicines
Medicines may affect the action of other medicines and this can sometimes
cause serious adverse reactions.
Please tell your doctor or pharmacist if you are taking or have taken any
other medicines (including those purchased without prescription) during the
last 14 days. This includes other medicines for depression (see Do not take
Cipramil above).
* The herbal remedy St John's wort (Hypericum perforatum). This should
not be taken at the same time as Cipramil.
* Monoamine oxidase inhibitors (MAOIs). These should not be taken at the
same time as Cipramil (see Do not take Cipramil above).
Tell your doctor if you are taking any of the following medicines:

* Linezolid (an antibiotic).
* Sumatriptan (used to treat migraine) or tramadol (a pain killer). If you

4 Possible side effects
5 How to store Cipramil
6 Further information

1

What Cipramil is and what it is used for

How does Cipramil work?
Cipramil is a Selective Serotonin Reuptake Inhibitor (SSRI) and belongs to a
group of medicines known as antidepressants.
These medicines help to correct certain chemical imbalances in the brain
that are causing the symptoms of your illness.
What is Cipramil used for?
Cipramil is used for the treatment of depression and, when you feel better, to
help prevent these symptoms recurring. Cipramil is also used for long-term
treatment to prevent the occurrence of new episodes of depression or if you
have recurrent depression.
Cipramil is also beneficial in relieving symptoms if you tend to suffer from
panic attacks.

2

Before you take Cipramil

Do not take Cipramil
* If you are allergic (hypersensitive) to citalopram, or any of the other
ingredients of Cipramil (see What Cipramil contain, section 6). Consult
your doctor if you think you might be.
* If you are also taking a medicine containing pimozide. Talk to your doctor.
* At the same time as taking medication known as monoamine oxidase
inhibitors (MAOIs). MAOIs include medicines such as phenelzine,
iproniazid, isocarboxazid, nialamide, tranylcypromine and moclobemide
(used for the treatment of depression), selegiline (used in the treatment of
Parkinson’s disease) and linezolid (an antibiotic). Even if you have finished
taking one of the following MAOIs: phenelzine, iproniazid, isocarboxazid,
nialamide or tranylcypromine you will need to wait 2 weeks before you
start taking Cipramil. One day must elapse after you have finished taking
moclobemide. After stopping Cipramil you must allow 1 week before taking
any MAOI.
* if you are born with or have had an episode of abnormal heart rhythm
(seen at ECG; an examination to evaluate how the heart is functioning).
* if you take medicines for heart rhythm problems or that may affect the
heart’s rhythm (see Taking other medicines, below).
Take special care with Cipramil
Please tell your doctor if you have any medical problems, especially if you
have:
* Liver disease
* Kidney disease
* Diabetes (you may need an adjustment of your antidiabetic therapy)
* Epilepsy or a history of seizures or fits
* A bleeding disorder or have ever suffered from bleeding in the stomach or
intestine
* Mania or panic disorder
* Low blood levels of sodium
* ECT (electroconvulsive therapy)
* Problems with your eyes, such as certain kinds of glaucoma
* Suffered or suffer from heart problems or have recently had a heart attack.
* A low resting heart-rate and/or you know that you may have salt
depletion as a result of prolonged severe diarrhoea and vomiting
(being sick) or usage of diuretics (water tablets).
* Experienced a fast or irregular heartbeat, fainting, collapse or dizziness
on standing up which may indicate abnormal functioning of the heart
rate.
Please consult your doctor, even if these statements were applicable to you
at any time in the past.
Some patients with manic-depressive illness may enter into a manic phase.
This is characterized by unusual and rapidly changing ideas, inappropriate
happiness and excessive physical activity. If you experience this, contact
your doctor.
Symptoms such as restlessness or difficulty in sitting or standing still can
also occur during the first weeks of the treatment. Tell your doctor
immediately if you experience these symptoms.
Special information relating to your disease
As with other medicines used to treat depression or related diseases, the
improvement is not achieved immediately. After the start of Cipramil
treatment it may take several weeks before you experience any
improvement. In the beginning of the treatment certain patients may
experience increased anxiety, which will disappear during continued
treatment. Therefore, it is very important that you follow exactly your doctor’s
orders and do not stop the treatment or change the dose without consulting
your doctor.
Thoughts of suicide and worsening of your depression or anxiety
disorder
If you are depressed and/or have anxiety disorders you can sometimes have
thoughts of harming or killing yourself. These may be increased when first
starting antidepressants, since these medicines all take time to work, usually
about two weeks but sometimes longer.
You may be more likely to think like this:
* If you have previously had thoughts about killing or harming yourself.
* If you are a young adult. Information from clinical trials has shown an
increased risk of suicidal behaviour in adults aged less than 25 years with
psychiatric conditions who were treated with an antidepressant.
If you have thoughts of harming or killing yourself at any time, contact your
doctor or go to a hospital straight away.
You may find it helpful to tell a relative or close friend that you are
depressed or have an anxiety disorder, and ask them to read this leaflet. You
might ask them to tell you if they think your depression or anxiety is getting
worse, or if they are worried about changes in your behaviour.
Use in children and adolescents under 18 years of age
Cipramil should normally not be used for children and adolescents under 18
years. Also, you should know that patients under 18 have an increased risk
of side-effects such as suicide attempt, suicidal thoughts and hostility
(predominantly aggression, oppositional behaviour and anger) when they
take this class of medicines. Despite this, your doctor may prescribe
Cipramil for patients under 18 because he/she decides that this is in their
best interests. If your doctor has prescribed Cipramil for a patient under 18
and you want to discuss this, please go back to your doctor. You should
inform your doctor if any of the symptoms listed above develop or worsen
when patients under 18 are taking Cipramil. Also, the long-term safety
effects concerning growth, maturation and cognitive and behavioural
development of Cipramil in this age group have not yet been demonstrated.

*
*
*
*
*
*
*
*

*
*

feel unwell when using these medicines with Cipramil you should see
your doctor.
Lithium (used to prevent and treat mania) and tryptophan (an
antidepressant)
Pimozide (a neuroleptic). This should not be taken at the same time as
Cipramil (see Do not take Cipramil above).
Imipramine and desipramine (used to treat depression).
Medicines containing selegiline (used to treat Parkinson’s disease)
Cimetidine (used to treat stomach ulcers).
Mefloquine (used to treat malaria).
Bupropion (used to treat depression).
Medicines known to affect the blood platelets (e.g. anticoagulant drugs
used to treat or prevent blood clots; aspirin and non-steroidal
antiinflammatory drugs (NSAIDs) such as ibuprofen and diclofenac used
as painkillers and some antipsychotic drugs and tricyclic antidepressants).
Metoprolol, a beta blocker used to treat migraine, some heart conditions
and high blood pressure. The effects of either drug could be increased,
decreased or altered.
Neuroleptics (used in the treatment of schizophrenia).

Do not take Cipramil if you take medicines for heart rhythm problems or
medicines that may affect the heart’s rhythm, e.g. such as Class IA and
III antiarrhythmics, antipsychotics (e.g. fentiazine derivatives, pimozide,
haloperidol), tricyclic antidepressants, certain antimicrobial agents (e.g.
sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, anti-malarial
treatment particularly halofantrine), certain antihistamines (astemizole,
mizolastine). If you have any further questions about this you should speak
to your doctor.
Taking Cipramil with food and drink
Cipramil can be taken with or without food (see section 3 “How to take
Cipramil”).
As with all antidepressants, it is sensible to avoid drinking alcohol whilst
receiving treatment although Cipramil has not been shown to increase the
effects of alcohol.
Pregnancy
Ask your doctor or pharmacist for advice before taking any medicine. If
you are pregnant, think you might be pregnant, or are trying to become
pregnant, tell your doctor. Do not take Cipramil if you are pregnant unless
you and your doctor have discussed the risks and benefits involved.
Make sure your midwife and/or doctor know you are on Cipramil. When
taken during pregnancy, particularly in the last 3 months of pregnancy,
medicines like Cipramil may increase the risk of a serious condition in
babies, called persistent pulmonary hypertension of the newborn (PPHN),
making the baby breathe faster and appear bluish. These symptoms
usually begin during the first 24 hours after the baby is born. If this happens
to your baby you should contact your midwife and/or doctor immediately.
Also, if you take Cipramil during the last 3 months of your pregnancy and
until the date of birth you should be aware that the following effects may be
seen in your newborn: fits, being too hot or cold, feeding difficulties,
vomiting, low blood sugar, stiff or floppy muscles, overactive reflexes, tremor,
jitteriness, irritability, lethargy, constant crying, sleepiness or sleeping
difficulties. If your newborn baby gets any of these symptoms please contact
your midwife and/or doctor immediately.
Breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
If you are breast-feeding, ask your doctor for advice. You should not
breast-feed your baby when taking Cipramil because small amounts of the
medicine can pass into the breast milk.
Fertility
Cipramil has been shown to reduce the quality of sperm in animal studies.
Theoretically, this could affect fertility, but impact on human fertility has not
been observed as yet.
Driving and using machines
Cipramil does not usually affect the ability to carry out normal daily activities.
However, if you feel dizzy or sleepy when you start to take this medicine,
you should be careful when driving, operating machinery or performing jobs
that need you to be alert until these effects wear off.
Important information about some of the ingredients of Cipramil Drops
This medicinal product contains small amounts of ethanol (alcohol), less
than 100 mg in all doses. These drops also contain the preservatives E216
and E218, which may cause allergic reactions (possibly delayed).

3

How to take Cipramil

How much to take
It is important to take your drops as instructed by your doctor. The label will
tell you how many to take and how often. If it does not, or you are not sure,
ask your doctor or pharmacist.
Adults
Depression
The usual dose is 16 mg (8 drops) per day. This may be increased by your
doctor to a maximum of 32 mg (16 drops) per day.
Panic disorder
The starting dose is 8 mg (4 drops) per day for the first week before
increasing the dose to between 16 –24 mg (8 to 12 drops) per day. The dose
may be increased by your doctor to a maximum of 32 mg (16 drops) per day.
Elderly patients (above 65 years of age)
The starting dose should be decreased to half of the recommended dose,
e.g. 8-16 mg per day. Elderly patients should not usually receive more than
16 mg (8 drops) per day.
Children and adolescents (< 18 years)
Cipramil should not be given to children or adolescents under 18 years of
age. For further information, please see section 2, Before you take
Cipramil.
Patients with special risks
Patients with liver complaints should not receive more than 16 mg (8 drops)
per day.
If you have previously taken Cipramil tablets, you will find that the dose of
your medicine in mg given as drops is a bit lower than that of tablets. This is
because your body more easily absorbs the drops than the tablets, so you
do not need as many mg to have the same effect.
The doses of tablets correspond to doses of drops as follows:
Tablets
10 mg
20 mg
30 mg
40 mg

Drops
8 mg (4 drops)
16 mg (8 drops)
24 mg (12 drops)
32 mg (16 drops)

Ref: 1112/231012/2/B

Cipramil® Drops 40mg/ml
(citalopram hydrochloride)
Patient Information Leaflet (continued)
How and when to take Cipramil
The drops are for oral use and can be taken in a drink of water, or orange or
apple juice.
Cipramil is taken every day as one dose at any time of the day.
Duration of treatment
Like other medicines for depression and panic disorder these drops may
take a few weeks before you feel any improvement. Continue to take
Cipramil even if it takes some time before you feel any improvement in your
condition.
The duration of treatment is individual, usually at least 6 months. Continue
to take the drops for as long as your doctor recommends. Do not stop
taking them even if you begin to feel better, unless you are told to do so by
your doctor. The underlying illness may persist for a long time and if you
stop your treatment too soon your symptoms may return.
Patients who have recurrent depression benefit from continued treatment,
sometimes for several years, to prevent the occurrence of new depressive
episodes.
Never change the dose of the medicine without talking to your doctor first.
If you take more Cipramil than you should
If you think that you or anyone else may have taken too many Cipramil
drops, contact your doctor or nearest hospital emergency department
immediately. Do this even if there are no signs of discomfort or poisoning.
Take the Cipramil box/container with you if you go to a doctor or hospital.
Some of the signs of an overdosage could be life-threatening.
Symptoms of overdosage may include:
* Irregular heart beat
* Seizures
* Changes in heart rhythm
* Feeling sick (nausea)
* Vomiting
* Sweating
* Drowsiness
* Unconsciousness
* Fast heart beats
* Tremor
* Changes in blood pressure
* Serotonin syndrome (see Section 4)
* Agitation
* Dizziness
* Enlarged eye pupils
* Bluish skin
* Breathing too quickly
If you forget to take Cipramil
If you forget to take a dose, take the next dose at the usual time. Do not
take a double dose.
Effects when treatment with Cipramil is stopped
Stopping this medicine quickly may cause symptoms such as dizziness,
nausea and numbness or tingling in hands or feet, sleep disturbances
(vivid dreams, nightmares, inability to sleep), feeling anxious, headaches,
feeling or being sick, sweating, feeling restless or agitated, tremor, feeling
confused or disorientated, feeling emotional or irritable, diarrhoea (loose
stools), visual disturbances, fluttering or pounding heartbeat (palpitations).
These are usually non-serious and disappear within a few days. When you
have completed your course of treatment, the dose of Cipramil is usually
reduced gradually over a couple of weeks.
If you have any further questions on the use of this product, ask your
doctor or pharmacist.

4

Possible side effects

Like all medicines, Cipramil can have side effects and some people may
experience unwanted effects (side effects) whilst taking Cipramil. Several of
the effects listed below can also be symptoms of your illness and may
disappear as you start to get better.

* Fast heart beat
* Slow heart beat
* Nettle rash
* Loss of hair
* Rash
* Sensitivity to sunlight
* Difficulties urinating
* Vaginal bleeding
* Swelling of the arms or legs
* Increased weight
Rare (likely to affect up to 1 in every 1000 people)
* Convulsions
* Involuntary movements
* Taste disturbances
* Bleeding
* Hepatitis
Some patient have reported (frequency not known)
* Thoughts of harming or killing themselves
* An increase in bleeding or bruising caused by a decrease in blood platelets
* Rash (hypersensitivity)
* Low potassium levels in the blood (hypokalaemia), which can cause
muscle weakness, twitching or abnormal heart rhythms
* Panic attack
* Grinding teeth
* Restlessness
* Unusual muscle movements or stiffness
* Involuntary movements of the muscles (akathisia)
* Low blood pressure
* Nosebleed
* Bleeding disorders including skin and mucosal bleeding (ecchymosis)
* Sudden swelling of skin or mucosa
* In men, painful erections
* Flow of breast milk in men or in women who are not breast-feeding
(galactorrhoea)
* Abnormal liver function tests
* An increased risk of bone fractures has been observed in patients taking
this type of medicines
SSRIs can, very rarely, increase the risk of bleeding, including stomach or
intestinal bleeding. Let your doctor know if you vomit blood or develop
black or blood stained stools.
Also let your doctor know if you continue to have other symptoms associated
with your depression. This might include hallucinations, anxiety, mania or
confusion.
Any side effects that do occur will usually disappear after a few days. If they
are troublesome or persistent, or if you develop any other unusual side
effects while taking Cipramil, please tell your doctor.
If you notice any other side effects not mentioned in this leaflet please tell
your doctor or pharmacist.

5

How to store Cipramil

Do not use this medicine after the expiry date shown on the carton label.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required.
These measures will help to protect the environment. Only keep this
medicine if your doctor tells you to. If your medicine becomes discoloured or
shows any signs of deterioration, consult your pharmacist (chemist) who will
tell you what to do.

* KEEP OUT OF THE SIGHT AND REACH OF CHILDREN
* Do not store above 25°C.
* Use within 16 weeks after first use.
6

Further information

Serious side effects
Stop taking Cipramil and seek medical advice immediately if you have any
of the following symptoms:
* Difficulty in breathing.
* Swelling of the face, lips, tongue or throat that causes difficulty in
swallowing or breathing.
* Severe itching of the skin (with raised lumps).
* Fast, irregular heartbeat, fainting which could be symptoms of a
life-threatening condition known as torsades de pointes.

What Cipramil Drops contain
Each ml of solution contains 40mg of the active ingredient citalopram.
Cipramil also contains the following inactive ingredients;
methyl-parahydroxybenzoate E218, propyl-parahydroxybenzoate E216,
ethyl alcohol 9% v/v, hydroxyethylcellulose, purified water.

If you notice any of the following you should contact your doctor immediately
as your dose may need to be reduced or stopped:
* You start having fits for the first time or fits that you have suffered from in
the past before become more frequent.
* Your behaviour changes because you feel elated or over excited.
* You experience high fever, agitation, confusion, and trembling or abrupt
contractions of muscles. These may be signs of a rare condition called
serotonin syndrome.
* Tiredness, confusion and twitching of your muscles. These may be signs of
a low blood level of sodium.

Manufacturer and Licence Holder
Cipramil is manufactured by Montefarmaco SPA, Via G. Galilei-7, 20016
Pero (MI) Italy and is procured from within the EU and repackaged by the
Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road,
East Moons Moat, Redditch, Worcestershire, B98 0RE.

What Cipramil Drops look like and contents of the pack
Cipramil comes in a brown glass bottle containing 15ml clear drops solution
with screw cap and polyethylene dropper.

POM

PL Number: 15184/1112

Cipramil is a registered trademark of H.Lundbeck A/S.
Leaflet revision date:

If you have thoughts of harming or killing yourself at any time, contact your
doctor or go to a hospital straight away.
The following side effects are often mild and usually disappear after a few
days’ treatment.
Very common side effects (likely to affect more than 1 in 10 people)

* Sleepiness
* Difficulty in sleeping
* Increased sweating
* Dry mouth (a dry mouth increases the risk of tooth decay, so be sure to
clean your teeth more often than usual)

* Feeling sick (nausea)
Common side effects (likely to affect up to 1 in 10 people)
* Lack of appetite
* Agitation
* Decreased sex drive
* Anxiety
* Nervousness
* Confusion
* Abnormal dreams
* Tremor
* Tingling or numbness in the hands or feet
* Ringing in the ears (tinnitus)
* Yawning
* Diarrhoea
* Vomiting
* Constipation
* Itching
* Pain in muscles and joints
* For men, problems with ejaculation and erection
* For females, failing to reach an orgasm
* Tiredness,
* Prickling of the skin
* Loss of weight
Uncommon (likely to affect up to 1 in every 100 people)
* Bruising easily
* Increased appetite
* Aggression
* Reduced emotions, indifference
* Hallucinations
* Mania
* Fainting
* Large pupils (the dark centre of the eye)

23/10/12

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.

Ref: 1112/231012/3/F

Citalopram Hydrochloride Drops 40mg/ml
Patient Information Leaflet
Read all of this leaflet carefully before you start taking this medicine
* Keep this leaflet. You may need to read it again.
* If you have further questions, please ask your doctor or pharmacist.
* This medicine has been prescribed for you. Do not pass it on to others. It
may harm them, even if their symptoms are the same as yours.
* If any of the side effects are troubling, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.
Your medicine is called Citalopram Hydrochloride Drops 40mg/ml, but will be
referred to as Citalopram Hydrochloride throughout this leaflet.
In this leaflet:
1 What Citalopram Hydrochloride is and what it is used for
2 Before you take Citalopram Hydrochloride
3 How to take Citalopram Hydrochloride
4 Possible side effects
5 How to store Citalopram Hydrochloride
6 Further information

1

What Citalopram Hydrochloride is and what it is used
for

How does Citalopram Hydrochloride work?
Citalopram Hydrochloride is a Selective Serotonin Reuptake Inhibitor (SSRI)
and belongs to a group of medicines known as antidepressants.
These medicines help to correct certain chemical imbalances in the brain
that are causing the symptoms of your illness.
What is Citalopram Hydrochloride used for?
Citalopram Hydrochloride is used for the treatment of depression and, when
you feel better, to help prevent these symptoms recurring. Citalopram
Hydrochloride is also used for long-term treatment to prevent the occurrence
of new episodes of depression or if you have recurrent depression.
Citalopram Hydrochloride is also beneficial in relieving symptoms if you tend
to suffer from panic attacks.

2

Before you take Citalopram Hydrochloride Drops

Do not take Citalopram Hydrochloride
* If you are allergic (hypersensitive) to citalopram, or any of the other
ingredients of Citalopram Hydrochloride (see What Citalopram
Hydrochloride contain, section 6). Consult your doctor if you think
you might be.
* If you are also taking a medicine containing pimozide. Talk to your doctor.
* At the same time as taking medication known as monoamine oxidase
inhibitors (MAOIs). MAOIs include medicines such as phenelzine,
iproniazid, isocarboxazid, nialamide, tranylcypromine and moclobemide
(used for the treatment of depression), selegiline (used in the treatment of
Parkinson’s disease) and linezolid (an antibiotic). Even if you have finished
taking one of the following MAOIs: phenelzine, iproniazid, isocarboxazid,
nialamide or tranylcypromine you will need to wait 2 weeks before you
start taking Citalopram Hydrochloride. One day must elapse after you have
finished taking moclobemide. After stopping Citalopram Hydrochloride you
must allow 1 week before taking any MAOI.
* if you are born with or have had an episode of abnormal heart rhythm
(seen at ECG; an examination to evaluate how the heart is functioning).
* if you take medicines for heart rhythm problems or that may affect the
heart’s rhythm (see Taking other medicines, below).
Take special care with Citalopram Hydrochloride
Please tell your doctor if you have any medical problems, especially if you
have:
* Liver disease
* Kidney disease
* Diabetes (you may need an adjustment of your antidiabetic therapy)
* Epilepsy or a history of seizures or fits
* A bleeding disorder or have ever suffered from bleeding in the stomach or
intestine
* Mania or panic disorder
* Low blood levels of sodium
* ECT (electroconvulsive therapy)
* Problems with your eyes, such as certain kinds of glaucoma
* Suffered or suffer from heart problems or have recently had a heart attack.
* A low resting heart-rate and/or you know that you may have salt
depletion as a result of prolonged severe diarrhoea and vomiting
(being sick) or usage of diuretics (water tablets).
* Experienced a fast or irregular heartbeat, fainting, collapse or dizziness
on standing up which may indicate abnormal functioning of the heart
rate.
Please consult your doctor, even if these statements were applicable to you
at any time in the past.
Some patients with manic-depressive illness may enter into a manic phase.
This is characterized by unusual and rapidly changing ideas, inappropriate
happiness and excessive physical activity. If you experience this, contact
your doctor.
Symptoms such as restlessness or difficulty in sitting or standing still can
also occur during the first weeks of the treatment. Tell your doctor
immediately if you experience these symptoms.
Special information relating to your disease
As with other medicines used to treat depression or related diseases, the
improvement is not achieved immediately. After the start of Citalopram
Hydrochloride treatment it may take several weeks before you experience
any improvement. In the beginning of the treatment certain patients may
experience increased anxiety, which will disappear during continued
treatment. Therefore, it is very important that you follow exactly your doctor’s
orders and do not stop the treatment or change the dose without consulting
your doctor.
Thoughts of suicide and worsening of your depression or anxiety
disorder
If you are depressed and/or have anxiety disorders you can sometimes have
thoughts of harming or killing yourself. These may be increased when first
starting antidepressants, since these medicines all take time to work, usually
about two weeks but sometimes longer.
You may be more likely to think like this:
* If you have previously had thoughts about killing or harming yourself.
* If you are a young adult. Information from clinical trials has shown an
increased risk of suicidal behaviour in adults aged less than 25 years with
psychiatric conditions who were treated with an antidepressant.

Taking other medicines
Medicines may affect the action of other medicines and this can sometimes
cause serious adverse reactions.
Please tell your doctor or pharmacist if you are taking or have taken any
other medicines (including those purchased without prescription) during the
last 14 days. This includes other medicines for depression (see Do not take
Citalopram Hydrochloride Drops above).
* The herbal remedy St John's wort (Hypericum perforatum). This should
not be taken at the same time as Citalopram Hydrochloride.
* Monoamine oxidase inhibitors (MAOIs). These should not be taken at the
same time as Citalopram Hydrochloride (see Do not take Citalopram
Hydrochloride above).
Tell your doctor if you are taking any of the following medicines:
* Linezolid (an antibiotic).
* Sumatriptan (used to treat migraine) or tramadol (a pain killer). If you
feel unwell when using these medicines with Citalopram Hydrochloride you
should see your doctor.
* Lithium (used to prevent and treat mania) and tryptophan (an
antidepressant)
* Pimozide (a neuroleptic). This should not be taken at the same time as
Citalopram Hydrochloride (see Do not take Citalopram Hydrochloride
above).
* mipramine and desipramine (used to treat depression).
* Medicines containing selegiline (used to treat Parkinson’s disease)
* Cimetidine (used to treat stomach ulcers).
* Mefloquine (used to treat malaria).
* Bupropion (used to treat depression).
* Medicines known to affect the blood platelets (e.g. anticoagulant drugs
used to treat or prevent blood clots; aspirin and non-steroidal
anti-inflammatory drugs (NSAIDs) such as ibuprofen and diclofenac used
as painkillers and some antipsychotic drugs and tricyclic antidepressants).
* Metoprolol, a beta blocker used to treat migraine, some heart conditions
and high blood pressure. The effects of either drug could be increased,
decreased or altered.
* Neuroleptics (used in the treatment of schizophrenia).
Do not take Citalopram Hydrochloride if you take medicines for heart
rhythm problems or medicines that may affect the heart’s rhythm, e.g. such
as Class IA and III antiarrhythmics, antipsychotics (e.g. fentiazine
derivatives, pimozide, haloperidol), tricyclic antidepressants, certain
antimicrobial agents (e.g. sparfloxacin, moxifloxacin, erythromycin IV,
pentamidine, anti-malarial treatment particularly halofantrine), certain
antihistamines (astemizole, mizolastine). If you have any further questions
about this you should speak to your doctor.
Taking Citalopram Hydrochloride with food and drink
Citalopram Hydrochloride can be taken with or without food (see section 3
“How to take Citalopram Hydrochloride”).
As with all antidepressants, it is sensible to avoid drinking alcohol whilst
receiving treatment although Citalopram Hydrochloride has not been shown
to increase the effects of alcohol.
Pregnancy
Ask your doctor or pharmacist for advice before taking any medicine. If
you are pregnant, think you might be pregnant, or are trying to become
pregnant, tell your doctor. Do not take Citalopram Hydrochloride if you are
pregnant unless you and your doctor have discussed the risks and benefits
involved.
Make sure your midwife and/or doctor know you are on Citalopram
Hydrochloride. When taken during pregnancy, particularly in the last 3
months of pregnancy, medicines like Citalopram Hydrochloride may increase
the risk of a serious condition in babies, called persistent pulmonary
hypertension of the newborn (PPHN), making the baby breathe faster and
appear bluish. These symptoms usually begin during the first 24 hours after
the baby is born. If this happens to your baby you should contact your
midwife and/or doctor immediately. Also, if you take Citalopram
Hydrochloride during the last 3 months of your pregnancy and until the date
of birth you should be aware that the following effects may be seen in your
newborn: fits, being too hot or cold, feeding difficulties, vomiting, low blood
sugar, stiff or floppy muscles, overactive reflexes, tremor, jitteriness,
irritability, lethargy, constant crying, sleepiness or sleeping difficulties. If your
newborn baby gets any of these symptoms please contact your midwife
and/or doctor immediately.
Breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
If you are breast-feeding, ask your doctor for advice. You should not
breast-feed your baby when taking Citalopram Hydrochloride because small
amounts of the medicine can pass into the breast milk.
Fertility
Citalopram Hydrochloride has been shown to reduce the quality of sperm in
animal studies. Theoretically, this could affect fertility, but impact on human
fertility has not been observed as yet.
Driving and using machines
Citalopram Hydrochloride does not usually affect the ability to carry out
normal daily activities. However, if you feel dizzy or sleepy when you start to
take this medicine, you should be careful when driving, operating machinery
or performing jobs that need you to be alert until these effects wear off.
Important information about some of the ingredients of Citalopram
Hydrochloride
This medicinal product contains small amounts of ethanol (alcohol), less
than 100 mg in all doses. These drops also contain the preservatives E216
and E218, which may cause allergic reactions (possibly delayed).
3

How to take Citalopram Hydrochloride

How much to take
It is important to take your drops as instructed by your doctor. The label will
tell you how many to take and how often. If it does not, or you are not sure,
ask your doctor or pharmacist.
Adults
Depression
The usual dose is 16 mg (8 drops) per day. This may be increased by your
doctor to a maximum of 32 mg (16 drops) per day.
Panic disorder
The starting dose is 8 mg (4 drops) per day for the first week before
increasing the dose to between 16 –24 mg (8 to 12 drops) per day. The dose
may be increased by your doctor to a maximum of 32 mg (16 drops) per day.

If you have thoughts of harming or killing yourself at any time, contact your
doctor or go to a hospital straight away.

Elderly patients (above 65 years of age)
The starting dose should be decreased to half of the recommended dose,
e.g. 8-16 mg per day. Elderly patients should not usually receive more than
16 mg (8 drops) per day.

You may find it helpful to tell a relative or close friend that you are
depressed or have an anxiety disorder, and ask them to read this leaflet. You
might ask them to tell you if they think your depression or anxiety is getting
worse, or if they are worried about changes in your behaviour.

Children and adolescents (< 18 years)
Citalopram Hydrochloride should not be given to children or adolescents
under 18 years of age. For further information, please see
section 2, Before you take Citalopram Hydrochloride Drops.

Use in children and adolescents under 18 years of age
Citalopram Hydrochloride should normally not be used for children and
adolescents under 18 years. Also, you should know that patients under 18
have an increased risk of side-effects such as suicide attempt, suicidal
thoughts and hostility (predominantly aggression, oppositional behaviour and
anger) when they take this class of medicines. Despite this, your doctor may
prescribe citalopram for patients under 18 because he/she decides that this
is in their best interests. If your doctor has prescribed Citalopram
Hydrochloride for a patient under 18 and you want to discuss this, please go
back to your doctor. You should inform your doctor if any of the symptoms
listed above develop or worsen when patients under 18 are taking
Citalopram Hydrochloride. Also, the long-term safety effects concerning
growth, maturation and cognitive and behavioural development of Citalopram
Hydrochloride in this age group have not yet been demonstrated.

Patients with special risks
Patients with liver complaints should not receive more than 16 mg (8 drops)
per day.
If you have previously taken Citalopram Hydrochloride tablets, you will find
that the dose of your medicine in mg given as drops is a bit lower than that
of tablets. This is because your body more easily absorbs the drops than the
tablets, so you do not need as many mg to have the same effect.
The doses
Tablets
10 mg
20 mg
30 mg
40 mg

of tablets correspond to doses of drops as follows:
Drops
8 mg (4 drops)
16 mg (8 drops)
24 mg (12 drops)
32 mg (16 drops)

Ref: 1112/231012/3/B

Citalopram Hydrochloride Drops 40mg/ml
Patient Information Leaflet (continued)
How and when to take Citalopram Hydrochloride
The drops are for oral use and can be taken in a drink of water, or orange or
apple juice.
Citalopram Hydrochloride is taken every day as one dose at any time of the
day.
Duration of treatment
Like other medicines for depression and panic disorder these drops may
take a few weeks before you feel any improvement. Continue to take
Citalopram Hydrochloride even if it takes some time before you feel any
improvement in your condition.
The duration of treatment is individual, usually at least 6 months. Continue
to take the drops for as long as your doctor recommends. Do not stop
taking them even if you begin to feel better, unless you are told to do so by
your doctor. The underlying illness may persist for a long time and if you
stop your treatment too soon your symptoms may return.
Patients who have recurrent depression benefit from continued treatment,
sometimes for several years, to prevent the occurrence of new depressive
episodes.
Never change the dose of the medicine without talking to your doctor first.
If you take more Citalopram Hydrochloride than you should
If you think that you or anyone else may have taken too many Citalopram
Hydrochloride
drops, contact your doctor or nearest hospital emergency department
immediately. Do this even if there are no signs of discomfort or poisoning.
Take the Citalopram Hydrochloride box/container with you if you go to a
doctor or hospital.
Some of the signs of an overdosage could be life-threatening.
Symptoms of overdosage may include:
* Irregular heart beat
* Seizures
* Changes in heart rhythm
* Feeling sick (nausea)
* Vomiting
* Sweating
* Drowsiness
* Unconsciousness
* Fast heart beats
* Tremor
* Changes in blood pressure
* Serotonin syndrome (see Section 4)
* Agitation
* Dizziness
* Enlarged eye pupils
* Bluish skin
* Breathing too quickly

* Reduced emotions, indifference
* Hallucinations
* Mania
* Fainting
* Large pupils (the dark centre of the eye)
* Fast heart beat
* Slow heart beat
* Nettle rash
* Loss of hair
* Rash
* Sensitivity to sunlight
* Difficulties urinating
* Vaginal bleeding
* Swelling of the arms or legs
* Increased weight
Rare (likely to affect up to 1 in every 1000 people)
* Convulsions
* Involuntary movements
* Taste disturbances
* Bleeding
* Hepatitis
Some patient have reported (frequency not known)
* Thoughts of harming or killing themselves
* An increase in bleeding or bruising caused by a decrease in blood platelets
* Rash (hypersensitivity)
* Low potassium levels in the blood (hypokalaemia), which can cause
muscle weakness, twitching or abnormal heart rhythms
* Panic attack
* Grinding teeth
* Restlessness
* Unusual muscle movements or stiffness
* Involuntary movements of the muscles (akathisia)
* Low blood pressure
* Nosebleed
* Bleeding disorders including skin and mucosal bleeding (ecchymosis)
* Sudden swelling of skin or mucosa
* In men, painful erections
* Flow of breast milk in men or in women who are not breast-feeding
(galactorrhoea)
* Abnormal liver function tests
* An increased risk of bone fractures has been observed in patients taking
this type of medicines
SSRIs can, very rarely, increase the risk of bleeding, including stomach or
intestinal bleeding. Let your doctor know if you vomit blood or develop
black or blood stained stools.
Also let your doctor know if you continue to have other symptoms associated
with your depression. This might include hallucinations, anxiety, mania or
confusion.

If you forget to take Citalopram Hydrochloride
If you forget to take a dose, take the next dose at the usual time. Do not
take a double dose.

Any side effects that do occur will usually disappear after a few days. If they
are troublesome or persistent, or if you develop any other unusual side
effects while taking Citalopram Hydrochloride, please tell your doctor.

Effects when treatment with Citalopram Hydrochloride is stopped
Stopping this medicine quickly may cause symptoms such as dizziness,
nausea and numbness or tingling in hands or feet, sleep disturbances
(vivid dreams, nightmares, inability to sleep), feeling anxious, headaches,
feeling or being sick, sweating, feeling restless or agitated, tremor, feeling
confused or disorientated, feeling emotional or irritable, diarrhoea (loose
stools), visual disturbances, fluttering or pounding heartbeat (palpitations).
These are usually non-serious and disappear within a few days. When you
have completed your course of treatment, the dose of Citalopram
Hydrochloride is usually reduced gradually over a couple of weeks.

If you notice any other side effects not mentioned in this leaflet please tell
your doctor or pharmacist.

If you have any further questions on the use of this product, ask your
doctor or pharmacist.

4

Possible side effects

Like all medicines, Citalopram Hydrochloride can have side effects and
some people may experience unwanted effects (side effects) whilst taking
Citalopram Hydrochloride. Several of the effects listed below can also be
symptoms of your illness and may
disappear as you start to get better.

5

How to store Citalopram Hydrochloride

Do not use this medicine after the expiry date shown on the carton label.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required.
These measures will help to protect the environment. Only keep this
medicine if your doctor tells you to. If your medicine becomes discoloured or
shows any signs of deterioration, consult your pharmacist (chemist) who will
tell you what to do.

* KEEP OUT OF THE SIGHT AND REACH OF CHILDREN
* Do not store above 25°C.
* Use within 16 weeks after first use.

6

Further information

Serious side effects
Stop taking Citalopram Hydrochloride and seek medical advice immediately
if you have any
of the following symptoms:
* Difficulty in breathing.
* Swelling of the face, lips, tongue or throat that causes difficulty in
swallowing or breathing.
* Severe itching of the skin (with raised lumps).
* Fast, irregular heartbeat, fainting which could be symptoms of a
life-threatening condition known as torsades de pointes.

What Citalopram Hydrochloride Drops contain
Each ml of solution contains 40mg of the active ingredient citalopram.
Citalopram Hydrochloride also contains the following inactive ingredients;
methyl-parahydroxybenzoate E218, propyl-parahydroxybenzoate E216,
ethyl alcohol 9% v/v, hydroxyethylcellulose, purified water.

If you notice any of the following you should contact your doctor immediately
as your dose may need to be reduced or stopped:
* You start having fits for the first time or fits that you have suffered from in
the past before become more frequent.
* Your behaviour changes because you feel elated or over excited.
* You experience high fever, agitation, confusion, and trembling or abrupt
contractions of muscles. These may be signs of a rare condition called
serotonin syndrome.
* Tiredness, confusion and twitching of your muscles. These may be signs of
a low blood level of sodium.

Manufacturer and Licence Holder
Citalopram Hydrochloride is manufactured by H. Lundbeck A/S Ottiliavej 9,
DK-2500 Valby Denmark and is procured from within the EU and
repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18,
Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.

If you have thoughts of harming or killing yourself at any time, contact your
doctor or go to a hospital straight away.
The following side effects are often mild and usually disappear after a few
days’ treatment.
Very common side effects (likely to affect more than 1 in 10 people)
* Sleepiness
* Difficulty in sleeping
* Increased sweating
* Dry mouth (a dry mouth increases the risk of tooth decay, so be sure to
clean your teeth more often that usual)
* Feeling sick (nausea)
Common side effects (likely to affect up to 1 in 10 people)
* Lack of appetite
* Agitation
* Decreased sex drive
* Anxiety
* Nervousness
* Confusion
* Abnormal dreams
* Tremor
* Tingling or numbness in the hands or feet
* Ringing in the ears (tinnitus)
* Yawning
* Diarrhoea
* Vomiting
* Constipation
* Itching
* Pain in muscles and joints
* For men, problems with ejaculation and erection
* For females, failing to reach an orgasm
* Tiredness,
* Prickling of the skin
* Loss of weight
Uncommon (likely to affect up to 1 in every 100 people)
* Bruising easily
* Increased appetite
* Aggression

What Citalopram Hydrochloride Drops look like and contents of the
pack
Citalopram Hydrochloride comes in a brown glass bottle containing 15ml
clear drops solution with screw cap and polyethylene dropper.

POM

PL Number: 15184/1112

Leaflet revision date:

23/10/12

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.

Ref: 1112/231012/4/F

Citalopram Hydrochloride Drops 40mg/ml
Patient Information Leaflet
Read all of this leaflet carefully before you start taking this medicine
* Keep this leaflet. You may need to read it again.
* If you have further questions, please ask your doctor or pharmacist.
* This medicine has been prescribed for you. Do not pass it on to others. It
may harm them, even if their symptoms are the same as yours.
* If any of the side effects are troubling, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.
Your medicine is called Citalopram Hydrochloride Drops 40mg/ml, but will be
referred to as Citalopram Hydrochloride throughout this leaflet.
In this leaflet:
1 What Citalopram Hydrochloride is and what it is used for
2 Before you take Citalopram Hydrochloride
3 How to take Citalopram Hydrochloride
4 Possible side effects
5 How to store Citalopram Hydrochloride
6 Further information

1

What Citalopram Hydrochloride is and what it is used
for

How does Citalopram Hydrochloride work?
Citalopram Hydrochloride is a Selective Serotonin Reuptake Inhibitor (SSRI)
and belongs to a group of medicines known as antidepressants.
These medicines help to correct certain chemical imbalances in the brain
that are causing the symptoms of your illness.
What is Citalopram Hydrochloride used for?
Citalopram Hydrochloride is used for the treatment of depression and, when
you feel better, to help prevent these symptoms recurring. Citalopram
Hydrochloride is also used for long-term treatment to prevent the occurrence
of new episodes of depression or if you have recurrent depression.
Citalopram Hydrochloride is also beneficial in relieving symptoms if you tend
to suffer from panic attacks.

2

Before you take Citalopram Hydrochloride

Do not take Citalopram Hydrochloride
* If you are allergic (hypersensitive) to citalopram, or any of the other
ingredients of Citalopram Hydrochloride (see What Citalopram
Hydrochloride contain, section 6). Consult your doctor if you think you
might be.
* If you are also taking a medicine containing pimozide. Talk to your doctor.
* At the same time as taking medication known as monoamine oxidase
inhibitors (MAOIs). MAOIs include medicines such as phenelzine,
iproniazid, isocarboxazid, nialamide, tranylcypromine and moclobemide
(used for the treatment of depression), selegiline (used in the treatment of
Parkinson’s disease) and linezolid (an antibiotic). Even if you have finished
taking one of the following MAOIs: phenelzine, iproniazid, isocarboxazid,
nialamide or tranylcypromine you will need to wait 2 weeks before you
start taking Citalopram Hydrochloride. One day must elapse after you have
finished taking moclobemide. After stopping Citalopram Hydrochloride you
must allow 1 week before taking any MAOI.
* if you are born with or have had an episode of abnormal heart rhythm
(seen at ECG; an examination to evaluate how the heart is functioning).
* if you take medicines for heart rhythm problems or that may affect the
heart’s rhythm (see Taking other medicines, below).
Take special care with Citalopram Hydrochloride
Please tell your doctor if you have any medical problems, especially if you
have:
* Liver disease
* Kidney disease
* Diabetes (you may need an adjustment of your antidiabetic therapy)
* Epilepsy or a history of seizures or fits
* A bleeding disorder or have ever suffered from bleeding in the stomach or
intestine
* Mania or panic disorder
* Low blood levels of sodium
* ECT (electroconvulsive therapy)
* Problems with your eyes, such as certain kinds of glaucoma
* Suffered or suffer from heart problems or have recently had a heart attack.
* A low resting heart-rate and/or you know that you may have salt
depletion as a result of prolonged severe diarrhoea and vomiting
(being sick) or usage of diuretics (water tablets).
* Experienced a fast or irregular heartbeat, fainting, collapse or dizziness
on standing up which may indicate abnormal functioning of the heart
rate.
Please consult your doctor, even if these statements were applicable to you
at any time in the past.
Some patients with manic-depressive illness may enter into a manic phase.
This is characterized by unusual and rapidly changing ideas, inappropriate
happiness and excessive physical activity. If you experience this, contact
your doctor.
Symptoms such as restlessness or difficulty in sitting or standing still can
also occur during the first weeks of the treatment. Tell your doctor
immediately if you experience these symptoms.
Special information relating to your disease
As with other medicines used to treat depression or related diseases, the
improvement is not achieved immediately. After the start of Citalopram
Hydrochloride treatment it may take several weeks before you experience
any improvement. In the beginning of the treatment certain patients may
experience increased anxiety, which will disappear during continued
treatment. Therefore, it is very important that you follow exactly your doctor’s
orders and do not stop the treatment or change the dose without consulting
your doctor.
Thoughts of suicide and worsening of your depression or anxiety
disorder
If you are depressed and/or have anxiety disorders you can sometimes have
thoughts of harming or killing yourself. These may be increased when first
starting antidepressants, since these medicines all take time to work, usually
about two weeks but sometimes longer.
You may be more likely to think like this:
* If you have previously had thoughts about killing or harming yourself.
* If you are a young adult. Information from clinical trials has shown an
increased risk of suicidal behaviour in adults aged less than 25 years with
psychiatric conditions who were treated with an antidepressant.

Taking other medicines
Medicines may affect the action of other medicines and this can sometimes
cause serious adverse reactions.
Please tell your doctor or pharmacist if you are taking or have taken any
other medicines (including those purchased without prescription) during the
last 14 days. This includes other medicines for depression (see Do not take
Citalopram Hydrochloride above).
* The herbal remedy St John's wort (Hypericum perforatum). This should
not be taken at the same time as Citalopram Hydrochloride.
* Monoamine oxidase inhibitors (MAOIs). These should not be taken at the
same time as Citalopram Hydrochloride (see Do not take Citalopram
Hydrochloride above).
Tell your doctor if you are taking any of the following medicines:
* Linezolid (an antibiotic).
* Sumatriptan (used to treat migraine) or tramadol (a pain killer). If you
feel unwell when using these medicines with Citalopram Hydrochloride you
should see your doctor.
* Lithium (used to prevent and treat mania) and tryptophan (an
antidepressant)
* Pimozide (a neuroleptic). This should not be taken at the same time as
Citalopram Hydrochloride (see Do not take Citalopram Hydrochloride
above).
* mipramine and desipramine (used to treat depression).
* Medicines containing selegiline (used to treat Parkinson’s disease)
* Cimetidine (used to treat stomach ulcers).
* Mefloquine (used to treat malaria).
* Bupropion (used to treat depression).
* Medicines known to affect the blood platelets (e.g. anticoagulant drugs
used to treat or prevent blood clots; aspirin and non-steroidal
anti-inflammatory drugs (NSAIDs) such as ibuprofen and diclofenac used
as painkillers and some antipsychotic drugs and tricyclic antidepressants).
* Metoprolol, a beta blocker used to treat migraine, some heart conditions
and high blood pressure. The effects of either drug could be increased,
decreased or altered.
* Neuroleptics (used in the treatment of schizophrenia).
Do not take Citalopram Hydrochloride if you take medicines for heart
rhythm problems or medicines that may affect the heart’s rhythm, e.g. such
as Class IA and III antiarrhythmics, antipsychotics (e.g. fentiazine
derivatives, pimozide, haloperidol), tricyclic antidepressants, certain
antimicrobial agents (e.g. sparfloxacin, moxifloxacin, erythromycin IV,
pentamidine, anti-malarial treatment particularly halofantrine), certain
antihistamines (astemizole, mizolastine). If you have any further questions
about this you should speak to your doctor.
Taking Citalopram Hydrochloride with food and drink
Citalopram Hydrochloride can be taken with or without food (see section 3
“How to take Citalopram Hydrochloride”).
As with all antidepressants, it is sensible to avoid drinking alcohol whilst
receiving treatment although Citalopram Hydrochloride has not been shown
to increase the effects of alcohol.
Pregnancy
Ask your doctor or pharmacist for advice before taking any medicine. If
you are pregnant, think you might be pregnant, or are trying to become
pregnant, tell your doctor. Do not take Citalopram Hydrochloride if you are
pregnant unless you and your doctor have discussed the risks and benefits
involved.
Make sure your midwife and/or doctor know you are on Citalopram
Hydrochloride. When taken during pregnancy, particularly in the last 3
months of pregnancy, medicines like Citalopram Hydrochloride may increase
the risk of a serious condition in babies, called persistent pulmonary
hypertension of the newborn (PPHN), making the baby breathe faster and
appear bluish. These symptoms usually begin during the first 24 hours after
the baby is born. If this happens to your baby you should contact your
midwife and/or doctor immediately. Also, if you take Citalopram
Hydrochloride during the last 3 months of your pregnancy and until the date
of birth you should be aware that the following effects may be seen in your
newborn: fits, being too hot or cold, feeding difficulties, vomiting, low blood
sugar, stiff or floppy muscles, overactive reflexes, tremor, jitteriness,
irritability, lethargy, constant crying, sleepiness or sleeping difficulties. If your
newborn baby gets any of these symptoms please contact your midwife
and/or doctor immediately.
Breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
If you are breast-feeding, ask your doctor for advice. You should not
breast-feed your baby when taking Citalopram Hydrochloride because small
amounts of the medicine can pass into the breast milk.
Fertility
Citalopram Hydrochloride has been shown to reduce the quality of sperm in
animal studies. Theoretically, this could affect fertility, but impact on human
fertility has not been observed as yet.
Driving and using machines
Citalopram Hydrochloride does not usually affect the ability to carry out
normal daily activities. However, if you feel dizzy or sleepy when you start to
take this medicine, you should be careful when driving, operating machinery
or performing jobs that need you to be alert until these effects wear off.
Important information about some of the ingredients of Citalopram
Hydrochloride
This medicinal product contains small amounts of ethanol (alcohol), less
than 100 mg in all doses. These drops also contain the preservatives E216
and E218, which may cause allergic reactions (possibly delayed).

3

How to take Citalopram Hydrochloride

How much to take
It is important to take your drops as instructed by your doctor. The label will
tell you how many to take and how often. If it does not, or you are not sure,
ask your doctor or pharmacist.
Adults
Depression
The usual dose is 16 mg (8 drops) per day. This may be increased by your
doctor to a maximum of 32 mg (16 drops) per day.
Panic disorder
The starting dose is 8 mg (4 drops) per day for the first week before
increasing the dose to between 16 –24 mg (8 to 12 drops) per day. The dose
may be increased by your doctor to a maximum of 32 mg (16 drops) per day.

If you have thoughts of harming or killing yourself at any time, contact your
doctor or go to a hospital straight away.

Elderly patients (above 65 years of age)
The starting dose should be decreased to half of the recommended dose,
e.g. 8-16 mg per day. Elderly patients should not usually receive more than
16 mg (8 drops) per day.

You may find it helpful to tell a relative or close friend that you are
depressed or have an anxiety disorder, and ask them to read this leaflet. You
might ask them to tell you if they think your depression or anxiety is getting
worse, or if they are worried about changes in your behaviour.

Children and adolescents (< 18 years)
Citalopram Hydrochloride should not be given to children or adolescents
under 18 years of age. For further information, please see
section 2, Before you take Citalopram Hydrochloride Drops.

Use in children and adolescents under 18 years of age
Citalopram Hydrochloride should normally not be used for children and
adolescents under 18 years. Also, you should know that patients under 18
have an increased risk of side-effects such as suicide attempt, suicidal
thoughts and hostility (predominantly aggression, oppositional behaviour and
anger) when they take this class of medicines. Despite this, your doctor may
prescribe citalopram for patients under 18 because he/she decides that this
is in their best interests. If your doctor has prescribed Citalopram
Hydrochloride for a patient under 18 and you want to discuss this, please go
back to your doctor. You should inform your doctor if any of the symptoms
listed above develop or worsen when patients under 18 are taking
Citalopram Hydrochloride. Also, the long-term safety effects concerning
growth, maturation and cognitive and behavioural development of Citalopram
Hydrochloride in this age group have not yet been demonstrated.

Patients with special risks
Patients with liver complaints should not receive more than 16 mg (8 drops)
per day.
If you have previously taken Citalopram Hydrochloride tablets, you will find
that the dose of your medicine in mg given as drops is a bit lower than that
of tablets. This is because your body more easily absorbs the drops than the
tablets, so you do not need as many mg to have the same effect.

Ref: 1112/231012/4/B

Citalopram Hydrochloride Drops 40mg/ml
Patient Information Leaflet (continued)
The doses
Tablets
10 mg
20 mg
30 mg
40 mg

of tablets correspond to doses of drops as follows:
Drops
8 mg (4 drops)
16 mg (8 drops)
24 mg (12 drops)
32 mg (16 drops)

How and when to take Citalopram Hydrochloride
The drops are for oral use and can be taken in a drink of water, or orange or
apple juice.
Citalopram Hydrochloride is taken every day as one dose at any time of the
day.
Duration of treatment
Like other medicines for depression and panic disorder these drops may
take a few weeks before you feel any improvement. Continue to take
Citalopram Hydrochloride even if it takes some time before you feel any
improvement in your condition.
The duration of treatment is individual, usually at least 6 months. Continue
to take the drops for as long as your doctor recommends. Do not stop
taking them even if you begin to feel better, unless you are told to do so by
your doctor. The underlying illness may persist for a long time and if you
stop your treatment too soon your symptoms may return.
Patients who have recurrent depression benefit from continued treatment,
sometimes for several years, to prevent the occurrence of new depressive
episodes.
Never change the dose of the medicine without talking to your doctor first.
If you take more Citalopram Hydrochloride than you should
If you think that you or anyone else may have taken too many Citalopram
Hydrochloride
drops, contact your doctor or nearest hospital emergency department
immediately. Do this even if there are no signs of discomfort or poisoning.
Take the Citalopram Hydrochloride box/container with you if you go to a
doctor or hospital.
Some of the signs of an overdosage could be life-threatening.
Symptoms of overdosage may include:
* Irregular heart beat
* Seizures
* Changes in heart rhythm
* Feeling sick (nausea)
* Vomiting
* Sweating
* Drowsiness
* Unconsciousness
* Fast heart beats
* Tremor
* Changes in blood pressure
* Serotonin syndrome (see Section 4)
* Agitation
* Dizziness
* Enlarged eye pupils
* Bluish skin
* Breathing too quickly
If you forget to take Citalopram Hydrochloride
If you forget to take a dose, take the next dose at the usual time. Do not
take a double dose.
Effects when treatment with Citalopram Hydrochloride is stopped
Stopping this medicine quickly may cause symptoms such as dizziness,
nausea and numbness or tingling in hands or feet, sleep disturbances
(vivid dreams, nightmares, inability to sleep), feeling anxious, headaches,
feeling or being sick, sweating, feeling restless or agitated, tremor, feeling
confused or disorientated, feeling emotional or irritable, diarrhoea (loose
stools), visual disturbances, fluttering or pounding heartbeat (palpitations).
These are usually non-serious and disappear within a few days. When you
have completed your course of treatment, the dose of Citalopram
Hydrochloride is usually reduced gradually over a couple of weeks.
If you have any further questions on the use of this product, ask your
doctor or pharmacist.

4

Possible side effects

Like all medicines, Citalopram Hydrochloride can have side effects and
some people may experience unwanted effects (side effects) whilst taking
Citalopram Hydrochloride. Several of the effects listed below can also be
symptoms of your illness and may disappear as you start to get better.
Serious side effects
Stop taking Citalopram Hydrochloride and seek medical advice immediately
if you have any
of the following symptoms:
* Difficulty in breathing.
* Swelling of the face, lips, tongue or throat that causes difficulty in
swallowing or breathing.
* Severe itching of the skin (with raised lumps).
* Fast, irregular heart beat, fainting which could be symptoms of a
life-threatening condition known as torsades de pointes.
If you notice any of the following you should contact your doctor immediately
as your dose may need to be reduced or stopped:
* You start having fits for the first time or fits that you have suffered from in
the past before become more frequent.
* Your behaviour changes because you feel elated or over excited.
* You experience high fever, agitation, confusion, and trembling or abrupt
contractions of muscles. These may be signs of a rare condition called
serotonin syndrome.
* Tiredness, confusion and twitching of your muscles. These may be signs of
a low blood level of sodium.
If you have thoughts of harming or killing yourself at any time, contact your
doctor or go to a hospital straight away.
The following side effects are often mild and usually disappear after a few
days’ treatment.
Very common side effects (likely to affect more than 1 in 10 people)

* Sleepiness
* Difficulty in sleeping
* Increased sweating
* Dry mouth (a dry mouth increases the risk of tooth decay, so be sure to
clean your teeth more often that usual)

* Feeling sick (nausea)
Common side effects (likely to affect up to 1 in 10 people)
* Lack of appetite
* Agitation
* Decreased sex drive
* Anxiety
* Nervousness
* Confusion
* Abnormal dreams
* Tremor
* Tingling or numbness in the hands or feet
* Ringing in the ears (tinnitus)
* Yawning
* Diarrhoea
* Vomiting
* Constipation
* Itching
* Pain in muscles and joints
* For men, problems with ejaculation and erection
* For females, failing to reach an orgasm
* Tiredness,
* Prickling of the skin
* Loss of weight

Uncommon (likely to affect up to 1 in every 100 people)
* Bruising easily
* Increased appetite
* Aggression
* Reduced emotions, indifference
* Hallucinations
* Mania
* Fainting
* Large pupils (the dark centre of the eye)
* Fast heart beat
* Slow heart beat
* Nettle rash
* Loss of hair
* Rash
* Sensitivity to sunlight
* Difficulties urinating
* Vaginal bleeding
* Swelling of the arms or legs
* Increased weight
Rare (likely to affect up to 1 in every 1000 people)
* Convulsions
* Involuntary movements
* Taste disturbances
* Bleeding
* Hepatitis
Some patient have reported (frequency not known)
* Thoughts of harming or killing themselves
* An increase in bleeding or bruising caused by a decrease in blood platelets
* Rash (hypersensitivity)
* Low potassium levels in the blood (hypokalaemia), which can cause
muscle weakness, twitching or abnormal heart rhythms
* Panic attack
* Grinding teeth
* Restlessness
* Unusual muscle movements or stiffness
* Involuntary movements of the muscles (akathisia)
* Low blood pressure
* Nosebleed
* Bleeding disorders including skin and mucosal bleeding (ecchymosis)
* Sudden swelling of skin or mucosa
* In men, painful erections
* Flow of breast milk in men or in women who are not breast-feeding
(galactorrhoea)
* Abnormal liver function tests
* An increased risk of bone fractures has been observed in patients taking
this type of medicines
SSRIs can, very rarely, increase the risk of bleeding, including stomach or
intestinal bleeding. Let your doctor know if you vomit blood or develop
black or blood stained stools.
Also let your doctor know if you continue to have other symptoms associated
with your depression. This might include hallucinations, anxiety, mania or
confusion.
Any side effects that do occur will usually disappear after a few days. If they
are troublesome or persistent, or if you develop any other unusual side
effects while taking Citalopram Hydrochloride, please tell your doctor.
If you notice any other side effects not mentioned in this leaflet please tell
your doctor or pharmacist.

5

How to store Citalopram Hydrochloride

Do not use this medicine after the expiry date shown on the carton label.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required.
These measures will help to protect the environment. Only keep this
medicine if your doctor tells you to. If your medicine becomes discoloured or
shows any signs of deterioration, consult your pharmacist (chemist) who will
tell you what to do.

* KEEP OUT OF THE SIGHT AND REACH OF CHILDREN
* Do not store above 25°C.
* Use within 16 weeks after first use.
6

Further information

What Citalopram Hydrochloride Drops contain
Each ml of solution contains 40mg of the active ingredient citalopram.
Citalopram Hydrochloride also contains the following inactive ingredients;
methyl-parahydroxybenzoate E218, propyl-parahydroxybenzoate E216,
ethyl alcohol 9% v/v, hydroxyethylcellulose, purified water.
What Citalopram Hydrochloride Drops look like and contents of the
pack
Citalopram Hydrochloride comes in a brown glass bottle containing 15ml
clear drops solution with screw cap and polyethylene dropper.
Manufacturer and Licence Holder
Citalopram Hydrochloride is manufactured by Montefarmaco SPA, Via G.
Galilei-7, 20016 Pero (MI) Italyand is procured from within the EU and
repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18,
Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.

POM

PL Number: 15184/1112

Leaflet revision date:

23/10/12

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.

Ref: 1112/231012/5/F

Seropram® Drops 40mg/ml
(citalopram hydrochloride)
Patient Information Leaflet
Read all of this leaflet carefully before you start taking this medicine
* Keep this leaflet. You may need to read it again.
* If you have further questions, please ask your doctor or pharmacist.
* This medicine has been prescribed for you. Do not pass it on to others. It
may harm them, even if their symptoms are the same as yours.
* If any of the side effects are troubling, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.
Your medicine is called Seropram Drops 40mg/ml, but will be referred to as
Seropram throughout this leaflet.
In this leaflet:
1 What Seropram is and what it is used for
2 Before you take Seropram
3 How to take Seropram
4 Possible side effects
5 How to store Seropram
6 Further information

1

What Seropram is and what it is used for

How does Seropram work?
Seropram is a Selective Serotonin Reuptake Inhibitor (SSRI) and belongs to
a group of medicines known as antidepressants.
These medicines help to correct certain chemical imbalances in the brain
that are causing the symptoms of your illness.
What is Seropram used for?
Seropram is used for the treatment of depression and, when you feel better,
to help prevent these symptoms recurring. Seropram is also used for
long-term treatment to prevent the occurrence of new episodes of
depression or if you have recurrent depression.
Seropram is also beneficial in relieving symptoms if you tend to suffer from
panic attacks.

2

Before you take Seropram

Do not take Seropram
* If you are allergic (hypersensitive) to citalopram, or any of the other
ingredients of Seropram (see What Seropram contain, section 6).
Consult your doctor if you think you might be.
* If you are also taking a medicine containing pimozide. Talk to your doctor.
* At the same time as taking medication known as monoamine oxidase
inhibitors (MAOIs). MAOIs include medicines such as phenelzine,
iproniazid, isocarboxazid, nialamide, tranylcypromine and moclobemide
(used for the treatment of depression), selegiline (used in the treatment of
Parkinson’s disease) and linezolid (an antibiotic). Even if you have finished
taking one of the following MAOIs: phenelzine, iproniazid, isocarboxazid,
nialamide or tranylcypromine you will need to wait 2 weeks before you
start taking Seropram. One day must elapse after you have finished taking
moclobemide. After stopping Seropram you must allow 1 week before
taking any MAOI.
* if you are born with or have had an episode of abnormal heart rhythm
(seen at ECG; an examination to evaluate how the heart is functioning).
* if you take medicines for heart rhythm problems or that may affect the
heart’s rhythm (see Taking other medicines, below).
Take special care with Seropram
Please tell your doctor if you have any medical problems, especially if you
have:
* Liver disease
* Kidney disease
* Diabetes (you may need an adjustment of your antidiabetic therapy)
* Epilepsy or a history of seizures or fits
* A bleeding disorder or have ever suffered from bleeding in the stomach or
intestine
* Mania or panic disorder
* Low blood levels of sodium
* ECT (electroconvulsive therapy)
* Problems with your eyes, such as certain kinds of glaucoma
* Suffered or suffer from heart problems or have recently had a heart attack.
* A low resting heart-rate and/or you know that you may have salt
depletion as a result of prolonged severe diarrhoea and vomiting
(being sick) or usage of diuretics (water tablets).
* Experienced a fast or irregular heartbeat, fainting, collapse or dizziness
on standing up which may indicate abnormal functioning of the heart
rate.
Please consult your doctor, even if these statements were applicable to you
at any time in the past.
Some patients with manic-depressive illness may enter into a manic phase.
This is characterized by unusual and rapidly changing ideas, inappropriate
happiness and excessive physical activity. If you experience this, contact
your doctor.
Symptoms such as restlessness or difficulty in sitting or standing still can
also occur during the first weeks of the treatment. Tell your doctor
immediately if you experience these symptoms.
Special information relating to your disease
As with other medicines used to treat depression or related diseases, the
improvement is not achieved immediately. After the start of Seropram
treatment it may take several weeks before you experience any
improvement. In the beginning of the treatment certain patients may
experience increased anxiety, which will disappear during continued
treatment. Therefore, it is very important that you follow exactly your doctor’s
orders and do not stop the treatment or change the dose without consulting
your doctor.
Thoughts of suicide and worsening of your depression or anxiety
disorder
If you are depressed and/or have anxiety disorders you can sometimes have
thoughts of harming or killing yourself. These may be increased when first
starting antidepressants, since these medicines all take time to work, usually
about two weeks but sometimes longer.
You may be more likely to think like this:
* If you have previously had thoughts about killing or harming yourself.
* If you are a young adult. Information from clinical trials has shown an
increased risk of suicidal behaviour in adults aged less than 25 years with
psychiatric conditions who were treated with an antidepressant.
If you have thoughts of harming or killing yourself at any time, contact your
doctor or go to a hospital straight away.
You may find it helpful to tell a relative or close friend that you are
depressed or have an anxiety disorder, and ask them to read this leaflet. You
might ask them to tell you if they think your depression or anxiety is getting
worse, or if they are worried about changes in your behaviour.
Use in children and adolescents under 18 years of age
Seropram should normally not be used for children and adolescents under
18 years. Also, you should know that patients under 18 have an increased
risk of side-effects such as suicide attempt, suicidal thoughts and hostility
(predominantly aggression, oppositional behaviour and anger) when they
take this class of medicines. Despite this, your doctor may prescribe
citalopram for patients under 18 because he/she decides that this is in their
best interests. If your doctor has prescribed Seropram for a patient under 18
and you want to discuss this, please go back to your doctor. You should
inform your doctor if any of the symptoms listed above develop or worsen
when patients under 18 are taking Seropram. Also, the long-term safety
effects concerning growth, maturation and cognitive and behavioural
development of Seropram in this age group have not yet been
demonstrated.

Taking other medicines
Medicines may affect the action of other medicines and this can sometimes
cause serious adverse reactions.
Please tell your doctor or pharmacist if you are taking or have taken any
other medicines (including those purchased without prescription) during the
last 14 days. This includes other medicines for depression (see Do not take
Seropram above).
* The herbal remedy St John's wort (Hypericum perforatum). This should
not be taken at the same time as Seropram.
* Monoamine oxidase inhibitors (MAOIs). These should not be taken at the
same time as Seropram (see Do not take Seropram above).
Tell your doctor if you are taking any of the following medicines:
* Linezolid (an antibiotic).
* Sumatriptan (used to treat migraine) or tramadol (a pain killer). If you
feel unwell when using these medicines with Seropram you should see
your doctor.
* Lithium (used to prevent and treat mania) and tryptophan (an
antidepressant)
* Pimozide (a neuroleptic). This should not be taken at the same time as
Seropram (see Do not take Seropram above).
* Imipramine and desipramine (used to treat depression).
* Medicines containing selegiline (used to treat Parkinson’s disease)
* Cimetidine (used to treat stomach ulcers).
* Mefloquine (used to treat malaria).
* Bupropion (used to treat depression).
* Medicines known to affect the blood platelets (e.g. anticoagulant drugs
used to treat or prevent blood clots; aspirin and non-steroidal
anti-inflammatory drugs (NSAIDs) such as ibuprofen and diclofenac used
as painkillers and some antipsychotic drugs and tricyclic antidepressants).
* Metoprolol, a beta blocker used to treat migraine, some heart conditions
and high blood pressure. The effects of either drug could be increased,
decreased or altered.
* Neuroleptics (used in the treatment of schizophrenia).
Do not take Seropram if you take medicines for heart rhythm problems or
medicines that may affect the heart’s rhythm, e.g. such as Class IA and
III antiarrhythmics, antipsychotics (e.g. fentiazine derivatives, pimozide,
haloperidol), tricyclic antidepressants, certain antimicrobial agents (e.g.
sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, anti-malarial
treatment particularly halofantrine), certain antihistamines (astemizole,
mizolastine). If you have any further questions about this you should speak
to your doctor.
Taking Seropram with food and drink
Seropram can be taken with or without food (see section 3 “How to take
Seropram”).
As with all antidepressants, it is sensible to avoid drinking alcohol whilst
receiving treatment although Seropram has not been shown to increase the
effects of alcohol.
Pregnancy
Ask your doctor or pharmacist for advice before taking any medicine. If
you are pregnant, think you might be pregnant, or are trying to become
pregnant, tell your doctor. Do not take Seropram if you are pregnant unless
you and your doctor have discussed the risks and benefits involved.
Make sure your midwife and/or doctor know you are on Seropram. When
taken during pregnancy, particularly in the last 3 months of pregnancy,
medicines like Seropram may increase the risk of a serious condition in
babies, called persistent pulmonary hypertension of the newborn (PPHN),
making the baby breathe faster and appear bluish. These symptoms
usually begin during the first 24 hours after the baby is born. If this happens
to your baby you should contact your midwife and/or doctor immediately.
Also, if you take Seropram during the last 3 months of your pregnancy and
until the date of birth you should be aware that the following effects may be
seen in your newborn: fits, being too hot or cold, feeding difficulties,
vomiting, low blood sugar, stiff or floppy muscles, overactive reflexes, tremor,
jitteriness, irritability, lethargy, constant crying, sleepiness or sleeping
difficulties. If your newborn baby gets any of these symptoms please contact
your midwife and/or doctor immediately.
Breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
If you are breast-feeding, ask your doctor for advice. You should not
breast-feed your baby when taking Seropram because small amounts of the
medicine can pass into the breast milk.
Fertility
Seropram has been shown to reduce the quality of sperm in animal studies.
Theoretically, this could affect fertility, but impact on human fertility has not
been observed as yet.
Driving and using machines
Seropram does not usually affect the ability to carry out normal daily
activities. However, if you feel dizzy or sleepy when you start to take this
medicine, you should be careful when driving, operating machinery or
performing jobs that need you to be alert until these effects wear off.
Important information about some of the ingredients of Seropram
This medicinal product contains small amounts of ethanol (alcohol), less
than 100 mg in all doses. These drops also contain the preservatives E216
and E218, which may cause allergic reactions (possibly delayed).

3

How to take Seropram

How much to take
It is important to take your drops as instructed by your doctor. The label will
tell you how many to take and how often. If it does not, or you are not sure,
ask your doctor or pharmacist.
Adults
Depression
The usual dose is 16 mg (8 drops) per day. This may be increased by your
doctor to a maximum of 32 mg (16 drops) per day.
Panic disorder
The starting dose is 8 mg (4 drops) per day for the first week before
increasing the dose to between 16 –24 mg (8 to 12 drops) per day. The dose
may be increased by your doctor to a maximum of 32 mg (16 drops) per day.
Elderly patients (above 65 years of age)
The starting dose should be decreased to half of the recommended dose,
e.g. 8-16 mg per day. Elderly patients should not usually receive more than
16 mg (8 drops) per day.
Children and adolescents (< 18 years)
Seropram should not be given to children or adolescents under 18 years of
age. For further information, please see section 2, Before you take
Seropram.
Patients with special risks
Patients with liver complaints should not receive more than 16 mg (8 drops)
per day.
If you have previously taken Seropram tablets, you will find that the dose of
your medicine in mg given as drops is a bit lower than that of tablets. This is
because your body more easily absorbs the drops than the tablets, so you
do not need as many mg to have the same effect.
The doses of tablets correspond to doses of drops as follows:
Tablets
10 mg
20 mg
30 mg
40 mg

Drops
8 mg (4 drops)
16 mg (8 drops)
24 mg (12 drops)
32 mg (16 drops)

Ref: 1112/231012/5/B

Seropram ® Drops 40mg/ml
(citalopram hydrochloride)
Patient Information Leaflet (continued)
How and when to take Seropram
The drops are for oral use and can be taken in a drink of water, or orange or
apple juice.
Seropram is taken every day as one dose at any time of the day.
Duration of treatment
Like other medicines for depression and panic disorder these drops may
take a few weeks before you feel any improvement. Continue to take
Seropram even if it takes some time before you feel any improvement in
your condition.
The duration of treatment is individual, usually at least 6 months. Continue
to take the drops for as long as your doctor recommends. Do not stop
taking them even if you begin to feel better, unless you are told to do so by
your doctor. The underlying illness may persist for a long time and if you
stop your treatment too soon your symptoms may return.
Patients who have recurrent depression benefit from continued treatment,
sometimes for several years, to prevent the occurrence of new depressive
episodes.
Never change the dose of the medicine without talking to your doctor first.
If you take more Seropram than you should
If you think that you or anyone else may have taken too many Seropram
drops, contact your doctor or nearest hospital emergency department
immediately. Do this even if there are no signs of discomfort or poisoning.
Take the Seropram box/container with you if you go to a doctor or hospital.
Some of the signs of an overdosage could be life-threatening.
Symptoms of overdosage may include:
* Irregular heart beat
* Seizures
* Changes in heart rhythm
* Feeling sick (nausea)
* Vomiting
* Sweating
* Drowsiness
* Unconsciousness
* Fast heart beats
* Tremor
* Changes in blood pressure
* Serotonin syndrome (see Section 4)
* Agitation
* Dizziness
* Enlarged eye pupils
* Bluish skin
* Breathing too quickly
If you forget to take Seropram
If you forget to take a dose, take the next dose at the usual time. Do not
take a double dose.
Effects when treatment with Seropram is stopped
Stopping this medicine quickly may cause symptoms such as dizziness,
nausea and numbness or tingling in hands or feet, sleep disturbances
(vivid dreams, nightmares, inability to sleep), feeling anxious, headaches,
feeling or being sick, sweating, feeling restless or agitated, tremor, feeling
confused or disorientated, feeling emotional or irritable, diarrhoea (loose
stools), visual disturbances, fluttering or pounding heartbeat (palpitations).
These are usually non-serious and disappear within a few days. When you
have completed your course of treatment, the dose of Seropram is usually
reduced gradually over a couple of weeks.
If you have any further questions on the use of this product, ask your
doctor or pharmacist.

4

Possible side effects

Like all medicines, Seropram can have side effects and some people may
experience unwanted effects (side effects) whilst taking Seropram. Several
of the effects listed below can also be symptoms of your illness and may
disappear as you start to get better.

* Fast heart beat
* Slow heart beat
* Nettle rash
* Loss of hair
* Rash
* Sensitivity to sunlight
* Difficulties urinating
* Vaginal bleeding
* Swelling of the arms or legs
* Increased weight
Rare (likely to affect up to 1 in every 1000 people)
* Convulsions
* Involuntary movements
* Taste disturbances
* Bleeding
* Hepatitis
Some patient have reported (frequency not known)
* Thoughts of harming or killing themselves
* An increase in bleeding or bruising caused by a decrease in blood platelets
* Rash (hypersensitivity)
* Low potassium levels in the blood (hypokalaemia), which can cause
muscle weakness, twitching or abnormal heart rhythms
* Panic attack
* Grinding teeth
* Restlessness
* Unusual muscle movements or stiffness
* Involuntary movements of the muscles (akathisia)
* Low blood pressure
* Nosebleed
* Bleeding disorders including skin and mucosal bleeding (ecchymosis)
* Sudden swelling of skin or mucosa
* In men, painful erections
* Flow of breast milk in men or in women who are not breast-feeding
(galactorrhoea)
* Abnormal liver function tests
* An increased risk of bone fractures has been observed in patients taking
this type of medicines
SSRIs can, very rarely, increase the risk of bleeding, including stomach or
intestinal bleeding. Let your doctor know if you vomit blood or develop
black or blood stained stools.
Also let your doctor know if you continue to have other symptoms associated
with your depression. This might include hallucinations, anxiety, mania or
confusion.
Any side effects that do occur will usually disappear after a few days. If they
are troublesome or persistent, or if you develop any other unusual side
effects while taking Seropram, please tell your doctor.
If you notice any other side effects not mentioned in this leaflet please tell
your doctor or pharmacist.

5

How to store Seropram

Do not use this medicine after the expiry date shown on the carton label.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required.
These measures will help to protect the environment. Only keep this
medicine if your doctor tells you to. If your medicine becomes discoloured or
shows any signs of deterioration, consult your pharmacist (chemist) who will
tell you what to do.

* KEEP OUT OF THE SIGHT AND REACH OF CHILDREN
* Do not store above 25°C.
* Use within 16 weeks after first use.

6

Further information

Serious side effects
Stop taking Seropram and seek medical advice immediately if you have any
of the following symptoms:
* Difficulty in breathing.
* Swelling of the face, lips, tongue or throat that causes difficulty in
swallowing or breathing.
* Severe itching of the skin (with raised lumps).
* Fast, irregular heart beat, fainting which could be symptoms of a
life-threatening condition known as torsades de pointes.

What Seropram Drops contain
Each ml of solution contains 40mg of the active ingredient citalopram.
Seropram also contains the following inactive ingredients;
methyl-parahydroxybenzoate E218, propyl-parahydroxybenzoate E216,
ethyl alcohol 9% v/v, hydroxyethylcellulose, purified water.

If you notice any of the following you should contact your doctor immediately
as your dose may need to be reduced or stopped:
* You start having fits for the first time or fits that you have suffered from in
the past before become more frequent.
* Your behaviour changes because you feel elated or over excited.
* You experience high fever, agitation, confusion, and trembling or abrupt
contractions of muscles. These may be signs of a rare condition called
serotonin syndrome.
* Tiredness, confusion and twitching of your muscles. These may be signs of
a low blood level of sodium.

Manufacturer and Licence Holder
Seropram is manufactured by H. Lundbeck A/S Ottiliavej 9, DK-2500 Valby
Denmark and is procured from within the EU and repackaged by the Product
Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road,
East Moons Moat, Redditch, Worcestershire, B98 0RE.

If you have thoughts of harming or killing yourself at any time, contact your
doctor or go to a hospital straight away.
The following side effects are often mild and usually disappear after a few
days’ treatment.
Very common side effects (likely to affect more than 1 in 10 people)
* Sleepiness
* Difficulty in sleeping
* Increased sweating
* Dry mouth (a dry mouth increases the risk of tooth decay, so be sure to
clean your teeth more often that usual)
* Feeling sick (nausea)
Common side effects (likely to affect up to 1 in 10 people)
* Lack of appetite
* Agitation
* Decreased sex drive
* Anxiety
* Nervousness
* Confusion
* Abnormal dreams
* Tremor
* Tingling or numbness in the hands or feet
* Ringing in the ears (tinnitus)
* Yawning
* Diarrhoea
* Vomiting
* Constipation
* Itching
* Pain in muscles and joints
* For men, problems with ejaculation and erection
* For females, failing to reach an orgasm
* Tiredness,
* Prickling of the skin
* Loss of weight
Uncommon (likely to affect up to 1 in every 100 people)
* Bruising easily
* Increased appetite
* Aggression
* Reduced emotions, indifference
* Hallucinations
* Mania
* Fainting
* Large pupils (the dark centre of the eye)

What Seropram Drops look like and contents of the pack
Seropram comes in a brown glass bottle containing 15ml clear drops
solution with screw cap and polyethylene dropper.

POM

PL Number: 15184/1112

Seropram is a registered trademark of H.Lundbeck A/S.
Leaflet revision date:

23/10/12

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.

Ref: 1112/231012/6/F

Seropram® Drops 40mg/ml
(citalopram hydrochloride)
Patient Information Leaflet
Read all of this leaflet carefully before you start taking this medicine
* Keep this leaflet. You may need to read it again.
* If you have further questions, please ask your doctor or pharmacist.
* This medicine has been prescribed for you. Do not pass it on to others. It
may harm them, even if their symptoms are the same as yours.
* If any of the side effects are troubling, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.
Your medicine is called Seropram Drops 40mg/ml, but will be referred to as
Seropram throughout this leaflet.
In this leaflet:
1 What Seropram is and what it is used for
2 Before you take Seropram
3 How to take Seropram
4 Possible side effects
5 How to store Seropram
6 Further information

1

What Seropram is and what it is used for

How does Seropram work?
Seropram is a Selective Serotonin Reuptake Inhibitor (SSRI) and belongs to
a group of medicines known as antidepressants.
These medicines help to correct certain chemical imbalances in the brain
that are causing the symptoms of your illness.
What is Seropram used for?
Seropram is used for the treatment of depression and, when you feel better,
to help prevent these symptoms recurring. Seropram is also used for
long-term treatment to prevent the occurrence of new episodes of
depression or if you have recurrent depression.
Seropram is also beneficial in relieving symptoms if you tend to suffer from
panic attacks.

2

Before you take Seropram

Do not take Seropram
* If you are allergic (hypersensitive) to citalopram, or any of the other
ingredients of Seropram (see What Seropram contain, section 6).
Consult your doctor if you think you might be.
* If you are also taking a medicine containing pimozide. Talk to your doctor.
* At the same time as taking medication known as monoamine oxidase
inhibitors (MAOIs). MAOIs include medicines such as phenelzine,
iproniazid, isocarboxazid, nialamide, tranylcypromine and moclobemide
(used for the treatment of depression), selegiline (used in the treatment of
Parkinson’s disease) and linezolid (an antibiotic). Even if you have finished
taking one of the following MAOIs: phenelzine, iproniazid, isocarboxazid,
nialamide or tranylcypromine you will need to wait 2 weeks before you
start taking Seropram. One day must elapse after you have finished taking
moclobemide. After stopping Seropram you must allow 1 week before
taking any MAOI.
* if you are born with or have had an episode of abnormal heart rhythm
(seen at ECG; an examination to evaluate how the heart is functioning).
* if you take medicines for heart rhythm problems or that may affect the
heart’s rhythm (see Taking other medicines, below).
Take special care with Seropram
Please tell your doctor if you have any medical problems, especially if you
have:
* Liver disease
* Kidney disease
* Diabetes (you may need an adjustment of your antidiabetic therapy)
* Epilepsy or a history of seizures or fits
* A bleeding disorder or have ever suffered from bleeding in the stomach or
intestine
* Mania or panic disorder
* Low blood levels of sodium
* ECT (electroconvulsive therapy)
* Problems with your eyes, such as certain kinds of glaucoma
* Suffered or suffer from heart problems or have recently had a heart attack.
* A low resting heart-rate and/or you know that you may have salt
depletion as a result of prolonged severe diarrhoea and vomiting
(being sick) or usage of diuretics (water tablets).
* Experienced a fast or irregular heartbeat, fainting, collapse or dizziness
on standing up which may indicate abnormal functioning of the heart
rate.
Please consult your doctor, even if these statements were applicable to you
at any time in the past.
Some patients with manic-depressive illness may enter into a manic phase.
This is characterized by unusual and rapidly changing ideas, inappropriate
happiness and excessive physical activity. If you experience this, contact
your doctor.
Symptoms such as restlessness or difficulty in sitting or standing still can
also occur during the first weeks of the treatment. Tell your doctor
immediately if you experience these symptoms.
Special information relating to your disease
As with other medicines used to treat depression or related diseases, the
improvement is not achieved immediately. After the start of Seropram
treatment it may take several weeks before you experience any
improvement. In the beginning of the treatment certain patients may
experience increased anxiety, which will disappear during continued
treatment. Therefore, it is very important that you follow exactly your doctor’s
orders and do not stop the treatment or change the dose without consulting
your doctor.
Thoughts of suicide and worsening of your depression or anxiety
disorder
If you are depressed and/or have anxiety disorders you can sometimes have
thoughts of harming or killing yourself. These may be increased when first
starting antidepressants, since these medicines all take time to work, usually
about two weeks but sometimes longer.
You may be more likely to think like this:
* If you have previously had thoughts about killing or harming yourself.
* If you are a young adult. Information from clinical trials has shown an
increased risk of suicidal behaviour in adults aged less than 25 years with
psychiatric conditions who were treated with an antidepressant.
If you have thoughts of harming or killing yourself at any time, contact your
doctor or go to a hospital straight away.
You may find it helpful to tell a relative or close friend that you are
depressed or have an anxiety disorder, and ask them to read this leaflet. You
might ask them to tell you if they think your depression or anxiety is getting
worse, or if they are worried about changes in your behaviour.
Use in children and adolescents under 18 years of age
Seropram should normally not be used for children and adolescents under
18 years. Also, you should know that patients under 18 have an increased
risk of side-effects such as suicide attempt, suicidal thoughts and hostility
(predominantly aggression, oppositional behaviour and anger) when they
take this class of medicines. Despite this, your doctor may prescribe
citalopram for patients under 18 because he/she decides that this is in their
best interests. If your doctor has prescribed Seropram for a patient under 18
and you want to discuss this, please go back to your doctor. You should
inform your doctor if any of the symptoms listed above develop or worsen
when patients under 18 are taking Seropram. Also, the long-term safety
effects concerning growth, maturation and cognitive and behavioural
development of Seropram in this age group have not yet been
demonstrated.

Taking other medicines
Medicines may affect the action of other medicines and this can sometimes
cause serious adverse reactions.
Please tell your doctor to pharmacist if you are taking or have taken any
other medicines (including those purchased without prescription) during the
last 14 days. This includes other medicines for depression (see Do not take
Seropram above).
* The herbal remedy St John's wort (Hypericum perforatum). This should
not be taken at the same time as Seropram.
* Monoamine oxidase inhibitors (MAOIs). These should not be taken at the
same time as Seropram (see Do not take Seropram above).
Tell your doctor if you are taking any of the following medicines:
* Linezolid (an antibiotic).
* Sumatriptan (used to treat migraine) or tramadol (a pain killer). If you
feel unwell when using these medicines with Seropram you should see
your doctor.
* Lithium (used to prevent and treat mania) and tryptophan (an
antidepressant)
* Pimozide (a neuroleptic). This should not be taken at the same time as
Seropram (see Do not take Seropram above).
* Imipramine and desipramine (used to treat depression).
* Medicines containing selegiline (used to treat Parkinson’s disease)
* Cimetidine (used to treat stomach ulcers).
* Mefloquine (used to treat malaria).
* Bupropion (used to treat depression).
* Medicines known to affect the blood platelets (e.g. anticoagulant drugs
used to treat or prevent blood clots; aspirin and non-steroidal
anti-inflammatory drugs (NSAIDs) such as ibuprofen and diclofenac used
as painkillers and some antipsychotic drugs and tricyclic antidepressants).
* Metoprolol, a beta blocker used to treat migraine, some heart conditions
and high blood pressure. The effects of either drug could be increased,
decreased or altered.
* Neuroleptics (used in the treatment of schizophrenia).
Do not take Seropram if you take medicines for heart rhythm problems or
medicines that may affect the heart’s rhythm, e.g. such as Class IA and
III antiarrhythmics, antipsychotics (e.g. fentiazine derivatives, pimozide,
haloperidol), tricyclic antidepressants, certain antimicrobial agents (e.g.
sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, anti-malarial
treatment particularly halofantrine), certain antihistamines (astemizole,
mizolastine). If you have any further questions about this you should speak
to your doctor.
Taking Seropram with food and drink
Seropram can be taken with or without food (see section 3 “How to take
Seropram”).
As with all antidepressants, it is sensible to avoid drinking alcohol whilst
receiving treatment although Seropram has not been shown to increase the
effects of alcohol.
Pregnancy
Ask your doctor or pharmacist for advice before taking any medicine. If
you are pregnant, think you might be pregnant, or are trying to become
pregnant, tell your doctor. Do not take Seropram if you are pregnant unless
you and your doctor have discussed the risks and benefits involved.
Make sure your midwife and/or doctor know you are on Seropram. When
taken during pregnancy, particularly in the last 3 months of pregnancy,
medicines like Seropram may increase the risk of a serious condition in
babies, called persistent pulmonary hypertension of the newborn (PPHN),
making the baby breathe faster and appear bluish. These symptoms
usually begin during the first 24 hours after the baby is born. If this happens
to your baby you should contact your midwife and/or doctor immediately.
Also, if you take Seropram during the last 3 months of your pregnancy and
until the date of birth you should be aware that the following effects may be
seen in your newborn: fits, being too hot or cold, feeding difficulties,
vomiting, low blood sugar, stiff or floppy muscles, overactive reflexes, tremor,
jitteriness, irritability, lethargy, constant crying, sleepiness or sleeping
difficulties. If your newborn baby gets any of these symptoms please contact
your midwife and/or doctor immediately.
Breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
If you are breast-feeding, ask your doctor for advice. You should not
breast-feed your baby when taking Seropram because small amounts of the
medicine can pass into the breast milk.
Fertility
Seropram has been shown to reduce the quality of sperm in animal studies.
Theoretically, this could affect fertility, but impact on human fertility has not
been observed as yet.
Driving and using machines
Seropram does not usually affect the ability to carry out normal daily
activities. However, if you feel dizzy or sleepy when you start to take this
medicine, you should be careful when driving, operating machinery or
performing jobs that need you to be alert until these effects wear off.
Important information about some of the ingredients of Seropram
This medicinal product contains small amounts of ethanol (alcohol), less
than 100 mg in all doses. These drops also contain the preservatives E216
and E218, which may cause allergic reactions (possibly delayed).

3

How to take Seropram

How much to take
It is important to take your drops as instructed by your doctor. The label will
tell you how many to take and how often. If it does not, or you are not sure,
ask your doctor or pharmacist.
Adults
Depression
The usual dose is 16 mg (8 drops) per day. This may be increased by your
doctor to a maximum of 32 mg (16 drops) per day.
Panic disorder
The starting dose is 8 mg (4 drops) per day for the first week before
increasing the dose to between 16 –24 mg (8 to 12 drops) per day. The dose
may be increased by your doctor to a maximum of 32 mg (16 drops) per day.
Elderly patients (above 65 years of age)
The starting dose should be decreased to half of the recommended dose,
e.g. 8-16 mg per day. Elderly patients should not usually receive more than
16 mg (8 drops) per day.
Children and adolescents (< 18 years)
Seropram should not normally by used by children or adolescents under 18
years of age. For further information, please see section 2, Before you take
Seropram.
Patients with special risks
Patients with liver complaints should not receive more than 16 mg (8 drops)
per day.
If you have previously taken Seropram tablets, you will find that the dose of
your medicine in mg given as drops is a bit lower than that of tablets. This is
because your body more easily absorbs the drops than the tablets, so you
do not need as many mg to have the same effect.
The doses of tablets correspond to doses of drops as follows:
Tablets
10 mg
20 mg
30 mg
40 mg

Drops
8 mg (4 drops)
16 mg (8 drops)
24 mg (12 drops)
32 mg (16 drops)

Ref: 1112/231012/6/B

Seropram® Drops 40mg/ml
(citalopram hydrochloride)
Patient Information Leaflet (continued)
How and when to take Seropram
The drops are for oral use and can be taken in a drink of water, or orange or
apple juice.
Seropram is taken every day as one dose at any time of the day.
Duration of treatment
Like other medicines for depression and panic disorder these drops may
take a few weeks before you feel any improvement. Continue to take
Seropram even if it takes some time before you feel any improvement in
your condition.
The duration of treatment is individual, usually at least 6 months. Continue
to take the drops for as long as your doctor recommends. Do not stop
taking them even if you begin to feel better, unless you are told to do so by
your doctor. The underlying illness may persist for a long time and if you
stop your treatment too soon your symptoms may return.
Patients who have recurrent depression benefit from continued treatment,
sometimes for several years, to prevent the occurrence of new depressive
episodes.
Never change the dose of the medicine without talking to your doctor first.
If you take more Seropram than you should
If you think that you or anyone else may have taken too many Seropram
drops, contact your doctor or nearest hospital emergency department
immediately. Do this even if there are no signs of discomfort or poisoning.
Take the Seropram box/container with you if you go to a doctor or hospital.
Some of the signs of an overdosage could be life-threatening.
Symptoms of overdosage may include:
* Irregular heart beat
* Seizures
* Changes in heart rhythm
* Feeling sick (nausea)
* Vomiting
* Sweating
* Drowsiness
* Unconsciousness
* Fast heart beats
* Tremor
* Changes in blood pressure
* Serotonin syndrome (see Section 4)
* Agitation
* Dizziness
* Enlarged eye pupils
* Bluish skin
* Breathing too quickly
If you forget to take Seropram
If you forget to take a dose, take the next dose at the usual time. Do not
take a double dose.
Effects when treatment with Seropram is stopped
Stopping this medicine quickly may cause symptoms such as dizziness,
nausea and numbness or tingling in hands or feet, sleep disturbances
(vivid dreams, nightmares, inability to sleep), feeling anxious, headaches,
feeling or being sick, sweating, feeling restless or agitated, tremor, feeling
confused or disorientated, feeling emotional or irritable, diarrhoea (loose
stools), visual disturbances, fluttering or pounding heartbeat (palpitations).
These are usually non-serious and disappear within a few days. When you
have completed your course of treatment, the dose of Seropram is usually
reduced gradually over a couple of weeks.
If you have any further questions on the use of this product, ask your
doctor or pharmacist.

4

Possible side effects

Like all medicines, Seropram can have side effects and some people may
experience unwanted effects (side effects) whilst taking Seropram. Several
of the effects listed below can also be symptoms of your illness and may
disappear as you start to get better.

* Fast heart beat
* Slow heart beat
* Nettle rash
* Loss of hair
* Rash
* Sensitivity to sunlight
* Difficulties urinating
* Vaginal bleeding
* Swelling of the arms or legs
* Increased weight
Rare (likely to affect up to 1 in every 1000 people)
* Convulsions
* Involuntary movements
* Taste disturbances
* Bleeding
* Hepatitis
Some patient have reported (frequency not known)
* Thoughts of harming or killing themselves
* An increase in bleeding or bruising caused by a decrease in blood platelets
* Rash (hypersensitivity)
* Low potassium levels in the blood (hypokalaemia), which can cause
muscle weakness, twitching or abnormal heart rhythms
* Panic attack
* Grinding teeth
* Restlessness
* Unusual muscle movements or stiffness
* Involuntary movements of the muscles (akathisia)
* Low blood pressure
* Nosebleed
* Bleeding disorders including skin and mucosal bleeding (ecchymosis)
* Sudden swelling of skin or mucosa
* In men, painful erections
* Flow of breast milk in men or in women who are not breast-feeding
(galactorrhoea)
* Abnormal liver function tests
* An increased risk of bone fractures has been observed in patients taking
this type of medicines
SSRIs can, very rarely, increase the risk of bleeding, including stomach or
intestinal bleeding. Let your doctor know if you vomit blood or develop
black or blood stained stools.
Also let your doctor know if you continue to have other symptoms associated
with your depression. This might include hallucinations, anxiety, mania or
confusion.
Any side effects that do occur will usually disappear after a few days. If they
are troublesome or persistent, or if you develop any other unusual side
effects while taking Seropram, please tell your doctor.
If you notice any other side effects not mentioned in this leaflet please tell
your doctor or pharmacist.

5

How to store Seropram

Do not use this medicine after the expiry date shown on the carton label.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required.
These measures will help to protect the environment. Only keep this
medicine if your doctor tells you to. If your medicine becomes discoloured or
shows any signs of deterioration, consult your pharmacist (chemist) who will
tell you what to do.

* KEEP OUT OF THE SIGHT AND REACH OF CHILDREN
* Do not store above 25°C.
* Use within 16 weeks after first use.

6

Further information

Serious side effects
Stop taking Seropram and seek medical advice immediately if you have any
of the following symptoms:
* Difficulty in breathing.
* Swelling of the face, lips, tongue or throat that causes difficulty in
swallowing or breathing.
* Severe itching of the skin (with raised lumps).
* Fast, irregular heart beat, fainting which could be symptoms of a
life-threatening condition known as torsades de pointes.

What Seropram Drops contain
Each ml of solution contains 40mg of the active ingredient citalopram.
Seropram also contains the following inactive ingredients;
methyl-parahydroxybenzoate E218, propyl-parahydroxybenzoate E216,
ethyl alcohol 9% v/v, hydroxyethylcellulose, purified water.

If you notice any of the following you should contact your doctor immediately
as your dose may need to be reduced or stopped:
* You start having fits for the first time or fits that you have suffered from in
the past before become more frequent.
* Your behaviour changes because you feel elated or over excited.
* You experience high fever, agitation, confusion, and trembling or abrupt
contractions of muscles. These may be signs of a rare condition called
serotonin syndrome.
* Tiredness, confusion and twitching of your muscles. These may be signs of
a low blood level of sodium.

Manufacturer and Licence Holder
Seropram is manufactured by Montefarmaco SPA, Via G. Galilei-7, 20016
Pero (MI) Italy and is procured from within the EU and repackaged by the
Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road,
East Moons Moat, Redditch, Worcestershire, B98 0RE.

If you have thoughts of harming or killing yourself at any time, contact your
doctor or go to a hospital straight away.
The following side effects are often mild and usually disappear after a few
days’ treatment.
Very common side effects (likely to affect more than 1 in 10 people)
* Sleepiness
* Difficulty in sleeping
* Increased sweating
* Dry mouth (a dry mouth increases the risk of tooth decay, so be sure to
clean your teeth more often that usual)
* Feeling sick (nausea)
Common side effects (likely to affect up to 1 in 10 people)
* Lack of appetite
* Agitation
* Decreased sex drive
* Anxiety
* Nervousness
* Confusion
* Abnormal dreams
* Tremor
* Tingling or numbness in the hands or feet
* Ringing in the ears (tinnitus)
* Yawning
* Diarrhoea
* Vomiting
* Constipation
* Itching
* Pain in muscles and joints
* For men, problems with ejaculation and erection
* For females, failing to reach an orgasm
* Tiredness,
* Prickling of the skin
* Loss of weight
Uncommon (likely to affect up to 1 in every 100 people)
* Bruising easily
* Increased appetite
* Aggression
* Reduced emotions, indifference
* Hallucinations
* Mania
* Fainting
* Large pupils (the dark centre of the eye)

What Seropram Drops look like and contents of the pack
Seropram comes in a brown glass bottle containing 15ml clear drops
solution with screw cap and polyethylene dropper.

POM

PL Number: 15184/1112

Seropram is a registered trademark of H.Lundbeck A/S.
Leaflet revision date:

23/10/12

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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