CIPRAMIL 40MG/ML ORAL DROPS SOLUTION

Active substance: CITALOPRAM HYDROCHLORIDE

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MOCK UP PIL
PACKAGE LEAFLET: INFORMATION FOR THE USER

Cipramil

®

40 mg/ml oral drops, solution
citalopram (as hydrochloride)
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.
The name of your medicine is Cipramil® 40 mg/ml Oral drops,
but it will be referred to as Cipramil in 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 contains citalopram and 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 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 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 nonsteroidal 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
Citalopram 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 16-24 mg (8-12 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
Drops
10 mg
8 mg (4 drops)
20 mg
16 mg (8 drops)
30 mg
24 mg (12 drops)
40 mg
32 mg (16 drops)
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.
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 heart beat, fainting which could be symptoms of a lifethreatening 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 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

• Always keep medicines out of sight and reach of children.
• After opening do not store above 250 C and use within 16 weeks.
• There is an expiry date on the label. Do not use the medicine after
this date.
If your medicine gets discoloured or shows any other signs of
deterioration, seek the advice of your pharmacist.
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.

6. FURTHER INFORMATION
What Cipramil contain
The active substance in Cipramil is citalopram (as hydrochloride).
Each ml of drops contains 40 mg citalopram. The other ingredients are
purified water, ethanol, hydroxyethylcellulose, methyl
parahydroxybenzoate E218 and propyl parahydroxybenzoate E216.
What Cipramil look like and contents of the pack
Cipramil drops are brown glass bottle containing 15 ml colourless solution
with screw cap and polyethylene dropper. One bottle per carton.
Manufactured by: RECORDATI Industria Chimica & Farmaceutica SpA,
Officina di Milano, via Civitali 1, Milan, Italy. Or
H. Lundbeck A/S-Copenhagen Valby, Denmark.
Procured from within the EU & repackaged by Product Licence
holder: Kosei Pharma (UK) Ltd., 897 Plymouth Road, Slough Trading
Estate, SL1 4LP
POM
Cipramil® 40 mg/ml Oral Drops, PL: 39352/0048
®
Cipramil is a registered trademark of H. Lundbeck A/S.
Leaflet date: 27.09.2012

PACKAGE LEAFLET: INFORMATION FOR THE USER

Citalopram
40 mg/ml oral drops, solution
citalopram (as hydrochloride)
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.
The name of your medicine is Citalopram® 40 mg/ml Oral drops,
but it will be referred to as Citalopram in this leaflet.
In this leaflet:
1. What Citalopram is and what it is used for
2. Before you take Citalopram
3. How to take Citalopram
4. Possible side effects
5. How to store Citalopram
6. Further information

1. WHAT CITALOPRAM IS AND WHAT IT IS USED FOR
How does Citalopram work?
Citalopram 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 used for?
Citalopram contains citalopram and is used for the treatment of
depression and, when you feel better, to help prevent these symptoms
recurring.
Citalopram is also used for long-term treatment to prevent the occurrence
of new episodes of depression or if you have recurrent depression.
Citalopram is also beneficial in relieving symptoms if you tend to suffer
from panic attacks.

2. BEFORE YOU TAKE CITALOPRAM
Do not take Citalopram
• If you are allergic (hypersensitive) to citalopram or any of the other
ingredients of Citalopram (see What Citalopram 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. One
day must elapse after you have finished taking moclobemide. After
stopping Citalopram 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 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 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
Citalopram 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
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.
Also, the long-term safety effects concerning growth, maturation and
cognitive and behavioural development of Citalopram 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 Citalopram above).
• The herbal remedy St John's wort (Hypericum perforatum). This
should not be taken at the same time as Citalopram.
• Monoamine oxidase inhibitors (MAOIs). These should not be taken
at the same time as Citalopram (see Do not take Citalopram
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 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 (see Do not take Citalopram 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 nonsteroidal 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 Citalopram with food and drink
Citalopram can be taken with or without food (see section 3 “How to take
Citalopram”).
As with all antidepressants, it is sensible to avoid drinking alcohol whilst
receiving treatment although Citalopram 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 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.
When taken during pregnancy, particularly in the last 3 months of
pregnancy, medicines like Citalopram 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 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 because small amounts of
the medicine can pass into the breast milk.
Fertility
Citalopram 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 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
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 CITALOPRAM
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 16-24 mg (8-12 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 Citalopram 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
Drops
10 mg
8 mg (4 drops)
20 mg
16 mg (8 drops)
30 mg
24 mg (12 drops)
40 mg
32 mg (16 drops)
How and when to take Citalopram
The drops are for oral use and can be taken in a drink of water, or orange
or apple juice.
Citalopram 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 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 than you should
If you think that you or anyone else may have taken too many Citalopram
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 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
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 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 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 can have side effects and some people
may experience unwanted effects (side effects) whilst taking Citalopram.
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 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 lifethreatening 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, 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

• Always keep medicines out of sight and reach of children.
• After opening do not store above 250 C and use within 16 weeks.
• There is an expiry date on the label. Do not use the medicine after
this date.
If your medicine gets discoloured or shows any other signs of
deterioration, seek the advice of your pharmacist.
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.

6. FURTHER INFORMATION
What Citalopram contain
The active substance in Citalopram is citalopram (as hydrochloride).
Each ml of drops contains 40 mg citalopram. The other ingredients are
purified water, ethanol, hydroxyethylcellulose, methyl
parahydroxybenzoate E218 and propyl parahydroxybenzoate E216.
What Citalopram look like and contents of the pack
Cipramil drops are brown glass bottle containing 15 ml colourless solution
with screw cap and polyethylene dropper. One bottle per carton.
Manufactured by: RECORDATI Industria Chimica & Farmaceutica SpA,
Officina di Milano, via Civitali 1, Milan, Italy. Or
H. Lundbeck A/S-Copenhagen Valby, Denmark.
Procured from within the EU & repackaged by Product Licence
holder: Kosei Pharma (UK) Ltd., 897 Plymouth Road, Slough Trading
Estate, SL1 4LP
POM
Citalopram 40 mg/ml Oral Drops, PL: 39352/0048
Leaflet date: 27.09.2012

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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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