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CITALOPRAM 40MG/ML ORAL DROPS

Active substance(s): CITALOPRAM / CITALOPRAM HYDROCHLORIDE

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Package leaflet: information for the user
®

Cipramil 40mg/ml Oral Drops
(citalopram hydrochloride)
Read all of this leaflet carefully before you start taking this medicine because it
contains important information for you.
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 only. Do not pass it on to others. It may harm
them, even if their signs of illness are the same as yours.
If you get any side effects talk to your doctor or pharmacist. This includes any possible
side effects not listed in this leaflet. See section 4.
The name of your medicine is Cipramil 40mg/ml Oral Drops but will be referred to as Cipramil or
Cipramil Drops throughout this leaflet.
What is in this leaflet:
1. What Cipramil is and what it is used for
2. What you need to know before you take Cipramil Drops
3. How to take Cipramil Drops
4. Possible side effects
5. How to store Cipramil Drops
6. Contents of the pack and other 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. What you need to know before you take Cipramil Drops

Other medicines and Cipramil Drops
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, have taken or might take any other
medicines. This includes other medicines for depression (see ‘Do not take Cipramil Drops’).
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’).
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 anti-depressant).
Pimozide (a neuroleptic). This should not be taken at the same time as Cipramil.
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 anti-psychotic 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, anti-psychotics
(e.g. phenothiazine 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, drink and alcohol
Cipramil can be taken with or without food (see section 3 ‘How to take Cipramil Drops’).
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.

Do not take Cipramil Drops
If you are allergic to citalopram, or any of the other ingredients of this medicine (listed in
section 6). Consult your doctor if you think you might be.
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
‘Other medicines and Cipramil Drops’).

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.

Warnings and Precautions
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 heart beat, fainting, collapse or dizziness on standing up
which may indicate abnormal functioning of the heart rate.

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.

Please consult your doctor, even if these statements were applicable to you at any time in the past.

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.

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 100mg in all doses.
These drops also contain the preservatives E216 and E218, which may cause allergic reactions
(possibly delayed).

3. How to take Cipramil Drops

Please note:
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.

How much to take
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your
doctor or pharmacist if you are not sure.

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.

Depression
The usual dose is 16mg (8 drops) per day. This may be increased by your doctor to a maximum of
32mg (16 drops) per day.

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.

Adults

Panic disorder
The starting dose is 8mg (4 drops) per day for the first week before increasing the dose to between
16-24mg (8 to 12 drops) per day. The dose may be increased by your doctor to a maximum of
32mg (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. 8-16mg per day.
Elderly patients should not usually receive more than 16mg (8 drops) per day.
Children and adolescents (less than 18 years of age)
Cipramil should not be given to children or adolescents under 18 years of age. For further
information, please see section 2, ‘What you need to know before you take Cipramil Drops.’
Patients with special risks
Patients with liver complaints should not receive more than 16mg (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
10mg
20mg
30mg
40mg

Drops
8mg (4 drops)
16mg (8 drops)
24mg (12 drops)
32mg (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, (loose stools), visual disturbances,
fluttering or pounding heart beat (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 this medicine can cause side effects, although not everybody gets them. 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 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 (hyponatraemia).
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 (may affect more than 1 in 10 people)
Sleepiness
Difficulty in sleeping
Headache
Changes in your sleeping pattern
Loss of body strength, weakness
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 (may affect up to 1 in 10 people)
Lack of appetite
Agitation
Decreased sex drive
Anxiety
Nervousness
Confusion
Abnormal dreams
Reduced emotions, indifference (apathy)
Tremor
Tingling or numbness in the hands or feet
Dizziness
Problems concentrating
Migraine
Loss of memory (amnesia)
Ringing in the ears (tinnitus)
Palpitations
Yawning
Blocked or runny nose (rhinitis)
Diarrhoea
Vomiting
Constipation
Stomach pain
Flatulence (wind)
Increase in saliva (drooling)
Itching
Pain in muscles and joints
For men, problems with ejaculation and erection
For women, failing to reach an orgasm
Tiredness
Prickling of the skin
Loss of weight

Uncommon (may affect up to 1 in 100 people)
Bruising easily
Increased appetite
Aggression
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
Excessive menstrual bleeding
Swelling of the arms or legs
Increased weight
Rare (may affect up to 1 in 1000 people)
Increased sex drive
Convulsions
Involuntary movements
Taste disturbances
Bleeding
Coughing
Hepatitis
Feeling unwell (malaise)
Some patients have reported (frequency not known)
Thoughts of harming or killing themselves, see also section 2. ‘What you need to know
before you take Cipramil Drops’
An increase in bleeding or bruising caused by a decrease in blood platelets
(thrombocytopenia)
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)
Irregular menstrual periods
Abnormal liver function tests
An increased risk of bone fractures has been observed in patients taking this type of
medicines
Abnormal heart rhythm
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.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. You can also report side effects directly via the Yellow Card
Scheme at: www.mhra.gov.uk/yellowcard.
Alternatively you can call Free phone 0808 100 3352 (available between 10am-2pm Monday –
Friday) or fill in a paper form available from your local pharmacy.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Cipramil Drops
Always keep medicines out of the sight and reach of children.
Do not store above 25ºC.
After breaking the seal for the first time, the drops can be used for 16 weeks.
There is an expiry date on the label. Do not use the medicine after this date.
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.
If your solution becomes discoloured or show any signs of deterioration, you should seek the
advice of your pharmacist.

6. Contents of the pack and other information
What Cipramil Drops contain
Each ml of drops contains 40mg of citalopram (as hydrochloride). The other ingredients are
purified water, ethanol, hydroxyethyl cellulose 300, methyl parahydroxybenzoate (E218) and propyl
parahydroxybenzoate (E216).
What Cipramil Drops look like and contents of the pack
Cipramil is clear, colourless oral solution supplied in amber glass bottle. Each bottle contains 15ml
Cipramil oral drops.
Manufactured by: H. Lundbeck A/S, – Copenhagen Valby, (Denmark).
Procured from within the EU and repackaged by the Product Licence holder:
B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.
Cipramil® 40mg/ml Oral Drops;

PL 18799/2020

Leaflet date: 11.04.2016
Cipramil is a registered trademark of H. Lundbeck A/S.

POM

Package leaflet: information for the user
Citalopram 40mg/ml Oral Drops
(citalopram hydrochloride)
Read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.
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 only. Do not pass it on to others. It may harm
them, even if their signs of illness are the same as yours.
If you get any side effects talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
The name of your medicine is Citalopram 40mg/ml Oral Drops but will be referred to as Citalopram
or Citalopram Drops throughout this leaflet.
What is in this leaflet:
1. What Citalopram is and what it is used for
2. What you need to know before you take Citalopram Drops
3. How to take Citalopram Drops
4. Possible side effects
5. How to store Citalopram Drops
6. Contents of the pack and other 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. What you need to know before you take Citalopram Drops
Do not take Citalopram Drops
If you are allergic to citalopram, or any of the other ingredients of this medicine (listed in
section 6). Consult your doctor if you think you might be.
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
‘Other medicines and Citalopram Drops’).
Warnings and Precautions
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 heart beat, 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.
Please note:
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.

Other medicines and Citalopram Drops
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, have taken or might take any other
medicines. This includes other medicines for depression (see ‘Do not take Citalopram Drops’).
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 Drops’).
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 anti-depressant).
Pimozide (a neuroleptic). This should not be taken at the same time as Citalopram.
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 anti-psychotic 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 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, anti-psychotics
(e.g. phenothiazine 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, drink and alcohol
Citalopram can be taken with or without food (see section 3 ‘How to take Citalopram Drops’).
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 100mg in all doses.
These drops also contain the preservatives E216 and E218, which may cause allergic reactions
(possibly delayed).

3. How to take Citalopram Drops
How much to take
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your
doctor or pharmacist if you are not sure.
Adults
Depression
The usual dose is 16mg (8 drops) per day. This may be increased by your doctor to a maximum of
32mg (16 drops) per day.
Panic disorder
The starting dose is 8mg (4 drops) per day for the first week before increasing the dose to between
16-24mg (8 to 12 drops) per day. The dose may be increased by your doctor to a maximum of
32mg (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. 8-16mg per day.
Elderly patients should not usually receive more than 16mg (8 drops) per day.
Children and adolescents (less than 18 years of age)
Citalopram should not be given to children or adolescents under 18 years of age. For further
information, please see section 2, ‘What you need to know before you take Citalopram Drops.’
Patients with special risks
Patients with liver complaints should not receive more than 16mg (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
10mg
8mg (4 drops)
20mg
16mg (8 drops)
30mg
24mg (12 drops)
40mg
32mg (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, (loose stools), visual disturbances,
fluttering or pounding heart beat (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 this medicine can cause side effects, although not everybody gets them. 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 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 (hyponatraemia).
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 (may affect more than 1 in 10 people)
Sleepiness
Difficulty in sleeping
Headache
Changes in your sleeping pattern
Loss of body strength, weakness
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 (may affect up to 1 in 10 people)
Lack of appetite
Agitation
Decreased sex drive
Anxiety
Nervousness
Confusion
Abnormal dreams
Reduced emotions, indifference (apathy)
Tremor
Tingling or numbness in the hands or feet
Dizziness
Problems concentrating
Migraine
Loss of memory (amnesia)
Ringing in the ears (tinnitus)
Palpitations
Yawning
Blocked or runny nose (rhinitis)
Diarrhoea
Vomiting
Constipation
Stomach pain
Flatulence (wind)
Increase in saliva (drooling)
Itching
Pain in muscles and joints
For men, problems with ejaculation and erection
For women, failing to reach an orgasm
Tiredness
Prickling of the skin
Loss of weight
Uncommon (may affect up to 1 in 100 people)
Bruising easily
Increased appetite
Aggression
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
Excessive menstrual bleeding
Swelling of the arms or legs
Increased weight
Rare (may affect up to 1 in 1000 people)
Increased sex drive
Convulsions
Involuntary movements
Taste disturbances
Bleeding
Coughing
Hepatitis
Feeling unwell (malaise)
Some patients have reported (frequency not known)
Thoughts of harming or killing themselves, see also section 2. ‘What you need to know
before you take Citalopram Drops’
An increase in bleeding or bruising caused by a decrease in blood platelets
(thrombocytopenia)
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)
Irregular menstrual periods
Abnormal liver function tests
An increased risk of bone fractures has been observed in patients taking this type of
medicines
Abnormal heart rhythm
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.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. You can also report side effects directly via the Yellow Card
Scheme at: www.mhra.gov.uk/yellowcard.
Alternatively you can call Free phone 0808 100 3352 (available between 10am-2pm Monday –
Friday) or fill in a paper form available from your local pharmacy.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Citalopram Drops
Always keep medicines out of the sight and reach of children.
Do not store above 25°C.
After breaking the seal for the first time, the drops can be used for 16 weeks.
There is an expiry date on the label. Do not use the medicine after this date.
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.
If your solution becomes discoloured or show any signs of deterioration, you should seek the
advice of your pharmacist.

6. Contents of the pack and other information
What Citalopram Drops contain
Each ml of drops contains 40mg of citalopram (as hydrochloride). The other ingredients are
purified water, ethanol, hydroxyethyl cellulose 300, methyl parahydroxybenzoate (E218) and propyl
parahydroxybenzoate (E216).
What Citalopram Drops look like and contents of the pack
Citalopram is clear, colourless oral solution supplied in amber glass bottle. Each bottle contains
15ml Citalopram oral drops.
Manufactured by: H. Lundbeck A/S, – Copenhagen Valby, (Denmark).
Procured from within the EU and repackaged by the Product Licence holder:
B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.
Citalopram 40mg/ml Oral Drops;
Leaflet date: 11.04.2016

PL 18799/2020
POM

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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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