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CIPRAMIL 40MG/ML ORAL DROPS SOLUTION

Active substance: CITALOPRAM HYDROCHLORIDE

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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
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 you doctor or pharmacist. This includes
any possible side effects not listed in this leaflet.
The name of your medicine is Cipramil® 40 mg/ml Oral drops, solution but it will
be referred to as Cipramil in this leaflet.

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.
Other medicines and Cipramil
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 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

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
3. How to take Cipramil
4. Possible side effects
5. How to store Cipramil
6. Contents of the pack and other information

1.

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.
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).










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

Do not take Cipramil
• 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 below).
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 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.

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. 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”).
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.

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.

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).

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.

3.

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

HOW TO TAKE CIPRAMIL

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 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 (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.
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, 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 patient have reported (frequency not known)
• Thoughts of harming or killing themselves, see also section 2. “What you need
to know before you take Cipramil”
• 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 you 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.
By reporting side effects, you can help provide more information on the safety of this
medicine.

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.

CONTENTS OF THE PACK AND OTHER 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 Limited, 956 Buckingham Avenue, Slough Trading Estate, SL1 4NL
Cipramil® 40 mg/ml Oral Drops, solution
Cipramil® is a registered trademark of H. Lundbeck A/S.
Leaflet date: 21.08.2014

PL: 39352/0048
POM

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
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 you doctor or pharmacist. This includes
any possible side effects not listed in this leaflet.
The name of your medicine is Citalopram® 40 mg/ml Oral drops, solution but it
will be referred to as Citalopram in 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
3. How to take Citalopram
4. Possible side effects
5. How to store Citalopram
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
Do not take Citalopram
• 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 below).
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 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.
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
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 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.
• 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 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, antipsychotics (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”).
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
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 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 (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.
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, 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 patient have reported (frequency not known)
• Thoughts of harming or killing themselves, see also section 2. “What you need
to know before you take Citalopram”
• 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 you 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.
By reporting side effects, you can help provide more information on the safety of this
medicine.

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.

CONTENTS OF THE PACK AND OTHER 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 Limited, 956 Buckingham Avenue, Slough Trading Estate, SL1 4NL.
Citalopram 40 mg/ml Oral Drops, solution
Leaflet date: 21.08.2014

PL: 39352/0048
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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