CIPRAMIL 40MG/ML ORAL DROPS

Active substance: CITALOPRAM HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
CIPRAMIL® 40MG/ML Oral Drops
(citalopram)
Your medicine is known as the above but will be referred to as Cipramil
throughout the remainder of this leaflet.
Read all of this leaflet carefully before you start taking this medicine
 Keep this leaflet. You may need to read it again.
 If you have further questions, please ask your doctor or pharmacist.
 This medicine has been prescribed for you. Do not pass it on to others. It may
harm them, even if their symptoms are the same as yours.
 If any of the side effects are troubling, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Cipramil is and what it is used for
2. Before you take Cipramil Drops
3. How to take Cipramil Drops
4. Possible side effects
5. How to store Cipramil Drops
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 Drops (see What Cipramil contains, 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.

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 non-steroidal antiinflammatory drugs (NSAIDs) such as ibuprofen and diclofenac used as
painkillers and some antipsychotic drugs and tricyclic antidepressants).
 Metoprolol, a beta blocker used to treat migraine, some heart conditions
and high blood pressure. The effects of either drug could be increased,
decreased or altered.
 Neuroleptics (used in the treatment of schizophrenia).
Do not take Cipramil if you take medicines for heart rhythm problems or
medicines that may affect the heart’s rhythm, e.g. such as Class IA and III
antiarrhythmics, antipsychotics (e.g. fentiazine derivatives, pimozide, haloperidol),
tricyclic antidepressants, certain antimicrobial agents (e.g. sparfloxacin,
moxifloxacin, erythromycin IV, pentamidine, anti-malarial treatment particularly
halofantrine), certain antihistamines (astemizole, mizolastine). If you have any
further questions about this you should speak to your doctor.
Taking Cipramil with food and drink
Cipramil can be taken with or without food (see section 3 “How to take Cipramil”).
As with all antidepressants, it is sensible to avoid drinking alcohol whilst receiving
treatment although Cipramil has not been shown to increase the effects of
alcohol.
Pregnancy
Ask your doctor or pharmacist for advice before taking any medicine. If you are
pregnant, think you might be pregnant, or are trying to become pregnant, tell your
doctor. Do not take Cipramil if you are pregnant unless you and your doctor have
discussed the risks and benefits involved.
Make sure your midwife and/or doctor know you are on Cipramil. When taken
during pregnancy, particularly in the last 3 months of pregnancy, medicines like
Cipramil may increase the risk of a serious condition in babies, called persistent
pulmonary hypertension of the newborn (PPHN), making the baby breathe faster
and appear bluish. These symptoms usually begin during the first 24 hours after
the baby is born. If this happens to your baby you should contact your midwife
and/or doctor immediately. Also, if you take Cipramil during the last 3 months of
your pregnancy and until the date of birth you should be aware that the following
effects may be seen in your newborn: fits, being too hot or cold, feeding
difficulties, vomiting, low blood sugar, stiff or floppy muscles, overactive reflexes,
tremor, jitteriness, irritability, lethargy, constant crying, sleepiness or sleeping
difficulties. If your newborn baby gets any of these symptoms please contact your
midwife and/or doctor immediately.

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

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.

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.

Citalopram has been shown to reduce the quality of the sperm in animal studies.
Theoretically, this could affect fertility, but impact on human fertility has not been
observed as yet.

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.

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.

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.

Important information about some of the ingredients of Cipramil
This medicinal product contains small amounts of ethanol (alcohol), less than 100
mg in all doses. These drops also contain the preservatives E216 and E218,
which may cause allergic reactions (possibly delayed).
3.

How to take Cipramil

How much to take
It is important to take your drops as instructed by your doctor. The label will tell
you how many to take and how often. If it does not, or you are not sure, ask your
doctor or pharmacist.
Adults
Depression
The usual dose is 16 mg (8 drops) per day. This may be increased by your doctor
to a maximum of 32 mg (16 drops) per day.
Panic disorder
The starting dose is 8 mg (4 drops) per day for the first week before increasing
the dose to between 16 –24 mg (8 to 12 drops) per day. The dose may be
increased by your doctor to a maximum of 32 mg (16 drops) per day.
Elderly patients (above 65 years of age)
The starting dose should be decreased to half of the recommended dose, e.g.
8-16 mg per day. Elderly patients should not usually receive more than 16 mg (8
drops) per day.




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



Patients with special risks
Patients with liver complaints should not receive more than 16 mg (8 drops) per
day.

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

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.

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

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.
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.

Rare (likely to affect up to 1 in every 1000 people)
 Convulsions
 Involuntary movements
 Taste disturbances
 Bleeding
 Hepatitis

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

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.

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.

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)

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.

Possible side effects
5.

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









6.

How to store Cipramil
KEEP OUT OF THE REACH AND SIGHT OF CHILDREN.
Do not store above 25°C
After first opening, use within 16 weeks.
There is an expiry date on the label. Do not use the medicine after this date.
If you notice that the solution has become discoloured or shows any other
signs of deterioration, you should seek the advice of your pharmacist.
Return any unused medicine to the 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.
Further information

What Cipramil contains
Each ml of solution contains 40mg citalopram (as hydrochloride) as the active
ingredient. The other ingredients are methyl parahydroxybenzoate, propyl
parahydroxybenzoate, ethanol, hydroxyethylcellulose and purified water.
What Cipramil look like and contents of the pack
Cipramil drops are a colourless solution and are supplied in amber glass
bottles containing 15 ml
Manufacturer
These drops are manufactured by: H. Lundbeck A/S - Copenhagen Valby,
Denmark. Procured from within the EU and repackaged by the Product Licence
Holder: G Pharma Ltd., Salford M50 2PU.
POM
PL NO: 16369/1481
Leaflet Revision: 25th May 2012
Cipramil® is the registered trademark of H. Lundbeck A/S.

PACKAGE LEAFLET: INFORMATION FOR THE USER
CIPRAMIL® 40MG/ML Oral Drops
(citalopram)
Your medicine is known as the above but will be referred to as Cipramil
throughout the remainder of this leaflet.
Read all of this leaflet carefully before you start taking this medicine
 Keep this leaflet. You may need to read it again.
 If you have further questions, please ask your doctor or pharmacist.
 This medicine has been prescribed for you. Do not pass it on to others. It may
harm them, even if their symptoms are the same as yours.
 If any of the side effects are troubling, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Cipramil is and what it is used for
2. Before you take Cipramil Drops
3. How to take Cipramil Drops
4. Possible side effects
5. How to store Cipramil Drops
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 Drops (see What Cipramil contains, 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.

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 non-steroidal antiinflammatory drugs (NSAIDs) such as ibuprofen and diclofenac used as
painkillers and some antipsychotic drugs and tricyclic antidepressants).
 Metoprolol, a beta blocker used to treat migraine, some heart conditions
and high blood pressure. The effects of either drug could be increased,
decreased or altered.
 Neuroleptics (used in the treatment of schizophrenia).
Do not take Cipramil if you take medicines for heart rhythm problems or
medicines that may affect the heart’s rhythm, e.g. such as Class IA and III
antiarrhythmics, antipsychotics (e.g. fentiazine derivatives, pimozide, haloperidol),
tricyclic antidepressants, certain antimicrobial agents (e.g. sparfloxacin,
moxifloxacin, erythromycin IV, pentamidine, anti-malarial treatment particularly
halofantrine), certain antihistamines (astemizole, mizolastine). If you have any
further questions about this you should speak to your doctor.
Taking Cipramil with food and drink
Cipramil can be taken with or without food (see section 3 “How to take Cipramil”).
As with all antidepressants, it is sensible to avoid drinking alcohol whilst receiving
treatment although Cipramil has not been shown to increase the effects of
alcohol.
Pregnancy
Ask your doctor or pharmacist for advice before taking any medicine. If you are
pregnant, think you might be pregnant, or are trying to become pregnant, tell your
doctor. Do not take Cipramil if you are pregnant unless you and your doctor have
discussed the risks and benefits involved.
Make sure your midwife and/or doctor know you are on Cipramil. When taken
during pregnancy, particularly in the last 3 months of pregnancy, medicines like
Cipramil may increase the risk of a serious condition in babies, called persistent
pulmonary hypertension of the newborn (PPHN), making the baby breathe faster
and appear bluish. These symptoms usually begin during the first 24 hours after
the baby is born. If this happens to your baby you should contact your midwife
and/or doctor immediately. Also, if you take Cipramil during the last 3 months of
your pregnancy and until the date of birth you should be aware that the following
effects may be seen in your newborn: fits, being too hot or cold, feeding
difficulties, vomiting, low blood sugar, stiff or floppy muscles, overactive reflexes,
tremor, jitteriness, irritability, lethargy, constant crying, sleepiness or sleeping
difficulties. If your newborn baby gets any of these symptoms please contact your
midwife and/or doctor immediately.

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

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.

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.

Citalopram has been shown to reduce the quality of the sperm in animal studies.
Theoretically, this could affect fertility, but impact on human fertility has not been
observed as yet.

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.

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.

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.

Important information about some of the ingredients of Cipramil
This medicinal product contains small amounts of ethanol (alcohol), less than 100
mg in all doses. These drops also contain the preservatives E216 and E218,
which may cause allergic reactions (possibly delayed).
3.

How to take Cipramil

How much to take
It is important to take your drops as instructed by your doctor. The label will tell
you how many to take and how often. If it does not, or you are not sure, ask your
doctor or pharmacist.
Adults
Depression
The usual dose is 16 mg (8 drops) per day. This may be increased by your doctor
to a maximum of 32 mg (16 drops) per day.
Panic disorder
The starting dose is 8 mg (4 drops) per day for the first week before increasing
the dose to between 16 –24 mg (8 to 12 drops) per day. The dose may be
increased by your doctor to a maximum of 32 mg (16 drops) per day.
Elderly patients (above 65 years of age)
The starting dose should be decreased to half of the recommended dose, e.g.
8-16 mg per day. Elderly patients should not usually receive more than 16 mg (8
drops) per day.

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





Patients with special risks
Patients with liver complaints should not receive more than 16 mg (8 drops) per
day.

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

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.

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

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.
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.

Rare (likely to affect up to 1 in every 1000 people)
 Convulsions
 Involuntary movements
 Taste disturbances
 Bleeding
 Hepatitis

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

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.

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)

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.
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6.

How to store Cipramil
KEEP OUT OF THE REACH AND SIGHT OF CHILDREN.
Do not store above 25°C
After first opening, use within 16 weeks.
There is an expiry date on the label. Do not use the medicine after this date.
If you notice that the solution has become discoloured or shows any other
signs of deterioration, you should seek the advice of your pharmacist.
Return any unused medicine to the 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.
Further information

What Cipramil contains
Each ml of solution contains 40mg citalopram (as hydrochloride) as the active
ingredient. The other ingredients are methyl parahydroxybenzoate, propyl
parahydroxybenzoate, ethanol, hydroxyethylcellulose and purified water.
What Cipramil look like and contents of the pack
Cipramil drops are a colourless solution and are supplied in amber glass
bottles containing 15 ml
Manufacturer
These drops are manufactured by: H. Lundbeck A/S - Copenhagen Valby,
Denmark. Procured from within the EU and repackaged by the Product Licence
Holder: G Pharma Ltd., Salford M50 2PU.
POM
PL NO: 16369/1481
Leaflet Revision: 25th May 2012
Cipramil® is the registered trademark of H. Lundbeck A/S.

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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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