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CITALOPRAM 40 MG/ML ORAL DROPS SOLUTION

Active substance(s): CITALOPRAM HYDROCHLORIDE

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Transcript
FPO
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 any further questions, 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, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Citalopram oral drops are and what they are used for
2. What you need to know before you take Citalopram oral drops
3. How to take Citalopram oral drops
4. Possible side effects
5. How to store Citalopram oral drops
6. Contents of the pack and other information

 A bleeding disorder or have ever suffered from bleeding in the stomach or

Other medicines and Citalopram

Tell your doctor or pharmacist if you are taking, or have recently taken or might
take any other medicines (including those purchased without prescription)
during the last 14 days. This includes other medicines for depression (see Do not
take Citalopram oral drops above).
 The herbal remedy St John’s wort (Hypericum perforatum). This should not
be taken at the same time as Citalopram oral drops.
 Monoamine oxidase inhibitors (MAOIs). These should not be taken at the
same time as Citalopram oral drops (see Do not take Citalopram oral drops
above).
Tell your doctor if you are taking any of the following medicines:
 Linezolid (an antibiotic).
 Sumatriptan (used to treat migraine) or tramadol (a pain killer). If you feel
unwell when using these medicines with Citalopram oral drops 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 oral drops (see Do not take Citalopram oral drops above).
 Imipramine and desipramine (used to treat depression).
 Medicines containing selegiline (used to treat Parkinson’s disease)
 Cimetidine (used to treat stomach ulcers).
 Mefloquine (used to treat malaria).
 Bupropion (used to treat depression).
 Medicines known to affect the blood platelets (e.g. anticoagulant drugs used
to treat or prevent blood clots; aspirin and non-steroidal anti-inflammatory
drugs (NSAIDs) such as ibuprofen and diclofenac used as painkillers; and
some antipsychotic drugs and tricyclic antidepressants).
 Metoprolol, a beta blocker used to treat migraine, some heart conditions and
high blood pressure. The effects of either drug could be increased, decreased
or altered.
 Neuroleptics (used in the treatment of schizophrenia).
Do not take 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.
Citalopram with food and drink
Citalopram oral drops can be taken with or without food (see section 3 “How to
take Citalopram oral 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 planning to have a baby, ask
your doctor or pharmacist for advice before taking this medicine. 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

Medicines may affect the action of other medicines and this can sometimes

crying, sleepiness or sleeping difficulties. If your newborn baby gets any of these

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

cause serious adverse reactions.

symptoms please contact your midwife and/or doctor immediately.

condition.

intestine.
 Mania or panic disorder.
 Low blood levels of sodium.
 ECT (electroconvulsive therapy).
 Problems with your eyes, such as certain kinds of glaucoma.
 Suffered or suffer from heart problems or have recently had a heart attack.
 A low resting heart-rate and/or you know that you may have salt depletion as
a result of prolonged severe diarrhoea and vomiting (being sick) or usage of
diuretics (water tablets).
 Experienced a fast or irregular heartbeat, fainting, collapse or dizziness on
standing up which may indicate abnormal functioning of the heart rate.
Please consult your doctor, even if these statements were applicable to you at any
time in the past.
Some patients with manic-depressive illness may enter into a manic phase. This
is characterized by unusual and rapidly changing ideas, inappropriate happiness
and excessive physical activity. If you experience this, contact your doctor.
Symptoms such as restlessness or difficulty in sitting or standing still can also
occur during the first weeks of the treatment. Tell your doctor immediately if

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 oral drops 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.

Special information relating to your disease

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CITALOPRAM
ORAL DROPS

about two weeks but sometimes longer.

Do not take Citalopram oral drops:
 If you are allergic (hypersensitive) to citalopram, or any of the other
ingredients of Citalopram oral drops (see what Citalopram oral drops
contain, in section 6). Consult your doctor if you think you might be.
 If you are also taking a medicine containing pimozide. Talk to your doctor.
 At the same time as taking medication known as monoamine oxidase
inhibitors (MAOIs). MAOIs include medicines such as phenelzine,
iproniazid, isocarboxazid, nialamide, tranylcypromine and moclobemide
(used for the treatment of depression), selegiline (used in the treatment of
Parkinson’s disease) and linezolid (an antibiotic). Even if you have finished
taking one of the following MAOIs: phenelzine, iproniazid, isocarboxazid,
nialamide or tranylcypromine you will need to wait 2 weeks before you start
taking Citalopram oral drops. One day must elapse after you have finished
taking moclobemide. After stopping Citalopram oral drops 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).

you experience these symptoms.
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
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.
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

Warnings and precautions

any of the symptoms listed above develop or worsen when patients under 18

Talk to your doctor, pharmacist or nurse before taking Citalopram.

are taking Citalopram oral drops. Also, the long-term safety effects concerning

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.

growth, maturation and cognitive and behavioural development of Citalopram in

Dimension: 450 x 310 mm

this age group have not yet been demonstrated.

3. HOW TO TAKE CITALOPRAM ORAL DROPS
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 people (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.
Use in children and adolescents (younger than 18 years of age)
Citalopram oral drops 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 oral drops.
Patients with special risks
Patients with liver complaints should not receive more than 16 mg (8 drops) per
day.
If you have previously taken 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 oral drops
The drops are for oral use and can be taken in a drink of water, or orange or
apple juice.
Citalopram oral drops 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

Front Side

FPO

1. WHAT CITALOPRAM ORAL DROPS ARE AND WHAT THEY ARE
USED FOR

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.
Citalopram oral drops contains ethanol (alcohol), E216 and E218
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).

FPO
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 any further questions, 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, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Citalopram oral drops are and what they are used for
2. What you need to know before you take Citalopram oral drops
3. How to take Citalopram oral drops
4. Possible side effects
5. How to store Citalopram oral drops
6. Contents of the pack and other information

 A bleeding disorder or have ever suffered from bleeding in the stomach or

Other medicines and Citalopram

Tell your doctor or pharmacist if you are taking, or have recently taken or might
take any other medicines (including those purchased without prescription)
during the last 14 days. This includes other medicines for depression (see Do not
take Citalopram oral drops above).
 The herbal remedy St John’s wort (Hypericum perforatum). This should not
be taken at the same time as Citalopram oral drops.
 Monoamine oxidase inhibitors (MAOIs). These should not be taken at the
same time as Citalopram oral drops (see Do not take Citalopram oral drops
above).
Tell your doctor if you are taking any of the following medicines:
 Linezolid (an antibiotic).
 Sumatriptan (used to treat migraine) or tramadol (a pain killer). If you feel
unwell when using these medicines with Citalopram oral drops 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 oral drops (see Do not take Citalopram oral drops above).
 Imipramine and desipramine (used to treat depression).
 Medicines containing selegiline (used to treat Parkinson’s disease)
 Cimetidine (used to treat stomach ulcers).
 Mefloquine (used to treat malaria).
 Bupropion (used to treat depression).
 Medicines known to affect the blood platelets (e.g. anticoagulant drugs used
to treat or prevent blood clots; aspirin and non-steroidal anti-inflammatory
drugs (NSAIDs) such as ibuprofen and diclofenac used as painkillers; and
some antipsychotic drugs and tricyclic antidepressants).
 Metoprolol, a beta blocker used to treat migraine, some heart conditions and
high blood pressure. The effects of either drug could be increased, decreased
or altered.
 Neuroleptics (used in the treatment of schizophrenia).
Do not take 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.
Citalopram with food and drink
Citalopram oral drops can be taken with or without food (see section 3 “How to
take Citalopram oral 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 planning to have a baby, ask
your doctor or pharmacist for advice before taking this medicine. 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

Medicines may affect the action of other medicines and this can sometimes

crying, sleepiness or sleeping difficulties. If your newborn baby gets any of these

How and when to take Citalopram oral drops
The drops are for oral use and can be taken in a drink of water, or orange or
apple juice.
Citalopram oral drops 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

cause serious adverse reactions.

symptoms please contact your midwife and/or doctor immediately.

condition.

intestine.
 Mania or panic disorder.
 Low blood levels of sodium.
 ECT (electroconvulsive therapy).
 Problems with your eyes, such as certain kinds of glaucoma.
 Suffered or suffer from heart problems or have recently had a heart attack.
 A low resting heart-rate and/or you know that you may have salt depletion as
a result of prolonged severe diarrhoea and vomiting (being sick) or usage of
diuretics (water tablets).
 Experienced a fast or irregular heartbeat, fainting, collapse or dizziness on
standing up which may indicate abnormal functioning of the heart rate.
Please consult your doctor, even if these statements were applicable to you at any
time in the past.
Some patients with manic-depressive illness may enter into a manic phase. This
is characterized by unusual and rapidly changing ideas, inappropriate happiness
and excessive physical activity. If you experience this, contact your doctor.
Symptoms such as restlessness or difficulty in sitting or standing still can also
occur during the first weeks of the treatment. Tell your doctor immediately if

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 oral drops 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.

Special information relating to your disease

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CITALOPRAM
ORAL DROPS

about two weeks but sometimes longer.

Do not take Citalopram oral drops:
 If you are allergic (hypersensitive) to citalopram, or any of the other
ingredients of Citalopram oral drops (see what Citalopram oral drops
contain, in section 6). Consult your doctor if you think you might be.
 If you are also taking a medicine containing pimozide. Talk to your doctor.
 At the same time as taking medication known as monoamine oxidase
inhibitors (MAOIs). MAOIs include medicines such as phenelzine,
iproniazid, isocarboxazid, nialamide, tranylcypromine and moclobemide
(used for the treatment of depression), selegiline (used in the treatment of
Parkinson’s disease) and linezolid (an antibiotic). Even if you have finished
taking one of the following MAOIs: phenelzine, iproniazid, isocarboxazid,
nialamide or tranylcypromine you will need to wait 2 weeks before you start
taking Citalopram oral drops. One day must elapse after you have finished
taking moclobemide. After stopping Citalopram oral drops 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).

you experience these symptoms.
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
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.
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

Warnings and precautions

any of the symptoms listed above develop or worsen when patients under 18

Talk to your doctor, pharmacist or nurse before taking Citalopram.

are taking Citalopram oral drops. Also, the long-term safety effects concerning

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.

growth, maturation and cognitive and behavioural development of Citalopram in

Dimension: 450 x 310 mm

this age group have not yet been demonstrated.

3. HOW TO TAKE CITALOPRAM ORAL DROPS
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 people (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.
Use in children and adolescents (younger than 18 years of age)
Citalopram oral drops 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 oral drops.
Patients with special risks
Patients with liver complaints should not receive more than 16 mg (8 drops) per
day.
If you have previously taken 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)

Front Side

FPO

1. WHAT CITALOPRAM ORAL DROPS ARE AND WHAT THEY ARE
USED FOR

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.
Citalopram oral drops contains ethanol (alcohol), E216 and E218
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).

4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can have side effects and some people may
experience unwanted effects (side effects) whilst taking Citalopram. Several of
the effects listed below can also be symptoms of your illness and may disappear
as you start to get better.
Serious side effects
Stop taking Citalopram oral drops 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).

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

 Vaginal bleeding
 Swelling of the arms or legs
 Increased weight
Rare (likely to affect up to 1 in every 1,000 people)
 Convulsions
 Involuntary movements
 Taste disturbances
 Bleeding
 Hepatitis
Not known (frequency cannot be estimated from the available data)
 Thoughts of harming or killing themselves
 An increase in bleeding or bruising caused by a decrease in blood platelets
 Rash (hypersensitivity)
 Low potassium levels in the blood (hypokalaemia), which can cause muscle
weakness, twitching or abnormal heart rhythms
 Panic attack
 Grinding teeth
 Restlessness
 Unusual muscle movements or stiffness
 Involuntary movements of the muscles (akathisia)
 Low blood pressure
 Nosebleed
 Bleeding disorders including skin and mucosal bleeding (ecchymosis)
 Sudden swelling of skin or mucosa
 In men, painful erections
 Flow of breast milk in men or in women who are not breast-feeding
(galactorrhoea)
 Abnormal liver function tests
 An increased risk of bone fractures has been observed in patients taking this
type of medicines
SSRIs can, very rarely, increase the risk of bleeding, including stomach or
intestinal bleeding. Let your doctor know if you vomit blood or develop black or
blood stained stools.
Also let your doctor know if you continue to have other symptoms associated
with your depression. This might include hallucinations, anxiety, mania or
confusion.
Any side effects that do occur will usually disappear after a few days. If they are
troublesome or persistent, or if you develop any other unusual side effects while
taking Citalopram oral drops, please tell your doctor.
If you notice any other side effects not mentioned in this leaflet please tell your
doctor or pharmacist.

The other ingredients are purified water, ethanol [96%], hydroxyethylcellulose,
E218 (methyl parahydroxybenzoate) and E216 (propyl parahydroxybenzoate).
What Citalopram oral drops looks like and contents of the pack
Citalopram oral drops is a clear, colorless to pale yellowish liquid supplied in
amber colored glass bottles.
Marketing Authorisation Holder
Strides Arcolab International Limited
Unit 4, Metro Centre
Tolpits Lane
Watford, Hertfordshire
WD18 9SS UNITED KINGDOM
Manufacturer
Beltapharm S.P.A
Via Stelvio, 66
20095 Cusano Milanino (MI)
Italy
1xxxxxx

 Fast, irregular heartbeat, 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.

Distributor:
Co-Pharma Limited
Unit 4, Metro Centre, Tolpits Lane, Watford,
Hertfordshire WD18 9SS
United Kingdom
This leaflet was last approved in {04/2015}

FPO

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 oral drops 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
oral drops 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 oral drops
If you forget to take a dose, take the next dose at the usual time. Do not take a
double dose.
If you stop taking Citalopram oral drops
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 oral drops is usually reduced gradually over a
couple of weeks.
If you have any further questions on the use of this medicine, ask your doctor or
pharmacist.

Reporting of side effects
If you get any side effects, talk to your doctor or 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 ORAL DROPS
 Keep this medicine out of the sight and reach of children.
 After breaking the seal for the first time, the drops can be used for 16 weeks
if stored below 25°C (room temperature)
 Do not use this medicine after the expiry date which is stated on the label
after EXP. The expiry date refers to the last day of that month.
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 oral drops contains
The active substance in Citalopram oral drops is citalopram (as hydrochloride).
Each ml of drops contains 40 mg citalopram.

FPO
Dimension: 450 x 310 mm

Back Side

4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can have side effects and some people may
experience unwanted effects (side effects) whilst taking Citalopram. Several of
the effects listed below can also be symptoms of your illness and may disappear
as you start to get better.
Serious side effects
Stop taking Citalopram oral drops 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).

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

 Vaginal bleeding
 Swelling of the arms or legs
 Increased weight
Rare (likely to affect up to 1 in every 1,000 people)
 Convulsions
 Involuntary movements
 Taste disturbances
 Bleeding
 Hepatitis
Not known (frequency cannot be estimated from the available data)
 Thoughts of harming or killing themselves
 An increase in bleeding or bruising caused by a decrease in blood platelets
 Rash (hypersensitivity)
 Low potassium levels in the blood (hypokalaemia), which can cause muscle
weakness, twitching or abnormal heart rhythms
 Panic attack
 Grinding teeth
 Restlessness
 Unusual muscle movements or stiffness
 Involuntary movements of the muscles (akathisia)
 Low blood pressure
 Nosebleed
 Bleeding disorders including skin and mucosal bleeding (ecchymosis)
 Sudden swelling of skin or mucosa
 In men, painful erections
 Flow of breast milk in men or in women who are not breast-feeding
(galactorrhoea)
 Abnormal liver function tests
 An increased risk of bone fractures has been observed in patients taking this
type of medicines
SSRIs can, very rarely, increase the risk of bleeding, including stomach or
intestinal bleeding. Let your doctor know if you vomit blood or develop black or
blood stained stools.
Also let your doctor know if you continue to have other symptoms associated
with your depression. This might include hallucinations, anxiety, mania or
confusion.
Any side effects that do occur will usually disappear after a few days. If they are
troublesome or persistent, or if you develop any other unusual side effects while
taking Citalopram oral drops, please tell your doctor.
If you notice any other side effects not mentioned in this leaflet please tell your
doctor or pharmacist.

The other ingredients are purified water, ethanol [96%], hydroxyethylcellulose,
E218 (methyl parahydroxybenzoate) and E216 (propyl parahydroxybenzoate).
What Citalopram oral drops looks like and contents of the pack
Citalopram oral drops is a clear, colorless to pale yellowish liquid supplied in
amber colored glass bottles.
Marketing Authorisation Holder
Strides Arcolab International Limited
Unit 4, Metro Centre
Tolpits Lane
Watford, Hertfordshire
WD18 9SS UNITED KINGDOM
Manufacturer
Beltapharm S.P.A
Via Stelvio, 66
20095 Cusano Milanino (MI)
Italy
1xxxxxx

 Fast, irregular heartbeat, 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.

Distributor:
Co-Pharma Limited
Unit 4, Metro Centre, Tolpits Lane, Watford,
Hertfordshire WD18 9SS
United Kingdom
This leaflet was last approved in {04/2015}

FPO

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 oral drops 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
oral drops 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 oral drops
If you forget to take a dose, take the next dose at the usual time. Do not take a
double dose.
If you stop taking Citalopram oral drops
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 oral drops is usually reduced gradually over a
couple of weeks.
If you have any further questions on the use of this medicine, ask your doctor or
pharmacist.

Reporting of side effects
If you get any side effects, talk to your doctor or 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 ORAL DROPS
 Keep this medicine out of the sight and reach of children.
 After breaking the seal for the first time, the drops can be used for 16 weeks
if stored below 25°C (room temperature)
 Do not use this medicine after the expiry date which is stated on the label
after EXP. The expiry date refers to the last day of that month.
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 oral drops contains
The active substance in Citalopram oral drops is citalopram (as hydrochloride).
Each ml of drops contains 40 mg citalopram.

FPO
Dimension: 450 x 310 mm

Back Side

Expand view ⇕

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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