CITALOPRAM 40MG/ML ORAL DROPS SOLUTION

Active substance: CITALOPRAM HYDROCHLORIDE

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Rare (likely to affect up to 1 in every 1000 people)


Convulsions

What Cipramil contains



Involuntary movements





Taste disturbances



Bleeding



Hepatitis





Epilepsy or a history of seizures or fits

PACKAGE LEAFLET: INFORMATION FOR THE USER
CIPRAMIL 40mg/ml ORAL DROPS



A bleeding disorder or have ever suffered from bleeding in the
stomach or intestine

S1204 LEAFLET Cipramil 20130227

6. Further information
Each ml contains 40mg of the active ingredient citalopram (as
the hydrochloride)
Cipramil also contain the following inactive ingredients: methylparahydroxybenzoate E218, propyl-parahydroxybenzoate
E216, ethanol, hydroxyethylcellulose and purified water.

Some patient have reported (frequency not known)

(citalopram hydrochloride)



Mania or panic disorder

The name of your medicine is Cipramil 40mg/ml Oral Drops but will
be referred to as Cipramil throughout the following leaflet.



Low blood levels of sodium



ECT (electroconvulsive therapy)

Read all of this leaflet carefully before you start taking this
medicine



Problems with your eyes, such as certain kinds of glaucoma



Suffered or suffer from heart problems or have recently had a
heart attack.



Thoughts of harming or killing themselves

What Cipramil looks like and contents of the pack



Keep this leaflet. You may need to read it again.



An increase in bleeding or bruising caused by a decrease in
blood platelets



Cipramil is a clear solution in an amber glass bottle with a screw
on child resistant cap.



If you have further questions, please ask your doctor or
pharmacist.





Rash (hypersensitivity)



Cipramil is available in bottles containing 15ml.





Low potassium levels in the blood (hypokalaemia), which can
cause muscle weakness, twitching or abnormal heart rhythms



Product Licence holder

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.

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 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.



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



Cipramil is a Selective Serotonin Reuptake Inhibitor (SSRI) and
belongs to a group of medicines known as antidepressants.

An increased risk of bone fractures has been observed in
patients taking this type of medicines

These medicines help to correct certain chemical imbalances in the
brain that are causing the symptoms of your illness.

Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Limited, Chemilines House,
Alperton Lane, Wembley, HA0 1DX.

In this leaflet:

Manufacturer
This product is manufactured by H Lundbeck A/S, Valby, Denmark.
POM

PL No.: 19488/1204

1. What Cipramil is and what it is used for
2. Before you take Cipramil

Cipramil is a registered trade mark of H Lundbeck A/S, Denmark.

4. Possible side effects
5. How to store Cipramil

Special information relating to your disease

6. Further information

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.

1. What Cipramil is and what it is used for
S1204 LEAFLET Cipramil 20130227

How does Cipramil work?

What is Cipramil used for?
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.

Cipramil contains citalopram and is used for the treatment of
depression and, when you feel better, to help prevent these
symptoms recurring.

Also let your doctor know if you continue to have other symptoms
associated with your depression. This might include hallucinations,
anxiety, mania or confusion.

Cipramil is also used for long-term treatment to prevent the
occurrence of new episodes of depression or if you have recurrent
depression.

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.

Cipramil is also beneficial in relieving symptoms if you tend to suffer
from panic attacks.

If you notice any other side effects not mentioned in this leaflet
please tell your doctor or pharmacist.

Do not take Cipramil

5. How to store Cipramil


Do not store above 25°C. Use within 16 weeks of first opening.



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.





If you are allergic (hypersensitive) to citalopram, or any of the
other ingredients of Cipramil (see What Cipramil contain,
section 6). Consult your doctor if you think you might be.



If you are also taking a medicine containing pimozide. Talk to
your doctor.



At the same time as taking medication known as monoamine
oxidase inhibitors (MAOIs). MAOIs include medicines such as
phenelzine, iproniazid, isocarboxazid, nialamide,
tranylcypromine and moclobemide (used for the treatment of
depression), selegiline (used in the treatment of Parkinson’s
disease) and linezolid (an antibiotic). Even if you have finished
taking one of the following MAOIs: phenelzine, iproniazid,
isocarboxazid, nialamide or tranylcypromine you will need to
wait 2 weeks before you start taking Cipramil. One day must
elapse after you have finished taking moclobemide. After
stopping Cipramil you must allow 1 week before taking any
MAOI.

If your doctor tells you to stop taking the tablets, take any which
you have left back to your pharmacist for safe disposal. Only
keep them if the doctor tells you to.



If the medicine becomes discoloured or shows any other signs
of deterioration, you should seek the advice of your pharmacist
who will tell you what to do.



Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines that are no longer required. These measures will
help to protect the environment.

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.

2. Before you take Cipramil

Do not use after the expiry date printed on the carton or bottle
label.



Some patients with manic-depressive illness may enter into a manic
phase. This is characterized by unusual and rapidly changing ideas,
inappropriate happiness and excessive physical activity. If you
experience this, contact your doctor.
Symptoms such as restlessness or difficulty in sitting or standing
still can also occur during the first weeks of the treatment. Tell your
doctor immediately if you experience these symptoms.

3. How to take Cipramil

Leaflet revision date: 27 February 2013

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



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)

If you have thoughts of harming or killing yourself at any time,
contact your doctor or go to a hospital straight away.
You may find it helpful to tell a relative or close friend that you
are depressed or have an anxiety disorder, and ask them to read
this leaflet. You might ask them to tell you if they think your
depression or anxiety is getting worse, or if they are worried about
changes in your behaviour.
Use in children and adolescents under 18 years of age
Cipramil should normally not be used for children and adolescents
under 18 years. Also, you should know that patients under 18 have
an increased risk of side-effects such as suicide attempt, suicidal
thoughts and hostility (predominantly aggression, oppositional
behaviour and anger) when they take this class of medicines.
Despite this, your doctor may prescribe citalopram for patients
under 18 because he/she decides that this is in their best interests.
If your doctor has prescribed Cipramil for a patient under 18 and
you want to discuss this, please go back to your doctor. You should
inform your doctor if any of the symptoms listed above develop or
worsen when patients under 18 are taking Cipramil. Also, the longterm safety effects concerning growth, maturation and cognitive and
behavioural development of Cipramil in this age group have not yet
been demonstrated.

Taking other medicines

Breast-feeding

Medicines may affect the action of other medicines and this can
sometimes cause serious adverse reactions.

Ask your doctor or pharmacist for advice before taking any
medicine. If you are breast-feeding, ask your doctor for advice. You
should not breast-feed your baby when taking Cipramil because
small amounts of the medicine can pass into the breast milk.

Please 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)

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.

Fertility

If you take more Cipramil than you should

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

If you think that you or anyone else may have taken too many
Cipramil, 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.

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.

Symptoms of overdosage may include:



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)

3. How to take Cipramil
How much to take

Seizures



Changes in heart rhythm

Common side effects (likely to affect up to 1 in 10 people)



Feeling sick (nausea)



Lack of appetite



Vomiting



Agitation



Sweating



Decreased sex drive



Drowsiness



Anxiety

Unconsciousness



Nervousness



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).

Irregular heart beat





Important information about some of the ingredients of
Cipramil



Fast heart beats



Confusion



Tremor



Abnormal dreams



Changes in blood pressure



Tremor



Serotonin syndrome (see Section 4)



Cimetidine (used to treat stomach ulcers).



Mefloquine (used to treat malaria).

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.



Tingling or numbness in the hands or feet



Bupropion (used to treat depression).

Adults



Agitation



Ringing in the ears (tinnitus)



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).

Depression



Dizziness



Yawning

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.



Enlarged eye pupils



Diarrhoea

Panic disorder



Bluish skin



Vomiting

 Breathing too quickly
If you forget to take Cipramil



Constipation



Itching

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



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



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.
phenothiazine derivatives, pimozide, haloperidol), tricyclic
antidepressants, certain antimicrobial agents (e.g. sparfloxacin,
moxifloxacin, erythromycin IV, pentamidine, anti-malarial treatment
particularly halofantrine), certain antihistamines (astemizole,
mizolastine). If you have any further questions about this you
should speak to your doctor.
Taking Cipramil with food and drink

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

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.

Uncommon (likely to affect up to 1 in every 100 people)


Bruising easily



Increased appetite



Aggression



Reduced emotions, indifference



Hallucinations



Mania

4. Possible side effects



Fainting



Large pupils (the dark centre of the eye)



Fast heart beat



Slow heart beat

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.

Patients with liver complaints should not receive more than 16 mg
(8 drops) per day. If you have previously taken Cipramil tablets, you
will find that the dose of your medicine in mg given as drops is a bit
lower than that of tablets. This is because your body more easily
absorbs the drops than the tablets, so you do not need as many mg
to have the same effect.

Pregnancy

The doses of tablets correspond to doses of drops as follows:

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.

Tablets

Drops

10 mg

8 mg (4 drops)

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.

20 mg

16 mg (8 drops)

Serious side effects



Nettle rash

30 mg

24 mg (12 drops)

Loss of hair

40 mg

32 mg (16 drops)



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.

Stop taking Cipramil and seek medical advice immediately if you
have any of the following symptoms:



Rash



Sensitivity to sunlight



Difficulties urinating
Vaginal bleeding

Cipramil can be taken with or without food (see section 3 “How to
take Cipramil”).

If you have any further questions on the use of this product, ask
your doctor or pharmacist.


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.

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).



Cipramil is taken every day as one dose at any time of the day.
Duration of treatment



Fast, irregular heart beat, fainting which could be symptoms of
a life-threatening condition known as torsades de pointes.



Swelling of the arms or legs



Increased weight

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

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.

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.



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.

S1204 LEAFLET Cipramil 20130227



PACKAGE LEAFLET: INFORMATION FOR THE USER
CITALOPRAM 40mg/ml ORAL DROPS, SOLUTION

Diabetes (you may need an adjustment of your antidiabetic
therapy)



Epilepsy or a history of seizures or fits

(citalopram hydrochloride)



A bleeding disorder or have ever suffered from bleeding in the
stomach or intestine

The name of your medicine is Citalopram 40mg/ml Oral Drops,
Solution but will be referred to as Citalopram throughout the
following leaflet.



Mania or panic disorder



Low blood levels of sodium



ECT (electroconvulsive therapy)

What Citalopram looks like and contents of the pack

Read all of this leaflet carefully before you start taking this
medicine



Problems with your eyes, such as certain kinds of glaucoma



Citalopram is a clear solution in an amber glass bottle with a
screw on child resistant cap.



Keep this leaflet. You may need to read it again.





Suffered or suffer from heart problems or have recently had a
heart attack.



Citalopram is available in bottles containing 15ml.

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.

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.

S1204 LEAFLET Citalopram 20130227

Rare (likely to affect up to 1 in every 1000 people)

6. Further information



Convulsions

What Citalopram contains



Involuntary movements





Taste disturbances

Each ml contains 40mg of the active ingredient citalopram (as
the hydrochloride)



Bleeding





Hepatitis

Citalopram also contain the following inactive ingredients:
methyl-parahydroxybenzoate E218, propylparahydroxybenzoate E216, ethanol, hydroxyethylcellulose and
purified water.

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

Product Licence holder



Grinding teeth



Restlessness



Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Limited, Chemilines House,
Alperton Lane, Wembley, HA0 1DX.

Unusual muscle movements or stiffness



Involuntary movements of the muscles (akathisia)



Manufacturer

Low blood pressure



This product is manufactured by H Lundbeck A/S, Valby, Denmark.

Nosebleed



Bleeding disorders including skin and mucosal bleeding
(ecchymosis)

POM

PL No.: 19488/1204



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 Citalopram is and what it is used for
2. Before you take Citalopram

Leaflet revision date: 27 February 2013

3. How to take Citalopram



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



How does Citalopram work?

An increased risk of bone fractures has been observed in
patients taking this type of medicines

Citalopram is a Selective Serotonin Reuptake Inhibitor (SSRI) and
belongs to a group of medicines known as antidepressants.

SSRIs can, very rarely, increase the risk of bleeding, including
stomach or intestinal bleeding. Let your doctor know if you vomit
blood or develop black or blood stained stools.
Also let your doctor know if you continue to have other symptoms
associated with your depression. This might include hallucinations,
anxiety, mania or confusion.
Any side effects that do occur will usually disappear after a few
days. If they are troublesome or persistent, or if you develop any
other unusual side effects while taking Citalopram, please tell your
doctor.
If you notice any other side effects not mentioned in this leaflet
please tell your doctor or pharmacist.

4. Possible side effects
5. How to store Citalopram

S1204 LEAFLET Citalopram 20130227

6. Further information
1. What Citalopram is and what it is used for

These medicines help to correct certain chemical imbalances in the
brain that are causing the symptoms of your illness.
What is Citalopram used for?
Citalopram contains citalopram and is used for the treatment of
depression and, when you feel better, to help prevent these
symptoms recurring.
Citalopram is also used for long-term treatment to prevent the
occurrence of new episodes of depression or if you have recurrent
depression.
Citalopram is also beneficial in relieving symptoms if you tend to
suffer from panic attacks.



If you are allergic (hypersensitive) to citalopram, or any of the
other ingredients of Citalopram (see What Citalopram contain,
section 6). Consult your doctor if you think you might be.

KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Do not use after the expiry date printed on the carton or bottle
label.

If you are also taking a medicine containing pimozide. Talk to
your doctor.



At the same time as taking medication known as monoamine
oxidase inhibitors (MAOIs). MAOIs include medicines such as
phenelzine, iproniazid, isocarboxazid, nialamide,
tranylcypromine and moclobemide (used for the treatment of
depression), selegiline (used in the treatment of Parkinson’s
disease) and linezolid (an antibiotic). Even if you have finished
taking one of the following MAOIs: phenelzine, iproniazid,
isocarboxazid, nialamide or tranylcypromine you will need to
wait 2 weeks before you start taking Citalopram. One day must
elapse after you have finished taking moclobemide. After
stopping Citalopram you must allow 1 week before taking any
MAOI.



Do not store above 25°C. Use within 16 weeks of first opening.





If your doctor tells you to stop taking the tablets, take any which
you have left back to your pharmacist for safe disposal. Only
keep them if the doctor tells you to.



If the medicine becomes discoloured or shows any other signs
of deterioration, you should seek the advice of your pharmacist
who will tell you what to do.



Some patients with manic-depressive illness may enter into a manic
phase. This is characterized by unusual and rapidly changing ideas,
inappropriate happiness and excessive physical activity. If you
experience this, contact your doctor.
Symptoms such as restlessness or difficulty in sitting or standing
still can also occur during the first weeks of the treatment. Tell your
doctor immediately if you experience these symptoms.
Special information relating to your disease
As with other medicines used to treat depression or related
diseases, the improvement is not achieved immediately. After the
start of Citalopram treatment it may take several weeks before you
experience any improvement. In the beginning of the treatment
certain patients may experience increased anxiety, which will
disappear during continued treatment. Therefore, it is very
important that you follow exactly your doctor’s orders and do not
stop the treatment or change the dose without consulting your
doctor.
Thoughts of suicide and worsening of your depression or
anxiety disorder
If you are depressed and/or have anxiety disorders you can
sometimes have thoughts of harming or killing yourself. These may
be increased when first starting antidepressants, since these
medicines all take time to work, usually about two weeks but
sometimes longer.
You may be more likely to think like this:


If you have previously had thoughts about killing or harming
yourself.



If you are a young adult. Information from clinical trials has
shown an increased risk of suicidal behaviour in adults aged
less than 25 years with psychiatric conditions who were treated
with an antidepressant.

2. Before you take Citalopram
Do not take Citalopram

5. How to store Citalopram

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

Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines that are no longer required. These measures will
help to protect the environment.


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 Citalopram
Please tell your doctor if you have any medical problems, especially
if you have:


Liver disease



Kidney disease

If you have thoughts of harming or killing yourself at any time,
contact your doctor or go to a hospital straight away.
You may find it helpful to tell a relative or close friend that you
are depressed or have an anxiety disorder, and ask them to read
this leaflet. You might ask them to tell you if they think your
depression or anxiety is getting worse, or if they are worried about
changes in your behaviour.
Use in children and adolescents under 18 years of age
Citalopram should normally not be used for children and
adolescents under 18 years. Also, you should know that patients
under 18 have an increased risk of side-effects such as suicide
attempt, suicidal thoughts and hostility (predominantly aggression,
oppositional behaviour and anger) when they take this class of
medicines. Despite this, your doctor may prescribe citalopram for
patients under 18 because he/she decides that this is in their best
interests. If your doctor has prescribed Citalopram for a patient
under 18 and you want to discuss this, please go back to your
doctor. You should inform your doctor if any of the symptoms listed
above develop or worsen when patients under 18 are taking
Citalopram. Also, the long-term safety effects concerning growth,
maturation and cognitive and behavioural development of
Citalopram in this age group have not yet been demonstrated.

Patients who have recurrent depression benefit from continued
treatment, sometimes for several years, to prevent the occurrence
of new depressive episodes.



You experience high fever, agitation, confusion, and trembling
or abrupt contractions of muscles. These may be signs of a rare
condition called serotonin syndrome.

Never change the dose of the medicine without talking to your
doctor first.



Tiredness, confusion and twitching of your muscles. These may
be signs of a low blood level of sodium.

Fertility

If you take more Citalopram than you should

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

If you think that you or anyone else may have taken too many
Citalopram, contact your doctor or nearest hospital emergency
department immediately. Do this even if there are no signs of
discomfort or poisoning. Take the Citalopram box/container with
you if you go to a doctor or hospital. Some of the signs of an
overdosage could be life-threatening.

If you have thoughts of harming or killing yourself at any time,
contact your doctor or go to a hospital straight away.

Taking other medicines

Breast-feeding

Medicines may affect the action of other medicines and this can
sometimes cause serious adverse reactions.

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.

Please tell your doctor or pharmacist if you are taking or have taken
any other medicines (including those purchased without
prescription) during the last 14 days. This includes other medicines
for depression (see Do not take Citalopram above).


The herbal remedy St John's wort (Hypericum perforatum). This
should not be taken at the same time as Citalopram.



Monoamine oxidase inhibitors (MAOIs). These should not be
taken at the same time as Citalopram (see Do not take
Citalopram above).

Tell your doctor if you are taking any of the following medicines:






Linezolid (an antibiotic).
Sumatriptan (used to treat migraine) or tramadol (a pain killer).
If you feel unwell when using these medicines with Citalopram
you should see your doctor.
Lithium (used to prevent and treat mania) and tryptophan (an
antidepressant)
Pimozide (a neuroleptic). This should not be taken at the same
time as Citalopram (see Do not take Citalopram above).



Imipramine and desipramine (used to treat depression).



Medicines containing selegiline (used to treat Parkinson’s
disease)

This medicinal product contains small amounts of ethanol (alcohol),
less than 100 mg in all doses. These drops also contain the
preservatives E216 and E218, which may cause allergic reactions
(possibly delayed).
3. How to take Citalopram
How much to take

Sleepiness



Difficulty in sleeping



Irregular heart beat



Increased sweating



Seizures





Changes in heart rhythm

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)



Feeling sick (nausea)



Vomiting



Sweating



Drowsiness
Unconsciousness



Important information about some of the ingredients of
Citalopram



Symptoms of overdosage may include:

Fast heart beats



Tremor



Changes in blood pressure



Serotonin syndrome (see Section 4)

Cimetidine (used to treat stomach ulcers).



Mefloquine (used to treat malaria).

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.



Bupropion (used to treat depression).

Adults



Agitation



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).

Depression



Dizziness

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.



Enlarged eye pupils



Bluish skin

Metoprolol, a beta blocker used to treat migraine, some heart
conditions and high blood pressure. The effects of either drug
could be increased, decreased or altered.

 Neuroleptics (used in the treatment of schizophrenia).
Do not take Citalopram if you take medicines for heart rhythm
problems or medicines that may affect the heart’s rhythm, e.g. such
as Class IA and III antiarrhythmics, antipsychotics (e.g.
phenothiazine derivatives, pimozide, haloperidol), tricyclic
antidepressants, certain antimicrobial agents (e.g. sparfloxacin,
moxifloxacin, erythromycin IV, pentamidine, anti-malarial treatment
particularly halofantrine), certain antihistamines (astemizole,
mizolastine). If you have any further questions about this you
should speak to your doctor.
Taking Citalopram with food and drink

Very common side effects (likely to affect more than 1 in 10 people)



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.





The following side effects are often mild and usually disappear after
a few days’ treatment.

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)
Citalopram should not be given to children or adolescents under 18
years of age. For further information, please see section 2, Before
you take Citalopram.
Patients with special risks

 Breathing too quickly
If you forget to take Citalopram
If you forget to take a dose, take the next dose at the usual time. Do
not take a double dose.
Effects when treatment with Citalopram is stopped
Stopping this medicine quickly may cause symptoms such as
dizziness, nausea and numbness or tingling in hands or feet, sleep
disturbances (vivid dreams, nightmares, inability to sleep), feeling
anxious, headaches, feeling or being sick, sweating, feeling restless
or agitated, tremor, feeling confused or disorientated, feeling
emotional or irritable, diarrhoea (loose stools), visual disturbances,
fluttering or pounding heartbeat (palpitations). These are usually
non-serious and disappear within a few days. When you have
completed your course of treatment, the dose of Citalopram is
usually reduced gradually over a couple of weeks.

Common side effects (likely to affect up to 1 in 10 people)


Lack of appetite



Agitation



Decreased sex drive



Anxiety



Nervousness



Confusion



Abnormal dreams



Tremor



Tingling or numbness in the hands or feet



Ringing in the ears (tinnitus)



Yawning



Diarrhoea



Vomiting



Constipation



Itching



Pain in muscles and joints



For men, problems with ejaculation and erection



For females, failing to reach an orgasm



Tiredness,



Prickling of the skin



Loss of weight

Uncommon (likely to affect up to 1 in every 100 people)

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.

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.

Pregnancy

The doses of tablets correspond to doses of drops as follows:

Ask your doctor or pharmacist for advice before taking any
medicine. If you are pregnant, think you might be pregnant, or are
trying to become pregnant, tell your doctor. Do not take Citalopram
if you are pregnant unless you and your doctor have discussed the
risks and benefits involved.

Tablets

Drops

10 mg

8 mg (4 drops)

20 mg

16 mg (8 drops)

30 mg

24 mg (12 drops)

Serious side effects

Make sure your midwife and/or doctor know you are on Citalopram.
When taken during pregnancy, particularly in the last 3 months of
pregnancy, medicines like Citalopram may increase the risk of a
serious condition in babies, called persistent pulmonary
hypertension of the newborn (PPHN), making the baby breathe
faster and appear bluish. These symptoms usually begin during the
first 24 hours after the baby is born. If this happens to your baby
you should contact your midwife and/or doctor immediately. Also, if
you take Citalopram during the last 3 months of your pregnancy and
until the date of birth you should be aware that the following effects
may be seen in your newborn: fits, being too hot or cold, feeding
difficulties, vomiting, low blood sugar, stiff or floppy muscles,
overactive reflexes, tremor, jitteriness, irritability, lethargy, constant
crying, sleepiness or sleeping difficulties. If your newborn baby gets
any of these symptoms please contact your midwife and/or doctor
immediately.

40 mg

32 mg (16 drops)

Stop taking Citalopram and seek medical advice immediately if you
have any of the following symptoms:



Slow heart beat



Nettle rash



Difficulty in breathing.



Loss of hair



Swelling of the face, lips, tongue or throat that causes difficulty
in swallowing or breathing.



Rash



Sensitivity to sunlight

Severe itching of the skin (with raised lumps).





Fast, irregular heart beat, fainting which could be symptoms of
a life-threatening condition known as torsades de pointes.



Difficulties urinating



Vaginal bleeding



Swelling of the arms or legs



Increased weight

Citalopram can be taken with or without food (see section 3 “How to
take Citalopram”).

How and when to take Citalopram
The drops are for oral use and can be taken in a drink of water, or
orange or apple juice.
Citalopram is taken every day as one dose at any time of the day.
Duration of treatment
Like other medicines for depression and panic disorder these drops
may take a few weeks before you feel any improvement. Continue
to take Citalopram even if it takes some time before you feel any
improvement in your condition
The duration of treatment is individual, usually at least 6 months.
Continue to take the drops for as long as your doctor recommends.
Do not stop taking them even if you begin to feel better, unless you
are told to do so by your doctor. The underlying illness may persist
for a long time and if you stop your treatment too soon your
symptoms may return.

4. Possible side effects
Like all medicines, Citalopram can have side effects and some
people may experience unwanted effects (side effects) whilst taking
Citalopram. Several of the effects listed below can also be
symptoms of your illness and may disappear as you start to get
better.

If you notice any of the following you should contact your doctor
immediately as your dose may need to be reduced or stopped:


Your behaviour changes because you feel elated or over
excited.

Bruising easily



Increased appetite
Aggression



Reduced emotions, indifference



Hallucinations



Mania



Fainting



Large pupils (the dark centre of the eye)



Fast heart beat

You start having fits for the first time or fits that you have
suffered from in the past before become more frequent.






If you have any further questions on the use of this product, ask
your doctor or pharmacist.

S1204 LEAFLET Citalopram 20130227

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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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