CIPRAMIL 40MG TABLETS

Active substance: CITALOPRAM HYDROBROMIDE

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Kidney disease.

PACKAGE LEAFLET: INFORMATION FOR THE USER



CIPRAMIL 40mg TABLETS
(citalopram hydrobromide)

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



Epilepsy or a history of seizures or fits.



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

S448 LEAFLET Cipramil 20130221

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

5. How to store Cipramil



Convulsions



Do not store above 25°C.



Involuntary movements



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Taste disturbances





Bleeding

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



Hepatitis



Some patient have reported (frequency not known)


Thoughts of harming or killing themselves



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



Rash (hypersensitivity)



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



Panic attack



Grinding teeth



Restlessness



Unusual muscle movements or stiffness



Involuntary movements of the muscles (akathisia)



Low blood pressure



Nosebleed



Bleeding disorders including skin and mucosal bleeding
(ecchymosis)



Sudden swelling of skin or mucosa



In men, painful erections



Flow of breast milk in men or in women who are not breastfeeding (galactorrhoea)



Abnormal liver function tests



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

If your doctor tells you to stop using the medicine, please take it
back to the pharmacist for safe disposal. Only keep the
medicine if your doctor tells you to.

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.





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.

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



Mania or panic disorder

Information for other strengths of Cipramil (Cipramil 10mg Tablets
and Cipramil 20mg Tablets) also may be present in this leaflet.



Low blood levels of sodium

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



ECT (electroconvulsive therapy)



Problems with your eyes, such as certain kinds of glaucoma.



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





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

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





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.

6. Further information


What Cipramil contains


Each Cipramil tablet contains 40mg of the active ingredient
citalopram (as the hydrobromide).



Cipramil also contain the following inactive ingredients: lactose,
maize starch, microcrystalline cellulose, magnesium stearate,
titanium dioxide (E171), hypromellose, macrogol 400,
croscarmellose sodium, glycerol and copolyvidone.

What Cipramil looks like and contents of the pack

If any of the side effects are troubling, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.

In this leaflet:
1. What Cipramil is and what it is used for
2. Before you take Cipramil
3. How to take Cipramil



The film-coated tablets are white; oval shaped and marked ‘C’
and ‘R’ symmetrically around the score and plain on the reverse.

4. Possible side effects



Cipramil is available as blister packs of 14 or 28 tablets
(Cipramil 40mg Tablets).

6. Further information

5. How to store Cipramil
1. What Cipramil is and what it is used for

Product Licence holder

How does Cipramil work?

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

Cipramil is a Selective Serotonin Reuptake Inhibitor (SSRI) and
belongs to a group of medicines known as antidepressants. These
medicines help to correct certain chemical imbalances in the brain
that are causing the symptoms of your illness.

Manufacturer

What is Cipramil used for?

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

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

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.

Leaflet revision date: 21st February 2013

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

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

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

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

POM

PL No. 19488/0448

S448 LEAFLET Cipramil 20130221

2. Before you take Cipramil
Do not take Cipramil


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



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



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



if you are born with or have had an episode of abnormal heart
rhythm (seen at ECG; an examination to evaluate how the heart
is functioning).



if you take medicines for heart rhythm problems or that may
affect the heart’s rhythm (see Taking other medicines, below).

Take special care with Cipramil
Please tell your doctor if you have any medical problems, especially
if you have


Liver disease.

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 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 Cipramil treatment it may take several weeks before you
experience any improvement. In the beginning of the treatment
certain patients may experience increased anxiety, which will
disappear during continued treatment. Therefore, it is very important
that you follow exactly your doctor’s orders and do not stop the
treatment or change the dose without consulting your doctor.
Thoughts of suicide and worsening of your depression or
anxiety disorder
If you are depressed and/or have anxiety disorders you can
sometimes have thoughts of harming or killing yourself. These may
be increased when first starting antidepressants, since these
medicines all take time to work, usually about two weeks but
sometimes longer.
You may be more likely to think like this:


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



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

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

Taking other medicines

Breast-feeding

If you take more Cipramil than you should

Medicines may affect the action of other medicines and this can
sometimes cause serious adverse reactions. Please tell your doctor
or pharmacist if you are taking or have taken any other medicines
(including those purchased without prescription) during the last 14
days. This includes other medicines for depression (see Do not
take Cipramil above).

Ask your doctor or pharmacist for advice before taking any
medicine.

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




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).

If you are breast-feeding, ask your doctor for advice. You should not
breast-feed your baby when taking Cipramil because small amounts
of the medicine can pass into the breast milk.
Fertility
Citalopram has been shown to reduce the quality of sperm in animal
studies. Theoretically, this could affect fertility, but impact on human
fertility has not been observed as yet.



Vomiting

Agitation



Sweating



Decreased sex drive



Drowsiness



Anxiety

Unconsciousness



Nervousness

Fast heart beats



Confusion



Tremor



Abnormal dreams



Changes in blood pressure



Tremor



Serotonin syndrome (see Section 4)



Tingling or numbness in the hands or feet



Agitation



Ringing in the ears (tinnitus)

Dizziness



Yawning

Enlarged eye pupils



Diarrhoea

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.



Pain in muscles and joints



For men, problems with ejaculation and erection

Effects when treatment with Cipramil is stopped



For females, failing to reach an orgasm

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.



Tiredness



Prickling of the skin



Loss of weight

Important information about some of the ingredients of
Cipramil
This product contains lactose.
If you have been told by your doctor that you have an intolerance to
some sugars, contact your doctor before taking this medicinal
product.

Medicines known to affect the blood platelets (e.g. anticoagulant
drugs used to treat or prevent blood clots; aspirin and nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen
and diclofenac used as painkillers and some antipsychotic drugs
and tricyclic antidepressants).

Ask your doctor or pharmacist for advice before taking any
medicine. If you are pregnant, think you might be pregnant, or are
trying to become pregnant, tell your doctor. Do not take Cipramil if
you are pregnant unless you and your doctor have discussed the
risks and benefits involved.
Make sure your midwife and/or doctor know you are on Cipramil.
When taken during pregnancy, particularly in the last 3 months of
pregnancy, medicines like Cipramil may increase the risk of a
serious condition in babies, called persistent pulmonary
hypertension of the newborn (PPHN), making the baby breathe
faster and appear bluish. These symptoms usually begin during the
first 24 hours after the baby is born. If this happens to your baby you
should contact your midwife and/or doctor immediately. Also, if you
take Cipramil during the last 3 months of your pregnancy and until
the date of birth you should be aware that the following effects may
be seen in your newborn: fits, being too hot or cold, feeding
difficulties, vomiting, low blood sugar, stiff or floppy muscles,
overactive reflexes, tremor, jitteriness, irritability, lethargy, constant
crying, sleepiness or sleeping difficulties. If your newborn baby gets
any of these symptoms please contact your midwife and/or doctor
immediately.



Lack of appetite



Pregnancy

Seizures



Bupropion (used to treat depression).

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.

Feeling sick (nausea)







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

Dry mouth (a dry mouth increases the risk of tooth decay, so be
sure to clean your teeth more often than usual)

Irregular heart beat

Feeling sick (nausea)

Mefloquine (used to treat malaria).

Taking Cipramil with food and drink





Changes in heart rhythm



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.

Increased sweating



It is important to take your tablets 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.

Neuroleptics (used in the treatment of schizophrenia).

Difficulty in sleeping





Cimetidine (used to treat stomach ulcers).



Sleepiness



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.



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.



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

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



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

Driving and using machines

3. How to take Cipramil



Symptoms of overdosage may include:

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

How much to take

Adults
Depression
The usual dose is 20 mg per day. This may be increased by your
doctor to a maximum of 40 mg per day.
Panic disorder
The starting dose is 10 mg per day for the first week before
increasing the dose to 20-30 mg per day. The dose may be
increased by your doctor to a maximum of 40 mg per day.
Elderly patients (above 65 years of age)
The starting dose should be decreased to half of the recommended
dose, e.g. 10-20 mg per day. Elderly patients should not usually
receive more than 20 mg per day.
Children and adolescents (< 18 years)
Cipramil should not be given to children or adolescents. For further
information, please see section 2, Before you take Cipramil.
Patients with special risks
Patients with liver complaints should not receive more than 20 mg
per day.








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


Bruising easily



Increased appetite



Aggression



Reduced emotions, indifference



Hallucinations

4. Possible side effects



Mania

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.



Fainting



Large pupils (the dark centre of the eye)



Fast heart beat



Slow heart beat



Nettle rash



Loss of hair

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

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

How and when to take Cipramil



Difficulty in breathing.



Rash

Cipramil is taken every day as a single daily dose. Cipramil can be
taken any time of the day with or without food. Swallow the tablets
with a drink of water. Do not chew them (they have a bitter taste).



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



Sensitivity to sunlight





Difficulties urinating

Severe itching of the skin (with raised lumps).





Vaginal bleeding

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

Duration of treatment
Like other medicines for depression and panic disorder these tablets
may take a few weeks before you feel any improvement. Continue to
take Cipramil even if it takes some time before you feel any
improvement in your condition. The duration of treatment is
individual, usually at least 6 months. Continue to take the tablets 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 notice any of the following symptoms 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 become more frequent.



Your behaviour changes because you feel elated or over
excited.



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



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

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

S448 LEAFLET Citalopram 20130221

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

5. How to store Citalopram Tablets



Convulsions



Do not store above 25°C.



Involuntary movements



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Taste disturbances





Bleeding

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



Hepatitis



If your doctor tells you to stop using the medicine, please take it
back to the pharmacist for safe disposal. Only keep the
medicine if your 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.

Some patient have reported (frequency not known)


Thoughts of harming or killing themselves



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



Rash (hypersensitivity)



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



Panic attack



Grinding teeth



Restlessness



Unusual muscle movements or stiffness



Involuntary movements of the muscles (akathisia)



Low blood pressure



Nosebleed



Bleeding disorders including skin and mucosal bleeding
(ecchymosis)



PACKAGE LEAFLET: INFORMATION FOR THE USER

Sudden swelling of skin or mucosa

6. Further information

CITALOPRAM 40mg TABLETS
(citalopram hydrobromide)
The name of your medicine is Citalopram 40mg Tablets but will be
referred to as Citalopram Tablet throughout the following leaflet.
Information for other strengths of Citalopram (Citalopram 10mg
Tablets and Citalopram 20mg Tablets) also may be present in this
leaflet.
Read all of this leaflet carefully before you start taking this
medicine



Citalopram Tablets also contain the following inactive
ingredients: lactose, maize starch, microcrystalline cellulose,
magnesium stearate, titanium dioxide (E171), hypromellose,
macrogol 400, croscarmellose sodium, glycerol and
copolyvidone.



Epilepsy or a history of seizures or fits.



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



Mania or panic disorder



Low blood levels of sodium



ECT (electroconvulsive therapy)

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.



Problems with your eyes, such as certain kinds of glaucoma.



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

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.



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.

In this leaflet:
1. What Citalopram Tablets are and what they are used for
2. Before you take Citalopram Tablets
3. How to take Citalopram Tablets
4. Possible side effects

What Citalopram Tablets look like and contents of the pack

Flow of breast milk in men or in women who are not breastfeeding (galactorrhoea)



6. Further information



The film-coated tablets are white; oval shaped and marked ‘C’
and ‘R’ symmetrically around the score and plain on the reverse.

Abnormal liver function tests





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

Citalopram Tablets are available as blister packs of 14 or 28
tablets (Citalopram 40mg Tablets).

1. What Citalopram Tablets are and what they are used for

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

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



In men, painful erections

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 Tablets, please
tell your doctor.

Kidney disease.



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



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

Liver disease.







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.



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

Each Citalopram Tablets contain 40mg of the active ingredient
citalopram (as the hydrobromide).



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





What Citalopram Tablets contain

Take special care with Citalopram Tablets

5. How to store Citalopram Tablets

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 you experience these symptoms.

How do Citalopram Tablets work?
Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: S & M Medical Ltd, Chemilines House, Alperton
Lane, Wembley, Middlesex, HA0 1DX.

What are Citalopram Tablets used for?

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

Citalopram Tablets are Selective Serotonin Reuptake Inhibitor
(SSRI) and belong 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.

PL No. 19488/0448
st

Leaflet revision date: 21 February 2013

Citalopram Tablets contain citalopram and is used for the treatment
of depression and, when you feel better, to help prevent these
symptoms recurring.
Citalopram Tablets are also used for long-term treatment to prevent
the occurrence of new episodes of depression if you have recurrent
depression.
Citalopram Tablets are also beneficial in relieving symptoms if you
tend to suffer from panic attacks.

S448 LEAFLET Citalopram 20130221

2. Before you take Citalopram Tablets
Do not take Citalopram Tablets


if you are allergic (hypersensitive) to citalopram or to any of the
other ingredients of Citalopram Tablets (see What Citalopram
Tablets 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 your Citalopram Tablets.
One day must elapse after you have finished taking
moclobemide. After stopping Citalopram Tablets 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).

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 Tablets treatment it may take several weeks
before you experience any improvement. In the beginning of the
treatment certain patients may experience increased anxiety, which
will disappear during continued treatment. Therefore, it is very
important that you follow exactly your doctor’s orders and do not
stop the treatment or change the dose without consulting your
doctor.
Thoughts of suicide and worsening of your depression or
anxiety disorder
If you are depressed and/or have anxiety disorders you can
sometimes have thoughts of harming or killing yourself. These may
be increased when first starting antidepressants, since these
medicines all take time to work, usually about two weeks but
sometimes longer.
You may be more likely to think like this:


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



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

If you have thoughts of harming or killing yourself at any time,
contact your doctor or go to a hospital straight away.
You may find it helpful to tell a relative or close friend that you
are depressed or have an anxiety disorder, and ask them to read
this leaflet. You might ask them to tell you if they think your
depression or anxiety is getting worse, or if they are worried about
changes in your behaviour.

Make sure your midwife and/or doctor know you are on Citalopram
Tablets. When taken during pregnancy, particularly in the last 3
months of pregnancy, medicines like Citalopram Tablets 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 Tablets 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.

Duration of treatment

Citalopram Tablets 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 Tablets 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 Tablets. Also, the long-term safety effects concerning
growth, maturation and cognitive and behavioural development of
Citalopram Tablets in this age group have not yet been
demonstrated.
Taking other medicines
Medicines may affect the action of other medicines and this can
sometimes cause serious adverse reactions. Please tell your doctor
or pharmacist if you are taking or have taken any other medicines
(including those purchased without prescription) during the last 14
days. This includes other medicines for depression (see Do not
take Citalopram Tablets above).

Use in children and adolescents under 18 years of age




The herbal remedy St John’s wort (Hypericum perforatum). This
should not be taken at the same time as Citalopram Tablets.
Monoamine oxidase inhibitors (MAOIs). These should not be
taken at the same time as Citalopram Tablets (see Do not take
Citalopram Tablets 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
Tablets 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 Tablets (see Do not take Citalopram Tablets
above).



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



Your behaviour changes because you feel elated or over
excited.



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, trembling or
abrupt contractions of muscles. These may be signs of a rare
condition called serotonin syndrome.



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

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

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

Breast-feeding

If you take more Citalopram Tablets than you should

Ask your doctor or pharmacist for advice before taking any
medicine.

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

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

If you are breast-feeding, ask your doctor for advice. You should not
breast-feed your baby when taking Citalopram Tablets 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 Tablets do not usually affect the ability to carry out
normal daily activities. However, if you feel dizzy or sleepy when you
start to take this medicine, you should be careful when driving,
operating machinery or performing jobs that need you to be alert
until these effects wear off.
Important information about some of the ingredients of
Citalopram Tablets
This product contains lactose.
If you have been told by your doctor that you have an intolerance to
some sugars, contact your doctor before taking this medicinal
product.

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 nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen
and diclofenac used as painkillers and some antipsychotic drugs
and tricyclic antidepressants).

Neuroleptics (used in the treatment of schizophrenia).

Do not take Citalopram Tablets 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 Tablets with food and drink
Citalopram Tablets can be taken with or without food (see section 3
“How to take Citalopram Tablets”).
As with all antidepressants, it is sensible to avoid drinking alcohol
whilst receiving treatment although Citalopram Tablets have not
been shown to increase the effects of alcohol.
Pregnancy
Ask your doctor or pharmacist for advice before taking any
medicine. If you are pregnant, think you might be pregnant, or are
trying to become pregnant, tell your doctor. Do not take Citalopram
Tablets if you are pregnant unless you and your doctor have
discussed the risks and benefits involved.

Adults
Depression
The usual dose is 20 mg per day. This may be increased by your
doctor to a maximum of 40 mg per day.
Panic disorder
The starting dose is 10 mg per day for the first week before
increasing the dose to 20-30 mg per day. The dose may be
increased by your doctor to a maximum of 40 mg per day.
Elderly patients (above 65 years of age)
The starting dose should be decreased to half of the recommended
dose, e.g. 10-20 mg per day. Elderly patients should not usually
receive more than 20 mg per day.

Changes in heart rhythm
Feeling sick (nausea)



Vomiting



Sweating



Drowsiness



Unconsciousness



Fast heart beats



Tremor



Changes in blood pressure



Serotonin syndrome (see Section 4)



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

Effects when treatment with Citalopram Tablets is stopped



For females, failing to reach an orgasm

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 Tablets
is usually reduced gradually over a couple of weeks.



Tiredness



Prickling of the skin



Loss of weight

 Breathing too quickly
If you forget to take Citalopram Tablets
If you forget to take a dose, take the next dose at the usual time. Do
not take a double dose.

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

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

Feeling sick (nausea)



Bluish skin



Dry mouth (a dry mouth increases the risk of tooth decay, so be
sure to clean your teeth more often than usual)





Mefloquine (used to treat malaria).

Increased sweating



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

Enlarged eye pupils









It is important to take your tablets 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.

Difficulty in sleeping

Seizures

How much to take

Cimetidine (used to treat stomach ulcers).

Sleepiness





Dizziness





Irregular heart beat



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

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



Agitation





Symptoms of overdosage may include:



Imipramine and desipramine (used to treat depression).

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.

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


3. How to take Citalopram Tablets



Like other medicines for depression and panic disorder these tablets
may take a few weeks before you feel any improvement. Continue to
take Citalopram Tablets 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 tablets 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.

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

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

Patients with special risks

Serious side effects



Nettle rash

Patients with liver complaints should not receive more than 20 mg
per day.

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



Loss of hair





Rash

Difficulty in breathing.





Sensitivity to sunlight

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



Difficulties urinating



Vaginal bleeding

How and when to take Citalopram Tablets
Citalopram Tablets are taken every day as a single daily dose.
Citalopram Tablets can be taken any time of the day with or without
food. Swallow the tablets with a drink of water. Do not chew them
(they have a bitter taste).



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.



Swelling of the arms or legs



Increased weight

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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