CITALOPRAM 40MG TABLETS

Active substance: CITALOPRAM HYDROBROMIDE

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Assessed against UK PIL dated January 2012, includes EU Safety
Warnings PACKAGE LEAFLET: INFORMATION FOR THE USER
Cipramil® 40mg Tablets / Citalopram 40mg Tablets
(citalopram hydrobromide)
This product is available as any of the above names but will be referred to as Cipramil
throughout the remainder of this leaflet. Please note that the leaflet also contains
information about other strengths (Cipramil 10mg and 20mg Tablets).
Read all of this leaflet carefully before you start taking this medicine
Keep this leaflet. You may need to read it again.
If you have further questions, please ask your doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to others. It may harm
them, even if their symptoms are the same as yours.
If any of the side effects are troubling, or if you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Cipramil is and what it is used for
2. Before you take Cipramil
3. How to take Cipramil
4. Possible side effects
5. How to store Cipramil
6. Further information
1. What Cipramil is and what it is used for
How does Cipramil work?
Cipramil is a Selective Serotonin Reuptake Inhibitor (SSRI) and belongs to a group of
medicines known as antidepressants. These medicines help to correct certain chemical
imbalances in the brain that are causing the symptoms of your illness.
What is Cipramil used for?
Cipramil contains citalopram and is used for the treatment of depression and when you feel
better, to help prevent these symptoms recurring.
Cipramil is also used for long-term treatment to prevent the occurrence of new episodes of
depression if you have recurrent depression.
Cipramil is also beneficial in relieving symptoms if you tend to suffer from panic attacks.
2. Before you take Cipramil
Do not take Cipramil
if you are allergic (hypersensitive) to citalopram or 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 EEG; an
examination to evaluate how the heart is functioning)
if you take medicines for heart rhythm problems or that may affect the heart’s rhythm.
(see Taking other medicines, below).
Take special care with Cipramil
Please tell your doctor if you have any medical problems, especially if you have
Liver disease.
Kidney disease.
Diabetes (you may need an adjustment of your antidiabetic therapy).
Epilepsy or a history of seizures or fits.
A bleeding disorder or have ever suffered from bleeding in the stomach or intestine.
Mania or panic disorder
Low blood levels of sodium
ECT (electroconvulsive therapy)
Problems with your eyes, such as certain kinds of glaucoma.
Suffered or suffer from heart problems or have recently had a heart attack
A low resting heart-rate and/or you know that you may have salt depletion as a result of
prolonged severe diarrhoea and vomiting (being sick) or usage of diuretics (water tablets)
Experienced a fast or irregular heartbeat, fainting, collapse or dizziness on standing up
which may indicate abnormal functioning of the heart rate.
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.

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Use in children and adolescents under 18choudhurya at 1:36 pm, Jul 16, 2012
By 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
Medicines may affect the action of other medicines and this can sometimes cause serious
adverse reactions. Please tell your doctor or pharmacist if you are taking or have taken any
other medicines (including those purchased without prescription) during the last 14 days.
This includes other medicines for depression (see Do not take Cipramil above).
The herbal remedy St John’s wort (Hypericum perforatum). This should not be taken at
the same time as Cipramil.
Monoamine oxidase inhibitors (MAOIs). These should not be taken at the same time as
Cipramil (see Do not take Cipramil above).
Tell your doctor if you are taking any of the following medicines:
Linezolid (an antibiotic).
Sumatriptan (used to treat migraine) or tramadol (a pain killer). If you feel unwell when
using these medicines with Cipramil you should see your doctor.
Lithium (used to prevent and treat mania) and tryptophan (an antidepressant)
Pimozide (a neuroleptic). This should not be taken at the same time as Cipramil (see Do
not take Cipramil above).
Imipramine and desipramine (used to treat depression).
Medicines containing selegiline (used to treat Parkinson’s disease)
Cimetidine (used to treat stomach ulcers).
Mefloquine (used to treat malaria).
Bupropion (used to treat depression).
Medicines known to affect the blood platelets (e.g. anticoagulant drugs used to treat or
prevent blood clots; aspirin and non-steroidal 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 Cipramil if you take medicines for heart rhythm problems or medicines that
may affect the heart’s rhythm, e.g. such as Class IA and III antiarrhythmics, antipsychotics
(e.g. fentiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain
antimicrobial agents (e.g. sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, antimalarial treatment particularly halofantrine), certain antihistamines (astemizole,
mizolastine). If you have any further questions about this you should speak to your doctor.
Taking Cipramil with food and drink
Cipramil can be taken with or without food (see section 3 “How to take Cipramil”).
As with all antidepressants, it is sensible to avoid drinking alcohol whilst receiving treatment
although Cipramil has not been shown to increase the effects of alcohol.
Pregnancy
Ask your doctor or pharmacist for advice before taking any medicine. If you are pregnant,
think you might be pregnant, or are trying to become pregnant, tell your doctor. Do not take
Cipramil if you are pregnant unless you and your doctor have discussed the risks and
benefits involved.
Make sure your midwife and/or doctor know you are on Cipramil. When taken during
pregnancy, particularly in the last 3 months of pregnancy, medicines like Cipramil may
increase the risk of a serious condition in babies, called persistent pulmonary hypertension
of the newborn (PPHN), making the baby breathe faster and appear bluish. These
symptoms usually begin during the first 24 hours after the baby is born. If this happens to
your baby you should contact your midwife and/or doctor immediately. Also, if you take
Cipramil during the last 3 months of your pregnancy and until the date of birth you should
be aware that the following effects may be seen in your newborn: fits, being too hot or cold,
feeding difficulties, vomiting, low blood sugar, stiff or floppy muscles, overactive reflexes,
tremor, jitteriness, irritability, lethargy, constant crying, sleepiness or sleeping difficulties. If
your newborn baby gets any of these symptoms please contact your midwife and/or doctor
immediately.
Breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
If you are breast-feeding, ask your doctor for advice. You should not breast-feed your baby
when taking Cipramil because small amounts of the medicine can pass into the breast milk.
Driving and using machines
Cipramil does not usually affect the ability to carry out normal daily activities. However, if
you feel dizzy or sleepy when you start to take this medicine, you should be careful when
driving, operating machinery or performing jobs that need you to be alert until these effects
wear off.

Special information relating to your disease
As with other medicines used to treat depression or related diseases, the improvement is
not achieved immediately. After the start of Cipramil treatment it may take several weeks
before you experience any improvement. In the beginning of the treatment certain patients
may experience increased anxiety, which will disappear during continued treatment.
Therefore, it is very important that you follow exactly your doctor’s orders and do not stop
the treatment or change the dose without consulting your doctor.

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.

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.

3. How to take Cipramil

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.

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.

How much to take
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.
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.
How and when to take Cipramil
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).
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 take more Cipramil than you should
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.
Symptoms of overdosage may include:
Irregular heart beat
Seizures
Changes in heart rhythm
Feeling sick (nausea)
Vomiting
Sweating
Drowsiness
Unconsciousness
Fast heart beats
Tremor
Changes in blood pressure
Serotonin syndrome (see Section 4)
Agitation
Dizziness
Enlarged eye pupils
Bluish skin
Breathing too quickly
If you forget to take Cipramil
If you forget to take a dose, take the next dose at the usual time. Do not take a double dose.
Effects when treatment with Cipramil is stopped
Stopping this medicine quickly may cause symptoms such as dizziness, nausea and
numbness or tingling in hands or feet, sleep disturbances (vivid dreams, nightmares, inability
to sleep), feeling anxious, headaches, feeling or being sick, sweating, feeling restless or
agitated, tremor, feeling confused or disorientated, feeling emotional or irritable, diarrhoea
(loose stools), visual disturbances, fluttering or pounding heartbeat (palpitations). These are
usually non-serious and disappear within a few days. When you have completed your course
of treatment, the dose of Cipramil is usually reduced gradually over a couple of weeks.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible Side Effects
Like all medicines, Cipramil can have side effects and some people may experience
unwanted effects (side effects) whilst taking Cipramil. Several of the effects listed below
can also be symptoms of your illness and may disappear as you start to get better.
Serious side effects
Stop taking Cipramil and seek medical advice immediately if you have any of the following
symptoms:
Difficulty in breathing.
Swelling of the face, lips, tongue or throat that causes difficulty in swallowing or breathing.
Severe itching of the skin (with raised lumps).
Fast, irregular heart beat, fainting which could be symptoms of a life-threatening
condition known as torsades de pointes.

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 1000 people)
Convulsions
Involuntary movements
Taste disturbances
Bleeding
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 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
Cipramil, please tell your doctor.
If you notice any other side effects not mentioned in this leaflet please tell your doctor or
pharmacist.
5. How to store Cipramil

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
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.
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 up to 1 in 10 people)
Lack of appetite
Agitation
Decreased sex drive
Anxiety
Nervousness
Confusion

Always keep medicines out of reach and sight of children.
Do not use after the expiry date printed on the carton label or blister strip.
Do not store above 25°C.
If your doctor tells you to stop taking the tablets, please take them back to the
pharmacist for safe disposal. Only keep the tablets if your doctor tells you to.
If the tablets become discoloured or show signs of any deterioration, you should consult
your pharmacist who will advise you what to do.
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. Further Information
Each tablet contains 40mg of the active ingredient citalopram (as hydrobromide). The
tablets are white, oval-shaped and film-coated and marked 'C' breakline 'R' on one side and
plain on the reverse.
Cipramil also contains the following ingredients: maize starch, lactose, copolyvidone,
glycerol, microcrystalline cellulose, croscarmellose sodium, magnesium stearate,
hypromellose, macrogol 400 and titanium dioxide (E171).
Cipramil is available as blister packs of 14 or 28 tablets.
PL No: 15814/0713
Cipramil 40mg Tablets / Citalopram 40mg Tablets
POM
This product is manufactured by H Lundbeck A/S, Ottiliavej DK-2500 Copenhagen-Valby,
Denmark and is procured from within the EU and repackaged by the Product Licence
holder: O.P.D Laboratories Ltd, Unit 6 Colonial Way, Watford, Herts WD2 4PR.
Leaflet revision and issue date (Ref.) 26.06.2012.

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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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