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Package leaflet: Information for the user

Cipramil® 10 mg film-coated tablets
Cipramil® 40 mg film-coated tablets
citalopram (as hydrobromide)
Read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm
them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to you doctor or pharmacist. This includes any possible
side effects not listed in this leaflet. See section 4.

What is in this leaflet:

What Cipramil is and what it is used for
What you need to know before you take Cipramil
How to take Cipramil
Possible side effects
How to store Cipramil
Contents of the pack and other 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
Cipramil is also beneficial in relieving symptoms if you tend to suffer from panic attacks.

2. What you need to know before you take Cipramil
Do not take Cipramil
• if you are allergic to citalopram or to any of the other ingredients of this medicine
(listed in section 6). Consult your doctor if you think you might be.
• 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
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 Other medicines and Cipramil below).

Warnings and precautions
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
• 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
Please note:
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
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
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.
Other medicines and Cipramil
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, have taken or might
take any other medicines. This includes other medicines for depression (see Do not take

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).

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.
• 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. 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, drink and alcohol
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.
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
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
Ask your doctor or pharmacist for advice before taking any medicine. If you are breastfeeding, 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.

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
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.
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.

3. How to take Cipramil
How much to take
Always take this medicine exactly as your doctor or pharmacist has told you. Check with
your doctor or pharmacist if you are not sure.
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 (less than 18 years of age)
Cipramil should not be given to children or adolescents. For further information, please see
section 2, What you need to know 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 this medicine can cause side effects, although not everybody gets them.
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
• Difficulty in breathing.
• Swelling of the face, lips, tongue or throat that causes difficulty in swallowing or
• 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.
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 (hyponatraemia).
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 (may affect more than 1 in 10 people)
• Sleepiness
• Difficulty in sleeping
• Headache
• Changes in your sleeping pattern
• Loss of body strength, weakness
• 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 (may affect up to 1 in 10 people)
• Lack of appetite
• Agitation
• Decreased sex drive
• Anxiety
• Nervousness
• Confusion

Abnormal dreams
Reduced emotions, indifference (apathy)
Tingling or numbness in the hands or feet
Problems concentrating
Loss of memory (amnesia)
Ringing in the ears (tinnitus)
Blocked or runny nose (rhinitis)
Stomach pain
Flatulence (wind)
Increase in saliva (drooling)
Pain in muscles and joints
For men, problems with ejaculation and erection
For women, failing to reach an orgasm
Prickling of the skin
Loss of weight

Uncommon (may affect up to 1 in 100 people)
• Bruising easily
• Increased appetite
• Aggression
• 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
• Excessive menstrual bleeding
• Swelling of the arms or legs
• Increased weight
Rare (may affect up to 1 in 1000 people)
• Increased sex drive

Involuntary movements
Taste disturbances
Feeling unwell (malaise)

Some patient have reported (frequency not known)
• Thoughts of harming or killing themselves, see also section 2 “What you need to
know before you take Cipramil”
• 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)
• Irregular menstrual periods
• Abnormal liver function tests
• An increased risk of bone fractures has been observed in patients taking this type of
• Abnormal heart rhythm
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.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any
possible side effects not listed in this leaflet. You can also report side effects directly via the
Yellow Card Scheme at:
Alternatively you can call Freephone 0808 100 3352 (available between 10am-2pm Monday
– Friday) or fill in a paper form available from your local pharmacy.

By reporting side effects you can help provide more information on the safety of this

5. How to store Cipramil

Always keep this medicine out of the sight and reach of children.
Store your tablets at or below 25°C.
Do not use this medicine after the expiry date which is stated on the label or carton. The
expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist
how to throw away medicines you no longer use. These measures will help to protect the

6. Contents of the pack and other information
What Cipramil contains
The active substance is citalopram (as hydrobromide). Each Cipramil film-coated tablets
contain 10 mg or 40 mg citalopram.
The other ingredients are maize starch, lactose monohydrate, microcrystalline cellulose,
copovidone, glycerol, croscarmellose sodium, magnesium stearate, methylhydroxypropylcellulose, macrogol and the white colour E 171 (titanium dioxide).
What Cipramil looks like and contents of the packs
The 10 mg tablets are round, white, film-coated, marked “CL”.
The 40 mg tablets are oval, white, scored, film-coated, marked with “C” and “R”.
Both the strengths are available in blister packs of 28 tablets.
These tablets are manufactured by:
H. Lundbeck A/S - Ottiliavej 9 - 2500 Valby - Denmark
For any information about this medicine, please contact the Marketing Authorisation holder:
Lundbeck Limited
Timbold Drive
Kents Hill
Milton Keynes MK7 6BZ
01908 638972
This leaflet was last revised in 03/2015

request a copy of this leaflet in braille, large print or audio please call free of charge:

0800 198 5000
Please be ready to give the following information:

Product name

Product code number

Cipramil 10 mg film-coated tablets

PL 0458/0057

Cipramil 40 mg film-coated tablets

PL 0458/0059

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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.