CIPRAMIL 20MG TABLETS

Active substance: CITALOPRAM HYDROBROMIDE

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CUSTOMER: Waymade

PRE-PRESS NO.:

02-1808

PRODUCT:

Cipramil 20mg tabs

ARTWORKER:

DT

Q.A.
APPROVED:

CUSTOMER
APPROVED:

CODE:

6464/0961G

DATE OF PROOF:

15/08/14

DATE:

PROOF HISTORY:
v.1 - waymade - 15/08/14

DATE:

Leaflet Flat Size = 296 x 420
ARIAL REGULAR FONT SIZE 8
ARIAL BOLD FONT SIZE 10
BRIDGED TO
TRANSTEC 6464/2327 2328 2329

TVT CHECKED
UK PIL DATED APRIL 2014
REPORTING OF SIDE EFFECTS

Pg 1

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CIPRAMIL®

20mg TABLETS/
CITALOPRAM 20mg TABLETS

Nettle rash
Loss of hair
Rash
Sensitivity to sunlight
Difficulties urinating
Excessive menstrual bleeding
Swelling of the arms or legs
Increased weight

(Citalopram hydrobromide)
Patient Information Leaflet

Your medicine is known as the above names but will usually be referred to as Cipramil throughout this leaflet.
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, please 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.

Rare (may affect up to 1 in 1000 people)
• Increased sex drive
• Convulsions
• Involuntary movements
• Taste disturbances
• Bleeding
• Coughing
• Hepatitis
• 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 (thrombocytopenia)
• 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 medicines
• 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:
www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Cipramil
Keep all medicines out of the sight and reach of children.
Cipramil should be stored below 25°C.
Do not use after the expiry date printed on the carton, label or blister strip.
If the tablets become discoloured or show any other signs of deterioration, you should ask 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. Contents of the pack and other information
Each Cipramil 20mg tablet/Citalopram 20mg tablet contains 24.98mg of the active ingredient, citalopram
hydrobromide (equivalent to 20mg citalopram base) in a white oval tablet, which is marked ’C’ breakline ‘N’ on
one side and is plain on the reverse.
Cipramil 20mg tablets/Citalopram 20mg tablets also contain the following ingredients:
Lactose, microcrystalline cellulose, maize starch, polyvinylpyrrolidone vinylacetate, glycerol, croscarmellose
sodium, magnesium stearate, hypromellose, macrogol 400 and titanium dioxide (E171).
Cipramil 20mg tablets/Citalopram 20mg tablets are available as blister packs of 28 tablets.
POM

PL No: 6464/0961

This product is manufactured by H. Lundbeck A/S, 9 Ottiliavej, DK-2500 Copenhagen-Valby, Denmark and is
procured from within the EU and repackaged by the Product Licence holder:
Waymade plc, Miles Gray Road, Basildon, Essex SS14 3FR.
Leaflet revision and issue date (Ref.) 15.08.2014
Cipramil is a registered trademark of H. Lundbeck Ltd.

What is in this leaflet:
1. What Cipramil is and what it is used for
2. What you need to know before you take Cipramil
3. How to take Cipramil
4. Possible side effects
5. How to store Cipramil
6. 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 depression.
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 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 Other
medicines and Cipramil overleaf).
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 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.
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 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.
Pg 2

PRE-PRESS NO.:

02-1808

PRODUCT:

Cipramil 20mg tabs

ARTWORKER:

DT

Q.A.
APPROVED:

CUSTOMER
APPROVED:

CODE:

6464/0961G

DATE OF PROOF:

15/08/14

DATE:

PROOF HISTORY:
v.1 - waymade - 15/08/14

DATE:

CUSTOMER: Waymade

Leaflet Flat Size = 296 x 420
ARIAL REGULAR FONT SIZE 8
ARIAL BOLD FONT SIZE 10
BRIDGED TO
TRANSTEC 6464/2327 2328 2329

TVT CHECKED
UK PIL DATED APRIL 2014
REPORTING OF SIDE EFFECTS

Pg 2

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 Cipramil overleaf).



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 overleaf).

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.
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.
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
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.
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 (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.

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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 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.
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)
• Tremor
• Tingling or numbness in the hands or feet
• Dizziness
• Problems concentrating
• Migraine
• Loss of memory (amnesia)
• Ringing in the ears (tinnitus)
• Palpitations
• Yawning
• Blocked or runny nose (rhinitis)
• Diarrhoea
• Vomiting
• Constipation
• Stomach pain
• Flatulence (wind)
• Increase in saliva (drooling)
• Itching
• Pain in muscles and joints
• For men, problems with ejaculation and erection
• For women, failing to reach an orgasm
• Tiredness
• 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

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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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