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ESCITALOPRAM 5MG FILM COATED TABLETS

Active substance(s): ESCITALOPRAM / ESCITALOPRAM OXALATE

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CUSTOMER:
PRODUCT:

Cipralex 5mg FC tabs

CODE:

PRE-PRESS NO.:

02-1808

ARTWORKER:
DATE OF PROOF:

DT

Q.A.
APPROVED:

CUSTOMER
APPROVED:

17/10/13

DATE:

DATE:

PROOF HISTORY:
v.1
- 17/10/13

«PAdBì
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 SEPTEMBER 2013

Pg 1

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In addition, a number of side effects are known to occur with drugs that work in a similar way to escitalopram
(the active ingredient of Cipralex). These are:
• Motor restlessness (akathisia)
• Loss of appetite

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 (see details below).
By reporting side effects you can help provide more information on the safety of this medicine.
United Kingdom
Via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
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.

5. Storing Cipralex
Always keep medicines out of the sight and reach of children.
There are no special storage conditions.
Do not use Cipralex after the expiry date, which is stated on the label or carton after EXP. The expiry date
refers to the last day of the month.
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
What Cipralex contains:
Each Cipralex 5mg film-coated tablet/Escitalopram 5mg film-coated tablet contains 5mg of the active
ingredient, Escitalopram (as the oxalate).
The other ingredients are:
microcrystalline cellulose, anhydrous colloidal silica, talc, croscarmellose sodium, magnesium stearate,
hypromellose, macrogol 400 and titanium dioxide (E171).
What do Cipralex 5mg film-coated tablets/Escitalopram 5mg film-coated tablets look like?
Each Cipralex 5mg film-coated tablet/Escitalopram 5mg film-coated tablet is a white, round, film-coated
tablet, which is marked ’EK’ on one side and is plain on the other side.
Cipralex 5mg film-coated tablets/Escitalopram 5mg film-coated tablets are available as blister packs of 28
tablets.
POM

PL No:

18799/2744

This product is manufactured by H Lundbeck A/S, DK-2500 Copenhagen-Valby, Denmark and procured
from within the EU and repackaged by the Product Licence holder:

B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.
Leaflet revision and issue date (Ref.)

15/06/2015

Cipralex is a registered trademark of H. Lundbeck A/S.

CIPRALEX® 5mg

FILM-COATED TABLETS/
ESCITALOPRAM 5mg FILM-COATED TABLETS
(escitalopram oxalate)
Patient Information Leaflet

This product is known as either of the above names but will be referred to as Cipralex in this leaflet. Other
strengths (10mg and 20mg) are also available.
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 your doctor or pharmacist. This includes any possible side effects
not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Cipralex is and what it is used for
2. What you need to know before you take Cipralex
3. How to take Cipralex
4. Possible side effects
5. How to store Cipralex
6. Contents of the pack and other information

1. What Cipralex is and what it is used for
Cipralex contains the active substance escitalopram. Cipralex belongs to a group of antidepressants called
selective serotonin reuptake inhibitors (SSRIs). These medicines act on the serotonin-system in the brain by
increasing the serotonin level. Disturbances in the serotonin-system are considered an important factor in the
development of depression and related diseases.
Cipralex contains escitalopram and is used to treat depression (major depressive episodes) and anxiety
disorders (such as panic disorder with or without agoraphobia, social anxiety disorder, generalised anxiety
disorder and obsessive-compulsive disorder).
It may take a couple of weeks before you start to feel better. Continue to take Cipralex, even if it takes some
time before you feel any improvement in your condition.
You must talk to a doctor if you do not feel better of if you feel worse.

2. What you need to know before you take Cipralex
Do not take Cipralex
• If you are allergic to escitalopram or any of the other ingredients of this medicine (listed in section 6).
• If you take other medicines which belong to a group called MAO inhibitors, including selegiline (used
in the treatment of Parkinson´s disease), moclobemide (used in the treatment of depression) and
linezolid (an antibiotic).
• 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 section 2
“Other medicines and Cipralex”).
Warnings and precautions
Talk to your doctor or pharmacist before taking Cipralex. Please tell your doctor if you have any other
condition or illness, as your doctor may need to take this into consideration. In particular, tell your doctor:
• If you have epilepsy. Treatment with Cipralex should be stopped if seizures occur for the first time,
or if there is an increase in the seizure frequency (see also section 4 “Possible side effects").
• If you suffer from impaired liver or kidney function. Your doctor may need to adjust your dosage.
• If you have diabetes. Treatment with Cipralex may alter glycaemic control. Insulin and/or oral
hypoglycaemic dosage may need to be adjusted.
• If you have a decreased level of sodium in the blood.
• If you have a tendency to easily develop bleedings or bruises.
• If you are receiving electroconvulsive treatment.
• If you have coronary heart disease.
• If you suffer or have suffered from heart problems or have recently had a heart attack.
• If you have 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).
• If you experience a fast or irregular heart beat, fainting, collapse or dizziness on standing up, which
may indicate abnormal functioning of the heart rate.
• If you have or have previously had eye problems, such as certain kinds of glaucoma (increased
pressure in the eye).
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.
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.
Children and adolescents under 18 years of age
Cipralex 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 attempts, suicidal thoughts and
hostility (predominately aggression, oppositional behaviour and anger) when they take this class of medicines.
Despite this, your doctor may prescribe Cipralex for patients under 18 because he/she decides that this is in
their best interest. If your doctor has prescribed Cipralex for a patient under 18 and you want to
discuss this, please go back to your doctor. You should inform your doctor if any symptoms listed above
develop or worsen when patients under 18 are taking Cipralex. Also, the long term safety effects concerning
growth, maturation and cognitive and behavioural development of Cipralex in this age group have not yet been
demonstrated.
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CUSTOMER:
PRODUCT:

Cipralex 5mg FC tabs

CODE:

PRE-PRESS NO.:

02-1808

ARTWORKER:
DATE OF PROOF:

DT

Q.A.
APPROVED:

CUSTOMER
APPROVED:

17/10/13

DATE:

DATE:

PROOF HISTORY:
v.1
- 17/10/13

«PAdBì
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 SEPTEMBER 2013

Pg 2

Other medicines and Cipralex
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Tell your doctor if you are taking any of the following medicines:
• “Non-selective monoamine oxidase inhibitors (MAOIs)”, containing phenelzine, iproniazid,
isocarboxazid, nialamide, and tranylcypromine as active ingredients. If you have taken any of these
medicines you will need to wait 14 days before you start taking Cipralex. After stopping Cipralex you
must allow 7 days before taking any of these medicines.
• “Reversible, selective MAO-A inhibitors”, containing moclobemide (used to treat depression).
• “Irreversible MAO-B inhibitors”, containing selegiline (used to treat Parkinson’s disease). These
increase the risk of side effects.
• The antibiotic linezolid.
• Lithium (used in the treatment of manic-depressive disorder) and tryptophan.
• Imipramine and desipramine (both used to treat depression).
• Sumatriptan and similar medicines (used to treat migraine) and tramadol (used against severe pain).
These increase the risk of side effects.
• Cimetidine, lansoprazole and omeprazole (used to treat stomach ulcers), fluvoxamine
(antidepressant) and ticlopidine (used to reduce the risk of stroke). These may cause increased
blood levels of escitalopram.
• St. John's Wort (hypericum perforatum) - a herbal remedy used for depression.
• Acetylsalicylic acid (aspirin) and non-steroidal anti-inflammatory drugs (medicines used for pain
relief or to thin the blood, so called anti-coagulant). These may increase bleeding-tendency.
• Warfarin, dipyridamole, and phenprocoumon (medicines used to thin the blood, so called
anti-coagulant). Your doctor will probably check the coagulation time of your blood when starting and
discontinuing Cipralex in order to verify that your dose of anti-coagulant is still adequate.
• Mefloquine (used to treat Malaria), bupropion (used to treat depression) and tramadol (used to treat
severe pain) due to a possible risk of a lowered threshold for seizures.
• Neuroleptics (medicines to treat schizophrenia, psychosis) and antidepressants (tricyclic
antidepressants and SSRIs) due to a possible risk of a lowered threshold for seizures.
• Flecainide, propafenone, and metoprolol (used in cardiovascular diseases) clomipramine, and
nortriptyline (antidepressants) and risperidone, thioridazine, and haloperidol (antipsychotics). The
dosage of Cipralex may need to be adjusted.
• Medicines that decrease blood levels of potassium or magnesium, as these conditions increase the
risk of life-threatening heart rhythm disorders.

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Duration of treatment
It may take a couple of weeks before you start to feel better. Continue to take Cipralex even if it takes some
time before you feel any improvement in your condition.
Do not change the dose of your medicine without talking to your doctor first.
Continue to take Cipralex for as long as your doctor recommends. If you stop your treatment too soon, your
symptoms may return. It is recommended that treatment should be continued for at least 6 months after you
feel well again.
If you take more Cipralex than you should
If you take more than the prescribed dose of Cipralex, contact your doctor or nearest hospital emergency
department immediately. Do this even if there are no signs of discomfort. Some of the signs of an overdose
could be dizziness, tremor, agitation, convulsion, coma, nausea, vomiting, change in heart rhythm, decreased
blood pressure and change in body fluid/salt balance. Take the Cipralex box/container with you when you
go to the doctor or hospital.
If you forget to take Cipralex
Do not take a double dose to make up for forgotten doses. If you do forget to take a dose, and you remember
before you go to bed, take it straight away. Carry on as usual the next day. If you only remember during the
night, or the next day, leave out the missed dose and carry on as usual.
If you stop taking Cipralex
Do not stop taking Cipralex until your doctor tells you to do so. When you have completed your course of
treatment, it is generally advised that the dose of Cipralex is gradually reduced over a number of weeks.
When you stop taking Cipralex, especially if it is abruptly, you may feel discontinuation symptoms. These are
common when treatment with Cipralex is stopped. The risk is higher, when Cipralex has been used for a long
time or in high doses or when the dose is reduced too quickly. Most people find that the symptoms are mild
and go away on their own within two weeks. However, in some patients they may be severe in intensity or they
may be prolonged (2-3 months or more). If you get severe discontinuation symptoms when you stop taking
Cipralex, please contact your doctor. He or she may ask you to start taking your tablets again and come off
them more slowly.

Do not take Cipralex if you take medicines for heart rhythm problems or medicines that may affect the heart’s
rhythm, 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 (e.g.
astemizole, mizolastine). If you have any further questions about this you should speak to your doctor.

Discontinuation symptoms include: Feeling dizzy (unsteady or off-balance), feelings like pins and needles,
burning sensations and (less commonly) electric shock sensations, including in the head, sleep disturbances
(vivid dreams, nightmares, inability to sleep), feeling anxious, headaches, feeling sick (nausea), sweating
(including night sweats), feeling restless or agitated, tremor (shakiness), feeling confused or disorientated,
feeling emotional or irritable, diarrhoea (loose stools), visual disturbances, fluttering or pounding
heartbeat (palpitations).

Cipralex with food, drink and alcohol
Cipralex can be taken with or without food (see section 3 “How to take Cipralex”).

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

As with many medicines, combining Cipralex with alcohol is not advisable, although Cipralex is not expected
to interact with alcohol.
Pregnancy, breast-feeding and fertility
Inform your doctor if you are pregnant or planning to become pregnant. Do not take Cipralex if you are
pregnant or breast-feeding, unless you and your doctor have discussed the risks and benefits involved.
If you take Cipralex during the last 3 months of your pregnancy you should be aware that the following effects
may be seen in your newborn baby: trouble with breathing, bluish skin, fits, body temperature changes,
feeding difficulties, vomiting, low blood sugar, stiff or floppy muscles, vivid reflexes, tremor, jitteriness,
irritability, lethargy, constant crying, sleepiness and sleeping difficulties. If your newborn baby has any of these
symptoms, please contact your doctor immediately.
Make sure your midwife and/or doctor know you are on Cipralex. When taken during pregnancy, particularly in
the last 3 months of pregnancy, medicines like Cipralex 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.
If used during pregnancy Cipralex should never be stopped abruptly.
It is expected that Cipralex will be excreted into breast milk.
Citalopram, a medicine like escitalopram, 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.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The side effects usually disappear after a few weeks of treatment. Please be aware that many of the effects
may also be symptoms of your illness and therefore will improve when you start to get better.
If you experience any of the following symptoms you should contact your doctor or go to the hospital
straight away:
Uncommon (may affect up to 1 in 100 people):
• Unusual bleeds, including gastrointestinal bleeds
Rare (may affect up to 1 in 1000 people):
• Swelling of skin, tongue, lips, or face, or have difficulties breathing or swallowing (allergic reaction).
• High fever, agitation, confusion, trembling and abrupt contractions of muscles these may be signs
of a rare condition called serotonin syndrome.
Not known (frequency cannot be estimated from the available data):
• Difficulties urinating
• Seizures (fits), see also section 2 “Warnings and precautions“
• Yellowing of the skin and the white in the eyes are signs of liver function impairment/hepatitis
• Fast, irregular heart beat, fainting which could be symptoms of a life-threatening condition known
as torsade de pointes
• Thoughts of harming or killing yourself, see also section 2 "Warnings and precautions"
In addition to the above the following side effects have been reported:
Very common (may affect more than 1 in 10 people):
• Feeling sick (nausea)
• Headache

Driving and using machines
You are advised not to drive a car or operate machinery until you know how Cipralex affects you.

3. How to take Cipralex
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are
not sure.
Adults
Depression
The normally recommended dose of Cipralex is 10 mg taken as one daily dose. The dose may be increased
by your doctor to a maximum of 20 mg per day.
Panic disorder
The starting dose of Cipralex is 5 mg as one daily dose for the first week before increasing the dose to 10 mg
per day. The dose may be further increased by your doctor to a maximum of 20 mg per day.
Social anxiety disorder
The normally recommended dose of Cipralex is 10 mg taken as one daily dose. Your doctor can either
decrease your dose to 5 mg per day or increase the dose to a maximum of 20 mg per day, depending on how
you respond to the medicine.

Common (may affect up to 1 in 10 people):
• Blocked or runny nose (sinusitis)
• Decreased or increased appetite
• Anxiety, restlessness, abnormal dreams, difficulties falling asleep, feeling sleepy, dizziness, yawning,
tremors, prickling of the skin
• Diarrhoea, constipation, vomiting, dry mouth
• Increased sweating
• Pain in muscle and joints (arthralgia and myalgia)
• Sexual disturbances (delayed ejaculation, problems with erection, decreased sexual drive and
women may experience difficulties achieving orgasm)
• Fatigue, fever
• Increased weight

Obsessive-compulsive disorder
The normally recommended dose of Cipralex is 10 mg taken as one daily dose. The dose may be increased
by your doctor to a maximum of 20 mg per day.

Uncommon (may affect up to 1 in 100 people):
• Nettle rash (urticaria), rash, itching (pruritus)
• Grinding one’s teeth, agitation, nervousness, panic attack, confusion
• Disturbed sleep, taste disturbance, fainting (syncope)
• Enlarged pupils (mydriasis), visual disturbance, ringing in the ears (tinnitus)
• Loss of hair
• Excessive menstrual bleeding
• Irregular menstrual period
• Decreased weight
• Fast heart beat
• Swelling of the arms or legs
• Nosebleeds

Elderly patients (above 65 years of age)
The recommended starting dose of Cipralex is 5 mg taken as one daily dose. The dose may be increased by
your doctor to 10 mg per day.

Rare (may affect up to 1 in 1000 people):
• Aggression, depersonalisation, hallucination
• Slow heart beat

Children and adolescents (below 18 years of age)
Cipralex should not normally be given to children and adolescents. For further information please see section
2 “What you need to know before you take Cipralex”.

Not known (frequency cannot be estimated from the available data):
• Decreased levels of sodium in the blood (the symptoms are feeling: sick and unwell with weak
muscles; or confused)
• Dizziness when you stand up due to low blood pressure (orthostatic hypotension)
• Abnormal liver function test (increased amounts of liver enzymes in the blood)
• Movement disorders (involuntary movements of the muscles)
• Painful erections (priapism)
• Signs of increased bleeding e.g. from skin and mucous membranes (ecchymosis)
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• Sudden swelling of skin or mucosa (angioedemas)
• Increase in the amount of urine excreted (inappropriate ADH secretion)
• Flow of milk in men and in women that are not nursing
• Mania
• An increased risk of bone fractures has been observed in patients taking this type of medicine
• Alteration of the heart rhythm (called “prolongation of QT interval”, seen on ECG, measuring
electrical activity of the heart).

Generalised anxiety disorder
The normally recommended dose of Cipralex is 10 mg taken as one daily dose. The dose may be increased
by your doctor to a maximum of 20 mg per day.

You can take Cipralex with or without food. Swallow the tablet with some water. Do not chew them, as the
taste is bitter.
If necessary, you can divide the tablets by firstly placing the tablet on a flat surface with the score facing
upwards. The tablets may then be broken by pressing down on each end of the tablet, using both forefingers
as shown in the drawing.

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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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