CIPRALEX 10MG TABLETS

PATIENT INFORMATION LEAFLET

1139
28.12.13[14]

Cipralex® 10 mg Tablets /
Escitalopram 10 mg Tablets
(escitalopram oxalate)
This medicine is known by the above names but will be referred to as
Cipralex throughout the leaflet.
Cipralex is also available in other strengths.
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 or 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 to sit or stand 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.
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
anticoagulant). 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.
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.
Cipralex with food, drink and alcohol
Cipralex can be taken with or without food (see section 3 "How to take
Cipralex").
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.
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 Cipralex exactly as your doctor has told you. You should
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.
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.
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.
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.
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 ".
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.
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.

Discontinuation symptoms include: Feeling dizzy (unsteady or offbalance), 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).
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.
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 lifethreatening 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
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
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
Rare (may affect up to 1 in 1000 people):
 Aggression, depersonalisation, hallucination
 Slow heart beat
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)
 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).
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. How to store Cipralex
Keep out of the sight and reach of children.
There are no special storage conditions.
There is an expiry date on the label. Do not use the medicine after this
date.
You should return any left over tablets to your pharmacist.
If your tablets become discoloured or show any other signs of
deterioration consult your doctor or pharmacist who will tell you what to
do.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required.
These measures will help to protect the environment.
6. Contents of the pack and other information
What Cipralex contains
Each tablet contains 10 mg escitalopram (as the oxalate) as the active
ingredient.
The other ingredients are: microcrystalline cellulose, colloidal anhydrous
silica, talc, croscarmellose sodium, magnesium stearate, hypromellose,
macrogol 400 and titanium dioxide (E171).
What Cipralex looks like and contents of the pack
Cipralex is presented as 10 mg film-coated tablets.
A description follows below.
10 mg: Oval white film-coated tablets. The tablets are scored and marked
with “E ” and “L ” on each side of the score on one side of the tablet.
Cipralex 10 mg is available in press-through blister strips, pack sizes of
28 tablets.
Manufacturer and Product Licence Holder
Manufactured by H. Lundbeck A/S, Ottiliavej 9, DK-2500 Copenhagen,
Denmark and procured from within the EU by the Product Licence holder
Star Pharmaceuticals Ltd., 5 Sandridge Close, Harrow, Middlesex HA1
1XD. Repackaged by Servipharm Ltd.

POM

Cipralex 10 mg Tablets / Escitalopram 10 mg Tablets –
PL 20636/1139

This leaflet revised and issued (Ref.) 28.12.13[14]
Cipralex is a trademark of H. Lundbeck A/S.