ESCITALOPRAM 5MG TABLETS

Active substance: ESCITALOPRAM OXALATE

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PATIENT INFORMATION LEAFLET

1137, 1138, 1139
15.06.12[14]

Cipralex® 5 mg Tablets /
Escitalopram 5 mg Tablets
Cipralex® 10 mg Tablets /
Escitalopram 10 mg Tablets

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.

(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 a 20 mg strength.
Read all of this leaflet carefully before you start taking this
medicine
 Keep this leaflet. You may need to read it again.
 If you have any further questions, ask your doctor or
pharmacist.
 This medicine has been prescribed for you. Do not pass it on
to others. It may harm them, even if their symptoms are the
same as yours.
 If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist
In this leaflet:
1. What Cipralex is and what it is used for
2. Before you take Cipralex
3. How to take Cipralex
4. Possible side effects
5. How to store Cipralex
6. Further information
1. What Cipralex is and what it is used for
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).
2. Before you take Cipralex
Do not take Cipralex
 if you are allergic (hypersensitive) to escitalopram or any of the other
ingredients of Cipralex (see section 6 "Further information").
 if you take other medicines that belongs 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 “Taking other medicines”).
Take special care with 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.
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.

Use in 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.
Taking other medicines
Please tell your doctor if you are taking or have recently taken any other
medicines, including medicines obtained without prescription.
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 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 Cipralex.
 St. John's Wort (Hypericum perforatum) - a herbal remedy used for
depression.
 Acetylsalycylic acid (aspirin) and non-steroidal anti-inflammatory
drugs (medicines used for pain relief or to thin the blood, so called
anticoagulants). These may increase bleeding tendency.
 Warfarin, dipyridamole, and phenprocoumon (medicines used to thin
the blood, so called anticoagulants). Your doctor will probably check
the coagulation time of your blood when starting and discontinuing
Cipralex in order to verify that your dose of anticoagulant is still
adequate.
 Mefloquin (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) due to a
possible risk of a lowered threshold for seizures, and
antidepressants.
 Flecainide, propafenone, and metoprolol (used in cardio-vascular
diseases), clomipramine, and nortriptyline (antidepressants) and
risperidone, thioridazine, and haloperidol (antipsychotics). The
dosage of Cipralex may need to be adjusted.
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
Taking Cipralex with food and drink
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.
Fertility, pregnancy and breast-feeding
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 new born
(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.

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.
Ask your doctor or pharmacist for advice before taking this medicine.
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 "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, Cipralex 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.
See your doctor if you get any of the following side effects during
treatment:
Uncommon (affects 1 to 10 users in 1000):
 Unusual bleeds, including gastrointestinal bleeds
Rare (affects 1 to 10 users in 10000):
 If you experience swelling of skin, tongue, lips, or face, or have
difficulties breathing or swallowing (allergic reaction), contact your
doctor or go to a hospital straight away.
 If you have a high fever, agitation, confusion, trembling and abrupt
contractions of muscles these may be signs of a rare condition
called serotonin syndrome. If you feel like this contact your doctor.
If you experience the following side effects you should contact your doctor
or go to the hospital straight away:
 Difficulties urinating
 Seizures (fits), see also section Take special care with Cipralex
 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
In addition to above the following side effects have been reported:
Very common (affects more than 1 user in 10):
 Feeling sick (nausea)
Common (affects 1 to 10 users in 100):
 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 (affects 1 to 10 users in 1000):
 Nettle rash (urticaria), rash, itching (pruritus)
 Grinding one's teeth, agitation, nervousness, panic attack, confusion
state
 Disturbed sleep, taste disturbance, fainting (syncope)
 Enlarged pupils (mydriasis), visual disturbance, ringing in the ears
(tinnitus)
 Loss of hair
 Vaginal bleeding
 Decreased weight
 Fast heart beat
 Swelling of the arms or legs
 Nosebleeds
Rare (affects 1 to 10 users in 10000):
 Aggression, depersonalisation, hallucination
 Slow heart beat
Some patients have reported (frequency can not be estimated from the
available data):
 Thoughts of harming yourself or thoughts of killing yourself, see also
section “Take special care with Cipralex”
 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)
 Bleeding disorders including skin and mucous bleeding
(ecchymosis) and low level of blood platelets (thrombycytopenia)
 Sudden swelling of skin or mucosa (angioedemas)
 Increase in the amount of urine excreted (inappropriate ADH
secretion)
 Flow of milk in women that are not nursing
 Mania
 An increased risk of bone fractures has been observed in patients
taking this type of medicines.
 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)
 Anorexia
If any of the side effects gets serious, or if you notice any side effects
not listed in this leaflet, please tell your doctor or pharmacist.
5. How to store Cipralex
Keep out of the reach and sight 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. Further information
What Cipralex contains
Each tablet contains either 5 mg or 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 5 mg and 10 mg film-coated tablets. A
description follows below.
5 mg: Round white biconvex film-coated tablets, marked with “E K ” on
one side of the tablet.
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 5 mg is available in press-through blister strips, pack size of 28
tablets. Cipralex 10 mg is available in press-through blister strips, pack
sizes of 14 or 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 5 mg Tablets / Escitalopram 5 mg Tablets –
PL 20636/1138
Cipralex 10 mg Tablets / Escitalopram 10 mg Tablets –
PL 20636/1137, PL 20636/1139

This leaflet revised and issued (Ref.) 15.06.12[14]
Cipralex is a trademark of H. Lundbeck A/S

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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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