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CIPRALEX 20MG TABLETS

Active substance: ESCITALOPRAM OXALATE

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Patient Information Leaflet

Cipralex® 10mg Tablets / Escitalopram 10mg Tablets
Cipralex® 20mg Tablets / Escitalopram 20mg Tablets
(escitalopram oxalate)
This medicine is known by the above name but will be referred to as Cipralex throughout this
leaflet.
Other strengths of this product are also available.
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.
2.
3.
4.
5.
6.

What Cipralex is and what it is used for
Before you take Cipralex
How to take Cipralex
Possible side effects
How to store Cipralex
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 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 “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 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.

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 MA • O-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.
Acetylsalicylic acid (aspirin) and non-steroidal anti-inflammatory drugs (medicines used for
pain relief or to thin the blood, so called anticoagulants). These may increase bleedingtendency.
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 cardiovascular 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, antimalarial 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 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.
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.
If used during pregnancy Cipralex should never be stopped abruptly.
Ask your doctor or pharmacist for advice before taking any 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 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).
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 life-threatening condition
known as torsades 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 requirements for Cipralex.
Do not use after the expiry date printed on the carton label or blister strip.
If the tablets become discoloured or show signs of any deterioration, you should seek the
advice of your pharmacist.
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
Cipralex 10mg Tablets. Each tablet contains 10mg of the active ingredient escitalopram (as
the oxalate). The tablets are white film-coated, oval shaped tablet marked ‘E’ breakline ‘L’ on
one side and plain on the reverse.
Cipralex 20mg Tablets. Each tablet contains 20mg of the active ingredient escitalopram (as
the oxalate). The tablets are white film-coated, oval shaped tablet marked ‘E’ breakline ‘N’ on
one side and plain on the reverse.
Cipralex Tablets are available as blister packs of 28 tablets.
Cipralex Tablets also contain the following inactive ingredients:
Microcrystalline cellulose, colloidal anhydrous silica, talc, croscarmellose sodium, magnesium
stearate, hypromellose, macrogol 400 and titanium dioxide (E171).
POM

PL No: 17805/0237
PL No: 17805/0238

®

Cipralex 10mg Tablets
®
Cipralex 20mg Tablets

This product is manufactured by H. Lundbeck A/S, Ottiliavej 9, Copenhagen, Valby 2500,
Denmark and procured from within the EU by the Product Licence holder Delta Pharma
(Europe) Ltd, 1 Colonial Way, P.O. Box 233, North Watford, Herts WD24 4EW and
repackaged by O.P.D. Laboratories Ltd, Watford, Herts WD2 4PR.
Leaflet revision and issue date (Ref.) 25.05.12
Cipralex is a registered Trade Mark 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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