CIPRALEX 20MG TABLETS

Active substance: ESCITALOPRAM OXALATE

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Package leaflet: Information for the user
®

Cipralex 10mg Tablets / Escitalopram 10mg Tablets
Cipralex® 20mg Tablets / Escitalopram 20mg Tablets
(escitalopram oxalate)
This medicine is known by any of the above names but will be referred to as Cipralex
throughout this leaflet. Please note that the leaflet also contains information about other
strength (Cipralex 5mg Tablets).
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 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.
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 anticoagulant 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, antimalarial 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 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.
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.

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

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).

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. 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.
By reporting side effects you can help provide more information on the safety of this
medicine.
5. How to store Cipralex
Keep out of the sight and reach 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.

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

6. Contents of the pack and other information

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.

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.

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.

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.

If you experience any of the following symptoms you should contact your doctor or
go to the hospital straight away:

Cipralex Tablets are available as blister packs of 28 tablets.

Uncommon (may affect up to 1 in 100 people):
Unusual bleeds, including gastrointestinal bleeds

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).

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

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.) 30.01.2014.
Cipralex is a registered Trade Mark of H. Lundbeck A/S.
To request a copy of this leaflet in Braille, large print or audio please call 01923 332 796.

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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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