CIPRALEX 10MG TABLETS

Active substance: ESCITALOPRAM OXALATE

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CIPRALEX 10mg Film-coated Tablets
ESCITALOPRAM 10mg Film-coated Tablets
(escitalopram oxalate)
Your medicine is available using any of the above-names but will be referred
to as Cipralex throughout this leaflet.
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 heartbeat, 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.

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.
 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 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 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, anti-malarian
treatment particularly halofantrine), certain antihistamines (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.
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.

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.

Ask your doctor or pharmacist for advice before taking any medicine.

If you have thoughts of harming or killing yourself at any time, contact your
doctor or go to a hospital straight away.

3) How to take Cipralex

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.

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

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 normally 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 (23 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.

In addition to above the following side effects have been reported:
Very common (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 rhrythm (called “pronlongation of QT interval”, seen
on ECG, 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

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

 KEEP OUT OF THE REACH AND SIGHT OF CHILDREN.
 There are no special storage conditions.
 Do not use Cipralex Tablets 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.
 If your doctor tells you to stop using the medicine, please take it back to the
pharmacist for safe disposal. Only keep the medicine if your doctor tells you
to.
 If the medicine becomes discoloured or show any other signs of
deterioration, you should seek the advice of your 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.

4) Possible side effects.

6) Further information.

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).

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 Torsades de Pointes.

What Cipralex contains
The active ingredient in Cipralex Tablets is Escitalopram (as oxalate). Each
film-coated tablet contains 10mg Escitalopram (as oxalate).
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 the contents of the pack
Each Cipralex 10mg film-coated tablet is oval, white, and is marked ‘E
breakline L’ on one side and plain on the reverse.
Cipralex Tablets are available as blister packs containing two press-through
strips each containing 14 tablets (28 tablets in total).
PL 10383/1143

Escitalopram 10mg Film-coated Tablets

POM

Who makes and repackages your medicine:
Your medicine is manufactured by H. Lundbeck A/S, Ottiliavej 9, DK-2500,
Copenhagen, Dinamarca, Denmark. Procured from within the EU and
repackaged by the Product Licence holder: Primecrown Ltd, 4/5 Northolt
Trading Estate, Belvue Road, Northolt, Middlesex, UB5 5QS.
Leaflet date: 14.06.2012

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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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