CIPRALEX 20 MG TABLETS

Active substance: ESCITALOPRAM OXALATE

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Patient Information Leaflet
®

Cipralex 10 mg tablets/Escitalopram 10mg Tablets
®
Cipralex 20 mg tablets/Escitalopram 20mg Tablets
(escitalopram oxalate)
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
These products are available as one of the above names but will be referred
to as CIPRALEX throughout this leaflet.
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 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 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
anticoagulant). 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 lA
And lll 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
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.
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 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 sign of liver
function impairment/hepatitis
• Fast, irregular heart beat, fainting which could be symptoms of a
life-threatening 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.
Do not use Cipralex after the expiry date, which is stated on the label
or carton after EXP.
The expiry date refers to the last day of that month.
This medicinal product does not require any special storage
conditions.
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
The active substance is escitalopram. Each Cipralex tablet contains 10
mg, g or 20 mg escitalopram (as oxalate).
The other ingredients are: Core: microcrystalline cellulose, colloidal
anhydrous silica, talc, croscarmellose sodium and magnesium
stearate.
Coating: hypromellose, macrogol 400 and titanium dioxide (E 171).
What Cipralex looks like and contents of the pack
Cipralex is presented as 10 mg and 20 mg film-coated tablets. The
tablets are described 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.
20 mg: Oval, white film-coated tablets. The tablets are scored and
marked with “E” and “N” on each side of the score on one side of
the tablet.
Cipralex Tablets come in press-through blister strips and are available
in packs containing 28 tablets in total.
Manufacturer
H Lundbeck A/S ,Ottiliavej 7-9, DK-2500 Copenhagen Denmark
Procured within the EU. Product Licence holder: Ecosse
Pharmaceuticals Ltd, 3 Young Place, East Kilbride, G75 0TD. Repackaged by: Munro Wholesale Medical Supplies Limited, 3 Young
Place, East Kilbride, G75 0TD.
PL 19065/0262
PL 19065/0263

Cipralex 10mg Tablets
Cipralex 20mg Tablets

This leaflet was last revised 31/05/2012
E0262/3-2
® is a Registered Trade mark of H.Lundbeck A/S

POM

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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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