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CIPRALEX MELTZ 10 MG ORODISPERSIBLE TABLETS

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GB-6428

PACKAGE LEAFLET: INFORMATION FOR THE USER

20 mg orodispersible tablets

escitalopram
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 MELTZ is and what it is used for
2. Before you take Cipralex MELTZ
3. How to take Cipralex MELTZ
4. Possible side effects
5. How to store Cipralex MELTZ
6. Further information


1. WHAT CIPRALEX MELTZ IS AND WHAT IT IS USED FOR

Cipralex MELTZ 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 MELTZ 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 MELTZ

Do not take Cipralex MELTZ
• If you are allergic (hypersensitive) to escitalopram or any of the other
ingredients of Cipralex MELTZ (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 MELTZ
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 MELTZ 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 MELTZ 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 characterised 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.

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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.

• 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 MELTZ.
• St. John's Wort (hypericum perforatum) - a herbal remedy used for
depression.
• Acetylsalicylic acid 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 MELTZ in order to verify that your dose of anti-coagulant 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 MELTZ may need to be adjusted.
Do not take Cipralex MELTZ 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 MELTZ with food and drink
Cipralex MELTZ should be taken without food (see section 3 “How to take
Cipralex MELTZ”).
As with many medicines, combining Cipralex MELTZ with alcohol is not
advisable, although Cipralex MELTZ 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 MELTZ if you are pregnant or breast-feeding, unless
you and your doctor have discussed the risks and benefits involved.
If you take Cipralex MELTZ 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.
If used during pregnancy Cipralex MELTZ should never be stopped abruptly.
Make sure your midwife and/or doctor know you are on Cipralex MELTZ.
When taken during pregnancy, particularly in the last 3 months of pregnancy,
medicines like Cipralex MELTZ 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 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 MELTZ affects you.


3. HOW TO TAKE CIPRALEX MELTZ
Always take Cipralex MELTZ exactly as your doctor has told you. You should
check with your doctor or pharmacist if you are not sure.
Cipralex MELTZ orodispersible tablets are taken every day as a single daily
dose. You should take Cipralex MELTZ without food.
Cipralex MELTZ orodispersible tablets break easily, so you should handle
the tablets carefully. Do not handle the tablets with wet hands as the
tablets may break up. The tablets do not have a score-line and cannot be
divided into equal doses. You should take other forms of this medicine
(e.g. film-coated tablets or oral drops, solution) when starting on doses of
5 mg; ask your doctor or pharmacist.
1.

2.
3.


Hold the blister strip at the edges and separate one blister cell from
the rest of the strip by gently tearing along the perforations around it.
Carefully peel off the backing.
Place the tablet on your tongue. The tablet will rapidly disintegrate
and can be swallowed without water.

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 MELTZ 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 MELTZ for patients under 18 because he/she
decides that this is in their best interest. If your doctor has prescribed
Cipralex MELTZ 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
MELTZ. Also, the long-term safety effects concerning growth, maturation
and cognitive and behavioural development of Cipralex MELTZ 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 MELTZ. After
stopping Cipralex MELTZ 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.


Adults
Depression
The normally recommended dose of Cipralex MELTZ 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 MELTZ 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 MELTZ 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 MELTZ 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 MELTZ 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 MELTZ 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 MELTZ should not normally be given to children and adolescents.
For further information please see section 2 “Before you take Cipralex MELTZ”.

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10 mg orodispersible tablets

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Continue to take Cipralex MELTZ 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 MELTZ than you should
If you take more than the prescribed dose of Cipralex MELTZ, 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 MELTZ carton with you when you go to
the doctor or hospital.
If you forget to take Cipralex MELTZ
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 MELTZ
Do not stop taking Cipralex MELTZ 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 MELTZ is gradually reduced over a number of weeks.
When you stop taking Cipralex MELTZ, especially if it is abruptly, you may
feel discontinuation symptoms. These are common when treatment with
Cipralex MELTZ is stopped. The risk is higher, when Cipralex MELTZ 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 MELTZ, 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 MELTZ 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.

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 MELTZ).
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 MELTZ

Keep out of the reach and sight of children.

Do not use Cipralex MELTZ after the expiry date which is stated on the
carton and blister foil after EXP.
The expiry date refers to the last day of that month.
Do not store above 30°C.
Store in the original package in order to protect from light.
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 MELTZ contains
The active substance is escitalopram. Each Cipralex MELTZ
orodispersible tablet contains 10 mg or 20 mg escitalopram.
The other ingredients are microcrystalline cellulose, hypromellose,
basic butylated methacrylate copolymer, magnesium stearate,
mannitol, crospovidone, sodium hydrogen carbonate, citric acid
anhydrous, natural and artificial mint flavour and sucralose (E955).

What Cipralex MELTZ looks like and contents of the pack
Cipralex MELTZ 10 mg: white to off white, slightly speckled, flat-faced,
round beveled edge tablet debossed with ELO on one side.
Cipralex MELTZ 20 mg: white to off white, slightly speckled, flat-faced,
round, beveled edge tablet debossed with ENO on one side.
Cipralex MELTZ 10 mg and 20 mg are available in cartons containing
12, 30 and 60 orodispersible tablets in blisters.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer:
H. Lundbeck A/S
Ottiliavej 9
2500 Valby
Denmark

This medicinal product is authorised in the Member States of the EEA
under the following names:
Austria

Cipralex MELTZ 10 mg, 20 mg Schmelztablette

Belgium

Sipralexa Odis 10 mg, 20 mg Comprimé
orodispersible / Orodispergeerbare tablet

Bulgaria

Cipralex MELTZ 10 mg, 20 mg Таблетка,
диспергираща се в устата

Cyprus

Cipralex MELTZ 10 mg, 20 mg Δισκίο διασπειρόμενο
στο οτόμα

Czech Republic

Cipralex Orotab 10 mg, 20 mg Tableta
dispergovatelná v ústech

Denmark

Cipralex MELTZ 10 mg, 20 mg Smeltetablet

Estonia

Cipralex MELTZ 10 mg, 20 mg

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
MELTZ”
• 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

Finland

Cipralex 10 mg, 20 mg Tabletti, suussa hajoava

France

Seroplexoro 10 mg, 20 mg Comprimé orodispersible

Germany

Cipralex MELTZ 10 mg, 20 mg Schmelztabletten

Greece

Cipralex MELTZ 10 mg, 20 mg Δισκίο διασπειρόμενο
στο οτόμα

Hungary

Cipralex MELTZ 10 mg, 20 mg szájban diszpergálódó
tabletta

In addition to above the following side effects have been reported:

Iceland

Cipralex MELTZ 10 mg, 20 mg Munndreifitafla

Very common (affects more than 1 user in 10):
• Feeling sick (nausea)

Ireland

Lexapro Meltz 10 mg, 20mg Orodispersible tablet

Italy

Cipralex 10 20 mg Compressa orodispersibile

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

Latvia

Cipralex MELTZ 10 mg, 20 mg Mutē disperģējamās
tabletes

Lithuania

Cipralex MELTZ 10 mg, 20 mg Burnoje
disperguojamoji tabletė

Luxembourg

Sipralexa Odis 10 20 mg Comprimé orodispersible /
Orodispergeerbare tablet

Malta

Cipralex MELTZ 10 mg, 20 mg Pillola li tinћall fil-ћalq

Norway

Cipralex MELTZ 10 mg, 20 mg Smeltetablett

Poland

Cipralex MELTZ 10 mg, 20 mg Tabletka ulegająca
rozpadowi w jamie ustnej

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

Portugal

Cipralex Odis 10 mg, 20 mg comprimido
orodispersível

Romania

Cipralex MELTZ 10 mg, 20 mg comprimate
orodispersabile

Slovakia

Cipralex MELTZ 10 mg, 20 mg Orodispergovateľná
tableta

Slovenia

Cipralex MELTZ 10 mg, 20 mg orodisperzibilne
tablete

Spain

Cipralex Flas 10 mg, 20 mg comprimido
bucodispersable

Rare (affects 1 to 10 users in 10000):
• Aggression, depersonalisation, hallucination
• Slow heart beat

Sweden

Cipralex

United Kingdom

Cipralex MELTZ 10 mg, 20mg Orodispersible tablet

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

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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.

Some patients have reported (frequency cannot be estimated from the
available data):
• Thoughts of harming yourself or thoughts of killing yourself, see also
section “Take special care with Cipralex MELTZ”
• 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 (thrombocytopenia)
• 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





This leaflet was last revised in: 07/2012

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Duration of treatment
It may take a couple of weeks before you start to feel better. Continue
to take Cipralex MELTZ 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.

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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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