iMeds.se

Cipralex

Information för alternativet: Cipralex 10 Mg Filmdragerad Tablett, Cipralex 20 Mg Filmdragerad Tablett, Cipralex 5 Mg Filmdragerad Tablett, Cipralex 15 Mg Filmdragerad Tablett, visar 3 alternativ
Document: Cipralex film-coated tablet ENG PL change

Package leaflet: Information for the user


Cipralex 5 mg film-coatedtablets

Cipralex 10 mg film-coatedtablets

Cipralex 15 mg film-coatedtablets

Cipralex 20 mg film-coatedtablets

escitalopram


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 inthis leaflet:

1. What Cipralex is and what it is used for

2. What you need to know beforeyou take Cipralex

3. How to take Cipralex

4. Possible side effects

5. How to store Cipralex

6. Contents of the pack and otherinformation


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 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



Warnings and precautions


Talk to your doctor or pharmacist before takingCipralex. 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:


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 sit or stand 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 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 friendthat 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.

Childrenand adolescents


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.


Othermedicines and Cipralex


Tellyour 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:



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.


Cipralex with food, drinkand 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-feedingand fertility


Ifyou are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. 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, bluishskin, 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 escitalopram 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 medicineexactly as your doctor has told you. Checkwith 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.


Use in children and adolescents

Cipralex should not normally be given to children and adolescents. For further information please see section 2 ”Warnings and precautions”.


How to take the tablets

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 bedizziness, tremor, agitation, convulsion, coma, nausea, vomiting, change in heart rhythm, decreased blood pressure and change in body fluid/salt balance. Take the Cipralex box/container with you when you go to the doctor or hospital.


If you forget to take Cipralex


Do not take a double dose to make up for forgotten doses. If you do forget to take a dose, and you remember before you go to bed, take it straight away. Carry on as usual the next day. If you only remember during the night, or the next day, leave out the missed dose and carry on as usual.


If you stop taking Cipralex


Do not stop taking Cipralex until your doctor tells you to do so. When you have completed your course of treatment, it is generally advised that the dose of Cipralex is gradually reduced over a number of weeks.


When you stop taking Cipralex, especially if it is abruptly, you may feel discontinuation symptoms. These are common when treatment with Cipralex is stopped. The risk is higher, when Cipralex has been used for a long time or in high doses or when the dose is reduced too quickly. Most people find that the symptoms are mild and go away on their own within two weeks. However, in some patients they may be severe in intensity or they may be prolonged (2-3 months or more). If you get severe discontinuation symptoms when you stop taking Cipralex, please contact your doctor. He or she may ask you to start taking your tablets again and come off them more slowly.


Discontinuation symptoms include: Feeling dizzy (unsteady or off-balance), feelings like pins and needles, burning sensations and (less commonly) electric shock sensations, including in the head, sleep disturbances (vivid dreams, nightmares, inability to sleep), feeling anxious, headaches, feeling sick (nausea), sweating (including night sweats), feeling restless or agitated, tremor (shakiness), feeling confused or disorientated, feeling emotional or irritable, diarrhoea (loose stools), visual disturbances, fluttering or pounding heartbeat (palpitations).


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


4. Possible side effects



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


The side effects usually disappear after a few weeks oftreatment. 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.


Ifyou experienceany of the following symptoms you should contact your doctor or go to the hospital straight away:


Uncommon (may affect up to1 in 100 people):

Unusual bleeds, including gastrointestinal bleeds


Rare (may affect up to 1in 1,000 people):


Not known (frequency cannot be estimated from the available data):

Difficulties urinating


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


Very common (may affectmore than 1 in 10people):


Common (may affect up to 1 in 10 people):


Uncommon (may affect up to 1in 100 people):


Rare (may affect up to 1in 1,000 people):


Not known (frequency cannot be estimated from the available data):


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:


Reporting ofside effects

If you getany side effects, talk toyour doctor or pharmacist.This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system (to be completed nationally). By reporting side effects you can help provide more information on the safety of this medicine.


5. How to store Cipralex


Keep this medicine out of the sight and reach of children.


Do not use this medicineafter 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 medicinedoes not require any special storage conditions.


Donot throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.


6. Contents of the pack and other information


What Cipralex contains


The active substance is escitalopram. Each Cipralex tablet contains 5 mg, 10 mg, 15 mg 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 5 mg, 10 mg, 15 mg and 20 mg film-coated tablets. The tablets are described below.


5 mg: Round, white biconvex film-coated tablets of 6 mm marked with “EK” on one side.


10 mg: Oval, white film-coated tabletsof 8x5.5 mm. The tablets are scored and marked with “E” and “L” on each side of the score on one side of the tablet.


15 mg: Oval, white film-coated tabletsof 9.8x6.3 mm. The tablets are scored and marked with “E” and “M” on each side of the score on one side of the tablet.


20 mg: Oval, white film-coated tablets11.5x7 mm. The tablets are scored and marked with “E” and “N” on each side of the score on one side of the tablet.


Cipralex is available in the following pack sizes:


Blister (transparent) in cardboard box

5, 10, 15 and 20 mg: 14, 28, 56 and 98 tablets


Blisters (white) in cardboard box

5, 10, 15 and 20 mg: 14, 20, 28, 50, 100 and 200 tablets


Polypropylene container

15 and 20 mg: 100 tablets

5 and 10 mg: 100 and 200 tablets


Polyethylene container

15 and 20 mg: 100 tablets

5 and 10 mg: 100 and 200 tablets


Unit dose:

5, 10, 15 and 20 mg: 49x1, 56x1, 98x1, 100x1 and 500x1 tablets


Not all pack sizes may be marketed.


Marketing Authorisation Holder and Manufacturer


To be completed nationally


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


Austria:

Cipralex

Belgium:

Sipralexa

Bulgaria:

Cipralex

Cyprus:

Cipralex

Czech Republic:

Cipralex

Denmark:

Cipralex

Estonia:

Cipralex

Finland:

Cipralex

France:

Seroplex

Germany:

Cipralex

Greece:

Cipralex

Hungary:

Cipralex

Iceland:

Cipralex

Ireland:

Lexapro

Italy:

Cipralex

Latvia:

Cipralex 10 mg film-coated tablets: Cipralex 20 mg film-coated tablets

Lithuania:

Cipralex

Luxembourg:

Sipralexa

Malta:

Cipralex

Netherlands:

Lexapro

Norway:

Cipralex

Poland:

Cipralex

Portugal:

Cipralex

Romania:

Cipralex

Slovakia:

Cipralex

Slovenia:

Cipralex

Spain:

Cipralex

Sweden:

Cipralex

United Kingdom:

Cipralex


This leaflet was last revised in:

13thJanuary 2016


11