Țară: Malta
Limbă: engleză
Sursă: Medicines Authority
ESCITALOPRAM
Aurobindo Pharma (Malta) Limited Vault 14, Level 2, Valletta Waterfront, Floriana FRN 1913, Malta
N06AB10
ESCITALOPRAM 20 mg
FILM-COATED TABLET
ESCITALOPRAM 20 mg
POM
PSYCHOANALEPTICS
Authorised
2013-08-01
Page 1 of 10 PACKAGE LEAFLET: INFORMATION FOR THE USER ESCITALOPRAM 5 MG FILM-COATED TABLETS ESCITALOPRAM 10 MG FILM-COATED TABLETS ESCITALOPRAM 15 MG FILM-COATED TABLETS ESCITALOPRAM 20 MG FILM-COATED TABLETS 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 IN THIS LEAFLET 1. What Escitalopram is and what it is used for 2. What you need to know before you take Escitalopram 3. How to take Escitalopram 4. Possible side effects 5. How to store Escitalopram 6. Contents of the pack and other information 1. WHAT ESCITALOPRAM IS AND WHAT IT IS USED FOR Escitalopram contains the active substance escitalopram. Escitalopram 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. Escitalopram 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 Escitalopram, 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 ESCITALOPRAM _ _ DO NOT TAKE ESCITALOPRAM: - 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 Citiți documentul complet
Page 1 of 17 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Escitalopram 5 mg film-coated tablets Escitalopram 10 mg film-coated tablets Escitalopram 15 mg film-coated tablets Escitalopram 20 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 5 mg escitalopram (as oxalate). Each film-coated tablet contains 10 mg escitalopram (as oxalate). Each film-coated tablet contains 15 mg escitalopram (as oxalate). Each film-coated tablet contains 20 mg escitalopram (as oxalate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. _Escitalopram 5 mg:_ White to off – white colored, round shaped [diameter 5.6 mm], film- coated, biconvex tablets debossed with ‘F’ on one side and ‘53’ on the other side. _Escitalopram 10 mg:_ White to off – white colored, oval shaped, film-coated, biconvex tablets debossed with ‘F’ on one side and ‘54’ on the other side with a deep scoreline between ‘5’ and ‘4’. The size is 8.1 mm X 5.6 mm. _Escitalopram 15 mg:_ White to off – white colored, oval shaped, film-coated, biconvex tablets debossed with ‘F’ on one side and ‘55’ on the other side with a deep scoreline between ‘5’ and ‘5’. The size is 9.8 mm X 6.3 mm. _Escitalopram 20 mg:_ White to off – white colored, oval shaped, film-coated, biconvex tablets debossed with ‘F’ on one side and ‘56’ on the other side with a deep scoreline between ‘5’ and ‘6’. The size is 11.6 mm X 7.1 mm. The 10 mg, 15 mg and 20 mg tablets can be divided into equal doses. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of major depressive episodes. Treatment of panic disorder with or without agoraphobia. Treatment of social anxiety disorder (social phobia). Treatment of generalised anxiety disorder. Treatment of obsessive-compulsive disorder. Page 2 of 17 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Safety of daily doses above 20 mg has not been demonstrated. Major depressive epi Citiți documentul complet