Pays: Malte
Langue: anglais
Source: Medicines Authority
ESCITALOPRAM
Actavis Group PTC ehf Revkjavikurvegi 76-78, 220 Hafnarfjordur, Iceland
N06AB10
ESCITALOPRAM 20 mg
FILM-COATED TABLET
ESCITALOPRAM 20 mg
POM
PSYCHOANALEPTICS
Authorised
2009-11-19
Page 1 of 10 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT S-OROPRAM 5 MG FILM-COATED TABLETS S-OROPRAM 10 MG FILM-COATED TABLETS S-OROPRAM 15 MG FILM-COATED TABLETS S-OROPRAM 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 S-Oropram is and what it is used for 2. What you need to know before you take S-Oropram 3. How to take S-Oropram 4. Possible side effects 5. How to store S-Oropram 6. Contents of the pack and other information 1. WHAT S-OROPRAM IS AND WHAT IT IS USED FOR S-Oropram contains the active substance escitalopram. S-Oropram 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. S-Oropram 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 S-Oropram, 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 S-OROPRAM DO NOT TAKE S-OROPRAM - If you are allergic to escitalopram or any of the other ingredients of this m Lire le document complet
PAGE 1 OF 14 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT S-Oropram 5 mg film-coated tablets S-Oropram 10 mg film-coated tablets S-Oropram 15 mg film-coated tablets S-Oropram 20 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION S-OROPRAM 5 MG Each film-coated tablet contains escitalopram oxalate equivalent to 5 mg escitalopram. S-OROPRAM 10 MG Each film-coated tablet contains escitalopram oxalate equivalent to 10 mg escitalopram. S-OROPRAM 15 MG Each film-coated tablet contains escitalopram oxalate equivalent to 15 mg escitalopram. S-OROPRAM 20 MG Each film-coated tablet contains escitalopram oxalate equivalent to 20 mg escitalopram. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet S-OROPRAM 5 MG Round, biconvex, white film-coated tablet (diameter 6 mm) marked ‘E’ on one side. S-OROPRAM 10 MG Oval, biconvex, white film-coated tablet (6.4 mm x 9.25 mm) with score on one side, sidescores and marked with ‘E’ on the other side. The tablet can be divided into equal doses. _ _ S-OROPRAM 15 MG Oval, biconvex, white film-coated tablet (7.3 mm x 10.6 mm) with score on one side, sidescores and marked with ‘E-’ on the other side. The tablet can be divided into equal doses. S-OROPRAM 20 MG Oval, biconvex, white film-coated tablet (8 mm x 11.7 mm) with score on one side, sidescores and marked with ‘E’ on the other side. The tablet can be divided into equal doses. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of - major depressive episodes - panic disorder with or without agoraphobia PAGE 2 OF 14 - social anxiety disorder (social phobia) - generalised anxiety disorder - obsessive-compulsive disorder 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY Safety of daily doses above 20 mg has not been demonstrated. Major depressive episodes Usual dosage is 10 mg once daily. Depending on individual patient response, the dose may be increased to a maximum of 20 mg daily. Usually 2-4 weeks are necessary to obtain antidepre Lire le document complet