Страна: Мальта
мова: англійська
Джерело: Medicines Authority
ESCITALOPRAM
Teva Pharma B.V. Swensweg 5, 2031 GA Haarlem, Netherlands
N06AB10
ESCITALOPRAM 5 mg
FILM-COATED TABLET
ESCITALOPRAM 5 mg
POM
PSYCHOANALEPTICS
Withdrawn
2009-06-17
Page 1 of 11 PACKAGE LEAFLET: INFORMATION FOR THE USER ESCITALOPRAM TEVA 5 MG FILM-COATED TABLETS ESCITALOPRAM TEVA 10 MG FILM-COATED TABLETS ESCITALOPRAM TEVA 15 MG FILM-COATED TABLETS ESCITALOPRAM TEVA 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 Teva is and what it is used for 2. What you need to know before you take Escitalopram Teva 3. How you take Escitalopram Teva 4. Possible side effects 5. How to store Escitalopram Teva 6. Contents of the pack and other information 1 WHAT ESCITALOPRAM TEVA IS AND WHAT IT IS USED FOR_ _ Escitalopram Teva 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. Escitalopram Teva 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 WHAT YOU NEED TO KNOW BEFORE YOU TAKE ESCITALOPRAM TEVA DO NOT TAKE ESCITALOPRAM TEVA if you are allergic to escitalopram or any of the other ingredients of this medicine (listed in section 6). if you take other medicines that belongs to a group called MAO inhibitors, including selegiline (used in the treatment of Parkinso Прочитайте повний документ
Page 1 of 17 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Escitalopram Teva 5 mg Film-coated Tablets Escitalopram Teva 10 mg Film-coated Tablets Escitalopram Teva 15 mg Film-coated Tablets Escitalopram Teva 20 mg Film-coated Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Escitalopram Teva 5 mg: Each film-coated tablet contains 5 mg escitalopram (as oxalate). Escitalopram Teva 10 mg: Each film-coated tablet contains 10 mg escitalopram (as oxalate). Escitalopram Teva 15 mg: Each film-coated tablet contains 15 mg escitalopram (as oxalate). Escitalopram Teva 20 mg: 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 Teva 5 mg: White, round, biconvex film-coated tablet, debossed with “93” on one side and “7414” on the other side. Escitalopram Teva 10 mg: White, round, biconvex film-coated tablet, scored on one side and debossed with “9” on the left side of the score and “3” on the right side of the score. The other side of the tablet is debossed with “7462”. The tablet can be divided into equal halves. Escitalopram Teva 15 mg: White, round, biconvex film-coated tablet, scored on one side and debossed with “S” on the left side of the score and “C” on the right side of the score. The other side of the tablet is debossed with “15”. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. Escitalopram Teva 20 mg: White, round, biconvex film-coated tablet, scored on one side and debossed with “9” on the left side of the score and “3” on the right side of the score. The other side of the tablet is debossed with “7463”. The tablet can be divided into equal halves. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of major depressive episodes Page 2 of 17 Treatment of panic disorder with or without agoraphobia. Treatment of social anxiety disorder (social phobia). Treatment of ge Прочитайте повний документ