Država: Malta
Jezik: engleski
Izvor: Medicines Authority
ESCITALOPRAM
Cipla (EU) Limited Hillbrow House, Hillbrow Road, Esher, Surrey, KT10 9NW, United Kingdom
N06AB10
ESCITALOPRAM 5 mg
FILM-COATED TABLET
ESCITALOPRAM 5 mg
POM
PSYCHOANALEPTICS
Withdrawn
2013-11-14
KS75 A PACKAGE LEAFLET: INFORMATION FOR THE USER ESCITALOPRAM 5 MG FILM-COATED TABLETS ESCITALOPRAM 10 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 or nurse. - 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 or nurse. This includes any possible side effects not listed in this leaflet. WHAT IS IN THIS LEAFLET 1. What this medicine is and what it is used for. 2. Before you take this medicine 3. How to take this medicine 4. Possible side effects 5. How to store this medicine 6. Contents of the pack and other information 1. WHAT THIS MEDICINE IS AND WHAT IT IS USED FOR This medicine 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. This medicine 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 THIS MEDICINE DO NOT TAKE THIS MEDICINE: If you are allergic (hypersensitive) to escitalopram or any of the other ingredients of this medicine (see section 6 “Contents of the pack and other information”). If you take other medicines that belongs to a group called MAO inhibitors, including sele Pročitajte cijeli dokument
Page 1 of 18 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Escitalopram 5 mg Film-Coated Tablets Escitalopram 10 mg Film-Coated Tablets Escitalopram 20 mg Film-Coated Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Escitalopram 5 mg Film-Coated Tablets: Each tablet contains 5 mg escitalopram (as oxalate) Escitalopram 10 mg Film-Coated Tablets: Each tablet contains 10 mg escitalopram (as oxalate) Escitalopram 20 mg Film-Coated Tablets: Each tablet contains 20 mg escitalopram (as oxalate) For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-Coated Tablet Escitalopram 5 mg: White to off white, round, biconvex film coated tablets with “E5” debossed on one side and plain on the other side. Diameter- 6.00 mm to 6.20 mm. Escitalopram 10 mg: White to off white, round, biconvex film coated tablets with “E10” debossed on one side and break line on the other side. The 10 mg tablets can be divided into equal halves. Diameter- 7.50 mm to 7.70 mm. Escitalopram 20 mg: White to off white, round, biconvex film coated tablets with “E20” debossed on one side and break line on the other side. The 20 mg tablets can be divided into equal halves. Diameter- 9.50 mm to 9.70 mm. 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 18 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Safety of daily doses above 20 mg has not been demonstrated. Escitalopram Tablets is administered as a single daily dose and may be taken with or without food. Major depressive episodes Usual dosage is 10 mg once daily. Depending on individual patient response, the dose Pročitajte cijeli dokument