País: Malta
Língua: inglês
Origem: Medicines Authority
ESCITALOPRAM
Bristol Laboratories Limited
N06AB10
ESCITALOPRAM
FILM-COATED TABLET
ESCITALOPRAM 5 milligram(s)
POM
PSYCHOANALEPTICS
Authorised
2015-02-27
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT 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 oxalate 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 this medicine is and what it is used for 2. What you need to know 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 The name of your medicine is Escitalopram 5 mg, 10 mg, 15 mg and 20 mg film-coated tablets and 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. Disturbances in the serotonin-system are considered an important factor in the development of depression and related diseases. Escitalopram 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 this medicine 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 Leia o documento completo
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 of escitalopram (as oxalate). Each film-coated tablet contains 10 mg of escitalopram (as oxalate). Each film-coated tablet contains 15 mg of escitalopram (as oxalate). Each film-coated tablet contains 20 mg of escitalopram (as oxalate). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet (tablet) White to off white, round, bevelled biconvex film-coated tablets debossed with ‘J’ on one side and ‘1’ on the other side. The tablet dimensions are 5.20 mm. White to off white, oval, scored, biconvex film-coated tablets debossed with ‘J’ on one side and ‘2’ on the other side. The tablet dimensions are 7.90 x 5.40 mm. White to off white, oval, scored, biconvex film-coated tablets debossed with ‘J’ on one side and ‘3’ on the other side. The tablet dimensions are 9.80 x 6.20 mm. White to off white, oval, scored, biconvex film-coated tablets debossed with ‘J’ on one side and ‘4’ on the other side. The tablet dimensions are 11.40 x 6.90 mm. The 10 mg, 15 mg and 20 mg tablet 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. 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 antidepressant response. After the symptoms resolve, treatment Leia o documento completo