Страна: Ирландия
Язык: английский
Источник: HPRA (Health Products Regulatory Authority)
ESCITALOPRAM OXALATE
Chanelle Healthcare Limited
ESCITALOPRAM OXALATE
20 Mg/Ml
Oral Drops Solution
Product subject to prescription which may not be renewed (A)
Authorised
0000-00-00
ID: PL 166-0171 Version: 02 Review Date: 01/08/2012 PACKAGE LEAFLET: INFORMATION FOR THE USER _ _ ESCITALOPRAM 20 MG / ML ORAL DROPS, SOLUTION Escitalopram READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. • 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. _ _ IN THIS LEAFLET: 1. What Esditalopram is and what it is used for 2. Before you take Escitalopram 3. How to take Escitalopram 4. Possible side effects 5. How to store Escitalopram 6. Further information 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 20 mg/ml oral drops solution 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). _ _ DO NOT TAKE ESCITALOPRAM: • If you are allergic (hypersensitive) to escitalopram or any of the other ingredients of Escitalopram (see section 6 "Further information"). • If you take other medicines which belongs to a group called MAO inhibitors, including Прочитать полный документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Escitalopram 20mg/ml Oral Drops Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of solution contains: 20 mg escitalopram (as 25.56 mg escitalopram oxalate). Each drop contains 1 mg of escitalopram. Excipients: Each drop contains 4.7mg of ethanol. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Oral drops, solution A clear solution with a bitter taste. 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 (20 drops) has not been demonstrated. _Major depressive episodes_ Usual dosage is 10 mg (10 drops) once daily. Depending on individual patient response, the dose may be increased to a maximum of 20 mg (20 drops) daily. Usually 2-4 weeks are necessary to obtain antidepressant response. After the symptoms resolve, treatment for at least 6 months is required for consolidation of the response. _Panic disorder with or without agoraphobia_ An initial dose of 5 mg (5 drops) is recommended for the first week before increasing the dose to 10 mg (10 drops) daily. The dose may be further increased, up to a maximum of 20 mg (20 drops) daily, dependent on individual patient response. Maximum effectiveness is reached after about 3 months. The treatment lasts several months. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 15/01/2014_ _CRN 2139465_ _page number: 1_ _Social anxiety disorder_ Usual d Прочитать полный документ