Ország: Írország
Nyelv: angol
Forrás: HPRA (Health Products Regulatory Authority)
Escitalopram oxalate
AS Grindeks
N06AB10
Escitalopram oxalate
Film-coated tablet
escitalopram
Not marketed
2023-10-27
1 PACKAGE LEAFLET: INFORMATION FOR THE USER ESCITALOPRAM GRINDEKS 5 MG FILM-COATED TABLETS ESCITALOPRAM GRINDEKS 10 MG FILM-COATED TABLETS ESCITALOPRAM GRINDEKS 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 Grindeks is and what it is used for 2. What you need to know before you take Escitalopram Grindeks 3. How to take Escitalopram Grindeks 4. Possible side effects 5. How to store Escitalopram Grindeks 6. Contents of the pack and other information 1. WHAT ESCITALOPRAM GRINDEKS IS AND WHAT IT IS USED FOR Escitalopram Grindeks 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. Escitalopram Grindeks 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 Escitalopram Grindeks, 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 ESCITALOPRAM GRINDEKS DO NOT TAKE ESCITALOPRAM GRINDEKS: - If you are allergic to escitalopram or any of the other ingredients of this medicine (listed in Olvassa el a teljes dokumentumot
Health℃Products℃Regulatory℃Authority 27℃October℃2023 CRN00CQZG Page℃1℃of℃12 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Escitalopram℃Grindeks℃10℃mg℃film-coated℃tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each℃film-coated℃tablet℃contains℃escitalopram℃oxalate℃equivalent℃to℃10 mg℃escitalopram.℃ For℃the℃full℃list℃of℃excipients,℃see℃section 6.1. 3 PHARMACEUTICAL FORM Film-coated℃tablet. White℃to℃off-white,℃oval,℃approximately℃8℃mm℃x℃6℃mm,℃biconvex℃film-coated℃tablet℃with℃inscription℃1℃and℃0℃on℃either℃side℃of℃ score℃line℃on℃one℃side.℃The℃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℃for℃at℃least℃6℃ months℃is℃required℃for℃consolidation℃of℃the℃response. _Panic disorder with or without agoraphobia_ An℃initial℃dose℃of℃5℃mg℃is℃recommended℃for℃the℃first℃week℃before℃increasing℃the℃dose℃to℃10℃mg℃daily.℃The℃dose℃may℃be℃further℃ increased,℃up℃to℃a℃maximum℃of℃20℃mg℃daily,℃dependent℃on℃individual℃patient℃response. Maximum℃effectiveness℃is℃reached℃after℃about℃3℃mo Olvassa el a teljes dokumentumot