Država: Irska
Jezik: engleski
Izvor: HPRA (Health Products Regulatory Authority)
Escitalopram
KRKA, d.d., Novo mesto
N06AB; N06AB10
Escitalopram
20 milligram(s)
Film-coated tablet
Product subject to prescription which may not be renewed (A)
Selective serotonin reuptake inhibitors; escitalopram
Marketed
2014-02-28
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ESCITALOPRAM KRKA 5 MG FILM-COATED TABLETS ESCITALOPRAM KRKA 10 MG FILM-COATED TABLETS ESCITALOPRAM KRKA 15 MG FILM-COATED TABLETS ESCITALOPRAM KRKA 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 Krka is and what it is used for 2. What you need to know before you take Escitalopram Krka 3. How to take Escitalopram Krka 4. Possible side effects 5. How to store Escitalopram Krka 6. Contents of the pack and other information 1. WHAT ESCITALOPRAM KRKA IS AND WHAT IT IS USED FOR Escitalopram Krka 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). 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. It may take a couple of weeks before you start to feel better. Continue to take Escitalopram Krka, 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 KRKA DO NOT TAKE ESCITALOPRAM KRKA - if you are Pročitajte cijeli dokument
Health Products Regulatory Authority 04 October 2022 CRN00CLMP Page 1 of 12 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Escitalopram Krka 20 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 20 mg escitalopram corresponding to 25.560 mg escitalopram oxalate. Excipient(s) with known effect: Each 20 mg film-coated tablet contains 205.3 mg lactose (as lactose monohydrate), respectively. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet White, oval, biconvex film-coated tablets, scored on one side with dimensions 12 x 7.5 mm, imprinted with "20" in black colour on each side of the tablet. 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 months. The treatment lasts several months. Social anxiety disorder Usual dosage is 10 mg once daily. Usually 2–4 weeks are necessary to obtain symptom relief. The dose may subsequently, depending on individual patient response, be decreased to 5 mg or increased Pročitajte cijeli dokument