Χώρα: Ιρλανδία
Γλώσσα: Αγγλικά
Πηγή: HPRA (Health Products Regulatory Authority)
Escitalopram
Imbat Limited
N06AB; N06AB10
Escitalopram
5 milligram(s)
Film-coated tablet
Product subject to prescription which may not be renewed (A)
Selective serotonin reuptake inhibitors; escitalopram
Authorised
2009-06-25
_Page 1 of 2 _ PACKAGE LEAFLET: INFORMATION FOR THE USER LEXAPRO ® 5MG FILM-COATED TABLETS LEXAPRO ® 10MG FILM-COATED TABLETS LEXAPRO ® 15MG FILM-COATED TABLETS LEXAPRO ® 20MG FILM-COATED TABLETS escitalopram (as oxalate) 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 Lexapro is and what it is used for 2. Before you take Lexapro 3. How to take Lexapro 4. Possible side effects 5. How to store Lexapro 6. Further information 1. WHAT LEXAPRO IS AND WHAT IT IS USED FOR Lexapro 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. Lexapro 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. BEFORE YOU TAKE LEXAPRO DO NOT TAKE LEXAPRO if you are allergic (hypersensitive) to escitalopram or any of the other ingredients of Lexapro (see section 6 “Further information”). if you take other medicines that belong to a group called MAO inhibitors, including selegiline (used in the treatment of Parkinson’s disease), moclobemide (used in the treatment of depression) and linezolid (an antibiotic). if you are born with or have had an episode of abnormal heart rhythm (seen at ECG: an examination to evalua Διαβάστε το πλήρες έγγραφο
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Lexapro 5mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 5mg escitalopram (as oxalate) For full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Film-coated tablet _Product imported from UK:_ Round, white, film-coated tablet marked with ‘EK’ on one side and plain on the other. 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 Safety of daily doses above 20 mg has not been demonstrated. Lexapro 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 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 to a maximum of 20 mg daily. Social anxiety disorder is a disease with a chronic course, and treatment for 12 weeks is recommended to consolidate response. Long-term treatment of responders has been studied for 6 months and can be considered on an individual basis to prevent rela Διαβάστε το πλήρες έγγραφο