Land: Irland
Språk: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
ESCITALOPRAM OXALATE
Ranbaxy Ireland Limited
ESCITALOPRAM OXALATE
20 Milligram
Film Coated Tablet
Product subject to prescription which may not be renewed (A)
Authorised
0000-00-00
Package leaflet: Information for the user ESCITALOPRAM 10 MG FILM-COATED TABLETS ESCITALOPRAM 20 MG FILM-COATED TABLETS ESCITALOPRAM (AS 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, pharmacist or nurse. • 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. WHAT IS IN THIS LEAFLET: 1. What Escitalopram is and what it is used for 2. What you need to know before you take Escitalopram 3. How to take Escitalopram 4. Possible side effects 5. How to store Escitalopram 6. Contents of the pack and other information 1. WHAT ESCITALOPRAM IS AND WHAT IT IS USED FOR Escitalopram 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, 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. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ESCITALOPRAM - DO NOT TAKE ESCITALOPRAM: - If you are allergic to escitalopram or any of the other ingredients of this medicine (listed in section 6) - If you take other medicines that belongs to a group called MAO inhibitors, including selegiline (used in the treatment of Parkinson´s disease), read_full_document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Escitalopram 20mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 20 mg of escitalopram equivalent to 25.54 mg of escitalopram oxalate. Excipient with known effect Each film-coated tablet contains 100.00 mg of lactose monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Escitalopram Ranbaxy 20 mg: White to off-white, oval biconvex film-coated tablets, debossed with "E” and “9" on either side of the eye breakline on one side and plain on the other side. The 20 mg tablets can be divided into equal halves. 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. Escitalopram 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 to 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 m read_full_document