देश: मलेशिया
भाषा: अंग्रेज़ी
स्रोत: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
ESCITALOPRAM OXALATE
Lundbeck Malaysia Sdn. Bhd.
ESCITALOPRAM OXALATE
28Tablet Tablets
H. LUNDBECK A/S
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ LEXAPRO FILM-COATED TABLETS Escitalopram (as oxalate) (5, 10, 15, 20mg) 1 WHAT IS IN THIS LEAFLET 1. What Lexapro is used for 2. How Lexapro works 3. Before you use Lexapro 4. How to use Lexapro 5. While you are using it 6. Side effects 7. Storage and Disposal of Lexapro 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT LEXAPRO IS USED FOR Lexapro contains escitalopram and is used to treat: • depression • panic disorder with or without agoraphobia (fear of public or open spaces) • social anxiety disorder/social phobia (fear or avoidance of social situations) • generalised anxiety disorder (generally feeling very anxious or nervous, even when there is little or no reason to worry about them) • obsessive-compulsive disorder (OCD) (persistent, obsessive thoughts that make you carry out repetitive behaviour) HOW LEXAPRO WORKS Lexapro contains the active substance escitalopram. 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. BEFORE YOU USE LEXAPRO - _When you must not use it _ Do not take: • if you are allergic to escitalopram or any of the other ingredients of this medicine (listed in section PRODUCT DESCRIPTION ). • If you take other medicines which belong to a group called monoamine oxidase inhibitors (MAOIs) (see subsection _Taking other medicines_ ). Taking Lexapro with a MAOI may cause a serious, sometimes fatal, reaction with features resembling serotonin syndrome (see section SIDE EFFECTS ). • at the same time as taking pimozide (used in the treatment of mental disorders or nervous system disorders) - _Before you start to use it _ Please tell your doctor if you have any other condition or illness, as your doctor may need to take th पूरा दस्तावेज़ पढ़ें
PHYSICIAN INFORMATION LEAFLET Page 1 of 18 PHYSICIAN INFORMATION LEAFLET Lexapro 5mg, 10mg, 15mg and 20mg film-coated tablets Escitalopram (as oxalate) 1. NAME OF THE MEDICINAL PRODUCT LEXAPRO 5 mg film-coated tablets LEXAPRO 10 mg film-coated tablets LEXAPRO 15 mg film-coated tablets LEXAPRO 20 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Lexapro 5 mg: Each tablet contains 5 mg escitalopram (as 6.39 mg escitalopram oxalate) Lexapro 10 mg: Each tablet contains 10 mg escitalopram (as 12.77 mg escitalopram oxalate) Lexapro 15 mg: Each tablet contains 15 mg escitalopram (as 19.16 mg escitalopram oxalate) Lexapro 20 mg: Each tablet contains 20 mg escitalopram (as 25.54 mg escitalopram oxalate) For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablets Lexapro 5 mg: Round, white, film-coated tablet marked with "EK" on one side. Lexapro 10 mg: Oval, white, scored, film-coated tablet marked with "E” and “L" on each side of the score on one side of the tablet. Lexapro 15 mg: Oval, white, scored, film-coated tablet marked with "E” and “M" on each side of the score on one side of the tablet. Lexapro 20 mg: Oval, white, scored, film-coated tablet marked with "E” and “N" on each side of the score on one side of the tablet. The 10, 15 and 20 mg tablets 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. PHYSICIAN INFORMATION LEAFLET Page 2 of 18 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- पूरा दस्तावेज़ पढ़ें