البلد: أيرلندا
اللغة: الإنجليزية
المصدر: HPRA (Health Products Regulatory Authority)
ESCITALOPRAM OXALATE
Rowex Ltd
N06AB10
ESCITALOPRAM OXALATE
5 Milligram
Orodispersible Tablet
Product subject to prescription which may not be renewed (A)
Selective serotonin reuptake inhibitors
Authorised
2014-09-12
PACKAGE LEAFLET: INFORMATION FOR THE USER ESCIPREX DISTAB 5 MG ORODISPERSIBLE TABLETS ESCIPREX DISTAB 10 MG ORODISPERSIBLE TABLETS ESCIPREX DISTAB 15 MG ORODISPERSIBLE TABLETS ESCIPREX DISTAB 20 MG ORODISPERSIBLE TABLETS ESCITALOPRAM READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THE 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 Esciprex DisTab is and what it is used for 2. What you need to know before you take Esciprex DisTab 3. How to take Esciprex DisTab 4. Possible side effects 5. How to store Esciprex DisTab 6. Contents of the pack and other information 1 WHAT ESCIPREX DISTAB IS AND WHAT IT IS USED FOR 2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE ESCIPREX DISTAB Esciprex DisTab contains the active substance escitalopram. Esciprex DisTab 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. Esciprex DisTab 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-com اقرأ الوثيقة كاملة
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Esciprex DisTab 5 mg Orodispersible Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each orodispersible tablet contains 5 mg escitalopram, equivalent to 6.3875 mg escitalopram oxalate. Excipient(s) with known effect: Each 5 mg tablet contains 58.935 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Orodispersible tablet White to off-white round, flat tablets with beveled edges, a diameter of 7 mm and engraved with “5” on one side. 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 The safety of daily doses above 20 mg has not been demonstrated. Method of administration Esciprex DisTab is administered as a single daily dose and should be taken without food. The tablet should be placed on the tongue, where it rapidly disintegrates and can be swallowed without water. The orodispersible tablet is fragile and should be handled carefully. Esciprex DisTab orodispersible tablet is bioequivalent to escitalopram film-coated tablets, with a similar rate and extent of absorption. It has the same dosage and frequency of administration as escitalopram coated tablets. Esciprex DisTab Orodispersible tablets may be used as an alternative to escitalopram film-coated tablets. Posology 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 اقرأ الوثيقة كاملة