Maa: Irlanti
Kieli: englanti
Lähde: HPRA (Health Products Regulatory Authority)
VENLAFAXINE HYDROCHLORIDE
Clonmel Healthcare Ltd
N06AX16
VENLAFAXINE HYDROCHLORIDE
150 Milligram
Prolonged Release Capsules
Product subject to prescription which may not be renewed (A)
Other antidepressants
Authorised
2008-10-17
PACKAGE LEAFLET: INFORMATION FOR THE USER VENEX XL 37.5MG PROLONGED-RELEASE CAPSULES, HARD VENEX XL 75MG PROLONGED-RELEASE CAPSULES, HARD VENEX XL 150MG PROLONGED-RELEASE CAPSULES, HARD Venlafaxine 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 Venex XL is and what it is used for 2. What you need to know before you take Venex XL 3. How to take Venex XL 4. Possible side effects 5. How to store Venex XL 6. Contents of the pack and other information 1. WHAT VENEX XL IS AND WHAT IT IS USED FOR Venex XL contains the active substance venlafaxine. Venex XL is an antidepressant that belongs to a group of medicines called serotonin and norepinephrine reuptake inhibitors (SNRIs). This group of medicines is used to treat depression and other conditions such as anxiety disorders. It is thought that people who are depressed and/or anxious have lower levels of serotonin and noradrenaline in the brain. It is not fully understood how antidepressants work, but they may help by increasing the levels of serotonin and noradrenaline in the brain. Venex XL is a treatment for adults with depression. It is also a treatment for adults with the following anxiety disorder: social anxiety disorder (fear or avoidance of social situations). Treating depression or anxiety disorders properly is important to help you get better. If it is not treated, your condition may not go away and may become more serious and more difficult to treat. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE VENEX XL DO NOT TAKE VENEX XL If you are aller Lue koko asiakirja
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Venex XL 150 mg prolonged-release capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One capsule contains venlafaxine hydrochloride, equivalent to 150 mg of venlafaxine. Excipients sucrose max. 185.38 mg sunset yellow FCF (E110) 0.0183 mg For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Prolonged release capsule, hard. White to off-white granules in a capsule size “0” with a buff cap and transparent body. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of major depressive episodes. For prevention of recurrence of major depressive episodes. Treatment of social anxiety disorder. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Major depressive episodes The recommended starting dose for prolonged-release venlafaxine is 75 mg given once daily. Patients not responding to the initial 75 mg/day dose may benefit from dose increases up to a maximum dose of 375 mg/day. Dosage increases can be made at intervals of 2 weeks or more. If clinically warranted due to symptom severity, dose increases can be made at more frequent intervals, but not less than 4 days. Because of the risk of dose-related adverse effects, dose increments should be made only after a clinical evaluation (see section 4.4). The lowest effective dose should be maintained. Patients should be treated for a sufficient period of time, usually several months or longer. Treatment should be reassessed regularly on a case-by-case basis. Longer-term treatment may also be appropriate for prevention of recurrence of major depressive episodes (MDE). In most of the cases, the recommended dose in prevention of recurrence of MDE is the same as the one used during the current episode. Anti-depressive medicinal products should continue for at least six months following remission. Social anxiety disorder The recommended dose for prolonged-release venlafaxine is 75 mg given once daily. There is no evidence that higher doses confer any additional benefit. However, in i Lue koko asiakirja