Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
VENLAFAXINE HYDROCHLORIDE
Milpharm Limited
N06AX16
VENLAFAXINE HYDROCHLORIDE
75 Milligram
Prolonged Release Capsules
Oral use
7, 10, 14, 20, 28, 30, 50, 56, 60, 90, 98 and 100 capsules
Product subject to prescription which may not be renewed (A)
Antidepressants, Other antidepressants
Other antidepressants
Treatment of major depressive episodes. For prevention of recurrence of major depressive episodes. Treatment of generalised anxiety disorder. Treatment of social anxiety disorder. Treatment of panic disorder, with or without agoraphobia
Transfer Pending
2015-03-06
PACKAGE LEAFLET: INFORMATION FOR THE USER VEDIXAL XL 37.5 MG PROLONGED-RELEASE CAPSULES, HARD VEDIXAL XL 75 MG PROLONGED-RELEASE CAPSULES, HARD VEDIXAL XL 150 MG 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 Vedixal XL is and what it is used for 2. What you need to know before you take Vedixal XL 3. How to take Vedixal XL 4. Possible side effects 5. How to store Vedixal XL 6. Contents of the pack and other information 1. WHAT VEDIXAL XL IS AND WHAT IT IS USED FOR Vedixal XL contains the active substance venlafaxine.Vedixal 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. Vedixal XL is a treatment for adults with depression. It is also a treatment for adults with the following anxiety disorders: generalised anxiety disorder, social anxiety disorder (fear or avoidance of social situations) and panic disorder (panic attacks). 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 t Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Vedixal XL 75mg Prolonged release capsules, hard 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each prolonged-release capsule contains 75 mg of venlafaxine (as hydrochloride). Excipient with known effect: Each capsule contains 87.1 mg sucrose. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Prolonged-release capsule, hard White to off-white spherical to oval pellets filled in Empty hard gelatin capsule shell (size ‘1’) of Opaque Peach color cap and Opaque Peach color body imprinted with “E” on cap and “74” on the body with edible black ink. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of major depressive episodes. For prevention of recurrence of major depressive episodes. Treatment of generalised anxiety disorder. Treatment of social anxiety disorder. Treatment of panic disorder, with or without agoraphobia. 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. H E A L T H P R O D U C T S R E G U L A T Read the complete document