Pays: Irlande
Langue: anglais
Source: HPRA (Health Products Regulatory Authority)
VENLAFAXINE HYDROCHLORIDE
B & S Healthcare
VENLAFAXINE HYDROCHLORIDE
75 Milligram
Prolonged Release Capsules
Product subject to prescription which may not be renewed (A)
Authorised
0000-00-00
PACKAGE LEAFLET: INFORMATION FOR THE USER EFEXOR ® XL 75MG PROLONGED-RELEASE CAPSULES, HARD (venlafaxine) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. • 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. The name of your medicine is Efexor XL 75mg prolonged-release capsules, hard but it will be referred to as Efexor XL throughout this leaflet. IN THIS LEAFLET: 1. What Efexor XL is and what it is used for 2. Before you take Efexor XL 3. How to take Efexor XL 4. Possible side effects 5. How to store Efexor XL 6. Further information 1. WHAT EFEXOR XL IS AND WHAT IT IS USED FOR Efexor 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. Efexor 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 Lire le document complet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Efexor XL 75mg Prolonged-Release Capsules, hard 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 84.85mg venlafaxine hydrochloride equivalent to 75mg venlafaxine. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Prolonged-release capsule, hard _Product imported from Italy and Spain:_ Opaque peach capsules printed in red with 'W' on the cap and ‘75' on the body 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 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 Lire le document complet