देश: आयरलैंड
भाषा: अंग्रेज़ी
स्रोत: HPRA (Health Products Regulatory Authority)
VENLAFAXINE HYDROCHLORIDE
DB Ashbourne Ltd
N06AX16
VENLAFAXINE HYDROCHLORIDE
225 Milligram
Tablet Prolonged Release
Product subject to prescription which may not be renewed (A)
Other antidepressants
Authorised
2014-06-25
PACKAGE LEAFLET: INFORMATION FOR THE USER VENLALIC ® XL 37.5 MG PROLONGED-RELEASE TABLETS VENLALIC ® XL 75 MG PROLONGED-RELEASE TABLETS VENLALIC ® XL 150 MG PROLONGED-RELEASE TABLETS VENLALIC ® XL 225 MG PROLONGED-RELEASE TABLETS 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 please 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 Venlalic XL is and what it is used for 2. What you need to know before you take Venlalic XL 3. How to take Venlalic XL 4. Possible side effects 5. How to store Venlalic XL 6. Contents of the pack and other information 1. WHAT VENLALIC XL IS AND WHAT IT IS USED FOR Venlalic XL contains the active substance venlafaxine. Venlalic 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. Venlalic XL is a treatment for adults with depression. Venlalic XL 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 ma पूरा दस्तावेज़ पढ़ें
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Venlalic XL 225 mg prolonged-release tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each prolonged-release tablet contains 225 mg venlafaxine (as hydrochloride). Excipient with known effect: lactose 6.5 mg For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Prolonged-release tablet. 11 mm round, biconvex, white tablets. 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. Antidepressive medicinal products should continue for at least six months following remission. _Generalised anxiety disorder_ The recommended starting dose for prolonged-release venlafaxine is 75 mg given once daily. Patients not responding to the initial 75 mg/day dose ma पूरा दस्तावेज़ पढ़ें