מדינה: אירלנד
שפה: אנגלית
מקור: HPRA (Health Products Regulatory Authority)
VENLAFAXINE HYDROCHLORIDE
Teva Pharma B.V.
N06AX16
VENLAFAXINE HYDROCHLORIDE
75 Milligram
Tablets
Product subject to prescription which may not be renewed (A)
Other antidepressants
Authorised
2008-10-10
1 PACKAGE LEAFLET: INFORMATION FOR THE USER25 MG TABLETS קרא את המסמך השלם37.5 MG TABLETS 50 MG TABLETS 75 MG 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, 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 of the 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 is and what it is used for 2. What you need to know before you take 3. How to take 4. Possible side effects 5. How to store 6. Contents of the pack and other information 1. WHAT IS AND WHAT IT IS USED FOR 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. is a treatment for adults with depression. Treating depression 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.
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Venlafaxine Teva 75 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 75 mg of venlafaxine as 84.852 mg venlafaxine hydrochloride. _Excipients with known effect:_ Each tablet contains 184.36 mg of lactose. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. Mottled peach, round, flat bevelled tablet, on one side scored and debossed “9” on one side of the score and “3” on the other side of the score. Debossed with “7382” on the opposite side of the tablet. The tablet can be divided into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of major depressive episodes. For prevention of recurrence of major depressive episodes. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Major depressive episodes The recommended starting dose of immediate-release venlafaxine is 75 mg/day in two or three divided doses taken with food. 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. Elderly patients H E A L T H P R O D U C T S R E G U L A T O R Y קרא את המסמך השלם