Pays: Irlande
Langue: anglais
Source: HPRA (Health Products Regulatory Authority)
Venlafaxine
Ethypharm UK Ltd
N06AX; N06AX16
Venlafaxine
300 milligram(s)
Prolonged-release tablet
Other antidepressants; venlafaxine
2019-07-19
PACKAGE LEAFLET: INFORMATION FOR THE USER VENLALIC XL 300 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, which 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 used to treat 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. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE VENLALIC XL DO NOT TAKE VENLALIC XL • If you are allergic to venlafaxine or any of the other ingredients of this medicine (listed in section 6). • If you are also taking or have taken any time within the last 14 days any medicines known as irreversible monoamine oxidase in Lire le document complet
Health Products Regulatory Authority 22 July 2019 CRN008LM3 Page 1 of 14 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Venlalic XL 300 mg prolonged-release tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each prolonged-release tablet contains 300 mg venlafaxine (as hydrochloride). Excipient with known effect: lactose 8.8 mg For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Prolonged-release tablet. 300 mg prolonged-release tablet, 12.8 mm round, biconvex, white tablet 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_ Venlalic XL 300 mg prolonged-release tablet is recommended for patients not responding to the initial low doses of venlafaxine. 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 300 mg/day dose and 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. Lower strengths are available to facilitate dose titration when initiating therapy and for individual dose adjustment. 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 sho Lire le document complet