Maa: Irlanti
Kieli: englanti
Lähde: HPRA (Health Products Regulatory Authority)
Venlafaxine
Wockhardt UK Limited
N06AX; N06AX16
Venlafaxine
150 milligram(s)
Prolonged-release capsule, hard
Product subject to prescription which may not be renewed (A)
Other antidepressants; venlafaxine
Not marketed
2010-01-08
PACKAGE LEAFLET: INFORMATION FOR THE USER TONPULAR XL 75MG PROLONGED-RELEASE HARD CAPSULES TONPULAR XL 150MG PROLONGED-RELEASE HARD CAPSULES Venlafaxine Hydrochloride 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 TONPULAR XL_ _IS AND WHAT IT IS USED FOR_ _ 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TONPULAR XL 3. HOW TO TAKE TONPULAR XL 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE TONPULAR XL 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. WHAT TONPULAR XL_ _IS AND WHAT IT IS USED FOR_ _ Tonpular XL_ _contains the active substance venlafaxine hydrochloride. Tonpular XL_ _is an antidepressant that belongs to a group of medicines called Serotonin and Noradrenaline 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. Tonpular 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 treat. _ Lue koko asiakirja
Health Products Regulatory Authority 17 October 2019 CRN00983S Page 1 of 17 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Tonpular XL 150 mg prolonged-release hard capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each prolonged release hard capsule contains 169.7mg of venlafaxine hydrochloride, equivalent to 150mg of venlafaxine. Excipients: Sunset yellow FCF (E110) 0.2286mg Tartrazine (E102) 0.0304mg For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Prolonged-release capsule, hard. Size '0' hard gelatin capsule with orange opaque cap and orange opaque body filled with white to off white pellets. The capsule is imprinted with _W _ 718 on cap in white colour. 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 dur Lue koko asiakirja