Χώρα: Ιρλανδία
Γλώσσα: Αγγλικά
Πηγή: HPRA (Health Products Regulatory Authority)
Venlafaxine
Clonmel Healthcare Ltd
N06AX; N06AX16
Venlafaxine
150 milligram(s)
Prolonged-release capsule, hard
Product subject to prescription which may not be renewed (A)
Other antidepressants; venlafaxine
Marketed
2017-11-10
Page 1 of 10 PACKAGE LEAFLET: INFORMATION FOR THE USER VENEX XL 37.5MG PROLONGED-RELEASE CAPSULES, HARD VENEX XL 75MG PROLONGED-RELEASE CAPSULES, HARD VENEX XL 150MG PROLONGED-RELEASE CAPSULES, HARD 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 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 Venex XL is and what is used for 2. What you need to know before you take Venex XL 3. How to take Venex XL 4. Possible side effects 5. How to store Venex XL 6. Contents of the pack and other information 1. WHAT VENEX XL IS AND WHAT IT IS USED FOR Venex XL contains the active substance venlafaxine. Venex 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 not fully understood how antidepressants work, but they may help by increasing the levels of serotonin and norepinephrine in the brain. Venex 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. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE VENEX XL DO NOT TAKE VENEX XL • if you are allergic to venlafaxine or any of the othe Διαβάστε το πλήρες έγγραφο
Health Products Regulatory Authority 20 March 2024 CRN00F535 Page 1 of 15 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Venex XL 150 mg Prolonged-release Capsules, hard 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 169.8 mg venlafaxine hydrochloride equivalent to 150 mg venlafaxine. Excipients with known effect Contains 0.2 mg allura red AC (E129) and 0.4 mg sunset yellow FCF (E110). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Prolonged-release capsule, hard Dark orange / dark orange opaque, size ‘0’ hard gelatin capsules of approximately 21.00 mm to 21.80 mm having thick and thin radial circular band on the body in white ink and thick and thin radial circular band on the cap in white ink. The capsule is filled with 12 white to off-white, round, biconvex, film coated mini tablets of 12.5 mg each. 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 appropria Διαβάστε το πλήρες έγγραφο