Land: Storbritannien
Språk: engelska
Källa: MHRA (Medicines & Healthcare Products Regulatory Agency)
Venlafaxine hydrochloride
Waymade Healthcare Plc
N06AX16
Venlafaxine hydrochloride
75mg
Modified-release capsule
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04030400
mockup 6104 Druckreif: Package Leaflet: Information for the user Efexor XL 75 mg prolonged-release capsules, hard Efexor XL 150 mg prolonged-release capsules, hard Efexor XL 225 mg prolonged-release capsules, hard venlafaxine IMPORTANT THINGS YOU SHOULD KNOW ABOUT EFEXOR XL Please read all of this leaflet before you start to take your medicine as it contains important information about Efexor XL • Efexor XL is used to treat depression, severe and persistent anxiety known as generalised anxiety disorder (GAD), social anxiety disorder (also known as social phobia) and panic disorder (panic attacks) • Efexor XL is not for use in children and adolescents – see in section 2 ‘Children and adolescents’ If you have any concerns about how you feel, or about this medication, it is important that you talk to your doctor – even if you feel anxious or worried about doing so. You may find it helpful to tell a friend or relative that you are depressed or suffering from an anxiety disorder, and that you have been prescribed this medication; it might be useful to show them this leaflet. • Efexor XL may not start to work immediately. Some people taking antidepressants may feel worse before feeling better. Your doctor may ask to see you again a couple of weeks after you start treatment and then regularly until you start to feel well again. Tell your doctor if you do not start to feel better. • Some people who are depressed may think of harming or killing themself. If this happens you should see your doctor or go to a hospital straight away – see in section 2 ‘Thoughts of suicide and worsening of your depression or anxiety disorder’ • If you take too many capsules it is important to seek immediate medical attention, even if you feel well, because of the risk of serious side effects • Do not stop taking Efexor XL or change your dose without the advice of your doctor even if you feel better. If you stop taking Efexor XL abruptly you may get withdrawal reactions – see in section 3 ‘If you stop taking Efexo Läs hela dokumentet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Efexor XL 75 mg prolonged-release capsules, hard 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each prolonged-release capsule contains 84.85 mg of venlafaxine hydrochloride, equivalent to 75 mg of venlafaxine free base. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Prolonged-release capsule, hard. Opaque peach capsules printed in red with ‘W’ and ‘75’ hard gelatin capsule, size 1 (19.4 mm x 6.91 mm). 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 v Läs hela dokumentet