País: Reino Unido
Idioma: inglés
Fuente: MHRA (Medicines & Healthcare Products Regulatory Agency)
Venlafaxine hydrochloride
Bristol Laboratories Ltd
N06AX16
Venlafaxine hydrochloride
37.5mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04030400; GTIN: 5060013943164
Package leaflet: Information for the user Venlafaxine 37.5 mg Tablets Venlafaxine 75 mg Tablets Important things you need to know about Venlafaxine Please read all of this leaflet before you start to take your medicine as it contains important information about Venlafaxine • Venlafaxine is used to treat depression • Venlafaxine should not be given to anyone under 18 years of age-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, and that you have been prescribed this medication; it might be useful to show them this leaflet. • Venlafaxine may not work straight away. After you start treatment, you may feel worse before you feel 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 feel better • Some people who are depressed may think of harming or killing themselves. If you have these thoughts at any time, tell 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 have taken too many tablets 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 your tablets or change the amount you take without checking with your doctor first. Keep taking them even if you feel better. If you stop taking Venlafaxine suddenly you may get withdrawal reactions-see in section 3 ‘If you stop taking Venlafaxine tablets’ • Taking some other medicines with Venlafaxine may cause problems. Tell your doctor if you are taking or have recently taken any other medicines- see in ‘Other medicines and Venlafaxine Tablets’ • Tell your doctor straight away if you feel restless Leer el documento completo
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Venlafaxine 37.5 mg Tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 37.5 mg of Venlafaxine as Venlafaxine Hydrochloride as the active substance. Excipients of known effect: Also contains 52.08 mg of Lactose Monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Peach coloured, circular, flat faced, bevelled edged, uncoated tablets having ‘37.5’ debossed on one side and ‘BL’ on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Venlafaxine tablets are indicated for the • treatment of major depressive disorder • prevention of the recurrence of major depressive episodes. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology MAJOR DEPRESSIVE EPISODES: The recommended starting dose 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.Anti-depressive medicinal products should continue for at least 6 months following remission. ELDERLY No specific dose adjustments of venlafaxine are considered necessary based on patient age alone. However, caution should be exercised in treating the elderly (e.g. due to the possibili Leer el documento completo