Страна: Великобритания
Язык: английский
Источник: MHRA (Medicines & Healthcare Products Regulatory Agency)
Venlafaxine hydrochloride
Phoenix Healthcare Distribution Ltd
N06AX16
Venlafaxine hydrochloride
37.5mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04030400
Top of page cut-off to middle of registration mark = 44 mm PAGE 4: AFTER FOLDING REAR FACE (OUTSIDE OF REEL AFTER FOLDING AND TACKING) PAGE 1: AFTER FOLDING FRONT FACE (INSIDE OF REEL AFTER FOLDING AND TACKING) FOLD LINE. Pharma code 854 First bar is 105mm from top edge. You may be more likely to think like this: • If you have previously had thoughts about killing or harming yourself • If you are a young adult. Information from clinical trials has shown an increased risk of suicidal behaviour in young adults (less than 25 years old) with psychiatric conditions who were treated with an antidepressant. If you have thoughts of harming or killing yourself at any time, contact your doctor or go to a hospital straight away. You may find it helpful to tell a relative or close friend that you are depressed or have an anxiety disorder, and ask them to read this leaflet. You might ask them to tell you if they think your depression or anxiety is getting worse, or if they are worried about changes in your behaviour. DRY MOUTH Dry mouth is reported in 10% of patients treated with Venlafaxine. This may increase the risk of tooth decay (caries). Therefore, you should take special care in your dental hygiene. DIABETES Your blood glucose levels may be altered due to Venlafaxine. Therefore, the dosage of your diabetes medicines may need to be adjusted. CHILDREN AND ADOLESCENTS Venlafaxine should normally not be used for children and adolescents under 18 years. Also, you should know that patients under 18 have an increased risk of side-effects such as suicide attempt, suicidal thoughts and hostility (predominantly aggression, oppositional behaviour and anger) when they take this class of medicines. Despite this, your doctor may prescribe Venlafaxine for patients under 18 because he/she decides that this is in their best interests. If your doctor has prescribed Venlafaxine for a patient under 18 and you want to discuss this, please go back to your doctor. You should inform your doctor if any of the symptoms listed above develop Прочитать полный документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Venlafaxine 37.5 mg Tablets Almus Venlafaxine 37.5 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains the equivalent of 37.5 mg of venlafaxine as 42.426 mg venlafaxine hydrochloride. _ _ _Excipients _ Each tablet contains 92.18 mg of lactose. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. Mottled peach, round, flat bevelled tablet, on one side scored and debossed “9” on one side of the score and “3” on the other side of the score. Debossed with “7380” on the opposite side of the tablet. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 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 The recommended starting dose of immediate-release venlafaxine is 75 mg/day in two or three divided doses taken with food. 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 Прочитать полный документ