VENLALIC XL 37.5 MG PROLONGED-RELEASE TABLETS
Страна: Ирландия
Язык: английский
Источник: HPRA (Health Products Regulatory Authority)
Характеристики продукта
(SPC)
27-04-2024
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Активный ингредиент:
VENLAFAXINE HYDROCHLORIDE
Доступна с:
Dallas Burston Ashbourne Ltd.
дозировка:
37.5 Milligram
Фармацевтическая форма:
Tablet Prolonged Release
Дата Авторизация:
2010-06-04
Характеристики продукта
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Venlalic XL 37.5 mg prolonged-release tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Venlalic 37.5 g prolonged-release tablets
Each prolonged-release tablet contains 37.5 mg venlafaxine (as hydrochloride).
Excipient: Lactose 3.0 mg
For a full list of excipients see section 6.1
3 PHARMACEUTICAL FORM
Prolonged-release tablet.
Round, biconvex, white tablets.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
•
Treatment of major depressive episodes.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
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.
USE IN ELDERLY PATIENTS
No specific dose adjustments of venlafaxine are considered necessary based on patient age alone. Howeve
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