EFAXIL XL
País: Irlanda
Língua: inglês
Origem: HPRA (Health Products Regulatory Authority)
Características técnicas
(SPC)
30-04-2024
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Ingredientes ativos:
VENLAFAXINE HYDROCHLORIDE
Disponível em:
Pinewood Laboratories Ltd,
Dosagem:
150 Milligram
Forma farmacêutica:
Prolonged Release Capsules
Data de autorização:
2008-12-02
Características técnicas
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Efaxil XL 150mg Prolonged-release Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged-release capsule contains 150mg of venlafaxine as venlafaxine hydrochloride.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged-release Capsule.
Scarlet opaque/scarlet opaque, size 00 hard gelatin capsules containing three white round, biconvex film-coated tablets.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of major depressive episodes.
For prevention of recurrence of major depressive episodes.
Treatment of social anxiety disorder.
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 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.
_SOCIA
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