EFEXOR Prolonged Release Capsules 150 Milligram
Country: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
Vara einkenni
(SPC)
30-04-2024
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Virkt innihaldsefni:
VENLAFAXINE HYDROCHLORIDE
Fáanlegur frá:
B & S Healthcare
Skammtar:
150 Milligram
Lyfjaform:
Prolonged Release Capsules
Leyfisdagur:
2009-10-23
Vara einkenni
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Efexor XL 150mg Prolonged-Release Capsules, hard
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 169.7mg venlafaxine hydrochloride equivalent to 150mg venlafaxine.
Excipient: lactose
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged-release capsule, hard
_Product imported from Italy:_
Opaque dark orange capsules printed in white with 'W' on the cap and ‘150' on the body.
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
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
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