Venlalic XL 150 mg prolonged-release tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Venlafaxine

Available from:

Macarthys Laboratories Limited

ATC code:

N06AX; N06AX16

INN (International Name):

Venlafaxine

Dosage:

150 milligram(s)

Pharmaceutical form:

Prolonged-release tablet

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Other antidepressants; venlafaxine

Authorization status:

Not marketed

Authorization date:

2007-09-14

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Venlalic XL 150 mg prolonged-release tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged-release tablet contains 150 mg venlafaxine (as
hydrochloride)
Excipient with known effect: lactose 5.7 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged-release tablet.
9.5 mm round, biconvex, white tablets.
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
Posology
_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.
_Generalised anxiety disorder_
The recommended starting dose for prolonged-release venlafaxine is 75
mg given once daily. Patients not responding
to the initial 75 mg/day dose ma