XATRAL SR alfuzosin 10mg (as hydrochloride) tablet bottle

देश: ऑस्ट्रेलिया

भाषा: अंग्रेज़ी

स्रोत: Department of Health (Therapeutic Goods Administration)

सक्रिय संघटक:

alfuzosin hydrochloride

थमां उपलब्ध:

Sanofi-Aventis Australia Pty Ltd

प्राधिकरण का दर्जा:

Registered

उत्पाद विशेषताएं

xatral-sr-ccdsv13-piv12-28sep20
1
AUSTRALIAN PRODUCT INFORMATION – XATRAL
® SR
(ALFUZOSIN HYDROCHLORIDE)
1
NAME OF THE MEDICINE
Alfuzosin hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Xatral (alfuzosin hydrochloride) is an orally active quinazoline
derivative.
Each tablet contains 10 mg of alfuzosin hydrochloride as the active
ingredient.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Modified release tablet.
Three-layered, round biconvex, prolonged release tablet containing the
active ingredient in a
white matrix layer between two inactive yellow layers.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of the functional symptoms of benign prostatic hyperplasia.
4.2
DOSE AND METHOD OF ADMINISTRATION
The recommended dose is one 10 mg tablet daily to be taken immediately
after the meal. The
tablets should be swallowed whole.
4.3
CONTRAINDICATIONS
Xatral SR must not be administered to patients with known
hypersensitivity to alfuzosin
hydrochloride or any other ingredient in this product, to patients
with a history of orthostatic
hypotension or hepatic insufficiency.
Xatral SR is contraindicated in combination with other alpha-blockers.
Concomitant administration of Xatral SR with potent CYP3A4 inhibitors
is contraindicated
(see Section 4.5 Interactions with other medicines and other forms of
interactions)
xatral-sr-ccdsv13-piv12-28sep20
2
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Xatral SR should be administered carefully to patients with known
hypersensitivity to
α1 blockers.
In certain subjects, in particular elderly patients and patients
receiving antihypertensive
medications, postural hypotension with or without symptoms (dizziness,
fatigue, sweating)
may develop within a few hours following administration. In such
cases, the patient should
lie down until symptoms have completely disappeared. These effects are
usually transient,
occur at the beginning of treatment and do not usually prevent the
continuation of treatment.
Pronounced drop in