XATRAL SR alfuzosin 10mg (as hydrochloride) tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

alfuzosin hydrochloride, Quantity: 10 mg

Available from:

Sanofi-Aventis Australia Pty Ltd

Pharmaceutical form:

Tablet, modified release

Composition:

Excipient Ingredients: magnesium stearate; ethylcellulose; microcrystalline cellulose; iron oxide yellow; silicon dioxide; mannitol; hypromellose; hydrogenated castor oil; povidone

Administration route:

Oral

Units in package:

30 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Indicated for the treatment of the functional symptoms of benign prostatic hyperplasia.

Product summary:

Visual Identification: ROUND, BICONVEX, THREE-LAYER TABLET: ONE WHITE LAYER BETWEEN TWO YELOW LAYERS.; Container Type: Blister Pack; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2002-09-17

Patient Information leaflet

XATRAL
® SR
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CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING XATRAL SR?
Xatral SR contains the active ingredient alfuzosin hydrochloride.
Xatral SR is used to a medical condition in men called Benign
Prostatic Hyperplasia or BPH. For more information, see Section 1. Why
am I using Xatral SR? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE XATRAL SR?
Do not use if you have ever had an allergic reaction to alfuzosin or
any of the ingredients listed at the end of the CMI.
Do not use if you have liver disease; you are currently taking another
alpha-blocker: prazosin (Minipress), terazosin (Hytrin) and
tamsulosin (Flomaxtra); you are currently taking potent CYP3A4
inhibitors (medicines used to treat certain types of infections):
ketoconazole (Nizoral), itraconazole (Sporanox) and ritonavir
(Norvir); you have a history of feeling dizzy, tired or sweating on
standing (orthostatic hypotension).
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS OR TAKE
ANY OTHER MEDICINES.
For more information, see Section 2. What should I know before I use
Xatral SR? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Xatral SR and affect how it works. A
list of these medicines is in Section 3. What if I am taking
other medicines? in the full CMI.
4.
HOW DO I USE XATRAL SR?
•
The standard dose for this medicine is one tablet taken after a meal
once each day, swallowed whole with a glass of water.
•
Do not divide, crush or chew the tablets.
More instructions can be found in Section 4. How do I use Xatral SR?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING XATRAL SR?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Xatral SR.
•
If you are having any kind of surgery, tell your doctor you are using
Xatral SR.
THINGS YOU
SHOULD NOT DO
•
Do not stop using this medicine sudde

Summary of Product characteristics

xatral-sr-ccdsv13-piv13-14feb22
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-piv13-14feb22
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