Страна: Австралия
Язык: английский
Источник: Department of Health (Therapeutic Goods Administration)
alfuzosin hydrochloride, Quantity: 10 mg
Sanofi-Aventis Australia Pty Ltd
Tablet, modified release
Excipient Ingredients: magnesium stearate; ethylcellulose; microcrystalline cellulose; iron oxide yellow; silicon dioxide; mannitol; hypromellose; hydrogenated castor oil; povidone
Oral
30 tablets
(S4) Prescription Only Medicine
Indicated for the treatment of the functional symptoms of benign prostatic hyperplasia.
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
Registered
2002-09-17
XATRAL ® SR X a t r a l ® S R 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 Прочитать полный документ
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 Прочитать полный документ