देश: ऑस्ट्रेलिया
भाषा: अंग्रेज़ी
स्रोत: Department of Health (Therapeutic Goods Administration)
irbesartan, Quantity: 300 mg; hydrochlorothiazide, Quantity: 25 mg
Arrotex Pharmaceuticals Pty Ltd
Hydrochlorothiazide,Irbesartan
Tablet, film coated
Excipient Ingredients: lactose monohydrate; povidone; croscarmellose sodium; magnesium stearate; iron oxide yellow; iron oxide red; titanium dioxide; hypromellose; macrogol 4000; iron oxide black
Oral
30s
(S4) Prescription Only Medicine
For the treatment of hypertension. Treatment should not be initiated with this fixed-dose combination.
Visual Identification: Pinkish brown, oval shaped, biconvex, film coated tablet, debossed with "L185" on one side and plain on the other side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2013-09-26
APO- IRBESARTAN HCTZ TABLETS 1 APO-IRBESARTAN HCTZ TABLETS _Irbesartan and hydrochlorothiazide _ CONSUMER MEDICINE INFORMATION _FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055 _ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about irbesartan HCTZ. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you using this medicine against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may want to read it again. WHAT THIS MEDICINE IS USED FOR Irbesartan HCTZ is used to treat high blood pressure (hypertension). Everyone has blood pressure. This pressure helps get your blood all around your body. Your blood pressure may be different at different times of the day, depending on how busy or worried you are. You have high blood pressure which means your blood pressure stays high, even when you are calm and relaxed. There are usually no symptoms of high blood pressure. The only way of knowing that you have hypertension is to have your blood pressure checked on a regularly basis. _HOW IT WORKS _ This product contains both irbesartan and hydrochlorothiazide (HCTZ). Both medicines reduce blood pressure in different ways. Irbesartan belongs to a group of medicines known as angiotensin-II receptor antagonists. Angiotensin II is a substance produced in the body which causes blood vessels to tighten. Irbesartan blocks angiotensin-II and therefore relaxes your blood vessels. This helps to lower your blood pressure. HCTZ belongs to the class of medicines known as diuretics. Diuretics cause an increase in the volume of urine. They also help with lowering blood pressure particularly when combined with other blood pressure reducing medicines. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may h पूरा दस्तावेज़ पढ़ें
1 AUSTRALIAN PRODUCT INFORMATION APO-IRBESARTAN HCTZ (IRBESARTAN/HYDROCHLOROTHIAZIDE) TABLETS 1 NAME OF THE MEDICINE Irbesartan and Hydrochlorothiazide 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 150 mg or 300 mg irbesartan and 12.5 mg or 25 mg hydrochlorothiazide, as the active ingredients. EXCIPIENTS WITH KNOWN EFFECT Lactose monohydrate For the full list of excipients see section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM 150/12.5 MG TABLETS: peach, oval, biconvex film-coated tablet debossed with "L183" on one side and plain on the other side. 300/12.5 MG TABLETS: peach, oval, biconvex film-coated tablet debossed with "L184" on one side and plain on the other side. 300/25 MG TABLETS: pinkish brown, oval, biconvex film-coated tablet debossed with "L185" on one side and plain on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Irbesartan/hydrochlorothiazide is indicated for the treatment of hypertension. Treatment should not be initiated with this fixed-dose combination. 4.2 DOSE AND METHOD OF ADMINISTRATION APO-Irbesartan HCTZ tablets are intended for oral administration. DOSAGE Irbesartan/hydrochlorothiazide should not be initiated as first-line therapy. The daily dose can be administered with or without food. REPLACEMENT THERAPY The combination may be substituted for the titrated components at the same dose level. DOSE TITRATION BY CLINICAL EFFECT When clinically appropriate, direct change from monotherapy to the fixed combinations may be considered: Irbesartan 150 mg/hydrochlorothiazide 12.5 mg may be administered to patients whose blood pressure is not adequately controlled with hydrochlorothiazide or irbesartan 150 mg alone. 2 Irbesartan 300 mg/hydrochlorothiazide 12.5 mg may be administered to patients insufficiently controlled by irbesartan 300 mg or by irbesartan 150 mg/hydrochlorothiazide 12.5 mg. Irbesartan 300 mg/hydrochlorothiazide 25 mg may be administered to patients insufficiently controlled by irbesartan 300 mg/hydrochlorothiazide 12.5 mg. Doses higher th पूरा दस्तावेज़ पढ़ें