Quốc gia: Úc
Ngôn ngữ: Tiếng Anh
Nguồn: Department of Health (Therapeutic Goods Administration)
olmesartan medoxomil, Quantity: 40 mg; hydrochlorothiazide, Quantity: 25 mg
Pharmacor Pty Ltd
Tablet
Excipient Ingredients: magnesium stearate; stearic acid; microcrystalline cellulose; lactose monohydrate; hyprolose; purified water; titanium dioxide; hypromellose; purified talc; iron oxide yellow; macrogol 6000; iron oxide red; macrogol 400
Oral
10's, 30's
(S4) Prescription Only Medicine
Olmesartan medoxomil and Hydrochlorothiazide is indicated for:,Treatment of hypertension.,Treatment should not be initiated with this fixed dose combination.
Visual Identification: Pink coloured, oval shape film coated tablets debossed with A003 on one side and plain on other side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2018-01-29
_APX-OLMESARTAN/HCTZ Ver 04 1 _ APX-OLMESARTAN/HCTZ TABLETS _ _ 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 APX-OLMESARTAN/HCTZ TABLETS? APX-OLMESARTAN/HCTZ TABLETS contains the active ingredient Olmesartan medoxomil and hydrochlorothiazide. Olmesartan medoxomil and hydrochlorothiazide is used to treat high blood pressure (hypertension). For more information, see Section 1.Why am I using APX-OLMESARTAN/HCTZ TABLETS? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE APX-OLMESARTAN/HCTZ TABLETS? Do not use if you have ever had an allergic reaction to APX-OLMESARTAN/HCTZ TABLETS or any of the ingredients listed at the end of the CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2. What should I know before I use APX-OLMESARTAN/HCTZ TABLETS? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with APX-OLMESARTAN/HCTZ TABLETS 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 APX-OLMESARTAN/HCTZ TABLETS? The dose of APX-OLMESARTAN/HCTZ TABLETS is one tablet to be taken once a day or talk to your doctor before taking this medicine. Follow all directions given to you by your doctor and pharmacist carefully. More instructions can be found in Section 4. How do I use APX-OLMESARTAN/HCTZ TABLETS? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING APX-OLMESARTAN/HCTZ TABLETS? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist you visit that you are using APX- OLMESARTAN/HCTZ TABLETS. • If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking APX-OLMESARTAN/HCTZ TABLETS. • If you need to have any blood tests, tell your doctor you are taking APX- OLMESART Đọc toàn bộ tài liệu
APX-OLMESARTAN/HCTZ V04 1 AUSTRALIAN PRODUCT INFORMATION APX-OLMESARTAN/HCTZ (OLMESARTAN MEDOXOMIL/HYDROCHLOROTHIAZIDE) TABLETS 1. NAME OF THE MEDICINE APX-OLMESARTAN/HCTZ Tablet consists of olmesartan medoxomil and hydrochlorothiazide (HCTZ). 2. QUALITATIVE AND QUANTITATIVE COMPOSITION APX-OLMESARTAN/HCTZ 20/12.5 Each tablet contains 20 mg of olmesartan medoxomil and 12.5 mg of hydrochlorothiazide. APX-OLMESARTAN/HCTZ 40/12.5 Each tablet contains 40 mg of olmesartan medoxomil and 12.5 mg of hydrochlorothiazide. APX-OLMESARTAN/HCTZ 40/25 Each tablet contains 40 mg of olmesartan medoxomil and 25 mg of hydrochlorothiazide. Olmesartan medoxomil is a white to off white, crystalline powder. It is practically insoluble in water and in heptane, slightly soluble in ethanol (96%), sparingly soluble in methanol. HCTZ is a white or almost white, crystalline powder. It is very slightly soluble in water, soluble in acetone, sparingly soluble in ethanol (96%). It dissolves in dilute solutions of alkali hydroxides. Excipients with known effect: contains sugars as lactose. For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS. 3. PHARMACEUTICAL FORM Film-coated tablet. APX-OLMESARTAN/HCTZ 20/12.5 TABLETS are reddish-yellow, round, film coated tablets debossed with "A01" on one side & plain on other side. APX-OLMESARTAN/HCTZ 40/12.5 TABLETS are reddish-yellow, oval, film coated tablets debossed with "A002" on one side & plain on other side. APX-OLMESARTAN/HCTZ 40/25 TABLETS are pink, oval, film coated tablets debossed with "A003" on one side & plain on other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of hypertension. Treatment should not be initiated with this fixed dose combination. 4.2 DOSE AND METHOD OF ADMINISTRATION NOTE: APX-OLMESARTAN/HCTZ are only available in the 20/12.5mg, 40/12.5mg and 40/25mg strengths. If 20/25mg is required, an alternative brand should be sought. ADULTS APX-OLMESARTAN/HCTZ is administered once daily, with or without food, in patients whose blood pressure is not Đọc toàn bộ tài liệu