Страна: Австралія
мова: англійська
Джерело: Department of Health (Therapeutic Goods Administration)
hydrochlorothiazide, Quantity: 12.5 mg; olmesartan medoxomil, Quantity: 40 mg; amlodipine besilate, Quantity: 13.9 mg
Accord Healthcare Pty Ltd
Tablet, film coated
Excipient Ingredients: lactose monohydrate; isopropyl alcohol; magnesium stearate; pregelatinised maize starch; povidone; silicified microcrystalline cellulose; titanium dioxide; purified talc; iron oxide yellow; iron oxide red; polyvinyl alcohol; macrogol 3350
Oral
10 tablets, 30 tablets
(S4) Prescription Only Medicine
Olamlo HCT is indicated for the treatment of hypertension, either as replacement for olmesartan medoxomil, amlodipine and hydrochlorothiazide being already taken as separate tablets or as add-on therapy where a patient's blood pressure is not controlled on a dual combination. This fixed dose combination is not indicated for initial therapy.
Visual Identification: Brick red, round, bevel-edged, film-coated tablets debossed with OC4 on one side and plain on other side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2019-11-21
OLAMLO HCT 1 OLAMLO HCT _Olmesartan medoxomil, amlodipine (as besilate) and hydrochlorothiazide_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about OLAMLO HCT. 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 taking OLAMLO HCT 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 need to read it again. WHAT OLAMLO HCT IS USED FOR OLAMLO HCT is used to treat high blood pressure which is sometimes called hypertension. Ever yone has blood pressure. This pressure helps push blood all around your body. Your blood pressure changes at different times of the day, depending on how busy or worried you are. You have hypertension (high blood pressure) when your blood pressure stays higher than is needed, even when you are calm and relaxed. There are usually no symptoms of hypertension. The only way of knowing that you have hypertension is to have your blood pressure checked on a regular basis. If high blood pressure is not treated it can lead to serious health problems, including stroke, heart disease and kidney failure. _HOW OLAMLO HCT WORKS_ OLAMLO HCT contains olmesartan medoxomil, which 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. OLAMLO HCT blocks the action of angiotensin-II and therefore relaxes your blood vessels. This helps lower your blood pressure. OLAMLO HCT also contains amlodipine besilate, a calcium channel blocker. This reduces the movement of calcium into the cells of the heart and blood vessels. This also helps to lower blood pressure as it relaxes the blood vessels and increases the supply of blood and oxygen to the heart. OLAMLO HCT also co ntains hydrochloro Прочитайте повний документ
OLAMLO HCT tablet PI V1.0 Page 1 of 38 AUSTRALIAN PRODUCT INFORMATION OLAMLO HCT 20/5/12.5 OLAMLO HCT 40/5/12.5 OLAMLO HCT 40/5/25 OLAMLO HCT 40/10/12.5 OLAMLO HCT 40/10/25 (olmesartan medoxomil/amlodipine (as besilate) and hydrochlorothiazide) film-coated tablet 1 NAME OF THE MEDICINE Olmesartan medoxomil, amlodipine (as besilate) and hydrochlorothiazide. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION OLAMLO HCT 20/5/12.5 mg contains 20 mg olmesartan medoxomil, 5 mg amlodipine as besilate and 12.5 mg hydrochlorothiazide. OLAMLO HCT 40/5/12.5 mg contains 40 mg of olmesartan medoxomil, 5 mg amlodipine as besilate and 12.5 mg hydrochlorothiazide. OLAMLO HCT 40/5/25 mg contains 40 mg of olmesartan medoxomil, 5 mg amlodipine as besilate and 25 mg hydrochlorothiazide. OLAMLO HCT 40/10/12.5 mg contains 40 mg of olmesartan medoxomil, 10 mg amlodipine as besilate and 12.5 mg hydrochlorothiazide. OLAMLO HCT 40/10/25 mg contains 40 mg of olmesartan medoxomil, 10 mg amlodipine as besilate and 25 mg hydrochlorothiazide. For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM Film-coated tablet . OLAMLO HCT 20/5/12.5 mg is an off white to peach, round, bevel-edged, film-coated tablets debossed with “OC1” on one side and plain on other side. OLAMLO HCT 40/5/12.5 mg is a light yellow, round, bevel-edged, film-coated tablets debossed with “OC2” on one side and plain on other side. OLAMLO HCT 40/5/25 mg is a light yellow, oval, bevel-edged, film-coated tablets debossed with “OC3” on one side and plain on other side. OLAMLO HCT 40/10/12.5 mg is a brick red, round, bevel-edged, film-coated tablets debossed with “OC4” on one side and plain on other side. OLAMLO HCT 40/10/25 mg is a brick red, oval, bevel-edged, film-coated tablets debossed with “OC5” on one side and plain on other side. OLAMLO HCT tablet PI V1.0 Page 2 of 38 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS OLAMLO HCT is indicated for the treatment of hypertension, either as replacement for olmesartan medoxomil, am Прочитайте повний документ