Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
amlodipine besilate, Quantity: 13.9 mg; hydrochlorothiazide, Quantity: 25 mg; olmesartan medoxomil, Quantity: 40 mg
Arrotex Pharmaceuticals Pty Ltd
Tablet, film coated
Excipient Ingredients: isopropyl alcohol; silicified microcrystalline cellulose; povidone; lactose monohydrate; pregelatinised maize starch; magnesium stearate; titanium dioxide; purified talc; iron oxide yellow; iron oxide red; polyvinyl alcohol; macrogol 3350
Oral
10 tablets, 30 tablets
(S4) Prescription Only Medicine
APO-OLMESARTAN/AMLODIPINE/HCTZ 40/10/25 mg 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, oval, bevel-edged, film-coated tablets debossed with OC5 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: Child resistant closure
Registered
2019-11-21
APO-OLMESARTAN/ AMLODIPINE/ HCTZ 1 APO-OLMESARTAN/ AMLODIPINE/ HCTZ _olmesartan medoxomil, amlodipine (as besilate) 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 this medicine. 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 APO- OLMESARTAN/ AMLODIPINE/ HCTZ 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 THIS MEDICINE USED FOR APO-OLMESARTAN/ AMLODIPINE/ HCTZ is used to treat high blood pressure which is sometimes called hypertension. Everyone 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 THIS MEDICINE WORKS _ This medicine 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. This medicine blocks the action of angiotensin-II and therefore relaxes your blood vessels. This helps lower your blood pressure. This medicine 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 Read the complete document
APO-OLMESARTAN/AMLODIPINE/HCTZ tablet PI V1.0 Page 1 of 40 AUSTRALIAN PRODUCT INFORMATION APO-OLMESARTAN/AMLODIPINE/HCTZ 20/5/12.5 APO-OLMESARTAN/AMLODIPINE/HCTZ 40/5/12.5 APO-OLMESARTAN/AMLODIPINE/HCTZ 40/5/25 APO-OLMESARTAN/AMLODIPINE/HCTZ 40/10/12.5 APO-OLMESARTAN/AMLODIPINE/HCTZ 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 APO-OLMESARTAN/AMLODIPINE/HCTZ 20/5/12.5 MG contains 20 mg olmesartan medoxomil, 5 mg amlodipine as besilate and 12.5 mg hydrochlorothiazide. APO-OLMESARTAN/AMLODIPINE/HCTZ 40/5/12.5 MG contains 40 mg of olmesartan medoxomil, 5 mg amlodipine as besilate and 12.5 mg hydrochlorothiazide. APO-OLMESARTAN/AMLODIPINE/HCTZ 40/5/25 MG contains 40 mg of olmesartan medoxomil, 5 mg amlodipine as besilate and 25 mg hydrochlorothiazide. APO-OLMESARTAN/AMLODIPINE/HCTZ 40/10/12.5 MG contains 40 mg of olmesartan medoxomil, 10 mg amlodipine as besilate and 12.5 mg hydrochlorothiazide. APO-OLMESARTAN/AMLODIPINE/HCTZ 40/10/25 MG contains 40 mg of olmesartan medoxomil, 10 mg amlodipine as besilate and 25 mg hydrochlorothiazide. EXCIPIENTS WITH KNOWN EFFECT Contains lactose. For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM FILM-COATED TABLET. APO-OLMESARTAN/AMLODIPINE/HCTZ 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. APO-OLMESARTAN/AMLODIPINE/HCTZ 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. APO-OLMESARTAN/AMLODIPINE/HCTZ 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. APO-OLMESARTAN/AMLODIPINE/HCTZ 40/10/12.5 MG is a brick red, round, bevel-edged, film-coated tablets debossed with “OC4” on one side and plain on oth Read the complete document