Maa: Australia
Kieli: englanti
Lähde: Department of Health (Therapeutic Goods Administration)
amlodipine besilate, Quantity: 6.935 mg (Equivalent: amlodipine, Qty 5 mg); hydrochlorothiazide, Quantity: 12.5 mg; olmesartan medoxomil, Quantity: 40 mg
Arrotex Pharmaceuticals Pty Ltd
Tablet, film coated
Excipient Ingredients: colloidal anhydrous silica; microcrystalline cellulose; croscarmellose sodium; magnesium stearate; pregelatinised maize starch; titanium dioxide; purified talc; iron oxide yellow; polyvinyl alcohol; macrogol 3350
Oral
10 tablets, 30 tablets
(S4) Prescription Only Medicine
It 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: Light yellow, round, biconvex, film coated tablets debossed with T 22 on one side and plain on other side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius
Registered
2018-04-23
OLMEKAR HCT _Olmesartan medoxomil, amlodipine (as besilate) and hydrochlorothiazide _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about OLMEKAR 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 OLMEKAR 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 OLMEKAR HCT IS USED FOR OLMEKAR HCT 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 OLMEKAR HCT WORKS _ OLMEKAR 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. OLMEKAR HCT blocks the action of angiotensin-II and therefore relaxes your blood vessels. This helps lower your blood pressure. OLMEKAR 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. OLMEKAR HCT also contains hydrochlorothi Lue koko asiakirja
1 AUSTRALIAN PRODUCT INFORMATION – OLMEKAR HCT (olmesartan/amlodipine/hydrochlorothiazide) FILM COATED TABLETS 1 NAME OF THE MEDICINE Olmesartan medoxomil, amlodipine (as besilate) and hydrochlorothiazide 2 QUALITATIVE AND QUANTITATIVE COMPOSITION OLMEKAR HCT 20/5/12.5 contains 20 mg olmesartan medoxomil, 5 mg amlodipine as besilate and 12.5 mg hydrochlorothiazide. OLMEKAR HCT 40/5/12.5 contains 40 mg of olmesartan medoxomil, 5 mg amlodipine as besilate and 12.5 mg hydrochlorothiazide. OLMEKAR HCT 40/5/25 contains 40 mg of olmesartan medoxomil, 5 mg amlodipine as besilate and 25 mg hydrochlorothiazide. OLMEKAR HCT 40/10/12.5 contains 40 mg of olmesartan medoxomil, 10 mg amlodipine as besilate and 12.5 mg hydrochlorothiazide. OLMEKAR HCT 40/10/25 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. OLMEKAR HCT 20/5/12.5 - orange white, round, biconvex, film coated tablets debossed with “T 21” on one side and plain on other side. OLMEKAR HCT 40/5/12.5 - light yellow, round, biconvex, film coated tablets debossed with “T22” on one side and plain on other side. OLMEKAR HCT 40/5/25 - light yellow, oval, biconvex, film coated tablets debossed with “T29” on one side and plain on other side. OLMEKAR HCT 40/10/12.5 - grayish red, round, biconvex, film coated tablets debossed with “T24” on one side and plain on other side. OLMEKAR HCT 40/10/25 - grayish red, oval, biconvex, film coated tablets debossed with “T30” on one side and plain on other side. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS OLMEKAR HCT is indicated for the treatment of hypertension, either as replacement for olmesartan medoxomil, amlodipine and hydrochlorothiazide being already taken as separate 2 tablets or as add-on therapy where a patient's blood pressure is not controlled on a dual combination (see Section 4.2 DOSE AND METHOD OF ADMINISTRATION). This fixed dose comb Lue koko asiakirja