Država: Avstralija
Jezik: angleščina
Source: Department of Health (Therapeutic Goods Administration)
olmesartan medoxomil, Quantity: 40 mg; amlodipine besilate, Quantity: 13.888 mg/mg (Equivalent: amlodipine, Qty mg); hydrochlorothiazide, Quantity: 25 mg
ORGANON PHARMA PTY LTD
amlodipine besilate,Hydrochlorothiazide,Olmesartan medoxomil
Tablet
Excipient Ingredients: magnesium stearate; microcrystalline cellulose; croscarmellose sodium; pregelatinised maize starch; colloidal anhydrous silica; titanium dioxide; purified talc; iron oxide yellow; iron oxide red; polyvinyl alcohol; macrogol 3350
Oral
30, 10
(S4) Prescription Only Medicine
SEVIKAR 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 (see DOSAGE AND ADMINISTRATION). This fixed dose combination is not indicated for initial therapy
Visual Identification: It is an oval film-coated tablet, approximately 15 x 7 mm, greyish red in colour with C57 debossed on one side; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2013-09-20
SEVIKAR ® HCT _Olmesartan medoxomil, amlodipine (as besilate) and hydrochlorothiazide_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about SEVIKAR 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 SEVIKAR 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 SEVIKAR HCT IS USED FOR SEVIKAR 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 SEVIKAR HCT WORKS_ SEVIKAR 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. SEVIKAR HCT blocks the action of angiotensin-II and therefore relaxes your blood vessels. This helps lower your blood pressure. SEVIKAR 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. SEVIKAR HCT also contains hydrochloroth Preberite celoten dokument
SEVIKAR HCT Page 1 of 36 AUSTRALIAN PRODUCT INFORMATION SEVIKAR ® HCT (OLMESARTAN MEDOXOMIL/AMLODIPINE (AS BESILATE) AND HYDROCHLOROTHIAZIDE) TABLETS 1 NAME OF THE MEDICINE Olmesartan medoxomil, amlodipine (as besilate) and hydrochlorothiazide. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION OLMESARTAN MEDOXOMIL is a white or almost white crystalline powder. It is practically insoluble in water and slightly soluble in ethanol (96 per cent), practically insoluble in heptane. The pH of a solution (2% w/v) of olmesartan medoxomil in water is 5.6. The dissociation constant (pKa) is 4.3. The partition coefficient Log P is 1.0 at pH 7.0. AMLODIPINE BESILATE is a white or almost white powder, slightly soluble in water and freely soluble in methanol, sparingly soluble in anhydrous ethanol, slightly soluble in 2-propanol. The pH of solution (1.0% w/v) of amlodipine besilate is in the pH range of 5.0-7.0. The dissociation constant (pKa) is 8.6. HYDROCHLOROTHIAZIDE is a white, or almost white, crystalline powder. Hydrochlorothiazide is very slightly soluble in water, soluble in acetone, sparingly soluble in alcohol. It dissolves in dilute solutions of alkali hydroxides. SEVIKAR HCT 20/5/12.5 MG contains 20 mg olmesartan medoxomil, 5 mg amlodipine as besilate and 12.5 mg hydrochlorothiazide. SEVIKAR HCT 40/5/12.5 MG contains 40 mg of olmesartan medoxomil, 5 mg amlodipine as besilate and 12.5 mg hydrochlorothiazide. SEVIKAR HCT 40/5/25 MG contains 40 mg of olmesartan medoxomil, 5 mg amlodipine as besilate and 25 mg hydrochlorothiazide. SEVIKAR HCT 40/10/12.5 MG contains 40 mg of olmesartan medoxomil, 10 mg amlodipine as besilate and 12.5 mg hydrochlorothiazide. SEVIKAR 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 SEVIKAR HCT 20/5/12.5 MG is a round film-coated tablet, approximately 8 mm in diameter, orange white in colour with C51 debossed on one side. SEVIKAR HCT 40/5/1 Preberite celoten dokument