Nchi: Australia
Lugha: Kiingereza
Chanzo: Department of Health (Therapeutic Goods Administration)
olmesartan medoxomil, Quantity: 40 mg; amlodipine besilate, Quantity: 13.87 mg (Equivalent: amlodipine, Qty 10 mg)
Arrotex Pharmaceuticals Pty Ltd
Tablet, film coated
Excipient Ingredients: croscarmellose sodium; colloidal anhydrous silica; silicified microcrystalline cellulose; pregelatinised maize starch; magnesium stearate; titanium dioxide; purified talc; iron oxide yellow; iron oxide red; polyvinyl alcohol; macrogol 3350
Oral
30 Tablets, 10 tablets
(S4) Prescription Only Medicine
It is indicated for the treatment of hypertension. Treatment should not be initiated with this fixed-dose combination (see Dosage and Administration).
Visual Identification: Red (brownish red), round, biconvex, film-coated tablets debossed with L78 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
2018-06-13
OLMEKAR Olmesartan medoxomil and amlodipine besilate CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about OLMEKAR. 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 using OLMEKAR against the benefits it is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT OLMEKAR IS USED FOR OLMEKAR 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 WORKS _ OLMEKAR 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 blocks the action of angiotensin-II and therefore relaxes your blood vessels. This helps lower your blood pressure. OLMEKAR 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. Your doctor may have prescribed OLMEKAR for another reason. Ask your doctor if you have any questions about w Soma hati kamili
AUSTRALIAN PRODUCT INFORMATION – OLMEKAR tablets (Olmesartan medoxomil/ amlodipine besilate) NAME OF THE MEDICINE Olmesartan medoxomil and amlodipine besilate QUALITATIVE AND QUANTITATIVE COMPOSITION OLMEKAR 20/5 tablets contain 20 mg olmesartan medoxomil and 5 mg amlodipine (as besilate). OLMEKAR 20/10 tablets contain 20 mg olmesartan medoxomil and 10 mg amlodipine (as besilate). OLMEKAR 40/5 tablets contain 40 mg olmesartan medoxomil and 5 mg amlodipine (as besilate). OLMEKAR 40/10 tablets contain 40 mg olmesartan medoxomil and 10 mg amlodipine (as besilate). The tablets contain no excipients with a known effect. For the full list of excipients, see Section 6.1 List of excipients. PHARMACEUTICAL FORM OLMEKAR 20/5 - white, round, biconvex, film-coated tablets debossed with “L75” on one side and plain on other side. OLMEKAR 20/10 - greyish-orange, round, biconvex, film-coated tablets debossed with “L76” on one side and plain on other side. OLMEKAR 40/5 - light yellow, round, biconvex, film-coated tablets debossed with “L77” on one side and plain on other side. OLMEKAR 40/10 - red (brownish red), round, biconvex, film-coated tablets debossed with “L78” on one side and plain on other side. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS OLMEKAR is indicated for the treatment of hypertension. Treatment should not be initiated with this fixed-dose combination (see 4.2 Dose and Method of Administration). 4.2 DOSE AND METHOD OF ADMINISTRATION OLMEKAR is registered in four strengths: OLMEKAR 20/5 (olmesartan medoxomil 20 mg and amlodipine as besilate 5 mg); OLMEKAR 20/10 (olmesartan medoxomil 20 mg and amlodipine as besilate 10 mg); OLMEKAR 40/5 (olmesartan medoxomil 40 mg and amlodipine as besilate 5 mg); OLMEKAR 40/10 (olmesartan medoxomil 40 mg and amlodipine as besilate 10 mg). USUAL ADULT DOSE The recommended dosage of OLMEKAR is one tablet daily, with or without food. Treatment should not be initiated with this combination. REPLACEMENT THERAPY For convenience, patients receiving olmesartan medox Soma hati kamili