Nchi: Australia
Lugha: Kiingereza
Chanzo: Department of Health (Therapeutic Goods Administration)
amlodipine besilate, Quantity: 6.944 mg (Equivalent: amlodipine, Qty 5 mg); olmesartan medoxomil, Quantity: 20 mg
ORGANON PHARMA PTY LTD
amlodipine besilate,Olmesartan medoxomil
Tablet, film coated
Excipient Ingredients: magnesium stearate; colloidal anhydrous silica; croscarmellose sodium; pregelatinised maize starch; microcrystalline cellulose; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3350
Oral
30 Tablets, 10 tablets
(S4) Prescription Only Medicine
OLMESARTAN/ AMLODIPINE-MYL is indicated for the treatment of hypertension. Treatment should not be initiated with this fixed-dose combination.
Visual Identification: Round, white, film-coated tablet, debossed "C73" on one side.; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius
Licence status A
2016-06-08
OLMESARTAN/ AMLODIPINE - MYL _Olmesartan medoxomil and amlodipine besilate_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about OLMESARTAN/ AMLODIPINE - MYL. 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 OLMESARTAN/ AMLODIPINE - MYL against the benefits he/she expects it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH YOUR TABLETS. You may need to read it again. WHAT OLMESARTAN/ AMLODIPINE - MYL IS USED FOR OLMESARTAN/ AMLODIPINE - MYL 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 OLMESARTAN/_ _AMLODIPINE - MYL WORKS_ OLMESARTAN/ AMLODIPINE - MYL 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. OLMESARTAN/ AMLODIPINE - MYL blocks the action of angiotensin-II and therefore relaxes your blood vessels. This helps lower your blood pressure. OLMESARTAN/ AMLODIPINE - MYL 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 a Soma hati kamili
OLMESARTAN/ AMLODIPINE - MYL Page 1 of 26 AUSTRALIAN PRODUCT INFORMATION OLMESARTAN/ AMLODIPINE - MYL (OLMESARTAN MEDOXOMIL AND AMLODIPINE AS BESILATE) TABLETS 1 NAME OF THE MEDICINE Olmesartan medoxomil and amlodipine as besilate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION OLMESARTAN/ AMLODIPINE - MYL 20/5 contains 20 mg of olmesartan medoxomil and amlodipine 5 mg as besilate. OLMESARTAN/ AMLODIPINE - MYL 40/5 contains 40 mg of olmesartan medoxomil and amlodipine 5 mg as besilate. OLMESARTAN/ AMLODIPINE - MYL 40/10 contains 40 mg of olmesartan medoxomil and amlodipine 10 mg as besilate. OLMESARTAN MEDOXOMIL is a white to light yellowish-white powder or crystalline powder. It is practically insoluble in water and sparingly soluble in methanol. AMLODIPINE BESILATE is a white crystalline powder, slightly soluble in water and sparingly soluble in ethanol. For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM OLMESARTAN/ AMLODIPINE - MYL 20/5 is a round tablet, approximately 6 mm in diameter, white in colour with C73 debossed on one side. OLMESARTAN/ AMLODIPINE - MYL 40/5 is a round tablet, approximately 8 mm in diameter, cream in colour with C75 debossed on one side. OLMESARTAN/ AMLODIPINE - MYL 40/10 is a round tablet, approximately 8 mm in diameter, brownish red in colour with C77 debossed on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS OLMESARTAN/ AMLODIPINE - MYL is indicated for the treatment of hypertension. Treatment should not be initiated with this fixed-dose combination (see SECTION 4.2 DOSE AND METHOD OF ADMINISTRATION). 4.2 DOSE AND METHOD OF ADMINISTRATION OLMESARTAN/ AMLODIPINE - MYL is registered in three strengths: OLMESARTAN/ AMLODIPINE - MYL 20/5 (olmesartan medoxomil 20 mg and amlodipine as besilate 5 mg); OLMESARTAN/ AMLODIPINE - MYL 40/5 (olmesartan medoxomil 40 mg and amlodipine as besilate 5 mg); OLMESARTAN/ AMLODIPINE - MYL 40/10 (olmesartan medoxomil 40 mg and amlodipine as besilate 10 mg). (See SECTION 6.5 NATURE AND CONTENTS OF CONTAINER Soma hati kamili