Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
olmesartan medoxomil, Quantity: 20 mg
Arrotex Pharmaceuticals Pty Ltd
Olmesartan medoxomil
Tablet, film coated
Excipient Ingredients: microcrystalline cellulose; lactose monohydrate; purified water; magnesium stearate; hyprolose; hypromellose; titanium dioxide; iron oxide yellow; macrogol 4000
Oral
30
(S4) Prescription Only Medicine
Olmertan is indicated for the treatment of hypertension.
Visual Identification: 20 mg tablet: Yellow film-coated, round, biconvex tablets debossed with 323 one one side, and L on the other side. Blister pack of 30.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
2015-02-05
1 OLMERTAN OLMESARTAN MEDOXOMIL CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about OLMERTAN. 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 OLMERTAN 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 OLMERTAN TABLETS. You may need to read it again. WHAT OLMERTAN IS USED FOR OLMERTAN 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 OLMERTAN WORKS OLMERTAN 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. OLMERTAN blocks the action of angiotensin-II and therefore relaxes your blood vessels. This helps lower your blood pressure. Your doctor may have prescribed OLMERTAN for another reason. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY OLMERTAN HAS BEEN PRESCRIBED FOR YOU. OLMERTAN is not addictive. This medicine is available only with a doctor's prescription. BEFORE YOU TAKE OLMERTAN _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE OLMERTAN IF: • YOU HAVE SERIOUS PROBLEMS WITH YOUR KIDNEYS • YOU HAVE SERIOUS PROBLEMS WITH YOUR LIVER • YOU HAVE DIABET Read the complete document
1 AUSTRALIAN PRODUCT INFORMATION – OLMERTAN (OLMESARTAN MEDOXOMIL) FILM COATED TABLETS 1 NAME OF THE MEDICINE Olmesartan medoxomil 2 QUALITATIVE AND QUANTITATIVE COMPOSITION OLMERTAN is available for oral use as film-coated tablets containing 10 mg, 20 mg, or 40 mg olmesartan medoxomil. Excipient with known effects: lactose For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM 10 MG TABLET: Yellow film-coated, round, biconvex tablets debossed with 392 one one side, and L on the other side. 20 MG TABLET: Yellow film coated, round, biconvex tablets debossed with 323 on one side and L on the other side. 40 MG TABLET: Yellow film coated, oval shaped, bioconvex tablets debossed with L324 on one side and plain on the other side. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS OLMERTAN is indicated for the treatment of hypertension. 4.2 D OSE AND METHOD OF ADMINISTRATION ADULTS Dosage must be individualised. The optimal recommended starting dose of OLMERTAN is 20 mg once daily when used as monotherapy in patients who are not volume-contracted. If additional blood pressure reduction is required, the dose of OLMERTAN may be increased to a maximum of 40 mg daily. 2 OLMERTAN may be administered with or without food. In order to assist compliance, it is recommended that OLMERTAN tablets be taken at about the same time each day. Twice-daily dosing offers no advantage over the same total dose given once daily. The antihypertensive effect of olmesartan medoxomil is substantially present within 2 weeks of initiating therapy and is maximal by about 8 weeks after initiating therapy. This should be borne in mind when considering changing the dose regimen for any patient. Hydrochlorothiazde therapy should be considered in those patients requiring additional blood pressure control beyond 40 mg daily. OLMERTAN may be administered with other antihypertensive agents. SPECIAL POPULATIONS ELDERLY No dosage adjustment is necessary. If up-titration to the maximum dose of 40 mg daily is required, bl Read the complete document