Country: Ástralía
Tungumál: enska
Heimild: Department of Health (Therapeutic Goods Administration)
methyldopa sesquihydrate, Quantity: 283 mg (Equivalent: methyldopa, Qty 250 mg)
Alphapharm Pty Ltd
Tablet, film coated
Excipient Ingredients: ethylcellulose; disodium edetate; magnesium stearate; Guar Gum; sodium starch glycollate; colloidal anhydrous silica; citric acid; titanium dioxide; hypromellose; sunset yellow FCF; quinoline yellow; macrogol 400
Oral
100, 90, 30, 500
Medicine Registered
(S4) Prescription Only Medicine
INDICATIONS AS AT 7 May 1996: Hypertension (mild, moderate to severe)
Visual Identification: 10.2 mm yellow film coated normal convex tablet marked MD 250 on one side, G on the reverse; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
1999-06-10
HYDOPA _Contains the active ingredient methyldopa (as sesquihydrate)_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Hydopa. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have benefits and risks. Your doctor has weighed the risks of you taking Hydopa 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 HYDOPA IS USED FOR Hydopa is used to lower high blood pressure, also called hypertension. Everyone had blood pressure. This pressure helps get your blood all around your body. Your blood pressure may be different 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. You may feel fine and have no symptoms, but eventually hypertension can cause stroke, heart disease and kidney failure. Hydopa helps to lower your blood pressure. Hydopa works by controlling impulses along certain nerve pathways and as a result, widens blood vessels so that blood passes through them more easily. This helps to lower blood pressure. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. There is no evidence that Hydopa is addictive. Hydopa is available only with a doctor's prescription. BEFORE YOU TAKE HYDOPA _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE HYDOPA IF YOU HAVE AN ALLERGY TO: • any medicine containing methyldopa (as sesquihydrate) (e.g. Aldomet) • any of the Lestu allt skjalið
AUSTRALIAN PRODUCT INFORMATION HYDOPA _Methyldopa (as sesquihydrate) _ 1 NAME OF THE MEDICINE Methyldopa (as sesquihydrate). 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains methyldopa (as sesquihydrate) equivalent to 250 mg of anhydrous methyldopa. Excipients with known effect: Hydopa also contains trace amounts of galactose. For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS . 3 PHARMACEUTICAL FORM HYDOPA 250mg tablets are yellow film-coated, marked MD 250 on one side, G on the reverse. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hypertension (mild, moderate to severe). 4.2 DOSE AND METHOD OF ADMINISTRATION GENERAL Methyldopa is primarily excreted by the kidneys. Therefore, patients with impaired renal function may respond to lower doses. Syncope in older patients may be related to an increased sensitivity and advanced arteriosclerotic vascular disease; this may be avoided by smaller doses. Cessation of methyldopa therapy is followed by return of hypertension, usually within 48 hours. This is not complicated by an overshoot of blood pressure. Therapy with methyldopa may be commenced in most patients already on treatment with other antihypertensive agents. Methyldopa may also be given concomitantly with hydrochlorothiazide or beta-blocking agents. When methyldopa is administered to patients on other antihypertensives, dosage adjustments of these agents may be required to effect a smooth transition. Withdraw these antihypertensive agents gradually if required (see manufacturers' recommendations on discontinuing these drugs). Following such previous antihypertensive therapy, the initial dose of methyldopa should be limited to not more than 500 mg per day and increased as required at intervals of not less than 2 days. ADULTS The usual starting dose is 250 mg two or three times daily in the first 48 hours. The daily dosage may then be increased or reduced, preferably at intervals of not less than 2 days, until an adequate response is achieved. The maximum recommended daily dosa Lestu allt skjalið