Država: Australija
Jezik: engleski
Izvor: Department of Health (Therapeutic Goods Administration)
metoprolol succinate, Quantity: 23.75 mg
Alphapharm Pty Ltd
Metoprolol succinate
Tablet, modified release
Excipient Ingredients: hypromellose; microcrystalline cellulose; macrogol 400; ethylcellulose; sodium stearylfumarate; macrogol 6000; colloidal anhydrous silica; titanium dioxide; lactose monohydrate; triacetin
Oral
15 tablets, 30 tablets
(S4) Prescription Only Medicine
Stable, chronic heart failure as an adjunct to other heart failure therapy.
Visual Identification: White to off white, round shaped, biconvex film coated tablets debossed with 'M' on one side of break line on one side of the tablet and 'MT1' on other side of the tablet.; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2014-04-09
MINAX XL _metoprolol succinate modified release tablets_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about MINAX XL. 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 MINAX XL against the benefits expected for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, TALK TO YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH YOUR MEDICINE. You may need to read it again. WHAT MINAX XL IS USED FOR MINAX XL belongs to a group of medicines called beta-blockers. It works by affecting the body's response to some nerve impulses, especially in the heart. As a result, it decreases the heart's need for blood and oxygen and therefore reduces the amount of work the heart has to do. It also helps the heart to beat more regularly. MINAX XL is used to treat heart failure - increase survival, reduce hospitalisation and improve symptoms. It is used in combination with other medicines to treat your condition. 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. BEFORE YOU TAKE MINAX XL _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE MINAX XL IF YOU HAVE AN ALLERGY TO: • any medicine containing metoprolol succinate • any of the ingredients listed at the end of this leaflet • any other beta-blockers. Some of the symptoms of an allergic reaction may include • shortness of breath • wheezing or difficulty breathing • swelling of the face, lips, tongue or other parts of the body • rash, itching or hives on the skin DO NOT TAKE THIS MEDICINE IF YOU HAVE OR HAVE HAD ASTHMA (DIFFICULTY IN BREATHING, WHEEZING AND COUGHING), BRONCHITIS OR OTHER LUNG PROBLEMS IN THE PAST. DO NOT TAKE MINAX XL IF YOU HAVE THE FOLLOWING CONDITIONS: • a history of allergic problems, including hayfever • a very slow heart beat (less than 45-50 beats/minu Pročitajte cijeli dokument
AUSTRALIAN PRODUCT INFORMATION MINAX XL _Metoprolol succinate modified release tablet _ 1 NAME OF THE MEDICINE Metoprolol succinate. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each MINAX XL modified release tablet contains, 23.75 mg, 47.5 mg, 95 mg, 190 mg metoprolol succinate as the active ingredient. Excipient with known effects: Lactose For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS . 3 PHARMACEUTICAL FORM MINAX XL 23.75 TABLETS (23.75 mg) : White to off-white, round shaped, biconvex film coated tablets debossed with “M” on one side of break line on one side of the tablet and “MT1” on other side of the tablet. MINAX XL 47.5 TABLETS (47.5 mg) : White to off-white, oval shaped, biconvex film coated tablet debossed with “M” on one side of break line on one side of the tablet and “MT2” on other side of the tablet. MINAX XL 95 TABLETS (95 mg) : White to off-white, oval shaped, biconvex film coated tablet debossed with “M” on one side of break line on one side of the tablet and “MT3” on other side of the tablet. MINAX XL 190 TABLETS (190 mg) : White to off-white, oval shaped, biconvex film coated tablet debossed with “M” on one side of break line on one side of the tablet and “MT4” on other side of the tablet. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Stable, chronic heart failure as an adjunct to other heart failure therapy. 4.2 DOSE AND METHOD OF ADMINISTRATION MINAX XL has not been established to be clinically equivalent to immediate release forms of metoprolol, and should not be used for treatment of conditions other than stable, chronic heart failure. MINAX XL is recommended for once daily treatment and is preferably taken together with the morning meal. The tablets may be broken in half. MINAX XL tablets should be swallowed with liquid and should not be chewed or crushed. The dose of MINAX XL should be individually adjusted in patients with chronic heart failure stabilised on other heart failure treatment. It is recommended that patients be titrated Pročitajte cijeli dokument