Ország: Ausztrália
Nyelv: angol
Forrás: Department of Health (Therapeutic Goods Administration)
metoprolol tartrate, Quantity: 50 mg
Arrotex Pharmaceuticals Pty Ltd
Metoprolol tartrate
Tablet, film coated
Excipient Ingredients: microcrystalline cellulose; sodium starch glycollate; iron oxide red; colloidal anhydrous silica; macrogol 400; croscarmellose sodium; hypromellose; magnesium stearate; titanium dioxide; lactose monohydrate; pregelatinised maize starch; purified talc
Oral
100, 10
(S4) Prescription Only Medicine
Hypertension: as monotherapy or for use in combination with other antihypertensives.,Angina pectoris: for long-term prophylaxis. Glyceryl trinitrate should be employed if necessary for alleviating acute attacks.,Confirmed or suspected myocardial infarction.,Prevention of migraine.
Visual Identification: Pink, round, biconvex film-coated tablets with notch break line on one side and '50' debossed on other side.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius
Registered
2013-01-08
APO-METOPROLOL TABLETS 1 APO-METOPROLOL TABLETS _Contains the active ingredient metoprolol tartrate _ CONSUMER MEDICINE INFORMATION _FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055 _ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about this medicine. 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 this medicine 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 THIS MEDICINE IS USED FOR The name of your medicine is APO- Metoprolol tablets. It contains the active ingredient metoprolol. It is used: • to treat high blood pressure, also called hypertension • to prevent a type of chest pain, also called angina • after a heart attack • to prevent migraine headaches. Metoprolol 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 reduces the amount of work that the heart must do. It also widens the blood vessels in the rest of the body. Metoprolol can be used alone or 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. Metoprolol is only available with a doctor's prescription. There is no evidence that this medicine is addictive. _USE IN CHILDREN _ Metoprolol is not recommended for use in children. BEFORE YOU TAKE THIS MEDICINE _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE THIS MEDICINE IF YOU HAVE OR HAVE HAD ANY OF THE FOLLOWING MEDICAL CONDITIONS: • sudden losses of consciousness • asthma, wheezing, difficulty breathing or other severe lung problems • a his Olvassa el a teljes dokumentumot
1 AUSTRALIAN PI - APO METOPROLOL (METOPROLOL TARTRATE) TABLETS 1 NAME OF THE MEDICINE Metoprolol tartrate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains either 50 mg or 100 mg of metoprolol tartrate as the active ingredient. EXCIPIENTS WITH KNOWN EFFECT Lactose monohydrate For the full list of excipients see section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM 50 MG TABLET: Pink, round, biconvex film-coated tablets with notch break line on one side and ‘50’ debossed on other side. 100 MG TABLET: White to off-white, round, biconvex film-coated tablets with notch break line on one side and ‘100’ debossed on other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS • Hypertension: as monotherapy or for use in combination with other antihypertensives. • Angina pectoris: for long-term prophylaxis. Glyceryl trinitrate should be employed if necessary for alleviating acute attacks. • Suspected or definite myocardial infarction. • Migraine prophylaxis. 2 4.2 DOSE AND METHOD OF ADMINISTRATION The maximum daily dose should not exceed 400 mg. Although twice daily dosage is optimal, in those patients whose maintenance dosage is 150 mg daily or less, it may be administered as a single dose. It is advisable to individualise the dosage. The film coated tablets should be swallowed whole. HYPERTENSION Mild: 50 or 100 mg, given once daily, for one week Moderate to severe: 50 or 100 mg, given twice daily for one week Maintenance: 50 or 100 mg, given once or twice daily. Some patients may respond to 50 mg once daily. However, a large number of patients will respond to 100 mg, given once daily as initial and maintenance therapy. Response is rarely improved by increasing the dose beyond 200 mg daily. ANGINA PECTORIS 50 mg to 100 mg, given two or three times daily MYOCARDIAL INFARCTION The recommended dosage can be reduced depending on the haemodynamic status of the patient. Initially Therapy should commence with 50 mg twice daily and be continued for 48 hours. Maintenance Generally 100 mg, given t Olvassa el a teljes dokumentumot