Land: Australië
Taal: Engels
Bron: Department of Health (Therapeutic Goods Administration)
propranolol hydrochloride, Quantity: 40 mg
Arrotex Pharmaceuticals Pty Ltd
Propranolol hydrochloride
Tablet
Excipient Ingredients: povidone; sodium starch glycollate; lactose monohydrate; quinoline yellow; magnesium stearate; maize starch; sunset yellow FCF aluminium lake; brilliant blue FCF aluminium lake
Oral
100
(S4) Prescription Only Medicine
Angina pectoris; Hypertension; Prevention of migraine; Cardiac dysrhythmias: certain intrinsic cardiac dysrhythmias; dysrhythmias associated with thyrotoxicosis; anxiety tachycardia; certain drug-induced dysrhythmias (eg tachycardia due to digitalis or adrenaline overdosage); Essential tremor, including familial and senile tremor; Phaeochromocytoma (only with concurrent alpha-receptor blockade); Hypertrophic subaortic stenosis; Suspected or definite myocardial infarction; Fallot?s tetralogy
Visual Identification: Green coloured, round, biconvex tablets, embossed with "P" and "40" on either side of the breakline on one side and plain on the other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Licence status A
2015-02-13
APO- PROPRANOLOL TABLETS 1 APO-PROPRANOLOL TABLETS _Propranolol hydrochloride _ 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 propranolol. 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 using 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 want to read it again. WHAT THIS MEDICINE IS USED FOR Propranolol is used to treat or prevent a number of conditions, most of which are related to the heart: • to lower high blood pressure, also called hypertension • to prevent angina • to treat or prevent heart attacks, or reduce your risk of heart problems following a heart attack • to treat irregularities in heartbeat, including those caused by anxiety • essential tremor (shaking of head, chin, hands) • phaeochromocytoma • Fallot's Tetralogy • to prevent migraine headaches Propranolol belongs to a group of medicines called beta-blockers. _HOW IT WORKS _ Propranolol works by affecting the body's response to some nerve impulses, especially in the heart. This decreases the heart's need for blood and oxygen, which reduces the amount of work the heart must do. Propranolol also widens the blood vessels in the body and helps the heart to beat more regularly. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed this medicine for another reason. This medicine is available only with a doctor's prescription. This medicine is not addictive. There is not enough information to recommend the use of this medicine in children under 7 years of age. BEFORE YOU TAKE THIS MEDICINE _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE THIS MEDICINE IF YOU HAVE AN Lees het volledige document
1 AUSTRALIAN PRODUCT INFORMATION – APO-PROPRANOLOL (PROPRANOLOL HYDROCHLORIDE) 1 NAME OF THE MEDICINE Propranolol hydrochloride. 2 AND 3 QUALITATIVE AND QUANTITATIVE COMPOSITION AND PHARMACEUTICAL FORM Each tablet contains propranolol hydrochloride as the active ingredient. In addition, each tablet contains the following inactive ingredients: lactose monohydrate, maize starch, sunset yellow FCF aluminium lake, quinoline yellow, povidone, sodium starch glycollate, magnesium stearate and brilliant blue FCF aluminium lake (40 mg only). EXCIPIENTS WITH KNOWN EFFECT Sugars (as Lactose monohydrate) 10 MG TABLETS EACH TABLET CONTAINS 10 MG OF PROPRANOLOL HYDROCHLORIDE. Orange coloured, round, biconvex tablets, embossed with "P" and "10" on either side of the breakline on one side and plain on the other side. 40 MG TABLETS EACH TABLET CONTAINS 40 MG OF PROPRANOLOL HYDROCHLORIDE. Green coloured, round, biconvex tablets, embossed with "P" and "40" on either side of the breakline on one side and plain on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS • Angina pectoris • Hypertension • Prevention of migraine • Cardiac dysrhythmias: certain intrinsic cardiac dysrhythmias; dysrhythmias associated with thyrotoxicosis; anxiety tachycardia; certain drug-induced dysrhythmias (e.g. tachycardia due to digitalis or adrenaline overdosage) • Essential tremor, including familial and senile tremor • Phaeochromocytoma (only with concurrent α-receptor blockade) • Hypertrophic subaortic stenosis • Suspected or definite myocardial infarction • Fallot’s tetralogy 2 4.2 DOSE AND METHOD OF ADMINISTRATION NOTE: Tablets may be taken before or after food. ADULT HYPERTENSION The standard starting dose is 40 mg twice daily, increasing by the same amount at weekly intervals according to patient response. An adequate response is usually seen in the range 120 – 320 mg/day. Although higher doses may be required, and have been used, the value and safety of doses exceeding 320 mg/day have not been established. Lees het volledige document