Ülke: Avustralya
Dil: İngilizce
Kaynak: Department of Health (Therapeutic Goods Administration)
propranolol hydrochloride, Quantity: 10 mg
Alphapharm Pty Ltd
Tablet, film coated
Excipient Ingredients: pregelatinised maize starch; croscarmellose sodium; calcium carbonate; magnesium stearate; Gelatin; titanium dioxide; hypromellose; sunset yellow FCF; erythrosine; macrogol 400
Oral
500, 100, 90
Medicine Registered
(S4) Prescription Only Medicine
1. Angina pectoris. 2. Hypertension. 3. Prevention of migraine. 4. Cardiac dysrythmias: certain intrinsic cardiac dysrythmias; dysrythmias associated with thyrotoxicosis; anxiety tachycardia; certain drug induced dysrythmias (eg. tachycardia due to digitalis or adrenaline overdosage). 5. Essential tremor including familial and senile tremor. 6. Phaeochromocytoma (only with concurrent alpha antagonist). 7. Hypertrophic subaortic stenosis. 8. Suspected or definite myocardial infarction.
Visual Identification: 7 mm red film coated normal convex tablet marked PP/10 with G on reverse; Container Type: Bottle; Container Material: HDPE; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius
Registered
1991-09-20
DERALIN ® _contains the active ingredient propranolol hydrochloride_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about DERALIN. It does not contain all of 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 DERALIN 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 DERALIN IS USED FOR DERALIN 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 widens the blood vessels in the body, as well as helping the heart to beat more regularly. DERALIN contains the active ingredient propranolol hydrochloride, which belongs to a group of medicines called beta-blockers. DERALIN is used to treat or prevent a number of conditions. These include: • hypertension (high blood pressure) • angina • heart beat or heart rhythm irregularities, including those caused by anxiety or an overactive thyroid gland • essential tremor (shaking of head, chin, hands) • phaeochromocytoma, a rare tumour of the adrenal gland (only when used in combination with another medicine) • heart attack prevention or treatment, or to reduce the risk of heart problems after a heart attack • Fallot's Tetralogy • migraine headache prevention. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY DERALIN HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed DERALIN for another reason. DERALIN is not addictive. DERALIN is available only with a doctor's prescription. BEFORE YOU TAKE DERALIN _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE DERALIN IF YOU ARE ALLERGIC TO: • propranolol hydrochloride • any of the ingredients listed at the end of this leaflet Belgenin tamamını okuyun
AUSTRALIAN PRODUCT INFORMATION DERALIN ® _propranolol hydrochloride film coated tablet _ 1 NAME OF THE MEDICINE Propranolol hydrochloride 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each DERALIN tablet contains 10 mg, 40 mg or 160 mg of propranolol hydrochloride as the active ingredient. Excipients of known effect: sulfites. For the full list of excipients, see section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM DERALIN 10 tablet: red film coated, marked PP/10 on one side, G on reverse. DERALIN 40 tablet: red film coated, marked PP/40 on one side, G on reverse. DERALIN 160 tablet: red film coated, marked PP/160 on one side, G on reverse. 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 (eg. tachycardia due to digitalis or adrenaline (epinephrine) 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 4.2 DOSE AND METHOD OF ADMINISTRATION _Note._ DERALIN tablets may be taken before or after food. ADULTS 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 to 320 mg/day. Although higher DERALIN ® – PRODUCT INFORMATION 2 doses may be required, and have been used, the value and safety of doses exceeding 320 mg/day have not been established. Angina Pectoris and Essential Tremor 40 mg two or three times daily, increasing by the same amount at weekly intervals according to patient response. An adequate response in essential tremor is usually seen in the range 80 to 160 mg/day and in angina 120 to 320 mg/day. Migraine The standard starting dose is 40 mg twi Belgenin tamamını okuyun