Pays: Israël
Langue: anglais
Source: Ministry of Health
PHENOXYBENZAMINE HYDROCHLORIDE
RAFA LABORATORIES LTD
C04AX02
CAPSULES
PHENOXYBENZAMINE HYDROCHLORIDE 10 MG
PER OS
Required
DALES PHARMACEUTICALS LTD, UK
PHENOXYBENZAMINE
PHENOXYBENZAMINE
Pheochromocytoma, benign prostatic hypertrophy.
2012-06-30
Patient Leaflet According to the Pharmacists’ Regulations (Preparations) - 1986 This medicine requires a doctor’s prescription Please read the entire leaflet carefully before using this medicine DIBENYLINE CAPSULES COMPOSITION: Active ingredient Each capsule contains: Phenoxybenzamine Hydrochloride 10 mg Inactive ingredients Lactose, talc, titanium dioxide, indigotine, erythrosine, edible grey ink, gelatin. Each capsule contains about 180 mg of lactose. THERAPEUTIC GROUP: Peripheral vasodilator. THERAPEUTIC ACTIVITY: Treatment of the prostate gland, Treatment of pheochromocytoma. WHEN SHOULD THIS MEDICINE NOT BE USED? Do not use this medicine if you are hypersensitive to any of its ingredients, or to any other medicine that is used to lower blood pressure. Do not use this medicine if you had a stroke. Do not use this medicine if you had a heart attack (coronary thrombosis) within the last month. DO NOT TAKE THIS MEDICINE WITHOUT CONSULTING A DOCTOR BEFORE STARTING TREATMENT, IN THE FOLLOWING CASES: If you are pregnant, planning to get pregnant or breastfeeding. If you suffer or have suffered in the past from impaired function of the: heart and/or vascular system, kidney/urinary tract, atherosclerosis (including in the brain), or if you suffer or have suffered in the past from extremity edema. If you are being treated for shock or your blood pressure is lower than normal. HOW MIGHT THIS MEDICINE AFFECT YOUR DAILY LIFE? Use of this drug may cause you to feel dizzy and therefore caution should be exercised when driving a vehicle, operating dangerous machinery, or performing any other activity that requires special vigilance. WARNINGS: If you are sensitive to any type of food or medicine, inform your doctor before starting treatment with this medication. This medicine contains lactose. If you are sensitive to lactose, inform your doctor before taking this medication. During treatment with this medicine you should be under medical observation by your doctor, furthermore it is recommended to take blood pressure rea Lire le document complet
Dibenyline-DL-Feb2012-01 דומע 1 ךותמ 3 PRODUCT INFORMATION DIBENYLINE CAPSULES 1. NAME OF THE MEDICINAL PRODUCT Dibenyline Capsules 10mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 10 mg Phenoxybenzamine hydrochloride. For full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Capsules 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Treatment of hypertensive episodes associated with phaeochromocytoma and treatment of benign prostatic hypertrophy. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION Method of Administration: Oral Posology Adults: The usual starting dose is 10 mg daily. This may be increased by 10 mg daily until control of hypertensive episodes is achieved, or postural hypotension occurs. Usually the dosage required is 1-2 mg/kg body weight split into 2 doses. Concomitant beta-adrenergic blockade may be necessary to control tachycardia and arrythmias notably when tumours are secreting an appreciable amount of adrenaline as well as noradrenaline. Elderly: Use with caution, 10 mg daily dose should be sufficient (see Contra-Indications and Cautions below). Children: There is little experience in children but, doses of 1 to 2 mg/kg daily have been used successfully. 4.3. CONTRAINDICATIONS Phenoxybenzamine should not be used in patients who have had a cerebrovascular accident; or in the recovery period (usually 3-4 weeks) after acute myocardial infarction. 4.4. SPECIAL WARNINGS AND PRECAUTIONS FOR USE Phenoxybenzamine should be used with great caution in patients in whom a fall in blood pressure and/or tachycardia may be undesirable, such as the elderly or those with severe heart disease, congestive heart failure, cerebrovascular disease or renal damage. The mode of action should be borne in mind, if used concurrently with α- sympatho-mimetics or myocardial depressants. Phenoxybenzamine is carcinogenic in the rat and has shown mutagenic activity in the bacterial Ames test and mouse lymphoma assay. It should only be used after very careful consideration of the risks, i Lire le document complet