Pays: Royaume-Uni
Langue: anglais
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Oxprenolol hydrochloride
Amdipharm Plc
C07AA02
Oxprenolol hydrochloride
80mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02040000; GTIN: 5060064170441
OXPRENOLOL 20 MG, 40 MG AND 80 MG TABLETS OXPRENOLOL HYDROCHLORIDE GB 727-0382-APIL SOVEREIGN M E D I C A L READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. - Please keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If any of the side effects becomes severe, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Oxprenolol Tablets are and what they are used for 2. Before you take Oxprenolol Tablets 3. How to take Oxprenolol Tablets 4. Possible side effects 5. How to store Oxprenolol Tablets 6. Further information 1. WHAT OXPRENOLOL TABLETS ARE AND WHAT THEY ARE USED FOR The name of your medicine is Oxprenolol 20 mg, 40 mg or 80 mg Tablets. Oxprenolol Tablets contain the active ingredient oxprenolol hydrochloride. Oxprenolol hydrochloride belongs to a group of medicines called beta-blockers. Oxprenolol is used to treat high blood pressure and to reduce or prevent chest pain (angina). It is also used to treat some heart disorders such as irregular heart beat and to relieve the symptoms of anxiety. 2. BEFORE YOU TAKE OXPRENOLOL TABLETS DO NOT TAKE OXPRENOLOL TABLETS IF YOU: • are ALLERGIC to OXPRENOLOL, any other beta-blockers, or any of the other ingredients of Oxprenolol Tablets (allergic reactions include mild symptoms such as itching and/or rash. More severe symptoms include swelling of the face, lips, tongue and/or throat with difficulty in swallowing or breathing); • have a history of asthma or wheezing attacks; • have any HEART problems (e.g. heart failure, cardiogenic shock); • have an untreated TUMOUR of the adrenal gland (phaeochromocytoma); • have any heart rhythm disorders (sick-sinus syndrome); • have a very LOW PULSE RATE (less than 50 beats per minute); • have Prinzmetal’s angina (a spec Lire le document complet
1. NAME OF THE MEDICINAL PRODUCT Trasicor 80 mg Tablets. Oxprenolol 80 mg Tablets. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 80 mg of oxprenolol hydrochloride. Excipients with known effect: Sodium starch glycollate (21.3 mg/ tablet) For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Film-coated tablets. Light yellow, round, biconvex, film-coated tablets, impressed OXP 80 on one face and no marking on the other. 4.1 THERAPEUTIC INDICATIONS Trasicor Tablets are indicated in adults for the treatment of: Angina Pectoris: For long-term prophylactic use (if necessary nitrates should be employed for alleviating acute attacks). Hypertension: As monotherapy or for use in combination with other antihypertensives, e.g. with a diuretic, peripheral vasodilator, calcium channel blocker or ACE inhibitor. Disturbances of cardiac rhythm: Especially supraventricular tachycardia, atrial fibrillation and digitalis-induced arrhythmias, ventricular tachycardia. Short-term relief of functional cardiovascular disorders due to adrenergic hyperactivity: Such as cardiac neurosis, hyperkinetic heart syndrome and anxiety-induced cardiovascular disorders. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _ _ The dosage should be individualised. Before raising the dosage, the heart rate at rest should always be checked. If it is 50-55 beats/min, the dosage should not be increased, see contraindications. If the maximum recommended dose is insufficient to produce the desired response appropriate combined therapy should be considered. When discontinuing prolonged treatment with a beta-blocker, the medication should not be interrupted abruptly, but withdrawn gradually. Higher doses using conventional Trasicor Tablets may be administered in two or more divided doses. Elderly _ _ No special dosage regime is necessary but concurrent hepatic insufficiency should be taken into account. _Paediatric population _ No adequate experience has been acquired on the use of Trasicor Tablets in children. Adults _Hypert Lire le document complet