Riik: Suurbritannia
keel: inglise
Allikas: MHRA (Medicines & Healthcare Products Regulatory Agency)
Propafenone hydrochloride
Accord-UK Ltd
C01BC03
Propafenone hydrochloride
150mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02030200; GTIN: 5055565705452
PACKAGE LEAFLET: INFORMATION FOR THE USER PROPAFENONE HYDROCHLORIDE 150MG FILM-COATED TABLETS PROPAFENONE HYDROCHLORIDE 300MG FILM-COATED TABLETS Propafenone Hydrochloride READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. WHAT IS IN THIS LEAFLET 1. What Propafenone Hydrochloride tablets are and what are they used for. 2. What you need to know before you take Propafenone Hydrochloride tablets 3. How to take Propafenone Hydrochloride tablets 4. Possible side effects 5. How to store Propafenone Hydrochloride tablets 6. Contents of the pack and other information 1. WHAT PROPAFENONE HYDROCHLORIDE TABLETS ARE AND WHAT ARE THEY USED FOR Propafenone belongs to a group of medicines called anti-arrhythmic agents. Propafenone is used for the following: to slow down the heart rate and help to regulate the heartbeat to treat and prevent arrhythmias (abnormal heart rhythms). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PROPAFENONE HYDROCHLORIDE TABLETS _ _ DO NOT TAKE PROPAFENONE HYDROCHLORIDE TABLETS: if you are allergic (hypersensitive) to propafenone hydrochloride or any of the other ingredients of this medicine (see section 6). if you suffer from a heart rhythm disorder called Brugada syndrome. if you have had a heart attack within the last 3 months. if you suffer from heart failure or any heart problems other than abnormal heart rate/heart rhythm. if you have an unusually slow heart rate or low blood pressure (hypotension). if you suffer from breathing problems, such as chronic bronchitis or emphysema (sometimes known Lugege kogu dokumenti
OBJECT 1 PROPAFENONE HYDROCHLORIDE 150MG FILM-COATED TABLETS Summary of Product Characteristics Updated 22-Apr-2016 | Accord Healthcare Limited 1. Name of the medicinal product Propafenone hydrochloride 150mg Film-coated tablets 2. Qualitative and quantitative composition Each film-coated tablet contains 150mg propafenone hydrochloride For the full list of excipients, see section 6.1 3. Pharmaceutical form Film-coated Tablet White to off white, round shaped, biconvex, film coated tablets plain on both sides. 4. Clinical particulars 4.1 Therapeutic indications Propafenone is indicated for the prophylaxis and treatment of ventricular arrhythmias. Propafenone is also indicated for the prophylaxis and treatment of paroxysmal supraventricular tachyarrhythmias which include paroxysmal atrial flutter/fibrillation and paroxysmal re-entrant tachycardia's involving the AV node or accessory bypass tracts, when standard therapy has failed or is contraindicated. 4.2 Posology and method of administration It is recommended that propafenone therapy should be initiated under hospital conditions, by a physician experienced in the treatment of arrhythmias. The individual maintenance dose should be determined under cardiological surveillance including ECG monitoring and blood pressure control. If the QRS interval is prolonged by more than 160msec or the PQ interval is prolonged by more than 20%, the dose should be reduced or discontinued until the ECG returns to normal limits. _ADULTS_ Initially, 150 mg three times daily increasing at a minimum of three-day intervals to 300 mg twice daily and if necessary, to a maximum of 300 mg three times daily. The tablets should be swallowed whole and taken with a drink after food. A reduction in the total daily dose is recommended for patients below 70 kg bodyweight. _ELDERLY_ No overall differences in safety or effectiveness were observed in this patient population, but greater sensitivity of some older individuals cannot be ruled out, therefore, these patients should be carefully monitored. T Lugege kogu dokumenti