Χώρα: Ιρλανδία
Γλώσσα: Αγγλικά
Πηγή: HPRA (Health Products Regulatory Authority)
PROPAFENONE HYDROCHLORIDE
Abbott Laboratories Ireland Ltd
PROPAFENONE HYDROCHLORIDE
300 Milligram
Film Coated Tablet
Product subject to prescription which may be renewed (B)
Authorised
0000-00-00
ARYTHMOL® 150 MG FILM-COATED TABLETS ARYTHMOL® 300 MG FILM-COATED TABLETS PROPAFENONE HYDROCHLORIDE IMPORTANT INFORMATION Read all of this leaflet carefully before you start taking this medicine. • Keep this leaflet as you may need to read it again • This leaflet provides a summary of the information currently available for Arythmol • For further information or advice ask your doctor or pharmacist • This medicine is for you only and should never be given to anyone else, even if they appear to have the same symptoms as you • Tell your doctor or pharmacist if you experience any side effects IN THIS LEAFLET: 1. What Arythmol is & what it is used for 2. Before you take Arythmol 3. How to take Arythmol 4. Possible side effects 5. How to store Arythmol 6. Further information 1. WHAT ARYTHMOL IS & WHAT IT IS USED FOR Arythmol belongs to a group of medicines called antiarrhythmic agents. Arythmol slows down the heart rate and helps to regulate the heartbeat. Arythmol tablets are used to treat arrhythmias (abnormal heart rhythms). 2. BEFORE YOU TAKE ARYTHMOL DO NOT TAKE THIS MEDICINE If you: - are allergic (hypersensitive) to propafenone hydrochloride or any of the other ingredients of this medicine (see section 6). - suffer from a heart rhythm disorder called Brugada syndrome. - have had a heart attack within the last 3 months. - suffer from heart failure or any other heart problems other than abnormal heart rate/heart rhythm. - have an unusually slow heart rate or low blood pressure (hypotension). - suffer from breathing problems, such as chronic bronchitis or emphysema (sometimes known as COPD). - have been told you that you have an imbalance of potassium or sodium in your blood. - suffer from myasthenia gravis which causes muscle weakness - are taking ritonavir. TAKE SPECIAL CARE WITH ARYTHMOL Tell your doctor BEFORE you take this medicine if you - are pregnant or thinking of becoming pregnant - are breast feeding - suffer from any breathing problems, such as as Διαβάστε το πλήρες έγγραφο
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Arythmol 300 mg Film-coated Tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 300 mg propafenone hydrochloride. For a full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablets. White to off-white film-coated tablet, biconvex, embossed “300” on one face. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Symptomatic supraventricular tachyarrhythmias requiring treatment, such as AV junctional tachycardias, supraventricular tachycardias in patients with Wolff-Parkinson-White (WPW) syndrome or paroxysmal atrial fibrillation. Severe symptomatic ventricular tachyarrhythmias, if the physician considers these to be life-threatening. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The dosage is to be adjusted to the individual patient’s requirements. In those patients in whom significant widening of the QRS complex or second or third degree AV block occurs, a dose reduction should be considered. _Adults_: A daily dose of 450 to 600 mg of propafenone hydrochloride, divided in two or three doses per day, is recommended in the titration period and for maintenance therapy in patients weighing around 70 kilograms. Occasionally, it may be necessary to increase the daily dose to 900 mg of propafenone hydrochloride. The daily dose should be reduced accordingly for patients with a lower body weight. Dose increases should not be attempted until the patient is receiving treatment for three to four days. _Elderly population:_ No overall differences in safety or effectiveness were observed in this patient population, but greater sensitivity of some older individuals cannot be ruled out, these patients should be carefully monitored. Treatment should be initiated gradually and with particular cautio Διαβάστε το πλήρες έγγραφο