Riik: Suurbritannia
keel: inglise
Allikas: MHRA (Medicines & Healthcare Products Regulatory Agency)
Propafenone hydrochloride
A A H Pharmaceuticals Ltd
C01BC03
Propafenone hydrochloride
150mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02030200
medicine. If you or someone else swallows several of these tablets all together, contact your doctor or nearest hospital emergency department immediately. Always take any tablets left over with you and also the box, as this will allow easier identification of the tablets. IF YOU FORGET TO TAKE PROPAFENONE HYDROCHLORIDE TABLETS If you forget to take a dose, take it as soon as you remember. If it is almost time for your next dose do not take a double dose to make up for a forgotten dose, just carry on as before. IF YOU STOP TAKING PROPAFENONE HYDROCHLORIDE TABLETS It is important that you keep taking these tablets until your doctor tells you to stop. Don’t stop just because you feel better. If you stop taking the tablets without your doctor’s advice, your condition may get worse. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 4. POSSIBLE SIDE EFFECTS Like all medicines, this medicine can cause side effects, although not everybody gets them. TELL YOUR DOCTOR OR PHARMACIST IMMEDIATELY IF YOU EXPERIENCE ANY OF THE FOLLOWING: • a rash, itching or skin reddening or other signs of an allergic reaction such as difficulty breathing. Although these are rare, they can be serious. • yellowing of the skin and/or eyes, as these may be a sign of liver problems • you start to bruise easily or if you develop a very sore throat with a high fever, as in very rare cases, treatment may affect the amount of white blood cells and platelets in the blood. Other side effects with , propafenone hydrochloride tablets may include: Very Common side effects (occurring in more than 1 in 10 users): • Dizziness • Irregular (slow or fast) heart beat • Heart palpitations (being aware of your heart beat) Common side effects (occurring in 1 to 10 users in 100): • Anxiety • Difficulty sleeping • Headache • Alteration of taste or a bitter taste • Blurred vision • Abnormal heart rhythm • Shortness of breath • Stomach pain • Feeling or being sick • Diarrhoea • Constipatio Lugege kogu dokumenti
SUMMARY OF PRODUCT CHARACTERISTICS 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. Treatment should be initiated gradually and with particular caution in small incremental doses. The same ap Lugege kogu dokumenti