ARYTHMOL 150 Milligram Film Coated Tablet
국가: 아일랜드
언어: 영어
출처: HPRA (Health Products Regulatory Authority)
환자 정보 전단 유효 성분:
PROPAFENONE HYDROCHLORIDE
제공처:
BGP Products Ireland Limited
ATC 코드:
C01BC03
INN (국제 이름):
PROPAFENONE HYDROCHLORIDE
복용량:
150 Milligram
약제 형태:
Film Coated Tablet
관리 경로:
Oral use
패키지 단위:
Pack size: 90
수업:
IC
처방전 유형:
Product subject to prescription which may be renewed (B)
Manufactured by:
AbbVie Deutschland GmbH & Co. KG
치료 그룹:
Antiarrhythmics
치료 영역:
Antiarrhythmics, class Ic
치료 징후:
Symptomatic supraventricular tachyarrhythmias requiring treatment, such as AV junctional tachycardia, supraventricular tachycardia in patients with Wolff-Parkinson-White (WPW) syndrome or paroxysmal atrial fibrillation. Severe symptomatic ventricular tachyarrhythmia, if the physician considers these to be life-threatening.
승인 상태:
Authorised
승인 날짜:
2015-03-27
환자 정보 전단
ARYTHMOL
®
150 MG FILM-COATED TABLETS
ARYTHMOL
®
300 MG FILM-COATED TABLETS
PROPAFENONE HYDROCHLORIDE
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 asthma.
- suffer from liver or kidney disease
- have a heart pacemaker, it may need to be altered.
If surgery is planned, tell your surgeon or dentist that you
are taking this medicine. It may affect the anaesthetic
used.
Arythmol is NOT suitable for children.
Your doctor may perform ECGs and blood pressure
monitoring prior to and during treatment to monitor your
individual dose.
TAKING OTHER MEDICINES
Please
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제품 특성 요약
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Arythmol 150 mg Film-coated Tablets.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 150 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 and embossed “150” on one face.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Symptomatic supraventricular tachyarrhythmias requiring treatment, such as AV junctional tachycardia,
supraventricular tachycardia in patients with Wolff-Parkinson-White (WPW) syndrome or paroxysmal atrial
fibrillation.
Severe symptomatic ventricular tachyarrhythmia, 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.
The individual maintenance dose should be determined under cardiological surveillance including ECG monitoring and
repeated blood pressure control (titration phase).
_Elderly population:_
No overall differences in safety or effectiveness were observed in this patient population, but greater sensiti
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