Felkarid tablets

Țară: Armenia

Limbă: engleză

Sursă: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Ingredient activ:

flecainide acetate

Disponibil de la:

Alkaloid AD Skopje

Codul ATC:

C01BC04

INN (nume internaţional):

flecainide acetate

Dozare:

50mg

Forma farmaceutică:

tablets

Unități în pachet:

(30/3x10/) in blister

Tip de prescriptie medicala:

Prescription

Statutul autorizaţiei:

Registered

Data de autorizare:

2021-08-19

Caracteristicilor produsului

Felkarid 50 mg and 100 mg tablets
Summary of Product Characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Felkarid 50 mg tablets
Felkarid 100 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50 mg or 100 mg flecainide acetate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Felkarid 50 mg tablets
White to off-white, round, biconvex tablets with diameter 7 mm.
Felkarid 100 mg tablets
White to off-white, round, biconvex tablets with diameter 9 mm and
score line on one side.
The tablet can be divided into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of
- AV nodal reciprocating tachycardia; arrhythmias associated with
Wolff-Parkinson-White
Syndrome and similar conditions with accessory pathways.
- Symptomatic sustained ventricular tachyarrhythmia.
- Premature ventricular contractions and/or non-sustained ventricular
tachycardia which are
causing disabling symptoms, where these are resistant to other therapy
or when other
treatment has not been tolerated.
- Paroxysmal atrial arrhythmias (atrial fibrillation, flutter and
tachycardia) in patients with
disabling symptoms when treatment need has been established.
Structural heart disease and/or impaired left ventricular function
should be excluded because of the
increased risk for pro-arrhythmic effects.
Flecainide Acetate tablets can be used for the maintenance of normal
rhythm following conversion
by other means.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Initiation of flecainide acetate therapy and dose adjustments should
be made under medical supervision
and monitoring of ECG and plasma level.
Felkarid 50 mg and 100 mg tablets
Summary of Product Characteristics
Hospitalization could be necessary during such procedures for certain
patients, especially for patients
with life-threatening ventricular arrhythmias. These decisions should
be made under supervision of
specialist.
In patients with an underlying organic cardiomyopathy and especially
those wit