Propafenon Alkaloid tablets film-coated

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

propafenone (propafenone hydrochloride)

Available from:

Alkaloid AD Skopje

ATC code:

C01BC03

INN (International Name):

propafenone (propafenone hydrochloride)

Dosage:

150mg

Pharmaceutical form:

tablets film-coated

Units in package:

(40/4x10/) in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2019-10-22

Summary of Product characteristics

Propafenon Alkaloid
150 mg film-coated tablets
Summary of Product Characteristics
1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Propafenon Alkaloid 150 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 150 mg propafenone hydrochloride.
Excipient(s) with known effect:
Lactose monohydrate
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablets
White, round, biconvex, film-coated tablets with a break-mark on one
side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_ _
Propafenon Alkaloid is indicated for the prophylaxis and treatment of
ventricular arrhythmias.
Propafenon Alkaloid is also indicated for the prophylaxis and
treatment of paroxysmal
supraventricular tachyarrhythmias which include paroxysmal atrial
flutter/fibrillation and
paroxysmal re-entrant tachycardias involving the AV node or accessory
bypass tracts, when
standard therapy has failed or is contraindicated.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
It is recommended that Propafenon Alkaloid 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 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.
Propafenon Alkaloid
150 mg film-coated tablets
Summary of Product Characteristics
2
Dose increases should not be attempted until the patient has been
receiving treatment for three
to four days.
The tablets should be swallowed whole and taken with a drink. A
reduction in the total daily
dose is recommended for patients below 70 kg bodyweight.
_Elderly population: _
No overall differences i