DRONCOR

País: Israel

Língua: inglês

Origem: Ministry of Health

Ingredientes ativos:

DRONEDARONE AS HYDROCHLORIDE

Disponível em:

UNIPHARM LTD, ISRAEL

Código ATC:

C01BD07

Forma farmacêutica:

COATED TABLETS

Composição:

DRONEDARONE AS HYDROCHLORIDE 400 MG

Via de administração:

PER OS

Tipo de prescrição:

Required

Fabricado por:

UNIPHARM LTD, ISRAEL

Área terapêutica:

DRONEDARONE

Indicações terapêuticas:

DRONCOR is indicated for the maintenance of sinus rhythm after successful cardioversion in adult clinically stable patients with paroxysmal or persistent atrial fibrillation (AF). Due to its safety profile, DRONCOR should only be prescribed after alternative treatment options have been considered. DRONCOR should not be given to patients with left ventricular systolic dysfunction or to patients with current or previous episodes of heart failure.

Data de autorização:

2020-10-28

Folheto informativo - Bula

PATIENT PACKAGE INSERT IN ACCORDANCE
WITH THE PHARMACISTS’ REGULATIONS
)PREPARATIONS( – 1986
The medicine is dispensed with a
doctor’s prescription only
DRONCOR
Film-coated tablets 400 mg
ACTIVE INGREDIENT
Each film-coated tablet contains dronedarone
400 mg )as hydrochloride(
For further information on inactive and allergenic
ingredients in the preparation: see section 6 ”Further
Information“.
READ THE LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING
THE MEDICINE.
Keep this leaflet; you may need to read it again.
This leaflet contains concise information about the
medicine.
If you have further questions, refer to the doctor or
pharmacist.
This medicine was prescribed for you. Do not pass it
on to others. It may harm them, even if it seems to you
that their medical condition is similar.
1. WHAT IS THE MEDICINE INTENDED FOR?
The medicine is used to treat atrial fibrillation after
return to normal heart rhythm )sinus rhythm(.
THERAPEUTIC GROUP: anti-arrhythmic preparation to
regulate heart rhythm.
2. BEFORE USING THE MEDICINE
DO NOT USE THE MEDICINE IF:
- You are sensitive )allergic( to the active ingredient
or to any of the other ingredients contained in the
medicine )see section 6(.
- You are suffering from nerve conductivity
disturbances in the heart, manifested by slow heart
rate or feeling dizzy. If you have a pacemaker, you
can use DRONCOR.
- You have a very slow heart rate )less than 50 beats
per minute(.
- ECG shows a heart problem called ”prolonged QT
interval“ )a segment of more than 500 milliseconds(.
- You have chronic atrial fibrillation )fibrillation that
persists continuously for at least 6 months( and a
decision has been made not to change your sinus
rhythm back by cardioversion.
- You have instability )drops( in blood pressure which
can lead to inadequate arterial blood flow to your
organs.
- You have or had heart failure that could manifest by
edemas in the legs, trouble breathing when lying
down or sleeping, or shortness of breath when
moving around.
- The volume of blood leaving the h