Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Accord-UK Ltd (Trading style: Accord), Whiddon Valley, Barnstaple, Devon, EX32 8NS
FLECAINIDE ACETATE TABLETS 100mg.
| Pharmaceutical Form |
|---|
|
Tablet. White, circular, biconvex, uncoated tablets one side embossed with a breakline and the identifying letters “C” above the line and “FJ” below, the reverse side embossed with a breakline. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. |
Each tablet contains 100mg Flecainide Acetate.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Flecainide |
Flecainide acetate is a Class IC antiarrhythmic agent used for the treatment of severe symptomatic life-threatening ventricular arrhythmias and supraventricular arrhythmias. Electrophysiologically, flecainide is a local anaesthetic-type (Class IC) of antiarrhythmic compound. It is an amide type of local anaesthetic, being structurally related to procainamide and encainide in so far as these agents are also benzamide derivatives. |
| List of Excipients |
|---|
|
Croscarmellose sodium |
The blister packs are manufactured from 250µm white rigid PVC/PVDC coated with 60gm-2 PVDC and 20µm hard temper aluminium foil with 5-7g/m² PVC/PVDC compatible heat seal lacquer. The polypropylene containers are manufactured from rigid injection moulded polypropylene with snap-on polyethylene lids. An alternative container is a polyethylene container with a snap-on polyethylene lid.
Blister: 20s, 28s, 30s, 50s, 56s, 60s, 84s, 90s, 100s, 112s, 120s, 168s, 180s.
Polypropylene container: 100s, 250s, 500s, 1000s.
Polyethylene container: 100s.
Not all pack sizes may be marketed.
Accord-UK Ltd (Trading style: Accord), Whiddon Valley, Barnstaple, Devon, EX32 8NS
PL 0142/0431
03/08/2009
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