GENERIC NAME OF THE MEDICINAL PRODUCT:
A) Flecainide Acetate Tablet USP 50mg
B) Flecainide Acetate Tablet USP 100mg
B) Flecainide Acetate Tablet USP 100mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A) Flecainide Acetate Tablet USP 50mg
Each Un-coated tablet contains:
Flecainide Acetate USP……………..………....50mg
Excipients …………………………………..…….……q.s
B) Flecainide Acetate Tablet USP 100mg
Each Un-coated tablet contains:
Flecainide Acetate USP……………..………....100mg
Excipients …………………………………..…….……q.s
Each Un-coated tablet contains:
Flecainide Acetate USP……………..………....50mg
Excipients …………………………………..…….……q.s
B) Flecainide Acetate Tablet USP 100mg
Each Un-coated tablet contains:
Flecainide Acetate USP……………..………....100mg
Excipients …………………………………..…….……q.s
THERAPEUTIC INDICATIONS:
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.
CAUTION & WARNING:
CAUTION: SWALLOW WHOLE DO NOT CHEW OR CRUSH.
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.
STORAGE & DOSAGE:
Storage: Store at 20° to 25°C (68° to 77°F).
Dosage: As directed by the Physician.
Attach dispensing label here.
Flecainide Acetate Tablet USP 100mg Technical Specification:
| Product Name: | Flecainide Acetate Tablet USP |
| Brand Name: | Generic |
| Strength: | 50mg, 100mg |
| Dosage Form: | Tablets (Film-coated) |
| Route of Administration: | Via Oral Route |
| Packing: | 10s, 20s, 30s, 50s, 100s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Regulatory Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
| Therapeutic use: | Antiarrhythmic |
| Indication: | 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 anesthetic-type (Class IC) of the antiarrhythmic compound. |
| Storage: | Store at 20° to 25°C (68° to 77°F). |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Flecainide Acetate Tablet USP 50mg
- Flecainide Acetate Tablet USP 100mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Flecainide Acetate Tablet USP 50mg
Each Un-coated tablet contains:
Flecainide Acetate USP……………..………….50mg
Excipients …………………………………..…….……q.s - Flecainide Acetate Tablet USP 100mg
Each Un-coated tablet contains:
Flecainide Acetate USP……………..………….100mg
Excipients …………………………………..…….……q.s
THERAPEUTIC INDICATIONS:
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 anesthetic-type (Class IC) antiarrhythmic compound.
CAUTION & WARNING:
CAUTION: SWALLOW WHOLE DO NOT CHEW OR CRUSH.
Read enclosed leaflet before use.
Keep medicine out of reach of children.
Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.
STORAGE & DOSAGE:
Storage: Store at 20° to 25°C (68° to 77°F).
Dosage: As directed by the Physician.
Attach dispensing label here.
