| Product Name: | Ivabradine Tablets |
| Brand Name: | Generic |
| Strength: | 5mg, 7.5mg |
| Dosage Form: | Tablets (Film coated) |
| Route of Administration: | Via Oral Route |
| Packing: | 10s, 30s, 100s, 500s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet) |
| Documents: | COA, MOA, Stability Studies, GMP |
| Therapeutic use: | Cardiovascular, Antihypertensive |
| Indication: | Ivabradine is used to treat adults who have chronic heart failure to reduce their risk of hospitalization for worsening heart failure. |
| Storage: | Store below 30 °C. Protect from Light. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Ivabradine Tablets 5mg
- Ivabradine Tablets 7.5mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Ivabradine Tablets 5mg
Each film coated tablet contains:
Ivabradine Hydrochloride
Equivalent to Ivabradine…………………5mg
Excipients……………………………. q.s.
Colour: Ponceau 4 R - Ivabradine Tablets 7.5mg
Each film coated tablet contains:
Ivabradine Hydrochloride
Equivalent to Ivabradine………….7.5mg
Excipients…………………………………q.s.
Colour: Quinoline yellow WS
THERAPEUTIC INDICATIONS:
Ivabradine is used to treat certain adults with heart failure (condition in which the heart is unable to pump enough blood to the other parts of the body) to decrease the risk that their condition will worsen and need to be treated in a hospital. It is also used to treat a certain type of heart failure in children 6 months of age and older due to cardiomyopathy (a condition in which the heart muscle becomes weakened and enlarged). Ivabradine is in a class of medications called hyperpolarization-activated cyclic nucleotide-gated (HCN) channel blockers. It works by slowing the heart rate so the heart can pump more blood through the body each time it beats.
CAUTION & SHEDULE:
CAUTION: Read enclosed leaflet before use.
Keep medicine out of reach of children
SWALLOW WHOLE DO NOT CHEW OR CRUSH
SCHEDULE: SCHEDULE H: NOT TO BE SOLD BY RETAIL WITHOUT THE PRESCRIPTION OF A Registered Medical Practitioner.
STORAGE & DOSAGE:
Storage: Store below 30 °C.
Protect from Light and moisture.
Dosage: As directed by the Physician