| Product Name: | Perindopril Erbumine BP |
| Brand Name: | Generics |
| Strength: | 2mg, 4mg, 8mg |
| Dosage Form: | Tablets (Uncoated) |
| Route of Administration: | Via oral Route |
| Packing: | 30s, 90s,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: | Antihypertension, ACE inhibitor |
| Indication: | Perindopril erbumine tablets are indicated for the treatment of patients with stable coronary artery disease to reduce the risk of cardiovascular mortality or nonfatal myocardial infarction. |
| Storage: | Protect from moisture at a temperature not exceeding 25˚C. Do not freeze. Keep the container tightly closed in order to protect it from moisture. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Perindopril Erbumine BP 2mg
- Perindopril Erbumine BP 4mg
- Perindopril Erbumine BP 8mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Perindopril Erbumine Tablets 2mg
Each uncoated tablet contains:
Perindopril Erbumine BP………….…2mg
Excipients……………………………. q.s.
Colours: Iron oxide red - Perindopril Erbumine Tablets 4mg
Each uncoated tablet contains:
Perindopril Erbumine BP…………….4mg
Excipients…………………….………q.s.
Colours: Sunset Yellow. - Perindopril Erbumine Tablets 8mg
Each uncoated tablet contains:
Perindopril Erbumine BP…………….8mg
Excipients…………………….………q.s.
Colours: Iron oxide Yellow.
THERAPEUTIC INDICATIONS:
Perindopril Erbumine is indicated for the control of hyperphosphatasemia in adult patients receiving hemodialysis or peritoneal dialysis.
Perindopril Erbumine is also indicated for the control of hyperphosphatasemia in adult patients with chronic kidney disease (CKD) not on dialysis with serum phosphorus ≥ 1.78 mmol/l.
CAUTION & WARNING:
CAUTION:
Read the enclosed leaflet before use.
Keep the medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.
STORAGE & DOSAGE:
Storage: Protect from moisture at a temperature not exceeding 25˚C. Do not freeze. Keep the container in a well-ventilated place. Keep away from sources of ignition and heat.
Dosage: As directed by the Physician.