Penicillamine Capsules USP 250mg Technical Specification:
| Product Name: | Penicillamine Capsules USP 250mg |
| Brand Name: | Generic |
| Strength: | 250mg |
| Dosage Form: | Capsules (Hard gelatin) |
| Route of Administration: | Via Oral Route |
| Packing: | 10s, 30s, 100s, 500s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Regulatory Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
| Therapeutic use: | Antirheumatic |
| Indication: | Penicillamine is used to treat rheumatoid arthritis, Wilson’s disease (a condition in which high levels of copper in the body cause damage to the liver, brain, and other organs), and a certain disorder which causes kidney stones (cystinuria). |
| Storage: | Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Penicillamine Capsules USP 250mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Penicillamine Capsules USP 250mg
Each Hard gelatin capsule contains:
Penicillamine USP……………………250mg
Excipients………………………………….q.s
Approved colours are used in capsule shells.
THERAPEUTIC INDICATIONS:
Penicillamine is used to treat rheumatoid arthritis, Wilson’s disease (a condition in which high levels of copper in the body cause damage to the liver, brain, and other organs), and a certain disorder which causes kidney stones (cystinuria).
CAUTION & WARNING:
CAUTION: Read enclosed leaflet before use.
Keep 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: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Dispense in tight and light resistant container.
Dosage: As directed by the physician.
Attach dispensing label as per end country.
GENERIC NAME OF THE MEDICINAL PRODUCT:
A) Penicillamine Capsules USP 250mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A) Penicillamine Capsules USP 250mg
Each Hard gelatin capsule contains:
Penicillamine USP……………………250mg
Excipients………………………………….q.s
Approved colours are used in capsule shells.
Each Hard gelatin capsule contains:
Penicillamine USP……………………250mg
Excipients………………………………….q.s
Approved colours are used in capsule shells.
THERAPEUTIC INDICATIONS:
Penicillamine is used to treat rheumatoid arthritis, Wilson's disease (a condition in which high levels of copper in the body cause damage to the liver, brain, and other organs), and a certain disorder which causes kidney stones (cystinuria).
CAUTION & WARNING:
CAUTION:
Read enclosed leaflet before use.
KEEP 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.
Read enclosed leaflet before use.
KEEP 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: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Dispense in tight and light resistant container.
Dosage: As directed by the physician.
Attach dispensing label as per end country.
Dispense in tight and light resistant container.
Dosage: As directed by the physician.
Attach dispensing label as per end country.
