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.


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.