Hydroxychloroquine Sulphate Tablets 200mg Technical Specification:

Product Name:                                            Hydroxychloroquine Sulphate Tablets 200mg
Brand Name:Generics
Strength:200mg, 300mg, 400mg
Dosage Form:Tablet (Film-coated)
Route of Administration:Via oral Route
Packing:10s, 30s, 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:Antimalarial
Indication: Hydroxychloroquine is used to treat discoid lupus erythematosus (DLE) or systemic lupus erythematosus (SLE or lupus). It is also used to treat acute and chronic rheumatoid arthritis. This medicine is available only with your doctor’s prescription.
Storage:Protect form moisture at a temperature not exceeding 30˚C.Do not freeze. Keep the container tightly closed in order to protect from moisture.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Hydroxychloroquine Sulphate Tablets 200mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Hydroxychloroquine Sulphate Tablets 200mg
    Each Film-coated tablet contains:
    Hydroxychloroquine Sulphate USP.…………….200mg
    Excipients…………………………………. q.s.
    Colours: Quinoline Yellow

THERAPEUTIC INDICATIONS:

Hydroxychloroquine is used to treat discoid lupus erythematosus (DLE) or systemic lupus erythematosus (SLE or lupus). It is also used to treat acute and chronic rheumatoid arthritis. This medicine is available only with your doctor’s prescription.

CAUTION & WARNING:

CAUTION:  SWALLOW WHOLE DO NOT CHEW OR CRUSH

*Not suitable for children under 5 years.

Prevent or treat malaria caused by mosquito bites.

Read enclosed leaflet before use.

Warning: Not to be sold by retail without the prescription of a Registered Medical Prescriber.

Keep medicine out of reach of children.

STORAGE & DOSAGE:

Storage:  Protect form moisture at a temperature not exceeding 30˚C.Do not freeze. Keep the container tightly closed in order to protect from moisture.

Dosage:  As directed by the Physician.

GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Hydroxychloroquine Sulphate Tablets 200mg
B. Hydroxychloroquine Sulphate Tablets 300mg
C. Hydroxychloroquine Sulphate Tablets 400mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Hydroxychloroquine Sulphate Tablets 200mg
Each Film-coated tablet contains:
Hydroxychloroquine Sulphate USP.…………….200mg
Excipients…………………………………. q.s.
Colours: Quinoline Yellow


B. Hydroxychloroquine Sulphate Tablets 300mg
Each Film-coated tablet contains:
Hydroxychloroquine Sulphate USP.…………….300mg
Excipients…………………………………. q.s.
Colours: Sunset Yellow

C. Hydroxychloroquine Sulphate Tablets 400mg
Each Film-coated tablet contains:
Hydroxychloroquine Sulphate USP……………….400mg
Excipients…………………………………. q.s.
Colours: Indigo Carmine

THERAPEUTIC INDICATIONS:

Hydroxychloroquine is used to treat discoid lupus erythematosus (DLE) or systemic lupus erythematosus (SLE or lupus). It is also used to treat acute and chronic rheumatoid arthritis. This medicine is available only with your doctor's prescription.

CAUTION & WARNING:

CAUTION: SWALLOW WHOLE DO NOT CHEW OR CRUSH
*Not suitable for children under 5 years.
Prevent or treat malaria caused by mosquito bites.
Read enclosed leaflet before use.
Warning: Not to be sold by retail without the prescription of a Registered Medical Prescriber.
KEEP MEDICINE OUT OF REACH OF CHILDREN.

STORAGE & DOSAGE:

Storage: Protect form moisture at a temperature not exceeding 30˚C.
Do not freeze.
Keep the container tightly closed in order to protect from moisture.
Dosage: As directed by the Physician.