Apremilast Tablets 10mg
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Apremilast Tablets 10mg Technical Specification:

Product Name: Apremilast Tablets 10mg
Brand Name: Generics
Strength: (10mg), (20mg), (30mg)
Dosage Form: Tablets (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, Stability Studies, GMP, CTD Dossier
Therapeutic use: Anti-Ulcer
Indication: Apremilast is used to treat ulcers in the mouth in people with Behcet’s syndrome (a disorder that causes blood vessel swelling in the body). Apremilast is in a class of medications called phosphodiesterase inhibitors. It works by blocking the action of certain natural substances in the body that cause inflammation.
Storage: Store at 20˚ to 25˚C (68˚ to 77˚F). See USP Controlled Room Temperature. Protect from Light and moisture.

GENERIC NAME OF THE MEDICINAL PRODUCT:

 QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Apremilast Tablets 10mg
    Each Film-coated tablet contains:
    Apremilast USP………………10mg
    Excipients…………………q.s.
    Colours: Ferric Oxide Red USP NF
  • Apremilast Tablets 20mg
    Each Film-coated tablet contains:
    Apremilast USP………………20mg
    Excipients…………………………q.s.
    Colours: Ferric Oxide Yellow USP NF
  • Apremilast Tablets 30mg
    Each Film-coated tablet contains:
    Apremilast USP………………30mg
    Excipients…………………………q.s.
    Colours: Ferrosoferric oxide USP-NF

THERAPEUTIC INDICATIONS:

Apremilast is used to treat ulcers in the mouth in people with Behcet’s syndrome (a disorder that causes blood vessel swelling in the body). Apremilast is in a class of medications called phosphodiesterase inhibitors. It works by blocking the action of certain natural substances in the body that cause inflammation.

CAUTION & WARNING:

CAUTION:  

Read enclosed leaflet before use.

Keep medicine out of reach of children.

SWALLOW WHOLE DO NOT CHEW OR CRUSH.

SCHEDULE “H” Prescription Drug -Warning: Not to be sold by retail without the prescription of a Registered Medical Prescriber.

STORAGE & DOSAGE:

Storage:  Store at 20˚ to 25˚C (68˚ to 77˚F). See USP Controlled Room Temperature. Protect from Light and moisture.

Dosage:  As directed by the Physician.

GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Apremilast Tablets 10mg
B. Apremilast Tablets 20mg
C. Apremilast Tablets 30mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

a) Apremilast Tablets 10mg
Each Film-coated tablet contains:
Apremilast USP………………10mg
Excipients…………………q.s.
Colours: Ferric Oxide Red USP NF

b) Apremilast Tablets 20mg
Each Film-coated tablet contains:
Apremilast USP………………20mg
Excipients…………………………q.s.
Colours: Ferric Oxide Yellow USP NF

c) Apremilast Tablets 30mg
Each Film-coated tablet contains:
Apremilast USP………………30mg
Excipients…………………………q.s.
Colours: Ferrosoferric oxide USP-NF

THERAPEUTIC INDICATIONS:

Apremilast is used to treat ulcers in the mouth in people with Behcet's syndrome (a disorder that causes blood vessel swelling in the body). Apremilast is in a class of medications called phosphodiesterase inhibitors. It works by blocking the action of certain natural substances in the body that cause inflammation.

CAUTION & WARNING:

CAUTION:
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH

SCHEDULE “H” Prescription Drug -Warning: Not to be sold by retail without the prescription of a Registered Medical Prescriber.

STORAGE & DOSAGE:

Storage: Store at 20˚ to 25˚C (68˚ to 77˚F). See USP Controlled room Temperature. Protect from Light and moisture.
Dosage: As directed by the Physician.