Nitrazepam Tablets 5mg Technical Specification:

Product Name:Nitrazepam Tablets 5mg
Brand Name:Generic
Strength:(5mg), (10mg)
Dosage Form:Tablets (Un-coated)
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:Sedative-hypnotics
Indication: Nitrazepam Tablets should be used for short term treatment of insomnia only when it is severe, disabling, or subjecting the individual to extreme distress, where daytime sedation is acceptable.
Storage:Store at 20° to 25°C (68° to 77°F). Store in dry place protected from light and moisture.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Nitrazepam Tablets 5mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Nitrazepam Tablets 5mg
    Each Un-coated tablet contains:
    Nitrazepam……….……5mg
    Excipients………………..q.s
    Colour: Sunset yellow FCF

THERAPEUTIC INDICATIONS:

Nitrazepam Tablets should be used for short term treatment of insomnia only when it is severe, disabling, or subjecting the individual to extreme distress, where daytime sedation is acceptable.

CAUTION & WARNING:

CAUTION: Read enclosed leaflet before use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
IT IS DANGEROUS TO TAKE THIS PREPARATION EXCEPT IN ACCORDANCE WITH MEDICAL ADVICE.

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)

Store in dry place protected from light and moisture.

Dosage: As directed by the Physician.

Attach dispensing label as per end country.

GENERIC NAME OF THE MEDICINAL PRODUCT:

1. Nitrazepam Tablets 5mg
2. Nitrazepam Tablets 10mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

1. Nitrazepam Tablets 5mg
Each Un-coated tablet contains:
Nitrazepam……….……5mg
Excipients………………..q.s
Colour: Sunset yellow FCF


2. Nitrazepam Tablets 10mg
Each Un-coated tablet contains:
Nitrazepam……….……10mg
Excipients………………..q.s
Colour: Sunset yellow

THERAPEUTIC INDICATIONS:

Nitrazepam Tablets should be used for short term treatment of insomnia only when it is severe, disabling, or subjecting the individual to extreme distress, where daytime sedation is acceptable.

CAUTION & WARNING:

CAUTION: Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
IT IS DANGEROUS TO TAKE THIS PREPARATION EXCEPT IN ACCORDANCE WITH MEDICAL ADVICE.
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)
Store in dry place protected from light and moisture.
Dosage: As directed by the Physician.
Attach dispensing label as per end country.