Nitrazepam Tablets 10mg Technical Specification:
| Product Name: | Nitrazepam Tablets |
| 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 10mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- 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.
GENERIC NAME OF THE MEDICINAL PRODUCT:
1. Nitrazepam Tablets 5mg
2. Nitrazepam Tablets 10mg
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
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. 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.
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.
Store in dry place protected from light and moisture.
Dosage: As directed by the Physician.
Attach dispensing label as per end country.
