GENERIC NAME OF THE MEDICINAL PRODUCT:
B) Zopiclone Tablets BP 10mg(Sliprex Fast)
C) Zopiclone Tablets BP 20mg (Sliprex Fast)
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each Film-coated tablet contains:
Zopiclone BP……….……7.5mg
Excipients………………..q.s
Colour: Sunset yellow FCF
B) Zopiclone Tablets BP 10mg
Each Film-coated tablet contains:
Zopiclone BP……….……10mg
Excipients……………..…..q.s
Colour: Sunset yellow
C) Zopiclone Tablets BP 20mg
Each Film-coated tablet contains:
Zopiclone BP……….……20mg
Excipients………………..q.s
Colour: Sunset yellow lake
THERAPEUTIC INDICATIONS:
CAUTION & WARNING:
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:
Store in dry place protected from light and moisture.
Dosage: As directed by the Physician.
Attach dispensing label as per end country.
Zopiclone Tablets BP 20mg Technical Specification:
| Product Name: | Zopiclone Tablets BP |
| Brand Name: | Sliprex Fast |
| Strength: | 7.5mg, 10mg, 20mg |
| Dosage Form: | Tablets (Film-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: | Zopiclone is a nonbenzodiazepine hypnotic from the pyrazolopyrimidine class and is indicated for the short-term treatment of insomnia. |
| 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:
A) Zopiclone Tablets BP 7.5mg (Sliprex Fast)
B) Zopiclone Tablets BP 10mg(Sliprex Fast)
C) Zopiclone Tablets BP 20mg (Sliprex Fast)
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A) Zopiclone Tablets BP 7.5mg
Each Film-coated tablet contains:
Zopiclone BP……….……7.5mg
Excipients………………..q.s
Colour: Sunset yellow FCF
B) Zopiclone Tablets BP 10mg
Each Film-coated tablet contains:
Zopiclone BP……….……10mg
Excipients……………..…..q.s
Colour: Sunset yellow
C) Zopiclone Tablets BP 20mg
Each Film-coated tablet contains:
Zopiclone BP……….……20mg
Excipients………………..q.s
Colour: Sunset yellow lake
THERAPEUTIC INDICATIONS:
Zopiclone is a nonbenzodiazepine hypnotic from the pyrazolopyrimidine class and is indicated for the short-term treatment of insomnia.
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.
