A. Zopiclone Tablets 7.5mg
B. Zopiclone Tablets 10mg
C. Zopiclone Tablets 20mg
GENERIC NAME OF THE MEDICINAL PRODUCT:
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A. Zopiclone Tablets 7.5mg
Each Film-coated tablet contains:
Zopiclone BP……….……7.5mg
Excipients………………. q. s
Colour: Titanium dioxide USP
B. Zopiclone Tablets 10mg
Each Film-coated tablet contains:
Zopiclone BP……….……10mg
Excipients…………….…. q. s
Colour: Sunset yellow FCF
C. Zopiclone Tablets 20mg
Each Film-coated tablet contains:
Zopiclone BP……….……20mg
Excipients………………. q. s
Colour: Iron oxide red
Each Film-coated tablet contains:
Zopiclone BP……….……7.5mg
Excipients………………. q. s
Colour: Titanium dioxide USP
B. Zopiclone Tablets 10mg
Each Film-coated tablet contains:
Zopiclone BP……….……10mg
Excipients…………….…. q. s
Colour: Sunset yellow FCF
C. Zopiclone Tablets 20mg
Each Film-coated tablet contains:
Zopiclone BP……….……20mg
Excipients………………. q. s
Colour: Iron oxide red
THERAPEUTIC INDICATIONS:
Zopiclone is a nonbenzodiazepine hypnotic from the pyrazolopyrimidine class and is indicated for the short-term treatment of insomnia.
Zopiclone is a type of sleeping pill that can be taken to treat bad bouts of insomnia. It helps you fall asleep more quickly, and also helps stop you waking up during the night.
**Long term continuous use is not recommended.
Zopiclone is a type of sleeping pill that can be taken to treat bad bouts of insomnia. It helps you fall asleep more quickly, and also helps stop you waking up during the night.
**Long term continuous use is not recommended.
CAUTION & WARNING:
CAUTION: SWALLOW WHOLE DO NOT CHEW OR CRUSH.
Patients who take Sliprex Fast and other medicines to help them sleep may experience decreased ability to be alert the day after taking the medicine, even if they feel fully awake. This can cause next-day impairment of driving or other activities that require full mental alertness.
*Treat bad bouts of insomnia. It helps you fall asleep more quickly.
Read enclosed leaflet before use.
WARNING: TO BE SOLD BY RETAIL ON THE PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER ONLY.
WARNING: In the elderly and/or debilitated patient an initial dose of 3.75mg is recommended. The dose maybe increased to a maximum of 7.5mg.
Prolong use of hypnotics is not recommended especially in the elderly.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
Patients who take Sliprex Fast and other medicines to help them sleep may experience decreased ability to be alert the day after taking the medicine, even if they feel fully awake. This can cause next-day impairment of driving or other activities that require full mental alertness.
*Treat bad bouts of insomnia. It helps you fall asleep more quickly.
Read enclosed leaflet before use.
WARNING: TO BE SOLD BY RETAIL ON THE PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER ONLY.
WARNING: In the elderly and/or debilitated patient an initial dose of 3.75mg is recommended. The dose maybe increased to a maximum of 7.5mg.
Prolong use of hypnotics is not recommended especially in the elderly.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
STORAGE & DOSAGE:
Storage: Store at 20° to 25°C (68° to 77°F).
Preserve in tight container.
Keep in a cool & dry place.
Protected from light and moisture.
Dosage: As directed by the Physician.
Attach dispensing label as per end country.
Preserve in tight container.
Keep in a cool & dry place.
Protected from light and moisture.
Dosage: As directed by the Physician.
Attach dispensing label as per end country.
Zopiclone Tablets 7.5mg Technical Specification:
| Product Name: | Zopiclone Tablets 7.5mg |
| 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). Preserve in tight container. Keep in a cool & dry place. Protected from light and moisture. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Zopiclone Tablets 7.5mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Zopiclone Tablets 7.5mg
Each Film-coated tablet contains:
Zopiclone BP……….……7.5mg
Excipients………………. q. s
Colour: Titanium dioxide USP
THERAPEUTIC INDICATIONS:
Zopiclone is a nonbenzodiazepine hypnotic from the pyrazolopyrimidine class and is indicated for the short-term treatment of insomnia.
Zopiclone is a type of sleeping pill that can be taken to treat bad bouts of insomnia. It helps you fall asleep more quickly, and also helps stop you waking up during the night.
**Long term continuous use is not recommended.
CAUTION & WARNING:
CAUTION: SWALLOW WHOLE DO NOT CHEW OR CRUSH.
Patients who take Sliprex Fast and other medicines to help them sleep may experience decreased ability to be alert the day after taking the medicine, even if they feel fully awake. This can cause next-day impairment of driving or other activities that require full mental alertness.
*Treat bad bouts of insomnia. It helps you fall asleep more quickly.
Read enclosed leaflet before use.
Warning: TO BE SOLD BY RETAIL ON THE PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER ONLY.
Warning: In the elderly and/or debilitated patient an initial dose of 3.75mg is recommended. The dose maybe increased to a maximum of 7.5mg.
Prolong use of hypnotics is not recommended especially in the elderly.
Keep medicine out of reach of children.
STORAGE & DOSAGE:
Storage: Store at 20° to 25°C (68° to 77°F). Preserve in tight container. Keep in a cool & dry place. Protected from light and moisture.
Dosage: As directed by the Physician.
Attach dispensing label as per end country.
