| Product Name: | Ramelteon Tablets |
| Brand Name: | Generic |
| Strength: | (8mg) |
| 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: | Ramelteon belongs to the group of medicines called central nervous system (CNS) depressants (medicines that slow down the nervous system). Ramelteon is used to treat insomnia (trouble sleeping). Ramelteon helps you get to sleep faster and sleep through the night. |
| Storage: | Store at 20° to 25°C (68° to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). Store in a dry place protected from light and moisture. |
Ramelteon Tablets 8mg Technical Specification:
GENERIC NAME OF THE MEDICINAL PRODUCT:
Ramelteon Tablets 8mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Ramelteon Tablets 8mg
Each Film-coated tablet contains:
Ramelteon……….……8mg
Excipients………………q.s
Colour: Sunset yellow lake
THERAPEUTIC INDICATIONS:
Ramelteon belongs to the group of medicines called central nervous system (CNS) depressants (medicines that slow down the nervous system). Ramelteon is used to treat insomnia (trouble sleeping). Ramelteon helps you get to sleep faster and sleep through the night.
CAUTION & WARNING:
CAUTION:
Read the enclosed leaflet before use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
DISPENSE IN A TIGHT, LIGHT-RESISTANT, CHILD-RESISTANT CONTAINER.
DO NOT ACCEPT IF THE SEAL OVER THE BOTTLE OPENING IS BROKEN OR MISSING.
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); excursions permitted between 15°C to 30°C (59°F to 86°F).
Store in a dry place protected from light and moisture.
Dosage: As directed by the Physician.