| Product Name: | Armodafinil Tablet |
| Brand Name: | Generics |
| Strength: | 50mg, 150mg, 250mg |
| Dosage Form: | Tablet (Un-coated) |
| Route of Administration: | Via oral Route |
| Packing: | 30s, 90s, 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: | CNS Depressant, benzodiazepines |
| Indication: | Armodafinil is used to help people who have narcolepsy, obstructive sleep apnea (hypopnea syndrome), or shift work sleep disorders to stay awake during the day. This medicine does not cure these conditions and will only work if you continue to take it. |
| Storage: | controlled room temperature medications must be stored between 68°F and 77°F (20°C and 25°C), with some allowances for temporary excursions. Keep the container tightly closed in order to protect it from moisture. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Armodafinil Tablet 50mg
- Armodafinil Tablet 150mg
- Armodafinil Tablet 250mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Armodafinil Tablet 50mg
Each Un-coated tablet contains:
Armodafinil …………….50mg
Excipients…………………… q.s.
Colour: Red Oxide iron - Armodafinil Tablet 150mg
Each Un-coated tablet contains:
Armodafinil …………….150mg
Excipients…………………… q.s.
Colour: Red Oxide iron - Armodafinil Tablet 250mg
Each Un-coated tablet contains:
Armodafinil …………….250mg
Excipients…………………… q.s.
Colour: Red Oxide iron
THERAPEUTIC INDICATIONS:
Armodafinil is used to help people who have narcolepsy, obstructive sleep apnea (hypopnea syndrome), or shift work sleep disorders to stay awake during the day. This medicine does not cure these conditions and will only work if you continue to take it.
CAUTION & WARNING:
CAUTION:
Keep the medicine out of reach of CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
WARNING: Not to be sold by retail without the prescription of a Registered Medical Prescriber.
STORAGE & DOSAGE:
Storage:
Controlled room temperature medications must be stored between 68°F and 77°F (20°C and 25°C), with some allowances for temporary excursions.
Keep the container tightly closed in order to protect it from moisture.
Dosage:
As directed by the physician.