| Product Name: | Naltrexone hydrochloride tablets 50mg |
| Brand Name: | Generic |
| Strength: | 50mg |
| Dosage Form: | Film-coated Oral Tablets |
| Route of Administration: | Via Oral Route |
| Packing: | 10s, 100s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
| Therapeutic use: | Analgesics |
| Indication: | used to treat alcohol use disorder and opioid dependence. Naltrexone blocks the effect of opioids and prevents opioid intoxication and physiologic dependence on opioid users. |
| Storage: | Store in in cool & Dry place. Protect from light & moisture. |
GENERIC NAME OF THE MEDICINAL PRODUCT
Naltrexone hydrochloride tablets 50mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Naltrexone hydrochloride tablets 50mg
Each film-coated tablet contains
Naltrexone hydrochloride……………..50.00mg
Excipient ……………………………………… q.s
THERAPEUTIC INDICATIONS:
used to treat alcohol use disorder and opioid dependence. Naltrexone blocks the effect of opioids and prevents opioid intoxication and physiologic dependence on opioid users.
CAUTION & SCHEDULE:
CAUTION:Read enclosed leaflet before use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
SCHEDULE: Not to be sold by retail without the prescription of a Registered Medical Prescriber.
STORAGE & DOSAGE:
storage: Store in in cool & Dry place.
Protect from light & moisture
Dosage: As directed by the Physician.