| Product Name: | Tapentadol Hydrochloride Tablets |
| Brand Name: | NUCYRETA |
| Strength: | 50mg, 75mg, 100mg,150mg, 200mg |
| 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: | Opioid Analgesic, Pain killer |
| Indication: | Tapentadol tablets are used to treat moderate to severe acute pain (pain that begins suddenly, has a specific cause, and is expected to go away when the cause of the pain is healed). |
| Storage: | Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Tapentadol Hydrochloride Tablets 50mg
- Tapentadol Hydrochloride Tablets 75mg
- Tapentadol Hydrochloride Tablets 100mg
- Tapentadol Hydrochloride Tablets 150mg
- Tapentadol Hydrochloride Tablets 200mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Tapentadol Hydrochloride Tablets 50mg
Each film-coated tablet contains:
Tapentadol Hydrochloride
Equivalent to Tapentadol…………..50mg
Excipients…………………………………..q.s.
Color: Lake brilliant blue - Tapentadol Hydrochloride Tablets 75mg
Each film-coated tablet contains:
Tapentadol Hydrochloride
Equivalent to Tapentadol.…………..75mg
Excipients……………………………………q.s.
Color: Lake of quinoline yellow FCF - Tapentadol Hydrochloride Tablets 100mg
Each film-coated tablet contains:
Tapentadol Hydrochloride
Equivalent to Tapentadol………100mg
Excipients………………………q.s.
Color: Lake of Erythrosine - Tapentadol Hydrochloride Tablets 150mg
Each film-coated tablet contains:
Tapentadol Hydrochloride
Equivalent to Tapentadol………150mg
Excipients………………………q.s.
Color: Lake of Erythrosine - Tapentadol Hydrochloride Tablets 200mg
Each film-coated tablet contains:
Tapentadol Hydrochloride
Equivalent to Tapentadol……..200mg
Excipients……………………..q.s.
Color: Ferric oxide yellow
THERAPEUTIC INDICATIONS:
Tapentadol tablets are used to treat moderate to severe acute pain (pain that begins suddenly, has a specific cause, and is expected to go away when the cause of the pain is healed). Tapentadol extended-release tablets are used to treat severe neuropathic pain (pain caused by nerve damage) in people who have diabetes.
CAUTION & WARNING:
CAUTION:
Read the enclosed leaflet before use.
Keep the medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
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) [see USP Controlled Room Temperature].
Dosage:
As directed by the Physician.