Flupirtine Maleate and Paracetamol Bilayer Tablets 100mg + 325mg Technical Specification:
| Product Name: | Flupirtine Maleate and Paracetamol Tablets |
| Brand Name: | Generic |
| Strength: | 100mg + 325mg |
| Dosage Form: | Bilayer Tablets |
| Route of Administration: | Via Oral Route |
| Packing: | 10s, 100s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet) |
| Documents: | COA, MOA, Stability Studies, GMP |
| Therapeutic use: | Analgesic & Antipyretic |
| Indication: | Used for pain relief |
| Storage: | Store below 30°C. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
Flupirtine Maleate and Paracetamol Bilayer Tablets 100mg + 325mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A. Flupirtine Maleate and Paracetamol Bilayer Tablets 100mg + 325mg
Each Uncoated Bilayer Tablet Contains:
Flupirtine Maleate… …….……100mg
Paracetamol IP …………………325mg
Excipients………………………..…Q.S.
Colour: Iron Oxide Red
THERAPEUTIC INDICATIONS:
It is to treat acute and chronic pain, fever, headache, joint pains, dysmenorrhea (period pain), postoperative pain, toothache after dental extraction and myalgia (muscle pain).
CAUTION & SCHEDULE:
CAUTION:
Keep medicine out of reach of children.
Taking more than daily dose of Paracetamol (4000mg) may cause serious liver damage or allergic reactions such as swelling of face, mouth and throat; difficulty in breathing, itching and rashes.
SCHEDULE: SCHEDULE H PRESCRIPTION DRUG: WARNING: TO BE SOLD BY RETAIL ON THE PRESCRIPTION OF A registered medical practitioner ONLY.
STORAGE & DOSAGE:
Storage: Must be stored in a cool, dry & dark place below 30°C.
Protect from direct sunlight, heat & moisture.
Dosage: As directed by the Physician.