Tolperisone Tablets 150mg Technical Specification:
| Product Name: | Tolperisone Tablets 150mg |
| Brand Name: | MIDOTAJ |
| Strength: | 50mg, 100mg, 150mg |
| Dosage Form: | Film-coated tablets |
| Packing: | 10s Blisters, 30s Blisters |
| Route of Administration: | For Oral Use Only |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Regulatory Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
| Therapeutic use: | Muscle relaxant (Musculoskeletal system) |
| Indication: | Tolperisone tablets is indicated for use in the treatment of pathologically increased tone of the skeletal muscle caused by neurological diseases (damage of the pyramidal tract, multiple sclerosis, myelopathy, encephalomyelitis) and of spastic paralysis and other encephalopathies manifested with muscular dystonia. |
| Storage: | Store protected from moisture at a temperature not exceeding 25°C. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Tolperisone Tablets (150mg)
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Tolperisone Tablets (150mg)
Composition:
Each film-coated tablet contains:
Tolperisone Hydrochloride JP………150mg
Excipients…………………………………. q.s.
Colours: Iron Oxide Red
THERAPEUTIC INDICATIONS:
Tolperisone tablets is indicated for use in the treatment of pathologically increased tone of the skeletal muscle caused by neurological diseases (damage of the pyramidal tract, multiple sclerosis, myelopathy, encephalomyelitis) and of spastic paralysis and other encephalopathies manifested with muscular dystonia.
Tolperisone used for muscle relaxation. It is used to treat acute musculoskeletal pain. This improves pain & movement of muscles.
DIRECTIONS:
Take it with or after food or a glass of milk.
CAUTION & WARNING:
CAUTION: Do not throw away consumer package insert.
Do not chew or crush the tablets. They should be swallowed whole with water.
PHARMACIST: Please dispense with medication guide provided separately.
WARNING: Do not stop taking it suddenly without talking to your doctor if you’ve been on it for a long time.
Side effects of Tolperisone: Sleepiness, weakness.
WARNING: To be sold by retail on the prescription of a psychiatrist only.
Keep out of the reach and sight of children.
STORAGE & DOSAGE:
Storage: Store protected from moisture at a temperature not exceeding 25°C.
Dosage: As directed by the Physician.
GENERIC NAME OF THE MEDICINAL PRODUCT:
A. Tolperisone Tablets (50mg)
B. Tolperisone Tablets (100mg)
C. Tolperisone Tablets (150mg)
B. Tolperisone Tablets (100mg)
C. Tolperisone Tablets (150mg)
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A. Tolperisone Tablets (50mg)
Composition:
Each film-coated tablet contains:
Tolperisone Hydrochloride JP………50mg
Excipients…………………………………. q.s.
Colours: Titanium Dioxide USP
B. Tolperisone Tablets (100mg)
Composition:
Each film-coated tablet contains:
Tolperisone Hydrochloride JP………100mg
Excipients…………………………………. q.s.
Colours: Iron Oxide Red
C. Tolperisone Tablets (150mg)
Composition:
Each film-coated tablet contains:
Tolperisone Hydrochloride JP………150mg
Excipients…………………………………. q.s.
Colours: Iron Oxide Yellow
Composition:
Each film-coated tablet contains:
Tolperisone Hydrochloride JP………50mg
Excipients…………………………………. q.s.
Colours: Titanium Dioxide USP
B. Tolperisone Tablets (100mg)
Composition:
Each film-coated tablet contains:
Tolperisone Hydrochloride JP………100mg
Excipients…………………………………. q.s.
Colours: Iron Oxide Red
C. Tolperisone Tablets (150mg)
Composition:
Each film-coated tablet contains:
Tolperisone Hydrochloride JP………150mg
Excipients…………………………………. q.s.
Colours: Iron Oxide Yellow
THERAPEUTIC INDICATIONS:
Tolperisone tablets is indicated for use in the treatment of pathologically increased tone of the skeletal muscle caused by neurological diseases (damage of the pyramidal tract, multiple sclerosis, myelopathy, encephalomyelitis) and of spastic paralysis and other encephalopathies manifested with muscular dystonia.
Tolperisone used for muscle relaxation. It is used to treat acute musculoskeletal pain. This improves pain & movement of muscles.
Tolperisone used for muscle relaxation. It is used to treat acute musculoskeletal pain. This improves pain & movement of muscles.
DIRECTIONS:
Take it with or after food or a glass of milk.
CAUTION & WARNING:
CAUTION: Do not throw away consumer package insert.
Do not chew or crush the tablets. They should be swallowed whole with water.
PHARMACIST: Please dispense with medication guide provided separately.
WARNING: Do not stop taking it suddenly without talking to your doctor if you’ve been on it for a long time.
Side effects of Tolperisone: Sleepiness, weakness.
WARNING: To be sold by retail on the prescription of a psychiatrist only.
Keep out of the reach and sight of children.
Do not chew or crush the tablets. They should be swallowed whole with water.
PHARMACIST: Please dispense with medication guide provided separately.
WARNING: Do not stop taking it suddenly without talking to your doctor if you’ve been on it for a long time.
Side effects of Tolperisone: Sleepiness, weakness.
WARNING: To be sold by retail on the prescription of a psychiatrist only.
Keep out of the reach and sight of children.
STORAGE & DOSAGE:
Storage: Store protected from moisture at a temperature not exceeding 25°C.
Dosage: As directed by the Physician.
Dosage: As directed by the Physician.
