Misoprostol Tablets IP 25mcg Technical Specification:
| Product Name: | Misoprostol Tablets IP 25mcg |
| Brand Name: | Generic |
| Strength: | (25mcg), (100mcg), (200mcg) |
| Dosage Form: | Tablets (Uncoated) |
| Route of Administration: | Via Oral Route |
| Packing: | 10s, 30s, 100s, 500s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet) |
| Documents: | COA, MOA, Stability Studies, GMP |
| Therapeutic use: | Anti-Ulcer, Gastroenterological, Gynaecological |
| Indication: | Misoprostol is used to prevent ulcers in people who take certain arthritis or pain medicines, including aspirin, that can cause ulcers. |
| Storage: | Store below 25°C. Protect from Light. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Misoprostol Tablets IP 25mcg
- Misoprostol Tablets IP 100mcg
- Misoprostol Tablets IP 200mcg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Misoprostol Tablets IP 25mcg
Each uncoated tablet contains:
Misoprostol…………………….25mcg
(As 1% HPMC Dispersion)
Excipients………………………..q.s.
- Misoprostol Tablets IP 100mcg
Each uncoated tablet contains:
Misoprostol…………………….100mcg
(As 1% HPMC Dispersion)
Excipients………………………..q.s.
- Misoprostol Tablets IP 200mcg
Each uncoated tablet contains:
Misoprostol…………………….200mcg
(As 1% HPMC Dispersion)
Excipients………………………..q.s.
THERAPEUTIC INDICATIONS:
Misoprostol is used to prevent stomach ulcers while you take NSAIDs (such as aspirin, ibuprofen, naproxen), especially if you are at risk for developing ulcers or have a history of ulcers. Misoprostol helps to decrease your risk of serious ulcer complications such as bleeding.
CAUTION & SCHEDULE:
CAUTION: Read enclosed leaflet before use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
DO NOT TAKE IT IF YOU ARE PREGNANT AND DO NOT BECOME PREGNANT WHILE TAKING THIS MEDICINE BECAUSE IT CAN CAUSE MISCARRIAGE OR OTHER SERIOUS COMPLICATIONS.
NOT FOR USE IN WOMEN OF CHILD BEARING POTENTIAL UNLESS AT HIGH RISK FROM NSAID THERAPY.
SCHEDULE: SCHEDULE H: TO BE SOLD BY RETAIL ON THE PRESCRIPTION OF A GYNAECOLOGIST ONLY.
STORAGE & DOSAGE:
Storage: Store below 25°C. Protect from Light and moisture.
Dosage: As directed by the Physician
GENERIC NAME OF THE MEDICINAL PRODUCT:
B) Misoprostol Tablets IP 100mcg
C) Misoprostol Tablets IP 200mcg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each uncoated tablet contains:
Misoprostol…………………….25mcg
(As 1% HPMC Dispersion)
Excipients………………………..q.s.
B) Misoprostol Tablets IP 100mcg
Each uncoated tablet contains:
Misoprostol…………………….100mcg
(As 1% HPMC Dispersion)
Excipients………………………..q.s.
C) Misoprostol Tablets IP 200mcg
Each uncoated tablet contains:
Misoprostol…………………….200mcg
(As 1% HPMC Dispersion)
Excipients………………………..q.s.
THERAPEUTIC INDICATIONS:
CAUTION & SCHEDULE:
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
DO NOT TAKE IF YOU ARE PREGNANT AND DONOT BECOME PREGNANT WHILE TAKING THIS MEDICINE BECAUSE IT CAN CAUSE MISCARRIAGE OR OTHER SERIOUS COMPLICATIONS.
NOT FOR USE IN WOMEN OF CHILD BEARING POTENTIAL UNLESS AT HIGH RISK FROM NSAID THERAPY.
SCHEDULE: SCHEDULE H: TO BE SOLD BY RETAIL ON THE PRESCRIPTION OF A GYNAECOLOGIST ONLY.
STORAGE & DOSAGE:
Dosage: As directed by the Physician

