OLIMELT 10 MG TAB

1. Specifications
Brand Name: Olinmet-10®
Product Name: Olanzapine Mouth Melt Tablets 10 mg
Generic Name: Olanzapine
Strength: 10 mg per tablet
Dosage Form: Mouth Melt Tablet (Orally Disintegrating Tablet)
Route of Administration: Oral
Product Category: Prescription Pharmaceutical Medicine
Active Ingredient: Olanzapine IP
Tablet Type: Uncoated Mouth Melt Tablet
Schedule Classification: Schedule H Prescription Drug
Storage Condition: Store in a cool and dry place.
Protection Instructions: Protect from light.
Pack Size: 10 tablets per strip
Manufacturing Licence Number: M51709
Batch Number: K401830
Manufacturing Date: September 2024 (09/2024)
Expiry Date: August 2027 (08/2027)
Maximum Retail Price (MRP): ₹341.59 per 10 tablets (inclusive of all taxes)
Country of Origin: India
2. General Information
Brand: Olinmet-10®
Name: Olanzapine Mouth Melt Tablets 10 mg
Generic Composition: Olanzapine IP
Strength: 10 mg
Quantity: 10 tablets per blister strip
Type: Prescription medication
Form Factor: Mouth melt / orally disintegrating tablet
Administration Method: Oral
Maximum Shelf Life: Approximately 35 months (from September 2024 to August 2027)
Food Preference: Not applicable. This is a pharmaceutical medicine and not a food product.
FSSAI Number: Not applicable and not mentioned on the package because FSSAI registration generally applies to food products and dietary supplements rather than prescription medicines.
3. Product Details (Ingredients)
Active Ingredient
Olanzapine IP – 10 mg
Excipients
Pharmaceutical excipients – Quantity sufficient (Q.S.)
Composition Statement
Each uncoated mouth melt tablet contains:
Olanzapine IP – 10 mg
Excipients – Q.S.
Colour Information
Colouring agents are not clearly visible on the uploaded package image and therefore cannot be accurately confirmed from the available information.
4. Directions for Use
Use only under the guidance of a psychiatrist or healthcare professional.
Place the mouth melt tablet on the tongue and allow it to dissolve naturally.
After disintegration, swallow with saliva; water may be taken if desired.
Follow the dosage schedule prescribed by the treating physician.
Do not exceed the recommended dose.
Do not stop or alter treatment without consulting your doctor.
Keep the medicine in its original blister packaging until administration.
Store in a cool and dry place away from excessive heat and moisture.
Protect the product from direct light exposure.
Keep out of reach of children.
Dosage
As directed by the Psychiatrist.
5. Product Description
Olinmet-10® is an orally disintegrating tablet formulation containing 10 mg of Olanzapine IP.
The mouth melt technology enables the tablet to dissolve rapidly in the mouth, providing ease of administration and convenience.
Each tablet contains a precisely measured amount of Olanzapine along with pharmaceutical excipients required for stability, consistency, and tablet performance.
The formulation is supplied in blister packaging designed to help protect the tablets from environmental factors and maintain product quality throughout the shelf life.
The packaging prominently displays regulatory information, storage instructions, dosage guidance, manufacturing details, and the Schedule H prescription warning.
The product is intended strictly for prescription use and should only be dispensed against a valid prescription from a qualified medical practitioner.
6. Schedule H Prescription Warning
SCHEDULE H PRESCRIPTION DRUG – CAUTION
Not to be sold by retail without the prescription of a Psychiatrist.
Use only under medical supervision.
Self-medication is not recommended.
7. Storage Instructions
Store in a cool and dry place.
Protect from light.
Keep tablets in the original blister pack until use.
Do not use after the expiry date printed on the package.
Keep out of reach of children.
8. Manufacturer Information
Manufactured By:
Intas Pharmaceuticals Ltd.
Bagheykhola, Majhitar
Sikkim – 737136
India
Phone: +91 266 5881012
Manufacturing Licence Number:
M51709
9. Marketed By
Marketed By:
Intas Pharmaceuticals Ltd.
Ahmedabad, Gujarat, India
10. Pack Information Summary
Brand: Olinmet-10®
Product Name: Olanzapine Mouth Melt Tablets
Generic Name: Olanzapine
Strength: 10 mg
Dosage Form: Uncoated Mouth Melt Tablet
Active Ingredient: Olanzapine IP 10 mg
Quantity: 10 Tablets.
Batch Number: K401830
Manufacturing Date: 09/2024
Expiry Date: 08/2027
Shelf Life: Approximately 35 Months
MRP: ₹341.59 per 10 Tablets (inclusive of all taxes)
Storage: Store in a cool and dry place and protect from light
Prescription Category: Schedule H Prescription Drug
Manufacturer: Intas Pharmaceuticals Ltd., Majhitar, Sikkim, India
Marketed By: Intas Pharmaceuticals Ltd., Ahmedabad, India