Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Cipla (EU) Limited, Dixcart House, Addlestone Road, Bourne Business Park, Addlestone, Surrey, KT15 2LE, United Kingdom
Methotrexate 2.5 mg Tablets.
| Pharmaceutical Form |
|---|
|
Tablet. Methotrexate 2.5 mg tablet: Yellow, circular, biconvex uncoated tablets with dimension of 4.50 mm ± 0.20 mm plain on both sides. |
Methotrexate 2.5 mg tablet.
Each tablet contains methotrexate 2.5 mg.
Excipients with known effects: Each tablet contains 12.50 mg lactose (as lactose monohydrate).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Methotrexate |
Methotrexate (4-amino-10-methylfolic acid) is a folic acid antagonist which inhibits the reduction of folic acid and increase of tissue cells. Methotrexate enters the cell through an active transport mechanism of reduced folates. As a result of polyglutamation of methotrexate caused by the folylpolyglutamylate enzyme, the duration of the cytotoxic effect of the drug substance in the cell increases. |
| List of Excipients |
|---|
|
Anhydrous calcium hydrogen phosphate |
2.5 mg tablets:
White high density polyethylene container with non CRC high density polyethylene cap with induction wad.
Pack size: 25 or 100 tablets.
Amber colour Polyvinylchloride (PVC)/Plain Aluminium blister foil.
Pack size: 10, 24, 25, 28 30, 50 or 100 tablets.
Not all pack sizes may be marketed.
Cipla (EU) Limited, Dixcart House, Addlestone Road, Bourne Business Park, Addlestone, Surrey, KT15 2LE, United Kingdom
PL 36390/0174
23-Jan-15
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