METHOTREXATE Tablets Ref.[6981] Active ingredients: Methotrexate

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

Product name and form

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.

Qualitative and quantitative composition

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
Lactose monohydrate
Sodium starch glycolate
Microcrystalline cellulose
Talc
Magnesium stearate

Pack sizes and marketing

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.

Marketing authorization holder

Cipla (EU) Limited, Dixcart House, Addlestone Road, Bourne Business Park, Addlestone, Surrey, KT15 2LE, United Kingdom

Marketing authorization dates and numbers

PL 36390/0174

23-Jan-15

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