CYCLOPHOSPHAMIDE Coated Tablet

Active ingredients: Cyclophosphamide

Product name and form

Cyclophosphamide Tablets 50 mg.

Pharmaceutical Form

Coated Tablet.

White round biconvex sugar coated tablets with a white core.

Qualitative and quantitative composition

Each tablet contains cyclophosphamide monohydrate equivalent to 50 mg anhydrous cyclophosphamide.

Active Ingredient
Description

Cyclophosphamide has been demonstrated to have a cytostatic effect in many tumour types. The active metabolites of cyclophosphamide are alkylating agents which transfer alkyl groups to DNA during the process of cell division, thus preventing normal synthesis of DNA.

List of Excipients

Tablet:

Maize starch
Lactose monohydrate
Calcium hydrogen phosphate dihydrate
Talc
Magnesium stearate
Gelatine
Glycerol (85%)

Coating:

Sucrose
Titanium dioxide
Calcium carbonate
Talc
Macrogol 35000
Silica colloidal anhydrous
Povidone
Sodium carboxymethylcellulose
Polysorbate 20
Montan glycol wax

Pack sizes and marketing

10 tablets in a PVC/aluminium blister strip and 10 blister strips in a box.

Marketing authorization holder

Baxter Healthcare Ltd, Caxton Way, Thetford, Norfolk, IP24 3SE, United Kingdom

Marketing authorization dates and numbers

PL 00116/0389

9 January 2004