REFOLINON Tablet Ref.[51174] Active ingredients: Calcium folinate

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2016  Publisher: Pfizer Ltd, Ramsgate Road, Sandwich, Kent, CT13 9NJ

Product name and form

Refolinon 15mg tablets.

Pharmaceutical Form

Tablet.

Light yellow, round, flat, scored, uncoated tablet marked with ‘CF’ on the scored side.

Qualitative and quantitative composition

Each tablet contains 15mg of leucovorin (folinic acid).

Excipients with known effect: Lactose.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Calcium folinate

Calcium folinate is an active metabolite of folinic acid and essential coenzyme for nucleic acid synthesis in cytotoxic therapy. Calcium folinate is frequently used to diminish the toxicity and counteract the action of folate antagonists, such as methotrexate.

List of Excipients

Microcrystalline cellulose NF
Magnesium stearate Ph. Eur
Lactose Ph. Eur

Pack sizes and marketing

The tablets are contained in white high density polyethylene containers with polyethylene screw closures. The bottles contain 30 or 100 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Pfizer Ltd, Ramsgate Road, Sandwich, Kent, CT13 9NJ

Marketing authorization dates and numbers

PL 00057/1040

02/12/2005

Drugs

Drug Countries
REFOLINON United Kingdom

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