FOLIFER Film-coated tablet Ref.[28305] Active ingredients: Ferrous sulfate Folic acid

Revision Year: 2018  Publisher: Bial โ€“Portela & Ca SA, A Av da Siderurgia Nacional, 4745 โ€“ 457, S. Mamede do Coronado, Portugal

Product name and form

FOLIFER, 1 mg + 90 mg, film coated tablet.

Pharmaceutical Form

Film-coated tablet.

Salmon, circular and biconvex film-coated tablets, engraved “Bial” on one side and “FF” on the other.

Qualitative and quantitative composition

Each film-coated tablet contains:

Folic acid 1 mg and Iron (as ferrous sulfate) 90 mg.

Excipient(s): Lactose mono-hydrate: 373 mg.

For a full list of excipients, see section 6.1.

Active Ingredient Description
Ferrous sulfate

Iron sulphate is a co-factor of various enzymes necessary for the transfer of energy (eg. cytochrome oxidase, xanthine oxidase). Iron is also present in hemoglobin and myoglobin, which are essential for the transport and use of oxygen.

Folic acid

Folic acid is a member of the vitamin B group which is reduced in the body to tetrahydrofolate, a co-enzyme active in several metabolic processes and produces a haemopoietic response in nutritional megaloblastic anaemias. Folic acid is rapidly absorbed and widely distributed in body tissues.

List of Excipients

Maize starch
Lactose mono-hydrate
Povidone
Talc
Citric acid anhydrous
Magnesium stearate
Eudragit RLPO
Opadry OY-S-33019

Pack sizes and marketing

Blister Alu/Alu. Each pack contains 20 or 60 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Bial –Portela & Ca SA, A Av da Siderurgia Nacional, 4745 – 457, S. Mamede do Coronado, Portugal

Marketing authorization dates and numbers

MA004/00301

Date of first authorisation: 30th April 2007

Drugs

Drug Countries
FOLIFER Brazil, Cyprus, Hong Kong, Malta

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