Revision Year: 2018 Publisher: Bial –Portela & Ca SA, A Av da Siderurgia Nacional, 4745 – 457, S. Mamede do Coronado, Portugal
Hypersensitivity to the folic acid or iron or to any of the excipients.
Iron overload (e.g. haemochromatosis, haemosiderosis).
Patients who have undergone repeated blood transfusions.
Megaloblastic anaemia due to vitamin B12 deficiency.
Concomitant iron parenteral therapy.
FOLIFER contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. The possibility of developing hypersensitivity reactions to folic acid exists, but is rare.
Due to the risk of mouth ulcerations and tooth discolouration, tablets should not be sucked, chewed or kept in the mouth, but swallowed whole with water.
Use cautiously in case of acute gastrointestinal pathologies.
This combination shall not be used to prevent neural tube defects in women who are planning to become pregnant. Furthermore, it shall not be used in the treatment of megaloblastic anemia: in case of folic acid deficiency the low doses of this micronutrient in the association are not sufficient for its treatment; in case of pernicious anemia the folic acid in FOLIFER may obscure the diagnosis by alleviating haematological manifestations while allowing neurologic complications of Vitamin B12 deficiency to progress.
Stools commonly become dark green or black when iron preparations are taken orally. This is caused by the presence of unabsorbed iron and is harmless.
Tetracyclines: Iron sulfate may interfere with absorption of tetracyclines from the GI and viceversa. Therefore these drugs should be taken within a 2-3 hours interval.
Quinolones: Ferrous sulfate also interferes with quinolones absorption (ciprofloxacin, norfloxacin, ofloxacin), resulting in decreased serum and urine concentration of these antimicrobial agents. Therefore these drugs should be administered within 2 hours interval.
Thyroxine: Signs of hypothyroidism may be observed in patients receiving thyroxine (ferrous sulfate and thyroxine form an insoluble complex, resulting in decreased absorption of thyroxine).
Penicillamine: Iron also reduces the cupruretic effect of penicillamine, probably by decreasing its absorption. Therefore 2 hours should elapse between administration of penicillamine and iron.
Antacids: Concurrent administration of antacids decreases iron absorption.
Chloramphenicol: Response to iron therapy may be delayed in patients receiving chloramphenicol. The concurrent administration of folic acid and chloramphenicol in folatedeficient patients may result in antagonism of the hematopoietic response to folic acid.
Ascorbic acid: Ascorbic acid increases iron absorption.
Phenytoin: In epileptic patients undergoing therapy with phenythoin, medicines containing folic acid may increase phenytoine metabolism, reduce its serum concentrations and increase seizure frequency.
Methyldopa: Iron sulfate decreases absorption, affects metabolism of methyldopa, and can reduce its hypotensive effect.
Many foods and vitamin supplements may reduce iron absorption: tea, coffee, milk, cereals, calcium supplements and medicines containing bicarbonate, carbonate, oxalates or phosphates.
Use of the combination of ferrous sulfate and folic acid during pregnancy and lactation is recommended. Deficiency of both nutrients is very common in such situations, and it is therefore, indicated to use FOLIFER as prevention.
FOLIFER has no or negligible influence on the ability to drive and use machines.
Very common (>1/10); Common (>1/100, <1/10); Uncommon (>1/1,000, <1/100); Rare (>1/10,000, <1/1,000); Very rare (<1/10,000), including isolated reports; Not known (cannot be estimated from the available data).
Common: abdominal pain, heartburn, nausea, vomiting, constipation or diarrhoea (iron intake related). Dark stools (iron excretion related).
Not known: mouth ulceration (in the context of incorrect administration, when the tablets are chewed, sucked or kept in mouth). Elderly patients and patients with deglutition disorders may also be at risk of oesophageal lesions or of bronchial necrosis, in case of false route.
Rare: Allergic reactions, specifically bronchospasm, erythema, skin rash or itching.
Not known: Anaphylactic reaction.
Not applicable.
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