QUALITATIVE AND QUANTITATIVE COMPOSITION
10 vials 15 ml 800 rng Each vial contains: - Iron Protein Acetyl Aspartate 800 rng.
(equal to Fe+++40 mg.)
PHARMACEUTICAL FORM Oral solution.
CLINICAL INFORMATION
Therapeutic indications Absolute and relative iron shortage conditions: latent or clear hypoferremia, in infants and adults, due to an iron supply or
absorption deficiency or due to increased requirement consequent on acute and chronic haemorrhaging, infective illnesses, pregnancy and lactation.
Posology and method of administration
Adults: 1-2 vials per day (equal to 40-80 rng of Fe+++),
according to the doctor's advice, subdivided into 2 doses, preferably before meals.
Children: Take 1.5 rnl/Kg/die from the vial (equal to 4 mg/Kg of Fe+++) per day, according to the doctor's advice, subdivided into 2 doses, preferably before meals. We advise against exceeding the daily dose of two vials (80 mg).
Contraindications Hypersensitivity to one of the product components. Haemosiderosis, haemachromatosis. Aplastic,
Special warnings and special precautions for use No special warnings are necessary as the
preparation does not give rise to addiction or dependency risks. The product should not be taken for longer than 6 months, except in cases of continuous haemorrhage, menorrhagia or pregnancy It may interfere with laboratory tests to find hidden blood in faeces. Keep the medicine out of the reach of children. Before starting therapy, establish the nature of the anaemia. The product contains 14 g of sorbitol. When taken at the recommended dosage, each dose supplies up to 1.4 g of sorbitol. Not recommended in cases of hereditary intolerance to fructose. It may cause stomach upsets and diarrhoea. It may cause urticaria. Generally it may cause delayed reactions such as contact dermatitis. Rare immediate 4.4. Special warnings and special precautions for use No special warnings are necessary as the
preparation does not give rise to addiction or dependency risks. The product should not be taken for longer than 6 months, except in cases of continuous haemorrhage, menorrhagia or pregnancy It may interfere with laboratory tests to find hidden blood in faeces. Keep the medicine out of the reach of children. Before starting therapy, establish the nature of the anaemia. The product contains 14 g of sorbitol. When taken at the recommended dosage, each dose supplies up to 1.4 g of sorbitol. Not recommended in cases of hereditary intolerance to fructose. It may cause stomach upsets and diarrhoea. It may cause urticaria. Generally it may cause delayed reactions such as contact dermatitis. Rare immediate reactions with urticaria and bronchospasm.
Interaction with other medicinal products and other forms of interaction Iron derivatives may
reduce tetracycline absorption.
Pregnancy and lactation The use of PROFER
is recommended in iron shortage conditions that
may occur during pregnancy and lactation
Effects on ability to drive and use machines The product has no influence on the ability to drive and use machines.
Undesirable effects Transitory, undesirable disturbances may occasionally occur at too high
doses.
Overdose In the case of the ingestion of massiveSpecial warnings and special precautions for use No special warnings are necessary as the
preparation does not give rise to addiction or dependency risks. The product should not be taken for longer than 6 months, except in cases of continuous haemorrhage, menorrhagia or pregnancy It may interfere with laboratory tests to find hidden blood in faeces. Keep the medicine out of the reach of children. Before starting therapy, establish the nature of the anaemia. The product contains 14 g of sorbitol. When taken at the recommended dosage, each dose supplies up to 1.4 g of sorbitol. Not recommended in cases of hereditary intolerance to fructose. It may cause stomach upsets and diarrhoea. It may cause urticaria. Generally it may cause delayed reactions such as contact dermatitis. Rare immediate reactions with urticaria and bronchospasm.
Interaction with other medicinal products and other forms of interaction Iron derivatives may
reduce tetracycline absorption.
Pregnancy and lactation The use of PROFER
is recommended in iron shortage conditions that
may occur during pregnancy and lactation
Effects on ability to drive and use machines The product has no influence on the ability to drive and use machines.
Undesirable effects Transitory, undesirable disturbances may occasionally occur at too high
doses.
Overdose In the case of the ingestion of massive
doses of iron salts, the patient demonstrates epigastralgia, nausea, diarrhoea and haematemesis, often associated with sleepiness, pallor, cyanosis, shock and even a coma. The treatment must be performed as swiftly as possible and consists of administering an emetic, possibly followed by gastrolavage and in practising a suitable support therapy.
PHARMACOLOGICAL PROPERTIES
Pharmacodynamic properties Pharmacotherapeutc group: PROFER is an iron-protein antianaemic product containing 5% of tri-valent iron. The complex is comprised of a milk protein to which the iron is
bound by an aspartic acid interface, an amino acid that constitutes 10% of human ferritin. The preparation frees the iron at the intestinal level, for absorption. The iron therefore remains protected from the chloride-peptic action of gastric juices by its protein casing and does not cause harmful action on gastric mucus, a common characteristic of the majority of the salts of this metal Pharmacodynamic effects: The therapy of clear or sub-clinical forms (infancy, geriatrics) must be continued for at least 2 months after the normalisation of haemoglobin values, because iron reserves are reconstituted more slowly-Good local and systemic product tolerability permits long duration treatment during pregnancy.
Pharmacokinetic properties In the event of hypoferremia, or of increased requirement, the product proves to be absorbed well and supplies considerably large increases in sideremia in a short period of time. In doing so, it never arrives at thresholds incompatible with normal homeostasis, even at high doses. Food does not influence iron absorption.
PHARMACEUTICAL PARTICULARS
List of excipients Sorbitol, dihydroxypropane,
Methyl p-hydroxybenzoate, Propyl p-hydroxybenzoate, Natural aromas, Purified water.
Incompatibilities Incompatible with strong alkalis and acids and reducing substances.
Shelf life In unopened packaging: 2 years.
Special precautions for storage No special precautions for storage.
Nature and contents of container Glass vials containing 15 ml of oral solution
Instructions for use and handling and disposal Any unused product or waste material should be
disposed of in accordance with local requirementes.
MARKETING AUTHORISATION HOLDER
AESCULAPIUS FARMACEUTICI S.r.l.-Via Cozzaglio, 24-25125 BRESCIA