BENFER

oral drops, solution

Iron polymaltose

COMPOSITION

1 ml contains: 178.5 mg iron polymaltose complex corresponding to 50 mg Fe (III).

Excipients: sucrose, methyl p-hydroxybenzoate (E218), propyl p-hydroxybenzoate (E216), lemon essential oil, ethanol, polysorbate 80 (E433), purified water.

PHARMACEUTICAL FORM AND PACKAGE CONTENTS

Oral drops, solution. 30 ml vial.

One drop contains: 2.5 mg Fe (III).

1 ml oral drops, solutioncontains: Active principle: 178.5 mg iron polymaltose complex corresponding to 50 mg Fe (III).

A 30 ml vial contains 600 mg Fe (III).

PHARMACOTHERAPEUTIC CATEGORY

Antianemics–Iron based preparations.

MARKETING AUTHORIZATION HOLDER

Lab. It. Biochim. Farm.co LISAPHARMA S.p.A.

Via Licino, 11 – 22036 ERBA (CO)

MANUFACTURER AND FINAL CONTROLLER

Francia Farmaceutici - Industria Farmaco Biologica S.r.l.

Via dei Pestagalli, 7 - 20138 MILAN

THERAPEUTIC INDICATIONS

Treatment of latent or manifest iron deficiency conditions.

In particular: iron deficiency anemia or increased iron requirement, especially during pregnancy and lactation, in premature babies, neonates, infants and after hemorrhages.

CONTRAINDICATIONS:

Hypersensitivity to the active principle or to any of the excipients.

Hemosiderosis, hemochromatosis. Aplastic, hemolytic, sideroachrestic anemia.

Chronic pancreatitis. Liver cirrhosis.

PRECAUTIONS FOR USE:

Iron supplementation at larger doses than 400 mg (8 ml) can be toxic, especially for children.          

INTERACTIONS:

Iron derivates may reduce the absorption of tetracyclines, calcium salts, bisphosphonates, fluoroquinolones, penicillamines and of gastrointestinal protectors (magnesium, aluminum and calcium salts, oxides, and hydroxides) and therefore should not be administered contextually with these drugs.

SPECIAL WARNINGS:

Concomitant iron injections should be avoided.

Stool may become dark, this however has no clinical relevance.

This medicinal product contains small quantities of ethanol (alcohol), accounting for less than 20 mg/maximum dose.

BENFER may cause allergic reactions, even belatedly.

If your doctor has told you that you are intolerant to some sugars, you must contact him/her before taking this product. The product can be harmful for the teeth.

The drug contains traces of heavy metals, such as lead; therefore it should not be taken for long periods of time, unless prescribed by a doctor.

POSOLOGY AND METHOD OF ADMINISTRATION

Unless otherwise prescribed by the treating physician:

Adults: 40 drops once or twice daily (100-200 mg), independently of meals.

Premature babies: 1 drop (2.5 mg) per kg/die.

Infants under 1 year of age: Treatment should start with 5 drops and gradually increase to 20 drops/die fractionated during the day.

Children 1 to 12 years old: 20 drops once or twice daily (50-100 mg).

Children over 12 years of age: 20 drops twice daily (100 mg).

UNDESIRABLE EFFECTS

Occasionally, especially at excessively high doses, gastrointestinal disorders may occur, such as bloating, abdominal tension, nausea, constipation, and diarrhea. These side effects are reversible upon treatment suspension or dose reduction.

Conformity to the instructions contained in the package leaflet reduces the risk of undesired effects.

It is important that you inform your doctor or pharmacist of any undesired effects, even if not described in this leaflet.

OVERDOSE

Accidental overdosing is fatal for children. It is therefore indispensable to keep the drug out of the reach and sight of children.

In case of accidental overdosing, the patient should be taken to a hospital for the necessary emergency treatment.

SHELF-LIFE AND STORAGE

Do not store above +25°C.

Do not refrigerate or freeze.

Shelf-life: 3 years if the product is correctly stored in its intact package.

After the first opening of the container, the product must be used within 21 days (3 weeks).

Keep out of reach and sight of children.

DATE OF THE LAST REVISION OF THE PACKAGE LEAFLET BY THE ITALIAN DRUGS AGENCY

5 April 2012

CONTAINER AND INSTRUCTIONS FOR USE

30 ml dark glass vial with dispensing valve and tamper-proof, child-proof cap.

Instructions for the opening of the vial: in order to open the vial push firmly down on the cap and twist it anticlockwise.