Presentation

1 flacon de 200 mL de solution buvable dosée à 100 mg de fer (polysaccharate ferrique) par 5 mL, pour prévenir les carences et soigner l'anémie ferriprive dès la naissance.

Information

Product details & mandatory information:

Benefits

Iron is a trace element essential to the functioning of the body. It is a component of haemoglobin, the red blood cell protein that carries oxygen from the lungs to all tissues, and it takes part in the formation of red blood cells. When iron stores become depleted, haemoglobin production decreases: this is iron-deficiency anaemia, which often shows as fatigue, pallor and shortness of breath on exertion.

Ferricure provides iron as a ferric polysaccharide complex, a form with a high ferric content (about 46 %) designed to gradually rebuild the body's stores and to correct or prevent iron deficiency.

Why choose Ferricure 100 mg/5 mL oral solution?

Each 5 mL dose delivers 100 mg of elemental iron (Fe³⁺) as a ferric polysaccharide complex (217.4 mg), a form that is well tolerated by the digestive system and highly concentrated in iron compared with conventional ferrous salts.

The liquid form allows precise, adjustable dosing at every stage of life: it is indicated from birth, including in premature infants, as well as in children under 12 years of age, for whom the capsules are not suitable. The bottle is fitted with a dropper (1 mL = 40 drops) and comes with a CE-marked graduated measuring cup, for easy administration, including in people who have difficulty swallowing.

Ferricure is a medicinal product holding a Marketing Authorisation (MA No. BE098926), manufactured by Laboratoires Pharmaceutiques Trenker in accordance with pharmaceutical Good Manufacturing Practices.

What does the science say?

Iron has recognised physiological roles and functions approved by the European Food Safety Authority (EFSA):

·      iron contributes to normal formation of red blood cells and haemoglobin;

·      iron contributes to normal oxygen transport in the body;

·      iron contributes to the reduction of tiredness and fatigue;

·      iron contributes to the normal function of the immune system.

As Ferricure is a medicinal product, its use relates to the prevention and treatment of diagnosed iron-deficiency anaemia. When iron-deficiency anaemia is confirmed, its underlying cause should also be investigated and treated.

Composition per 5 mL of solution

Equivalent to 20 mg of elemental iron per mL of solution (1 mL = 40 drops).

Ingredients:

Ferric polysaccharide complex (equivalent to 100 mg of Fe³⁺ per 5 mL), sorbitol (E 420), ethanol, sucrose, purified water, hydrochloric acid (for pH adjustment).

Excipients with known effect: ethanol (10 % vol, i.e. 420 mg per 5 mL), sorbitol (2.1 g per 5 mL) and sucrose (0.03 g per 5 mL). To be taken into account in particular in children, pregnant or breastfeeding women, in case of liver disease or epilepsy, and in case of intolerance to some sugars.

Recommended daily dose:

Shake the bottle before use.

Usual dosage for adults: 7.5 mL per day (i.e. 150 mg of iron). If needed, the dosage may be increased to 10 to 15 mL per day, split over 2 or 3 intakes of 5 mL respectively.

Children from 0 to 2 years: 2 drops per kg of body weight, 3 times a day. Children from 2 to 6 years: 50 drops, twice a day. Children from 6 to 12 years: 2.5 mL, twice a day.

Pregnant women: doses of 40 to 100 mg of iron per day (i.e. 2 to 5 mL) are recognised as effective in preventing deficiency. Breastfeeding women: 10 mg of iron per day (i.e. 0.5 mL, that is 20 drops).

Storage and usage advice:

·      Prescription-only medicine: to be used in accordance with your doctor's advice.

·      Do not exceed the recommended dose.

·      Shake the bottle before each use; administer with the dropper or the measuring cup provided.

·      Calcium-rich foods and dairy products reduce iron absorption: take away from meals and dairy products.

·      Do not combine with other iron-based medicines; leave at least 2 hours between Ferricure and certain medicines (antibiotics, thyroid treatments, antacids, etc.).

·      Inform your doctor and/or pharmacist in case of simultaneous use of medicines.

·      In case of accidental aspiration (solution entering the airways), seek medical advice as soon as possible.

·      Keep out of the sight and reach of children.

·      Store in the original packaging, protected from light and moisture, at a temperature not exceeding 25 °C.

·      After first opening of the bottle, the solution keeps for 3 months.

Regulatory information:

Dispensing status: prescription-only medicine.

MA number: BE098926.

Quantity:

200 mL (amber glass bottle fitted with a dropper, with graduated measuring cup)

Manufacturer information:

LABORATOIRES PHARMACEUTIQUES TRENKER

AVENUE THOMAS EDISON, 32

1402 THINES

BELGIUM