FERRUM HAUSMANN Oral drops, 30 ml

Name of the drug

Ferrum Hausmann® 50 mg iron/ml oral drops, solution

Active ingredient and other ingredients

1 ml (approx. 20 drops) solution contains: 172.4 - 200 mg iron (III) hydroxide polymaltose complex (IPC) (equivalent to 50 mg iron).For a complete list of other ingredients, see the “List of Other Ingredients” section".

Areas of application

Ferrum Hausmann® is used to treat iron deficiency anemia in children and adults.Iron is an essential building block of hemoglobin, myoglobin and iron-containing enzymes.An iron deficiency can lead to tiredness, reduced performance, irritability, headaches, loss of appetite, weakened immune system, paleness, dry skin, brittle hair and nails and a reluctance to play in children.It is particularly important to treat iron deficiency in young children up to 1 year old, as iron deficiency at this age can cause impairment of brain functions.

Dosage and method of administration

The duration of treatment depends on the iron requirement and the severity of the iron deficiency and should be determined by the doctor.Ferrum Hausmann® should be taken for at least 3 months to correct iron deficiency anemia.Hemoglobin (Hb) and iron parameters should be monitored during treatment.

Adults (from 18 years of age): 40 - 80 drops (100 - 200 mg iron) per day.

Children and adolescents up to the age of 18: The dosage information is based on a dosage of 3 mg iron/kg body weight per day.The maximum permissible dose for children is 5 mg iron per kg body weight and should not be exceeded.

Infants and young children: 10 to 20 drops (25 to 50 mg iron) per day, divided into 1-2 single doses.

Children (15 - 30 kg): 20 - 40 drops daily (50 - 100 mg iron daily).

Children and adolescents (> 30 kg): 40 - 80 drops daily (100 - 200 mg iron daily).

Use in older patients: Clinical experience with Ferrum Hausmann® in this age group is limited.

Use in persons with renal and hepatic impairment: Clinical experience with Ferrum Hausmann® in these patients is limited.

Ferrum Hausmann® should be taken with or directly after meals.It can be mixed with fruit and vegetable juices or with baby food or formula.The slight discoloration of the mixture does not affect the taste of the juices/baby food or the effectiveness of Ferrum Hausmann®.To ensure precise dosage of the Ferrum Hausmann® drops, the bottle must be held vertically.Drip flow should begin immediately.Otherwise, gently tap the bottle until a drop forms.Do not shake the bottle.

Contraindications

Ferrum Hausmann® must not be used in cases of known hypersensitivity to iron (III) hydroxide-polymaltose complex or one of the other ingredients mentioned in section 6.1, in cases of iron overload such as hemochromatosis, hemosiderosis, in cases of iron utilization disorders such as anemia due to lead poisoning, sideroachrestic anemia, thalassemia as well as in anemias that are not caused by iron deficiency, such as hemolytic anemia or megaloblastic anemia due to aVitamin B12 deficiency.

Special warnings and precautions for use

Infections or tumors can cause anemia.Since iron can only be used after the primary disease has been resolved, a benefit-risk assessment is recommended.Darkening of the faeces may occur during treatment with Ferrum Hausmann®, but this has no clinical relevance.Iron overload or intoxication with Ferrum Hausmann® is unlikely due to the low toxicity of IPC.

The other ingredients sodium methyl 4-hydroxybenzoate (E219) and sodium propyl 4-hydroxybenzoate (E217) can cause allergic reactions, which may only occur with a delay.

Ferrum Hausmann® contains sucrose.Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not use this medicine.Sucrose can be harmful to teeth.

Note for diabetics: 1 ml solution contains 50 mg sucrose (corresponds to a total of 0.01 bread units (BU)).

Interactions with other drugs and other interactions

There are no interactions of IPC with tetracycline or other phenolic compounds as well as aluminum hydroxide.There are no interactions with food components.The hemoccult test (selective for Hb) for detecting occult blood is not interfered with;The therapy therefore does not have to be interrupted. Concomitant administration of parenteral and oral iron is not recommended as it would inhibit the absorption of oral iron.

Fertility, pregnancy and breastfeeding

Pregnancy: There are no data from clinical studies on the use of Ferrum Hausmann® in pregnant women during the first trimester.Very limited experience (less than 300 pregnancy outcomes) with the use of Ferrum Hausmann® in pregnant women after the first trimester showed no adverse effects of Ferrum Hausmann® on mothers and/or newborns.Therefore, administration of Ferrum Hausmann® is unlikely to have a negative impact on the fetus.Animal studies did not provide any evidence of direct or indirect adverse health effects related to reproductive toxicity.For reasons of caution, women of childbearing age and women during pregnancy should only use Ferrum Hausmann® after consulting a doctor.A benefit-risk assessment is recommended.

Breastfeeding: Human breast milk naturally contains iron bound to lactoferrin.It is not known how much iron from IPC passes into breast milk.Administration of Ferrum Hausmann® to breast-feeding women is unlikely to cause adverse effects in the infant.As a precautionary measure, women who are breastfeeding should only use Ferrum Hausmann® after consulting a doctor.A benefit-risk assessment is recommended.

Fertility: No effects on fertility were observed in animal fertility studies with IPC.

Effects on the ability to drive and use machines

No relevant studies have been conducted.Ferrum Hausmann® solution is unlikely to have any effect on the ability to drive or use machines.

Side effects

The main adverse drug reactions reported in clinical trials occurred in the following system organ classes: gastrointestinal disorders (very common: faecal discoloration; common: diarrhea, nausea, dyspepsia; uncommon: vomiting, constipation, abdominal pain, tooth discoloration), skin and subcutaneous tissue disorders (uncommon: rash, pruritus), nervous system disorders (uncommon: headache).

Overdose

In the event of an overdose, iron overload or intoxication with Ferrum Hausmann® is unlikely due to the low toxicity of IPC and the controlled absorption of iron.There are no reports of accidental poisonings with fatal outcomes.

Pharmaceutical information

List of other ingredients

Purified water, sucrose, sodium methyl 4-hydroxybenzoate (Ph. Eur.) (E219), sodium propyl 4-hydroxybenzoate (Ph. Eur.) (E217), cream flavor, sodium hydroxide.

Duration of shelf life

3 Years.Shelf life after opening: 2 months.

Special precautions for storage

Do not store above 25°C.

Type and contents of the container

Oral drops, solution, N 1 pack with 1 dropper bottle of 30 ml.

Non-prescription notice

No prescription is required for this product.