Ferrum Hausmann

Ferrum Hausmann

iron polymaltose

Manufacturer:

Vifor

Distributor:

HK Medical Supplies
/
Health Express
Full Prescribing Info
Contents
Iron (as iron hydroxide polymaltose complex).
Description
Chewable tab: Each chewable tablet contains 100 mg of iron as Iron (III)-Hydroxide Polymaltose Complex (IPC), cyclamate, flavouring, excip. pro compresso.
Drops: 1 ml (20 drops) contains 50 mg of iron as Iron (III)-Hydroxide Polymaltose Complex (IPC), flavouring, sucrose, preservatives (E 217, E 219), excip. ad solutionem.
Syr: 5 mL Ferrum Hausmann syrup contains 50 mg of iron as the active substance in the form of an iron(III) hydroxide polymaltose complex, preservative (E218, E216), sugar, flavourings, vanillin and other ingredients.
Sugar content: 200 mg per 1 mL Ferrum Hausmann syrup.
Alcohol content: less than 0.33%.
Action
Pharmacotherapeutical group: Antianaemicum. ATC Code: B03AB05.
Pharmacology: Ferrum Hausmann is an iron preparation for the treatment of latent iron deficiency and iron deficiency anaemia. Iron is an important constituent of haemoglobin, myoglobin, and the enzymes which contain iron. In general, iron deficiency can cause chronic fatigue, lack of concentration, irritability, ner­vousness, headache, loss of appetite, susceptibility to stress and infection, paleness, cracks at the corners of the mouth (rhagades), dry skin, brittle hair and nails.
The iron in Ferrum Hausmann is present as Iron (III)-Hydroxide Complex, where individual particles are embedded in a carbohydrate polymer (polymaltose). This prevents the iron from causing any harm in the gastrointestinal system. This protection inhibits interactions of the iron with food. Moreover, it ensures the bio­availability of the iron.
The structure of IPC is similar to ferritin, the naturally occurring iron storage protein. Due to this similarity, iron is ab­sorbed through natural mechanisms.
IPC has no pro-oxidative properties such as there are with bivalent iron salts.
Indications/Uses
Treatment of latent iron deficiency and iron deficiency anaemia (manifest iron deficiency).
Chewable tab: Prophylactic therapy of iron deficiency during pregnancy.
Drops: Prophylactic therapy of iron deficiency to cover the recommended daily dietary allowances (RDA) during pregnancy and lactation, for children, adolescents, women capable of bearing children and adults (eg, vegetarians and elderly).
Dosage/Direction for Use
Dosage and duration of therapy are dependent upon the extent of iron deficiency.
Chewable tab: Children (> 12 years), adults and nursing mothers: Manifest iron deficiency: 1 chewable tablet 1 to 3 times daily for 3-5 months until a normalisation of the haemoglobin value is achieved. Afterwards the therapy should be continued for several weeks with 1 chewable tablet daily to replenish the iron stores.
Latent iron deficiency: 1 chewable tablet daily.
Pregnant women: Manifest iron deficiency: 1 chewable tablet 2 to 3 times daily until a normalisation of the haemoglobin value is achieved. Afterwards the therapy should be continued with 1 chewable tablet daily at least until the end of the pregnancy to replenish the iron stores.
Latent iron deficiency and prevention of iron deficiency: 1 chewable tablet daily.
Administration: The daily dosage can be divided into separate doses or can be taken at one time. Ferrum Hausmann chewable tablets can be chewed or swallowed whole and should be taken during or immediately after a meal.
Drops: Manifest iron deficiency: the therapy takes about 3-5 months until a normal­isation of the haemoglobin value is achieved. Afterwards the therapy should be continued for several weeks or for pregnant women, at least until the end of the pregnancy with a dosage such as described for latent iron deficiency to replenish the iron stores.
Latent iron deficiency: the therapy takes about 1-2 months.
See table.

Click on icon to see table/diagram/image

Due to low dosages, these indications can only be treated with iron in drop form (Ferrum Hausmann drops).
Administration: The daily dosage can be divided into separate doses or can be taken at one time. Ferrum Hausmann drops/Ferrum Hausmann syrup should be taken during or immediately after a meal.
Ferrum Hausmann drops/Ferrum Hausmann syrup can be mixed with fruit and vegetable juices or with bottle-feed. The slight colouration does not affect the taste or the efficacy.
Syr: Ferrum Hausmann syrup should be taken with or directly after meals. It can be mixed with fruit or vegetable juice or with bottle food. The slight discolouration does not impair the effect or the taste. Use the measuring cup included for exact dosing.
One measuring cup corresponds to a volume of 15 mL, corresponding to 150 mg iron.
The daily dose can be taken all at once or divided into multiple individual doses.
Iron deficiency with anaemia: Infants aged up to 1 year: 2.5-5 mL daily.
Children (aged 1-12 years): 5-10 mL daily.
Adolescents over 12 years and adults: 10-30 mL daily.
Iron deficiency without anaemia: The syrup is not suitable for infants aged up to 1 year. Ferrum Hausmann drops are available for the treatment of these children.
Children (aged 1-12 years): 2.5-5 mL daily.
Adolescents over 12 years and adults: 5-10 mL daily.
The dose and duration of treatment depend on the severity of the iron deficiency. In the case of iron deficiency with anaemia, treatment lasts an average of 3-5 months until blood test values are normal again. Treatment is then continued as described for the dose for latent iron deficiency without anaemia for several weeks to replenish the iron stores.
For iron deficiency without anaemia, treatment lasts about 1-2 months. The exact duration of treatment is determined by the doctor in each case. If the patient takes more Ferrum Hausmann than he/she should, the patient should talk to the doctor or pharmacist. If the patient forgets to take Ferrum Hausmann, simply take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.
Always take this medicine exactly as described or as advised by the doctor. If the patient feels that the medicinal effect is too strong or too weak, the patient should talk to the doctor or pharmacist.
Overdosage
In cases of overdosage neither intoxi­cation nor iron overload have been reported to date.
Contraindications
Iron overload (e.g. haemochromatosis, haemosiderosis) or disturbances in iron utilisation (e.g. lead anaemia, sidero­-achrestic anaemia, thalassaemia) and anaemia not caused by iron deficiency (e.g. haemolytic anaemia).
Known intolerance of any of the ingredients.
Special Precautions
In cases of anaemia due to infections or malignancy, the substituted iron is stored in the reticulo-endothelial system, from which it is mobilised and utilised only after curing the primary disease.
Notice to diabetics: Chewable tab: 0.03 bread units per chewable tablet.
Drops: 0.01 bread units per ml (20 drops).
Syr: Before the patient begins taking Ferrum Hausmann syrup, a doctor should confirm the blood's iron and haemoglobin levels using appropriate tests. If the symptoms are not caused by iron deficiency, Ferrum Hausmann syrup will not be effective.
The doctor will want to monitor the progress of the treatment with periodic follow-up examinations and maybe even with blood tests. This is normal and should not alarm the patient. If the symptoms do not improve within three weeks, the patient should see the doctor.
Tell the doctor or pharmacist before taking Ferrum Hausmann if the patient has an infection or a tumour.
Tell the doctor or pharmacist if the patient has recently been treated with injectable iron preparations or might be treated with these. Taking such iron preparations at the same time as Ferrum Hausmann is not recommended. Tell the doctor if the patient has received blood transfusions as there is a risk of iron overload as a result of the additional administration of iron.
Tell the doctor or pharmacist if the patient: suffers from other illnesses; has any allergies; is taking any other medicines (even those purchased over the counter).
Use In Pregnancy & Lactation
Reproduction studies with animals did not show any foetal risk. Controlled stu­dies in pregnant women after the first tri­mester have not shown any undesirable effects on mother and neonates. There is no evidence of a risk during the first trimester and a negative influence on the foetus is unlikely. The administration of Ferrum Hausmann is unlikely to cause undesirable effects to the nursed child.
During pregnancy and lactation Ferrum Hausmann should be used only after consulting a medical doctor or pharmacist.
Adverse Reactions
The following adverse drug reactions could very rarely be observed after the intake of Ferrum Hausmann: constipation, diarrhea, nausea, abdominal pain, gastric disorders, indigestion (dyspepsia), vomiting, rash (urticaria, exanthema, pruritus).
A dark colouration of the stool due to iron elimination is of no clinical significance.
Ferrum Hausmann does not stain dental enamel.
Syr: The following side effects may occur when taking Ferrum Hausmann syrup: A very common side effect is a discolouration of the stool caused by the excretion of iron, but this is harmless.
Other common side effects include diarrhoea, nausea and indigestion. Occasionally there may be vomiting, constipation, abdominal pain, tooth discolouration or headaches and local skin reactions (itching, rash).
These side effects are usually harmless and temporary.
In very rare cases, patients may experience allergic reactions. These may be, for example, skin reactions, swelling (oedema) or shortness of breath. In such cases, the patient should stop taking the medicine and consult a doctor.
If the patient gets any side effect not listed, he/she should talk to the doctor or pharmacist.
Drug Interactions
Until now interactions have not been observed. Since the iron is complex­ bound, ionic interactions with food components (phytin, oxalates, tannin etc.) and concomitant administration of medicaments (tetracyclines, antacids) are unlikely to occur.
The haemoccult test (selective for Hb) for the detection of occult blood is not impaired and therefore there is no need to interrupt iron therapy.
Storage
Chewable tab: Below 25°C in the original container.
Drops/Syr: Do not store above 30°C.
Syr: The doctor or pharmacist will provide the patient with additional information if necessary.
ATC Classification
B03AB04 - ferric hydroxide ; Belongs to the class of oral iron trivalent preparations. Used in the treatment of anemia.
Presentation/Packing
Chewable tab 100 mg x 30's. Drops 50 mg/mL x 30 mL. Syr 50 mg/5 mL x 150 mL.
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