ENRICH ORAL DROPS 30ML

Description

ENRICH Composition:

active substance:

Enrich contains:

• Iron (II) hydroxide polymaltose complex 156.25 mg (eq.to 50 mg elementation

excipients:

Enrich drops contain:

• Sorbitol 70/70 non crystallizing, Methyl Paraben Sodium (Nipagen), Propy Panten
• Sodium (Nipasol), Ethanol 96%, Banana Flavor, Purified Water,

Indications Applications:

• Therapy of iron deficiency without anemia (latent iron deficiency) and iron deficiency
• The iron deficiency and its extent must be diagnosed and confirmed by suitable
• laboratory analysis.

Dosage/Application:

• Preterm infants:
•  2.5-5 mg iron/kg body weight (1-2 drops) daily during 3-5 months.
•  The daily dose can be divided into single doses or given at one time.
•  The Enrich preparations should be taken during or immediately after eating.
•  Enrich drops can be mixed with fruit or vegetable juices, or with the bottle food.
•  Light coloring does not affect the effect or taste.
• To ensure precise dosage of Enrich drops, the bottle must be inverted and held vertically.
• A drop will immediately form at the end of the dripping flap.
• If this is not the case, gently tap the bottle until a drop is formed.
• Do not shake the bottle.
• For children under 12 years, Enrich drops should be used for the administration of
• the recommended doses of iron.
• The dosage and the treatment time depend on the extent of the iron deficit. In the case
• of manifest iron deficiency with anemia, the treatment lasts for an average of 3-5
• months until the normalization of the hemoglobin value. In conclusion, the therapy
• with the respective dosage for latent iron deficiency without anemia is continued for
• several weeks to replenish the iron storage. The therapy of latent iron deficiency without
• anemia takes about 1-2 months.

Pregnancy/Breastfeeding:

• effects in the breast-fed child.
•  Data in a limited number of pregnant women after the first trimester showed no adverse
  effects on pregnancy or the health of the fetus or newborn.
• Animal experiments showed development of the fetus. However, it should be taken with caution during pregnancy.
• no direct or indirect toxicity with effects on pregnancy, embryo development or the Nutmilk naturally contains iron bound to lactoferrin. How much iron from the iron
  (III) hydroxide transitions polymaltose complex into the mother’s milk is not known.
• It is unlikely that the use of Enrich products by nursing mothers could cause undesirable
•  Enrich preparations should be taken during pregnancy and lactation consultation with a doctor.

Side effects

The frequency of the side effects described below is very often (21/10),often (<1/10; >1/100 orecasionally <1/100 21/1000).

The most frequently observed side effect
is clinical insignificant stain stalning in 23% of patients) caused by Iron excretion
immune system
Very rare: allergic reactions
Gastrointestinal disorders
Very common: Stool staining
Common: diarrhea, nausea, dyspepsia,
Uncommon: abdominal pain, vomiting, constipation, tooth discoloration,

Nunctional disorders of skin and subcutaneous tissue:

Uncommon: pruritus, rash,

Disorders of the nervous system:

Uncommon: headache,

Overdose:

• in overdoses, an intoxication or iron overload is due to the low toxicity of the ferric
  hydroxide polymaltose complex [in mice or rats is the 50% lethal dose (LD 50)> 2000
  mg Fe/kg body weight) and the expected saturation of the iron intake unlikely.

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