Download ROTAFER PLUS ROTAFER PLUS (Capsules) (iron (III) hydroxide

ROTAFER PLUS
ROTAFER PLUS (Capsules)
(iron (III) hydroxide polymaltose complex, zinc gluconate, folic acid, vitamin B1, vitamin B2,
vitamin B6)
COMPOSITION
One capsule contains
iron (III) hydroxide polymaltose complex
50 mg
zinc gluconate
50 mg
folic acid
0.35 mg
vitamin B 1 (thiamine hydrochloride)
2 mg
vitamin B 2 (riboflavin)
1 mg
vitamin B 6 (pyridoxine hydrochloride)
2 mg
PHARMACOLOGICAL PROPERTIES
PHARMACODYNAMICS
Rotafer Puls is a complex of iron, zinc and group-B vitamins.
Iron is a compound in the form of hydroxide Fe3+ polymaltose complex. The outer multi-core
hydroxide Fe3+ centres are surrounded by many noncovalently bound polymaltose molecules, thusly
forming a complex with total weight of 50,000 daltons, which is high enough that its diffusion
through gastrointestinal mucus membrane is 40 fold lower than hydroxide Fe2+.
This macromolecular complex is stable, it does not excrete iron as free ions. It is compatible in
structure with natural iron and ferritin compounds. Due to this compatibility, Fe3+ ions from the
gastrointestinal tract are transferred to blood only via active absorption, which prevents overdose
(as well as intoxication) as opposed to simple iron salts, which are absorbed in accordance with
concentration gradient.
Absorbed iron is deposited as ferritin compound mainly in liver. Later, in bone marrow, it is
transported into haemoglobin. Iron in the form of hydroxide Fe3+ polymaltose complex does not
have prooxidant properties (as opposed to simple Fe2+ salts), which leads to oxidation reduction of
low-density lipoprotein (LDL) and very low-density lipoprotein (VLDL).
The medication quickly corrects iron deficit in the organism, stimulates erythropoiesis and improves
haemoglobin level.
Zinc is a vital element in human organism. It is mainly a component of erythrocytes in the form of
carboanhydrase zinc metalloenzyme and, to a lesser degree, a component of blood plasma as an
element bound with alpha 2-macroglobulin. It is part of more than 70 ferments that catalyse key
stages of DNA, RNA and protein synthesis. It affects growth and maturation of tissues and helps
when children’s psychological and physical development is compromised. It stabilizes cell
membranes, facilitates regeneration and transmission of nerve impulses; it also enhances the effect
of insulin. It stimulates hair growth and has immunomodifying effect on T-cell immunity bond and
improves general immunity. Zinc is a strong antioxidant. It is effective in the treatment of acne and
alopecia.
Folic acid is a group-B vitamin, it takes part in key biological processes, especially in DNA, RNA and
protein synthesis. During pregnancy folic acid prevents defects to neural tube in foetus. Folate
deficiency leads to megaloblastic anemia. Folic acid deficiency may cause miscarriages, premature
labour, and child’s developmental brain disorders.
Vitamin B 1 is an active compound. In the organism, in the process of phosphorylation it is
transformed into cocarboxylase, which is a coferment of various fermentative reactions. It plays a
valid role in carbohydrate, protein and lipid metabolism as well as transmission of nerve impulses in
synapses. It protects cell membranes against toxic effect of lipid peroxidation.
Vitamin B 2 (riboflavin) is a vital catalyst in cellular respiration and visual perception. It plays
significant part in DNA-formation and facilitates tissue regeneration (including skin cell
regeneration).
Vitamin B 6 (pyridoxine hydrochloride) in phosphorylation form is a component of enzymes
responsible for decarboxylation and transformation of amino acids and lipid metabolism. It is crucial
for peripheral and central nervous system (CNS).
PHARMACOKINETICS
Rotafer Plus is a complex therefore, it is impossible to conduct pharmacokinetic research.
THERAPEUTIC INDICATIONS
As part of complex therapy, symptomatic treatment of such conditions as:
-
iron deficiency anaemia of any origin and latent iron deficiency;
-
increased need for iron (pregnancy, breastfeeding, blood donating, intense growth period,
vegetarianism, aging).
CONTRADICTIONS
-
hypersensitivity to any components of the medication;
-
iron overload (such as haemochromatosis, haemosiderosis);
-
iron utilization disorders (lead poisoning, sideroblastic anemia, thalassemia);
-
anemia not associated with iron deficiency (haemolytic anemia, metabolic anemia, vitamin
B 12 deficiency anemia);
-
children under 12 years-old (since there is no clinical data).
With caution: gastric and duodenal ulcer, inflammatory gastrointestinal diseases (enteritis,
diverticulitis, ulcerative colitis, Crohn’s disease).
SIDE EFFECTS
Gastrointestinal tract side effects: very rare – symptoms of gastrointestinal irritation (including
feeling of repletion and pressure in epigastrium, nausea, constipation or diarrhea). Darkening of
stool may occur as unabsorbed iron is excreted (it does not bear clinical importance).
Other: allergic reactions to folic acid.
DOSAGE AND ADMINISTRATION
Rotafer Plus should be taken enterally.
The duration of treatment and dosage depend on the severity of iron deficiency. Daily dose may be
administered once. The medication should be taken with or immediately after food and washed
down with water.
Treatment of mild and moderate clinically significant iron deficiency (iron deficiency anaemia): 2
capsules daily for 3-5 months until the level of haemoglobin in blood normalizes. When normal level
of haemoglobin in blood is reached the dose should be adjusted by a doctor.
Pregnant women should be administered 1-2 capsules daily until the level of haemoglobin in blood
normalizes. Afterwards the therapy should be continued with the dose of 1 capsule daily until labour
so that the iron reserves can be restored.
In therapy and prevention of latent iron deficiency as part of complex therapy 1 capsule daily should
be administered.
PACKAGING
Hard gelatine capsules.
15 capsules are in a blister.
2 blisters together with a leaflet are in a carton box.