LOFFER-F [Iron (III) Hydroxide Polymaltose + Folic Acid] 100 + 0.35 mg Chewable Tablets
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instructions for the medical use of a medicinal product
LOFFER-F
Tradename: Loffer-F, Лоффер-Ф
International
non-proprietary name or generic name: Iron (III) hydroxide polymaltosate +
Folic acid, Ferric (III) hydroxide polymaltosate + Folic acid
Dosage form: chewable tablets.
Composition per
1 tablet:
active
substance: iron (III) hydroxide polymaltose complex equivalent to elemental iron 100
mg, folic acid 0.35 mg;
excipients: Microcrystalline
cellulose, dextrose monohydrate, PVP K-30, aspartame, vanilla powder, magnesium
stearate, silicon dioxide.
Pharmacotherapeutic group
Antianemic agents. Iron-based agents in combination
with folic acid.
Code АТХ: B03AD04
Pharmacological properties
Pharmacodynamics
The polymaltose complex of iron (III) hydroxide is a polynuclear center
of iron (III) hydroxide surrounded by non-covalently bound polymaltose
molecules with a total average molecular weight of about 50 kDa. The
polynuclear centers of iron (III) hydroxide polymaltose are similar in
structure to the natural iron depot protein ferritin. This macromolecular
complex is stable and does not release large amounts of iron under
physiological conditions. Due to its large size, the degree of diffusion of
iron (III) hydroxide polymaltose through the mucosal membrane is approximately
40 times lower than the degree of diffusion of the iron (II) hexaaqua complex.
Iron (III) hydroxide polymaltose comes from the intestine by active transport.
Folic acid is a B vitamin. It is a precursor of tetrahydrofolate, a coenzyme
involved in various metabolic processes, including the biosynthesis of purines
and thymidylate nucleic acids; it is also necessary for the synthesis of
nucleoproteins and maintaining normal levels of erythropoiesis. Pharmacodynamic
effects
Absorbed iron binds to transferrin and is used for the
synthesis of hemoglobin (Hb) in the bone marrow or is deposited, mainly in the
liver, where it binds to ferritin.
Pharmacokinetics
The most active absorption of the polymaltose
complex of iron (III) hydroxide occurs in the duodenum and jejunum. The degree
of absorption is about 10%. Iron (III) hydroxide polymaltose after absorption
is used for the synthesis of hemoglobin in the bone marrow or deposited, mainly
in the liver, where it binds to ferritin.
Folic acid is mainly absorbed in the
small intestine, primarily in the duodenum and jejunum. After taking 0.35 mg of
folic acid, 80% of its absorption can be expected. The maximum concentration of
folic acid in the blood plasma is achieved after 30-60 minutes. Folic acid is
metabolized in the cells of the intestine and liver, as well as in other
organs. The formed folates bind to transport proteins and are distributed
throughout all organs.
Unabsorbed iron is excreted in the
feces. Folic acid is excreted by the kidneys and also through the digestive
tract.
Indications for use
• treatment and prevention of iron deficiency without anemia (latent iron
deficiency) and clinically expressed iron deficiency anemia;
• treatment and prevention of iron and folic acid deficiency during
pregnancy and breastfeeding, taking into account the assessment of the
benefit-risk ratio.
Iron deficiency and its severity should be established and confirmed by
appropriate laboratory tests.
Contraindications
• known hypersensitivity to iron (III) hydroxide polymaltose, folic acid or
any of the excipients;
• iron overload (e.g. hemosiderosis, hemochromatosis);
• impaired iron utilization (e.g. lead anemia, sideroachrestic anemia,
thalassemia);
• anemia not due to iron deficiency (e.g. hemolytic anemia or megaloblastic
anemia due to vitamin B12 deficiency);
• children under 12 years of age.
Method of administration and dosage
The drug is taken orally during or
immediately after meals. Tablets can be chewed or swallowed whole. The daily
dose of the drug can be divided into several doses or taken at one time.
Treatment of iron deficiency anemia
in children over 12 years of age and adults. 1-3 tablets daily for 3-5 months
until hemoglobin levels are normalized. After this, treatment should be
continued for several weeks at the dose described for latent iron deficiency to
replenish iron stores.
Treatment
of iron deficiency anemia during pregnancy. Pregnant women should take 1 tablet 2-3 times a day
until hemoglobin levels are normalized. Then therapy should be continued at a
dosage of 1 tablet per day, at least until delivery (to restore iron reserves).
For
the treatment of latent iron deficiency and prevention of iron and folic acid
deficiency, take 1 tablet daily.
The duration of
treatment for latent iron deficiency is 1–2 months. In the case of clinically
expressed iron deficiency, normalization of hemoglobin levels and replenishment
of iron reserves occurs only 2–3 months after the start of treatment.
Special instructions and precautions
Consult
a doctor before using the drug.
Treatment
of anemia should always be carried out under medical supervision.
If
there is no effect (the hemoglobin level has not increased by approximately
20-30 g / l after 3 weeks), the treatment plan should be revised. Caution
should be exercised when prescribing the drug to patients who have repeatedly
received blood transfusions, since iron enters with red blood cells, which can
cause iron oversaturation.
During
treatment with the drug, darkening of feces is possible, which has no clinical
significance.
The
drug Loffer-F contains folic acid and can mask the symptoms of vitamin B12
deficiency.
Infectious
diseases or malignant neoplasms can cause anemia. Since iron can be taken only
after eliminating the underlying cause of the disease, the benefit-risk ratio
of treatment should be determined.
Iron
deficiency and its severity should be established and confirmed by appropriate
laboratory tests.
Side effect
From the
gastrointestinal tract: nausea, vomiting, abdominal pain, diarrhea,
change in stool color, constipation, change in tooth enamel color, gastritis.
From the
nervous system: headache.
From the
musculoskeletal and connective tissue: muscle spasms, myalgia.
From the
skin and subcutaneous tissue: itching, rash,
urticaria, erythema.
If any of
the side effects listed in the instructions worsen, or you notice any other
side effects not listed in the instructions, tell your doctor.
Interaction with other medicinal products
Concomitant
use of parenteral and oral iron preparations should be avoided, since the
absorption of orally administered iron is delayed.
Folic
acid treatment may increase the metabolism of phenytoin, resulting in decreased
serum phenytoin concentrations, especially in folate-deficient patients.
Although this interaction is not clinically significant, some patients may
experience an increase in the frequency of seizures. Patients receiving
phenytoin or other anticonvulsants should consult a physician before starting
treatment with a folate-containing preparation.
It
has been shown that concomitant use of chloramphenicol and folic acid in
folate-deficient patients may result in a decrease in the hematopoietic
response to folic acid due to the antagonistic effect of chloramphenicol.
Although the significance and mechanism of the interaction are unclear,
patients receiving both drugs concomitantly should be closely monitored for the
hematopoietic response to folic acid treatment.
In case of
overdose of iron (III) hydroxide polymaltosate, signs of poisoning and iron
overload are unlikely, which is due to the low toxicity of the drug and
controlled absorption of iron. There are no reports of accidental poisoning
with a fatal outcome. When using too high doses of folic acid, changes in the
central nervous system (changes in mental state, sleep and wakefulness
disorders, increased irritability, hyperactivity), nausea and flatulence may
develop. If these symptoms occur, discontinue taking the drug, perform gastric
lavage, and, if necessary, symptomatic therapy.
Storage conditions
Store in a cool, dry place at temperatures below 25°C.
Keep out of reach of children!
Shelf life
3 years. Do not use after the expiration date stated
on the package.
Vacation conditions
By prescription.
Release form
10 tablets in an aluminum foil blister. 3 blisters together with instructions for use in a cardboard box.