FEROMAX

INSTRUCTIONS FOR USE

FEROMAX

Trade name of the drug: Feromax

Dosage form: capsules

Composition:

Active substance:

Carbonyl iron equiv.

Elemental iron 100 mg

Zinc Sulfate Monohydrate F.USA 61.8 mg

(equivalent to 22.5 mg elemental zinc)

Folic acid BF 1 mg

Description: capsules consisting of a red cap and a transparent body, filled with dark brown, yellow-orange and white colored granules.

Pharmacotherapeutic group: antianemic agent.

Code ATH: B03AA

Pharmacological properties

The pharmacological properties of the drug Feromax are determined by the action of its constituent components.

Iron

Iron, as a component of hemoglobin, plays an important role in oxygen transport. It is also present in myoglobin and in the liver. Iron deficiency leads to anemia.

Folic acid

Folic acid is reduced in the body to tetrahydrofolate, which is one of the coenzymes in various metabolic processes, including the synthesis of purine and pyrimidine nucleotides and, consequently, in the synthesis of DNA. It is also involved in the transformation of some amino acids. Folic acid deficiency leads to megaloblastic anemia.

Zinc (zinc sulfate)

Zinc is part of many enzymes and plays an important role in the physiological processes of the body. It is involved in the production of insulin in the pancreas. It is involved in DNA synthesis and cell division. Zinc deficiency leads to delayed puberty and hypogonadal dwarfism.

Indications for use

— treatment of anemia caused by combined deficiency of iron, folic acid, occurring against the background of chronic blood loss (gastric bleeding, intestinal bleeding, bleeding from the bladder, bleeding from hemorrhoids, menorrhagia and metrorrhagia), as well as against the background of chronic alcoholism, infectious diseases, taking anticonvulsants and oral contraceptives;

— treatment of anemia that occurs during pregnancy and lactation;

— prevention of iron and folic acid deficiency in the II and III trimesters of pregnancy, in the postpartum period, and during lactation.

Directions for use and doses

Patients with anemia — 1-2 capsules once a day for 3 months (depending on the severity of anemia).

Patients with latent iron deficiency: 1 capsule once a day for 3-4 weeks.

Pregnant women starting from the 14th week should take one capsule once a day for two weeks with a one-week break and then repeat taking the drug until delivery (take two weeks, one week break).

Women during lactation should take one capsule once a day.

Women during menstruation: one capsule per day two weeks before menstruation, during the cycle and for two weeks after the end of the cycle. The total duration of taking the drug, including the menstrual cycle, should not exceed ten days.

People with intense physical activity and patients diagnosed with Beri-Beri are recommended to take the drug 1-2 capsules per day. The drug is taken orally during or after meals, or as prescribed by a doctor.

Side effects

Possible side effects: nausea, vomiting, loss of appetite up to anorexia, constipation, diarrhea, gastralgia, intestinal colic, belching, allergic reactions.

Contraindications

An increase in the amount of iron in the body (hemosiderosis, hemochromatosis), impaired iron utilization (aplastic anemia), chronic liver and kidney diseases, chronic inflammatory diseases, uncontrolled hypertension, hypersensitivity to the components of the drug, children under 12 years of age.

Drug interactions

Concomitant therapy with antacids reduces iron absorption. When iron and tetracyclines are used together, there is a noticeable decrease in the absorption of the drug, which leads to a decrease in the effectiveness of treatment.

Concurrent use may reduce the effectiveness of fluoroquinolones, levodopa, carbidopa, thyroxine and bisphosphonates. Iron may reduce the absorption of penicillamine due to complex formation. Serum concentrations of anticonvulsants may be decreased when administered with folic acid.

special instructions

The drug is effective for anemia associated with iron and folic acid deficiency, but is not effective for anemia of other etiologies. Before prescribing the drug, it is necessary to confirm iron deficiency in the patient based on laboratory tests. Concomitant use of other drugs containing iron should be avoided. When using drugs containing iron, stool may turn black, which has no clinical significance.

Use during pregnancy and lactation. It is not known whether this product may cause fetal harm when used in pregnant women or affect fertility. The drug should be used in pregnant women only when absolutely necessary.

It is not known whether this drug passes into breast milk. Because many drugs pass into breast milk, caution should be used when this product is used in nursing mothers.

Impact on the ability to drive a car and operate complex machinery. Does not affect.

The drug should not be used after the expiration date and should be stored out of the reach of children.

Overdose

There have been no cases of overdose reported during therapy with Feromax capsules. If iron overdose is suspected, symptoms may include nausea, vomiting, diarrhea, abdominal pain, hematemesis, rectal bleeding, lethargy and circulatory collapse. Hyperglycemia and metabolic acidosis may also occur. Treatment should be carried out immediately. In severe cases, after the latent phase, relapse

may occur within 24-48 hours, manifesting as coma, hypotension and hepatocellular necrosis and renal failure.

Treatment.

The following steps are recommended to minimize or prevent further absorption of the drug:

Administration of an emetic.
Gastric lavage may be necessary to remove drug that has already entered the stomach. This should be done using deferroxamine solution (2 g/l). Deferroxamine (5 g in 50-100 ml of water) should be administered into the stomach after gastric emptying. Keep the patient under constant observation to identify possible aspiration of vomit, support breathing with an oxygen machine if necessary.
Give a solution of mannitol or sorbitol to induce bowel movements.
Severe poisoning: In the presence of shock and/or coma with high serum iron levels (> 142 µmol/l), immediately initiate life support measures and immediately administer an IV infusion of deferroxamine. The recommended dose of deferroxamine is
5 mg/kg/h in a slow IV solution up to a maximum of 80 mg/kg over 24 hours. Caution: Hypotension may occur if the infusion rate is too fast.
Less severe poisoning: administer deferroxamine 50 mg/kg intramuscularly (maximum dose 4 g).
Serum iron levels should be monitored.
Take any fluids to compensate for water or electrolyte imbalance.

Folic acid is generally well tolerated. Gastrointestinal disturbances may occur. Allergic reactions are rarely recorded.

Release form

15 capsules each in a blister pack (blister) made of polyvinyl chloride film and aluminum foil. 2 blisters along with instructions for use in a cardboard box.

Food conditions

In a dry place, protected from light. At a temperature not higher than 25 ^o C.

Best before date

18 months from production date.

Conditions for dispensing from pharmacies

No prescription.

Manufacturer

Saga Laboratories, India