Feromaks syrop

INSTRUCTIONS FOR USE 

FEROMAX

Trade name of the drug : Feromax

Active ingredient (INN) : no

Dosage form : syrup

Composition :

15 ml of syrup contains:

active substance:  iron ammonium citrate USP-160 mg (which corresponds to an elemental iron content of 32.8 mg); folic acid BP-0.5 mg; cyanocobalamin BP-7.5 mcg; copper sulfate USP-30 mcg; magnesium sulfate USP-30 mcg.

excipients:  sucrose – 6000.0 mg; methylparaben-27.0 mg; propylparaben 3.0 mg; Sodium benzoate-30.0 mg; disodium EDTA-30.0 mg; liquid glucose – 3000.0 mg; glycerin-375.0 mg; xanthan gum – 30.0 mg; sodium hydroxide-0.9 mg; povidone-15.0 mg; citric acid – 37.5 mg; sodium citrate – 15.0 mg; vanilla essence – 150.0 mg; caramel coloring – 0.0375 ml; purified water – qs up to 15 ml.

Description: dark brown color with vanilla flavor viscous liquid

Pharmacotherapeutic group:  antianemic agent.

Code ATH:  B03AB

Pharmacological properties

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

Iron is an essential metal necessary for the normal functioning of the body. It is part of hemoglobin, myoglobin, as well as various enzymes; reversibly binds oxygen and participates in a number of redox reactions, plays an important role in hematopoietic processes. Lack of iron in the body leads to the development of iron deficiency anemia, accompanied by slower physical development, general weakness, decreased performance, symptoms of anemic hypoxia, stomatitis, glossitis and other pathological phenomena.

Folic acid is part of the B group of vitamins. In the body, folic acid is reduced to tetrahydrofolic acid, which is a coenzyme involved in various metabolic processes. Folic acid is necessary for normal blood cell formation, including the processes of megaloblast maturation and normoblast synthesis. Lack of folic acid inhibits the transition from the megaloblastic phase of hematopoiesis to the normoblastic phase. Folic acid, together with vitamin B12, stimulates erythropoiesis and is also involved in the synthesis of amino acids (methionine, serine, etc.), nucleic acids, purines and pyrimidines, and in choline metabolism.

Cyanocobalamin (vitamin B12) has high biological activity. It is a growth factor, necessary for normal hematopoiesis and red blood cell maturation; participates in the synthesis of labile methyl groups and in the formation of choline, methionine, creatine, and nucleic acids. Lack of vitamin B12 in the body leads to pernicious anemia.

Copper and magnesium are vital trace elements and play a role in metabolism. Copper sulfate in small doses enhances erythropoiesis in anemia.

Indications for use

— Iron deficiency anemia due to chronic blood loss, helminthiases, insufficient iron intake, etc.;

– Dimorphic anemia due to lack of iron, folic acid and / or vitamin B12; -Anemia during pregnancy and lactation as well as prevention of iron deficiency during pregnancy;

— As a tonic for general weakness, lack of appetite, exposure to negative environmental conditions and during recovery;

— Post-surgical and other conditions.

Directions for use and doses

The drug is taken orally.

For children aged 1 to 6 years, it is recommended to prescribe 1 teaspoon of syrup 1 time per day (5 ml of syrup per day, 5 ml single dose in a measuring cup).

Children aged 6 to 12 years – 1 teaspoon 2 times a day (10 ml of syrup per day, 5 ml single dose in a measuring cup).

The syrup can be given from a spoon or measuring cup and can be washed down with water.

Adults, including pregnant women, 1 tablespoon or 10 ml in a measuring cup 2 times a day

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. Diabetes.

Drug interactions

When Feromax syrup is used simultaneously with tetracyclines and penicillins, iron absorption may be reduced due to the formation of chelate compounds. With the simultaneous use of antacids containing aluminum, magnesium and calcium salts, iron absorption is reduced.

special instructions

The drug is effective for anemia associated with deficiency of iron, folic acid and vitamin B12, 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

Adequate and strictly controlled studies of the safety of the drug during pregnancy and lactation have not been conducted. When used in the second and third trimesters of pregnancy in recommended doses, no negative effects were observed. When a nursing mother uses the drug, only a small part of the iron passes into breast milk. Therefore, adverse effects are unlikely to occur in breastfed infants.

Overdose

There have been no cases of overdose reported during Feromax syrup therapy. Any symptoms that may be observed due to consumption of large amounts of Feromax syrup will be due to the content of fat-soluble vitamins. 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 a latent phase, relapse may occur within 24 to 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:

1. Administration of an emetic.
2. Gastric lavage may be necessary to remove drug that has already entered the stomach. This should be carried out 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 mechanical breathing if necessary.
3. Give a solution of mannitol or sorbitol to induce bowel movements.
4. 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/24 hours. Caution: Hypotension may occur if the infusion rate is too fast.
5. Less severe poisoning: administer deferroxamine 50 mg/kg IM (maximum dose 4 g).
6. Serum iron levels should be monitored.
7. 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

in bottles of 100 ml, 150 ml, 200 ml

 Food conditions

Store in a dark, dry place at a temperature not exceeding 25 ⁰  C.

Best before date

24 months from production date

Conditions for dispensing from pharmacies

On prescription

Manufacturer :

Saga Laboratories

Plot no. 1409, phase — iii, G.I.D.C., Vatva,

Ahmedabad — 382 445, India.

Tel: -011-26415292

Name and address of the organization accepting claims (proposals)

on the quality of the medicinal product in the territory of the Republic of Uzbekistan:

ООО «SHAYANA FARM»

Republic of Uzbekistan, city Tashkent 700057, st. Usta Shirin house-117,

Phone: 99(871) 2281692(93/94)

Fax: 99 (871) 2281695