Heferol kaps. 350 mg No. 30

HEFEROL (HEFEROL)

FERRI FUMARAS * B03A A02

Alkaloid

STRUCTURE AND PACKAGING:

kaps. 350 mg blister, No. 10, No. 30

kaps. 350 mg fl., No. 30

fumarate

Iron

350 mg

No. UA/0263/01/01 from 11.03.2009 to 11.03.2014

PHARMACOLOGICAL PROPERTIES:

Pharmacodynamics. Heferol contains elementary iron in the form of fumarat iron. Near ² / ₃ gland in an organism contains in hemoglobin of the circulating mass of erythrocytes. At insufficient intake of iron with food or violation of its absorption the latent or clinically apparent deficiency of iron in an organism develops (iron deficiency anemia). The corresponding intake of iron in an organism is of particular importance during pregnancy for ensuring normal fetation and prevention of low body weight of newborns.
Dosage form of Heferol (capsules) allows to prevent contact of iron with a mucous membrane of a stomach. Reception of capsules provides protection of teeth, and the fast passage of iron through a stomach interferes with development of side effects which are caused by irritant action of iron on a mucous membrane of a stomach. In intestines iron is gradually released from the capsule and soaked up.
Pharmacokinetics. Gland fumarating provides gradual and uniform release of iron from a digestive tract. Absorption of iron happens almost completely by active transfer in duodenal and a jejunum. At healthy people about 5-10% of the dose accepted inside are absorbed, and at deficiency of iron absorption increases to 80–95%. Muscle tissues (squirrels who contain cysteine) and the ascorbic acid accepted inside stimulate iron absorption. The food containing phytic acid (soy, bean plants and breadstuff) and polyphenols (tea, coffee, chocolate, red wine) complicate iron absorption. The hydrolyzed tea tannins — the main inhibitors; calcium — in organic substances or food, some proteins (soy, eggs, casein). With _max gland of the fumarat is reached by br in 4 h after reception. Iron in the form of ferritin and hemosiderin creates depot of iron in an organism. Biological T _½ gland makes 12.9 h. The t _½ at intake and parenteral use of iron makes 6 h. Only in the minimum quantities iron is removed from an organism with bile and sweating, and 12–30 mg of iron are allocated at a normal menstrual cycle. In the period of a normal lactation about 0.25 mg/days (0.15-0.3 mg) of iron come to maternal milk.

INDICATION:

treatment and prevention of an iron deficiency anemia.
Increased iron loss: bleedings from a GIT (ulcer of stomach and duodenum, ulcer colitis, polyposes, hemorrhoids), bleedings from an urogenital path (polymenorrhea, a hypermenorrhea, a metrorrhagia, a hamaturia), at a fibromiomatoza, bleedings of various genesis.
Increased need of an organism for iron: period of intensive growth and puberty, period of pregnancy and feeding by a breast.
Insufficiency of intake of iron: reduced receipt with food, violation of absorption of iron at a sprue, presence of inflammatory diseases of a digestive tract.

USE:

to accept

capsule on an empty stomach in 30 min. prior to a breakfast, to wash down with a large amount of liquid.
Adults and children are aged more senior than 12 years: for prevention — 1 capsule a day; for treatment — 1 capsule 2 times a day.
For treatment and prevention of a dose to pregnant women in ІІ and ІІІ the trimester is appointed usual, as for adults.
Patients of advanced age
For treatment and prevention of a dose same, as well as for adults.
Course of treatment — 6–12 weeks. Administration of medicament needs to be continued after normalization of a picture of peripheral blood for some time to fill up depot of iron in an organism.
dose exceeding 30 mg/kg of body weight can cause overdose symptoms In some patients. For children the medicine dose higher than 75 mg/kg of body weight can be toxic.

CONTRAINDICATION:

hypersensitivity to any of medicine components.
Hemochromatosis, a hemosiderosis and other types of anemias which are not connected with deficiency of iron in an organism (hemolytic anemia, aplastic anemia, a thalassemia). Children's age up to 12 years.

SIDE EFFECTS:

most often at treatment by iron preparations are noted by violations from a GIT: pain in epigastriums, nausea, vomiting, coloring of excrements in black color, diarrhea, metal smack in a mouth; allergic reactions. Prolonged unjustified use can lead to a constipation and a hemosiderosis.

SPECIAL INSTRUCTIONS:

should not be accepted Heferol to patients who perform repeated transfusion of blood as enough iron is released from hemoglobin and erythrocytes.
should not take the medicament more than 6 months, except patients with long bleeding, a menorrhagia or repeated pregnancy.
needs to adhere to Extra care the patient with a round ulcer, regional enteritis (Crohn's disease), nonspecific ulcer colitis and hepatitis.
For prevention of a constipation should wash down medicine with a large amount of liquid. If administration of medicament serves as the cause of a stomach ache, it needs to be accepted at meal time.
Before purpose of therapy by iron to patients 50 years are aged more senior it is necessary to find out the cause of anemia as anemia at this age can be caused by bleeding in a digestive tract.
Heferol contains lactoses monohydrate therefore patients with rare hereditary intolerance of a galactose, at insufficiency of lactase and glyukozo-galaktozny malabsorption should not take this drug.
Capsules contain dyes (azoruby and diamond black), preservatives (methylparahydroxybenzoate and propilparagidroksibenzoat which can be the cause of allergic reaction).
Use during pregnancy and feeding by a breast. it is not established any negative influences on a fruit (and on the child) at Heferol's application during pregnancy and feeding by a breast.
Children. Capsules cannot be divided therefore there are no recommendations concerning Heferol's application for children aged up to 12 years.
Ability to influence speed of response at control of vehicles or work with other mechanisms. does not influence.

INTERACTION:

in case of a concomitant use of Heferol and tetracycline (or ciprofloxacin) is recommended to take these antibiotics for 3 h before administration of medicament of iron or in 2 h after its reception.
does not recommend simultaneous application with the antacids and food reducing iron absorption.
Ascorbic acid and proteins which contain cysteine increase iron absorption. Colestyraminum, food and antacids reduce absorption of iron in a digestive tract.
Iron delays absorption in a GIT of tetracycline, some hinolonovy means (ciprofloxacin), Methyldopums.
Iron preparations reduce absorption of Penicillaminum at their simultaneous application.
Hematologic response to therapy by iron preparations develops later at patients who at the same time receive therapy by chloramphenicol.
Salts of iron reduce absorption in a GIT of antibiotics from group of hinolon (ciprofloxacin, ofloxacin), levodopas, Methyldopums, Penicillaminum, biphosphonates, an entakapon. Their simultaneous application is not recommended or it is necessary to take them for 2 h to or after Heferol's reception.
Salts of iron delay absorption of tetracycline and Colestyraminum therefore this combination should not be applied. In case of need a concomitant use of these medicines, it is recommended to accept them with an interval not less than 2 h. Salts of iron can reduce efficiency of left thyroxine.

OVERDOSE:

administration of medicament in a dose of 400 mg/kg of elementary iron leads

to a lethal outcome. Overdose symptoms: pain in epigastric area, diarrhea, vomiting. At overdose in a liver can develop vacuolar dystrophy of hepatocytes, increase quantity of gepatotsitny lysosomes, hemosiderin and ferritin and also to appear acidophilic little bodies as symptom of necrosis of a liver. A large amount of elementary iron has corrosive effect on a mucous membrane of a stomach. Cyanosis, a hyperventilation as a result of acidosis and cardiovascular collapse can develop. The acute massive overdose by iron preparations can cause shock.
Treatment symptomatic. To cause vomiting, to wash out a stomach. It is necessary to be careful because of possible perforation owing to the gastric necroses caused by iron. Replenishment of electrolytes, treatment of shock, arterial hypotension and hyperglycemia. Prescribing of specific antidote of Deferoxaminum if concentration in blood makes> 500 mkg/dl. Performing such therapy, as at the damages caused by iron preparations.

STORAGE CONDITIONS:

at a temperature not above 25 °C

Description of goods is certified by the Alkaloid producer .

Editorial group Date of creation: 08.02.2023 Date of updating: 05.04.2023 Yashch_shin Mart of a =vgen_vn Author Oleksander V_ktorovich Sevryukov Reviewer

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only with the fact-finding purpose and should not be used as the management to self-treatment. Only the doctor can make the decision on prescribing of medicine and also define doses and ways of its application.

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Frequently asked questions

How much is Heferol kaps. 350 mg No. 30?

Prices of Heferol kaps. 350 mg No. 30 begin from 195.68 UAH for packing. whether

Can give this medicine to children?

Since 12 years. It is necessary to consult with your attending physician more in details.

What storage conditions at the Heferol capsules (Alkaloid)?

It agrees with the instruction storage temperature Heferol (Alkaloid) makes from 15 °C to 25 °C. To store out of children's reach.

What country of origin at Heferol (Alkaloid)?

Country the producer at Heferol (Alkaloid) - Macedonia.

Structure

Active ingredient: ferrous fumarate;

1 capsule contains gland of the fumarat 350 mg that is equivalent to 115 mg of elementary iron;

Excipients: magnesium stearate; lactose, monohydrate; sodium lauryl sulfate; silicon dioxide colloidal waterless;

Structure of the capsule: titan dioxide (E 171), quinolinic yellow (E 104), azoruby (E 122), patent blue V (E 131), diamond black BN (E 151), gelatin.

Dosage form

Capsule.

Main physical and chemical properties: capsules firm gelatinous No. 1: the body – opaque yellow-beige color; a lid – opaque dark green color; capsule contents – melkogranulirovanny powder of red-brown color with white impregnations.

Pharmacotherapeutic group

Antianemic means. Iron preparations. Drugs of bivalent iron for oral administration. Gland fumarates. ATX B03A A02 code.

Pharmacological properties

Pharmacodynamics

Heferol contains elementary iron in the form of fumarat iron. About two thirds of iron in an organism contain in hemoglobin of the circulating mass of erythrocytes. At insufficient intake of iron with food or violation of its absorption the latent or clinically apparent deficiency of iron in an organism develops (iron deficiency anemia). The corresponding intake of iron in an organism is of particular importance during pregnancy for ensuring normal fetation and prevention of small body weight of newborns.

Dosage form of the medicine "Heferol" (capsule) gives to

chance to prevent contact of iron with a mucous membrane of a stomach. Reception of capsules provides protection of teeth, and the fast passage of iron through a stomach interferes with development of side effects which are caused by irritant action of iron on a mucous membrane of a stomach. In intestines iron is gradually released from the capsule and soaked up.

Pharmacokinetics fumarating provides to

Iron with

gradual and uniform release of iron from a digestive tract. Absorption of iron happens almost completely by active transfer in duodenal and lean guts. At healthy people about 5-10% of the dose accepted inside are absorbed, and at deficiency of iron absorption increases to 80-95%. Muscle tissues (squirrels who contain cysteine) and the ascorbic acid accepted inside stimulate absorption of negemovy iron. The food containing phytic acid (soy, bean plants and breadstuff) and polyphenols (tea, coffee, chocolate, red wine) complicate absorption of negemovy iron. The hydrolyzed tea tannins – the main inhibitors; calcium – in organic substances or food, some proteins (soy, eggs, casein).

Maximum concentration of iron of the fumarat is reached by

in 4 hours after reception. Iron in the form of ferritin and hemosiderin creates depot of iron in an organism. Biological elimination half-life of iron makes 12.9 hours. Elimination half-life at intake and parenteral use of iron makes 6 hours. Only in the minimum quantities iron is removed from an organism with bile and then, and 12-30 mg of iron are allocated at a normal menstrual cycle. In the period of a normal lactation about 0.25 mg/days (0.15-0.3 mg) of iron come to breast milk.

Indication

Treatment and prevention of an iron deficiency anemia.

Contraindication

Hypersensitivity to active ingredient or any of medicine excipients.

Paroxysmal night haemoglobinuria.

Hemochromatosis, a hemosiderosis and other types of anemias which are not connected with deficiency of iron in an organism (hemolytic anemia, aplastic anemia, a thalassemia).

Hemoglobinopathy.

Round ulcer in an active form.

Regional enteritis (Crohn's disease) and ulcer colitis.

Repeated transfusions of blood.

Parenteral use of iron preparations.

Children's age up to 12 years.

Interaction with other medicines and other types of interactions

in case of a concomitant use of the medicine "Heferol" and tetracycline (or ciprofloxacin) is recommended to accept these antibiotics in 3 hours prior to administration of medicament of iron or in 2 hours after its reception.

to

does not recommend simultaneous application with antacids, calcium a carbonate, phosphates, oxalates, trientiny, coffee, tea, eggs, milk and dairy products which reduce iron absorption. Therefore Heferol it is necessary to accept in 1 hour prior to or in 2 hours after reception of these products.

Ascorbic acid and proteins which contain cysteine increase iron absorption. Holestiramin, food and antacids reduce absorption of iron from a digestive tract.

Iron delays absorption from a digestive tract of tetracycline, some hinolonovy means (ciprofloxacin), Methyldopum.

Iron preparations reduce absorption of Penicillaminum at their simultaneous application.

Hematologic response to therapy by iron preparations develops later at patients who at the same time receive therapy by chloramphenicol.

Salt of iron reduce absorption from a digestive tract of antibiotics from group of hinolon (ciprofloxacin, ofloxacin, levofloxacin); levodopas, Methyldopums, Penicillaminum, biphosphonates, left thyroxine (thyroxine), entakapon, zinc. Their simultaneous application is not recommended – it is necessary to accept them in 2 hours prior to or in 2 hours after administration of medicament of Heferol.

Salt of iron delay absorption of tetracycline and a holesteramin therefore this combination should not be applied. In case of need a concomitant use of these medicines, it is recommended to accept with an interval not less than 2 hours.

Salt of iron can reduce efficiency of left thyroxine.

Feature of application

should not take the medicament more than 6 months, except patients with long bleeding, a menorrhagia or repeated pregnancy.

needs to adhere to

Extra care the patient with a round ulcer and hepatitis.

For prevention of a constipation needs to wash down medicine with a large amount of liquid. If administration of medicament serves as the cause of a stomach ache, it needs to be accepted at meal time.

At some patients after gastrectomy the bad absorption of iron was revealed

.

As anemia can be microcytic type that is caused by the combined deficiency of iron and B12 vitamin or deficiency of folic acid, patients with microcytic anemia which rezistentna to therapy by iron, it is necessary to survey on deficiency of folic acid or B12 vitamin.

Iron preparations can paint a chair in black color. It can prevent tests which are used for identification of the occult blood in a chair.

Before purpose of therapy by iron to patients at the age of more than 50 years needs to find out the cause of anemia as anemia at this age can be caused by bleeding in a digestive tract.

Heferol contains lactose monohydrate therefore patients with rare hereditary intolerance of a galactose, at insufficiency of lactase and glyukozo-galaktozny malabsorption should not take this drug.

Medicine contains an azoruby (E 122) and diamond black BN (E 151) that can cause allergic reactions.

Use during pregnancy and feeding by a breast

Heferol is shown to

at deficiency of iron during pregnancy or feeding by a breast.

Prescription of medicines in the first trimester of pregnancy is recommended to

only after careful assessment of a ratio advantage/risk and only at emergency. During the last period of pregnancy iron preparations can be used only according to the recommendation of the doctor.

to Pregnant women should accept folic acid also.

Ability to influence speed of response at control of transport or other mechanisms

does not influence.

Route of administration and doses

Capsule to accept

on an empty stomach in 30 minutes prior to a breakfast, to wash down with a large amount of liquid.

Adults and children aged from 12 years: for prevention – 1 capsule a day; for treatment – 1 capsule 2 times a day.

For treatment and prevention to pregnant women in ІІ and ІІІ trimesters are appointed by usual doses, as for adults.

Patients of advanced age.

For treatment and prevention of a dose same, as well as for adults.

Course of treatment – from 6 to 12 weeks. Administration of medicament needs to be continued after normalization of a picture of peripheral blood for some time to fill up depot of iron in an organism.

dose exceeding 30 mg/kg of body weight can cause overdose symptoms In some patients. For children the medicine dose higher than 75 mg/kg of body weight can be toxic.

Children.

Capsule cannot be divided therefore there are no recommendations concerning use of the medicine "Heferol" to children up to 12 years.

Overdose

Ingestion of 20 mg/kg of elementary iron is potentially toxic

, and 200-250 mg/kg are potentially deadly. Any of methods of assessment is not completely satisfactory – it is necessary to consider both clinical features, and the laboratory analysis. The iron level in blood serum measured approximately in 4 hours after intake is the best laboratory indicator of weight of a condition of the patient.

Iron in serum	Gravity
<3 mg/l (55 µmol/l)	Light toxicity
3-5 mg/l (55-90 µmol/l)	Moderate toxicity
> 5 mg/l (90 µmol/l)	Strong toxicity

Symptoms.

Precursory symptoms and symptoms include nausea, vomiting, an abdominal pain and diarrhea. Vomiting and a chair can be gray or black. In more serious cases there can be symptoms of hypoperfusion (cold extremities and hypotension), a metabolic acidosis and system toxicity. In serious cases the recurrence of vomiting and gastrointestinal bleeding in 12 hours after reception is possible. Shock can result from a hypovolemia or direct cardiotoxicity.

At this stage there are symptoms of hepatocellular necrosis which are shown by jaundice, bleeding, a hypoglycemia, encephalopathy and a metabolic acidosis with a positive anion crack. Bad perfusion of fabrics can lead to a renal failure. Seldom, the stomach hems causing a stricture or a pyloric stenosis can lead to partial or full obstruction of intestines in 2-5 weeks after intake.

Treatment: supporting and symptomatic measures include ensuring passability of airways, monitoring of a warm rhythm, arterial blood pressure and discharge of urine, establishment of intravenous access and introduction of enough liquid for ensuring adequate hydration. It is necessary to consider need of enteroclysis. If the metabolic acidosis remains, despite correction of a hypoxia and adequate restoration of liquid, it is possible to appoint sodium bicarbonate in an initial dose of 50 mmol for adults and to repeat, if necessary, considering results of monitoring of gases of arterial blood (the purpose – rn 7.4). It is necessary to consider need of purpose of a desferrioksamin in the presence of symptoms at the patient (except nausea) if concentration of iron in blood serum makes 3-5 mg/l (55-90 mikromol/l) and continues to increase. The hemodialysis is not effective, but it can be useful at a sharp renal failure as it accelerates removal of the "iron-desferrioksamin" complex.

Side reactions

Most often at treatment by iron preparations are observed by

violations from a digestive tract: pain in epigastriums, nausea, vomiting, anorexia, coloring of excrements in black color, diarrhea, metal smack in a mouth; allergic reactions, including rash and an itch. Prolonged unjustified use can lead to a constipation and a hemosiderosis.

Expiration date

5 years.

Storage conditions

to Store

at a temperature not above 25 °C.

to Store

out of children's reach.

Packing

On 10 capsules in the blister; on 3 blisters (30 capsules) in a pack cardboard.

Category of a holiday

According to the prescription.

Producer

Skopje ABP Alkaloid.

Location of the producer and address of the place of implementation of its activity

Boulevard Alexander of Macedon, 12, Skopje, 1000, Republic Northern Macedonia.