Universal reference book for medicines
Product name: TARDYFERON ® (TARDYFERON ® )

Active substance: ferrous sulfate

Type: Anti-anemic drug

Manufacturer: PIERRE FABRE MEDICAMENT PRODUCTION (France)
Composition, form of production and packaging
Tablets of prolonged action, covered with sugar shell
almost white (from white to light beige), biconvex, with a smooth, flat surface.

1 tab.

iron sulphate x 1 1/2 H 2 O 256.3 mg,

which corresponds to the iron content of 80 mg

[PRING] ascorbic acid, mucoproteosis (anhydrous), potato starch, methacrylic acid and methacrylate copolymer (Eudragit S), magnesium trisilicate, triethyl citrate, povidone, magnesium stearate, castor oil hydrogenated, talc.

Sheath composition: talc, titanium dioxide, rice starch, methyl methacrylate, dimethylaminoethyl methacrylate and butyl methacrylate copolymer (Eudragit E), carnauba wax, sucrose.

10 pieces.
- blisters (3) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.

The product description was approved by the manufacturer for the 2009 print edition.

PHARMACHOLOGIC EFFECT

Anti-anemic drug, the effect of which is due to the properties of the components that make up its composition.

Iron sulfate is a salt of iron, a microelement necessary for the synthesis of hemoglobin.
Iron is a part of hemoglobin, myoglobin and a number of enzymes. When iron is used in the form of salts, its deficiency in the body is rapidly replenished, which leads to a gradual regression of clinical (weakness, fatigue, dizziness, tachycardia, tenderness and dry skin) and laboratory symptoms of anemia.
Mucoproteosis provides better tolerability of the drug and increases bioavailability and gradual release of ferrous iron (Fe 2+ ) from the drug.

Ascorbic acid improves the absorption of iron.

A special neutral shell of the tablets ensures the absorption of active components, mainly in the distal part of the small intestine.
The absence of local irritant effect on the gastric mucosa promotes good tolerability of the drug from the gastrointestinal tract.
PHARMACOKINETICS

After taking the drug, iron absorption occurs mainly in the duodenum and in the proximal part of the jejunum.
C max of iron ions in the blood plasma is achieved 7 hours after taking the drug and remains elevated during the day. On average, 10-20% of the dose is absorbed. Absorption increases with a decrease in iron stores in the body.
Binding of iron with plasma proteins - 90% or more.
Deposited in the form of ferritin or hemosiderin in the cells of the phagocytic macrophage system, a small amount - in the form of myoglobin in the muscles. Iron is excreted with feces, urine and sweat.
INDICATIONS

- treatment and prevention of iron deficiency conditions of various etiologies (including during pregnancy and lactation, a decrease in iron absorption from the gastrointestinal tract, with prolonged bleeding, inadequate and unbalanced nutrition).

DOSING MODE

Adults and children over 6 years of age : tablets are taken orally (without chewing).
It is advisable to take the drug with water, before meals or during meals.Application for medicinal purposes: children over 6 years old - 1 tab. / Day, children older than 10 years and adults - 1-2 tablets / day.
Application for preventive purposes: pregnant women - 1 tab. / Day or every other day for the last two trimesters of pregnancy (or starting from the 4th month).

Duration of admission

Adult patients should take the drug for a period that ensures correction of anemia and restoration of the iron reserve in the body.
The dose for women is 600 mg, for men 1200 mg.
With iron deficiency anemia, the duration of admission is 3 to 6 months, depending on the degree of depletion of the iron reserve: if necessary, in the absence of adequate control of anemia, it is necessary to increase the duration of the drug intake.

SIDE EFFECT

From the digestive system: rarely - abdominal pain, nausea, vomiting, diarrhea, constipation.

In some cases , skin allergic reactions are possible.

CONTRAINDICATIONS

- anemia not related to iron deficiency (aplastic and hemolytic anemia, thalassemia, megaloblastic anemia associated with isolated vitamin B deficiency 12 );

- increased iron content in the body (hemosiderosis, hemochromatosis);

- violation of iron utilization mechanisms (sidero-sacrificial anemia, anemia caused by lead poisoning);

- stenosis of the esophagus, intestinal obstruction and / or obstructive changes in the gastrointestinal tract, acute bleeding from the gastrointestinal tract;

- fructose intolerance, glucose and galactose absorption impairment syndrome, invertase / isomaltase deficiency syndrome;

- Children's age (up to 6 years);

- Hypersensitivity to the components of the drug.

With caution should take the drug for inflammatory bowel disease, alcoholism, hepatic or renal insufficiency, peptic ulcer of the stomach and duodenum.

PREGNANCY AND LACTATION

Application for preventive purposes: pregnant women - 1 tab. / Day or every other day for the last two trimesters of pregnancy (or starting from the 4th month).

APPLICATION FOR FUNCTIONS OF THE LIVER

With caution should take the drug for kidney failure.

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

With caution should take the drug with liver failure.

APPLICATION FOR CHILDREN

Children older than 6 years : tablets are taken orally (without chewing).
It is advisable to take the drug with water, before meals or during meals. Application formedical purposes: children over 6 years old - 1 tab. / Day, children older than 10 years - 1-2 tablets / day.
Contraindicated for children under 6 years.

SPECIAL INSTRUCTIONS

Before the beginning of therapy it is necessary to determine the content of iron and ferritin in the blood serum.

In the period of taking the drug must take into account that coffee, milk, vegetables, cereals reduce the absorption of iron.

During the period of taking the drug, a dark colouration of the stool can be observed, which is due to the excretion of non-absorbed iron and has no clinical significance, as well as a false positive benzidine test.

Due to the presence of sucrose in the formulation, it is contraindicated for its use by persons with fructose intolerance, glucose absorption malabsorption syndrome and galactose insufficiency syndrome or invertase / isomaltase deficiency syndrome (rare metabolic disorders).

OVERDOSE

Symptoms: There may be an increase in the manifestations of the described side effects.

Treatment: gastric lavage with 1% aqueous sodium bicarbonate solution, symptomatic therapy.
Antidote is deferoxamine.
DRUG INTERACTION

Reduce iron absorption:

- Antacid medicines containing salts of aluminum, calcium, magnesium, calcium preparations, etidronic acid, drugs that reduce the acidity of gastric juice (including cimetidine);

- medicines containing carbonates, hydrocarbonates, phosphates, oxalates;

- pancreatin, pancreolipase.

Mutually reduce absorption when combined:

- tetracyclines, D-penicillamine, tea, egg yolk.

If necessary, combining with the above drugs or foods, iron preparations should be taken 1 hour before or 2 hours after they are consumed.

Increase absorbability:

- ascorbic acid, ethanol (including increases the risk of toxic complications).

Iron drug in high doses reduces the absorption of zinc.

Do not administer together with other iron preparations, incl.
for parenteral use, to avoid an overdose.
TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

Keep out of the reach of children at temperatures up to 30 ° C.
Shelf life - 3 years.
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