Expiration date: 11/2026
The composition and form of issue:
Drops for reception inside. 1 ml contains:
iron in the form polymaltose complex iron (III) hydroxide 50 mg
excipients: sodium methyl parahydroxybenzoate, sodium parahydroxybenzoate, sodium hydroxide sucrose purified water, flavoring cream
1 ml contains 20 drops
1 drop contains 2.5 mg of iron
in dark glass bottles of 10 or 30 ml, sealed PE drip dispenser, enclosed screw-on plastic caps with safety ring of the first control opening or polymer containers (tubes) for 10 or 30 ml, with integrated drip feeders, enclosed screw-on plastic caps with tamper-evident and the mechanism for protection against opening by children in a box 1 vial or container of polymer.
Syrup. 1 ml contains:
iron in the form polymaltose complex iron hydroxide (III) 10 mg
excipients: methyl parahydroxybenzoate parahydroxybenzoate sodium hydroxide solution, sorbitol 70% ethanol 96% (3,25 mg) water sucrose flavoring cream
in dark glass bottles, 75 or 150 ml, closed screw caps from high density polyethylene with a tamper-evident, and measuring cap, put on the lid in gift box 1 bottle.
Chewable tablets, 1 tab. contains:
iron in the form polymaltose complex iron hydroxide (III) 100 mg
excipients: dexterity vanillin, sodium cyclamate, purified talc macrogol 6000 chocolate flavor cocoa powder MKC
blistere in 10 PCs in the paper cartons 1, or 3 blisters.
The oral solution. 1 ml contains:
iron in the form polymaltose complex iron hydroxide (III) 20 mg
excipients: sodium methyl parahydroxybenzoate, sodium parahydroxybenzoate, sodium hydroxide, sorbitol solution 70% distilled water sucrose, flavoring cream
vials clear glass hydrolytic class, closed stretched PE caps for 5 ml in a cardboard pack of 10 bottles.
Description pharmaceutical form:
Drops for oral administration, oral solution and syrup: liquid dark brown color.
Chewable tablets: valium brown, with inclusions of white color, and scored.
Description pharmacological action:
Contains iron in the form polymaltose complex ferric hydroxide (III). This macromolecular complex is stable and does not emit iron in the form of free ions in the digestive tract. The structure of the drug Maltofer similar to the natural compound of iron — San. Due to this similarity, iron (III) is transported from intestine to the blood by active transport. The absorbed iron associated with the San and is stored in the body, mainly in the liver. Then in the bone marrow, it is included in the composition of hemoglobin. Iron, part polymaltose complex ferric hydroxide (III), does not possess prooxidant properties, unlike simple salts of iron. There is a correlation between the severity of iron deficiency and the level of its absorption (the more the severity of iron deficiency, the better suction). The most active absorption occurs in the duodenum and small intestine.
The drug Maltofer does not cause staining of tooth enamel.
Indications:
latent iron deficiency and clinically evident iron deficiency (iron deficiency anemia)
prevention of iron deficiency in women during pregnancy, breastfeeding, of childbearing age, children, including Teens, adults (such as vegetarians and the elderly).
Contraindications:
iron overload (e.g., hemosiderosis and hemochromatosis)
violation of iron utilization (lead anemia, anemia sideroahrestical)
nieestetyczne anemia (hemolytic, megaloblastnaya caused by the lack of vitamin B12).
Application of pregnancy and breast-feeding:
In controlled studies in pregnant women after the first trimester of pregnancy had no adverse effects on the mother and fetus. Negative effects exerted by the drug on the fetus during the first trimester of pregnancy were revealed.
Side effects:
On the part of the digestive tract: very rare (&ge0,001% and <0.01%) — feeling of fullness, pressure in the epigastric region, nausea, constipation or diarrhea possible dark staining of feces, due to the release of iron nevsosavsheysya and having no clinical significance.
Drug interactions:
It is not revealed.
Method of application and dose:
Inside, during or immediately after a meal (drops, solution, and syrup is mixed with fruit, vegetable juices or soft drinks, pills, chewing or swallowing whole). Daily dose of the drug depends on the degree of iron deficiency (see table).
Table
Daily doses of the drug Maltofer
| Category of patients | The form of the drug | Iron deficiency anemia | Latent iron deficiency | Prevention |
| Premature infants | Drops for reception inside | 1-2 drops per kg body mass for 3-5 months | — | — |
| Children up to 1 year | Drops for reception inside | 10–20 drops (25–50 mg of iron) | 6–10 drops (15–25 mg of iron) | 6–10 drops (15–25 mg of iron) |
| Syrup | 2,5–5 ml (25–50 mg of iron) | * | * | |
| Children from 1 year to 12 years | Drops for reception inside | 20–40 drops (50–100 mg of iron) | 10–20 drops (25–50 mg of iron) | 10–20 drops (25–50 mg of iron) |
| Syrup | 5–10 ml (50–100 mg of iron) | 2,5–5 ml (25–50 mg of iron) | 2,5–5 ml (25–50 mg of iron) | |
| Children older than 12 years | Drops for reception inside | 40–120 drops (100–300 mg of iron) | 20–40 drops (50–100 mg of iron) | 20–40 frops (50–100 mg of iron) |
| Syrup | 10–30 ml (100–300 mg of iron) | 5–10 ml (50–100 mg of iron) | 5–10 ml (50–100 mg of iron) | |
| Adults (including breastfeeding women) | Drops for reception inside | 40–120 drops (100–300 mg of iron) | 20–40 srops (50–100 mg of iron) | 20–40 drops (50–100 mg of iron) |
| Syrup | 10–30 ml (100–300 mg of iron) | 5–10 ml (50–100 mg of iron) | 5–10 ml (50–100 mg of iron) | |
| Tablets | 1–3 tablets . (100–300 mg of iron) | 1 tablet (50–100 mg of iron) | ** | |
| The solution for the reception inside | 1–3 fl. (100–300 mg of iron) | 1 fl. (50–100 mg of iron) | ** | |
| Pregnant women | Drops for reception inside | 80–120 drops (200–300 mg of iron) | 40 drops (100 mg of iron) | 40 drops (100 mg of iron) |
| Syrup | 20–30 ml (200–300 mg of iron) | 10 ml (100 mg of iron) | 10 ml (100 mg of iron) | |
| Tablets | 2–3 tablets (200–300 mg of iron) | 1 tablet (100 mg of iron) | 1 tablet (100 mg of iron) | |
| The solution for the reception inside | 2–3 fl. (200–300 mg of iron) | 1 fl. (100 mg of iron) | 1 fl. (100 mg of iron) |
* In connection with the need to use very small doses for these indications it is recommended to use the drug Maltofer drops for reception inside.
** In connection with the need to use small doses in these indications it is recommended to use the drug Maltofer drops for reception inside or Maltofer syrup.
The duration of treatment clinically expressed iron deficiency (iron deficiency anemia) is 3-5 months, until the normalization of hemoglobin levels. After that the drug should continue the dosage for the treatment of latent iron deficiency for several months, and for pregnant women, at least until delivery to restore iron stores.
The duration of treatment of latent iron deficiency is 1-2 months.
In case of clinically expressed iron deficiency, normalization of hemoglobin and replenishment of iron stores occurs only after 2-3 months after the start of treatment.
Overdose:
In cases of drug overdose to date, not been described or signs of intoxication or signs of excess of iron in the body.
Special instructions:
Patients with diabetes should be aware that 1 ml drops reception inside contains 0.01 XE, 1 ml of syrup 0,04 XE 1 tablet — 0,04 XE and 1 vial (5 ml) — 0,11 HEH.
