Aktiferrin compositum (Capsules) Instructions for Use

Marketing Authorization Holder

Teva Pharmaceutical Industries, Ltd. (Israel)

Manufactured By

Catalent Germany Eberbach, GmbH (Germany)

ATC Code

B03AE10 (Iron preparations in combination with other drugs)

Active Substances

Folic acid (Rec.INN registered by WHO)

Ferrous sulfate (USP United States Pharmacopeia)

Serine (Rec.INN registered by WHO)

Dosage Form

Aktiferrin compositum

Capsules 113.85 mg+129 mg+0.5 mg: 30 pcs.

Dosage Form, Packaging, and Composition

Capsules longitudinally colored, one half light brown, the other half dark brown, with the white inscription “Aktiferrin F”, size No. 6; the capsule contents are an oily paste of a greyish-yellow color.

* +15% overage 0.575 mg.

Excipients: rapeseed oil – 123.96 mg, yellow beeswax – 10.33 mg, hydrogenated soybean oil – 10.33 mg, partially hydrogenated soybean oil – 41.32 mg, soy lecithin – 10.635 mg.

Capsule shell composition sorbitol – 26.95 mg, glycerol 85% – 41.49 mg, gelatin – 165.82 mg, iron oxide black color (E172) – 1.11 mg, titanium dioxide (E171) – 0.93 mg, iron oxide yellow color (E172) – 0.15 mg, iron oxide brown color (E172) – 0.37 mg, iron oxide red color (E172) – 0.65 mg, white printing ink – q.s. (titanium dioxide – 37.96%, ethyl acetate – 1.03%, shellac – 26.62%, butanol – 14.75%, methanol – 19.64%).

10 pcs. – blisters (3) – cardboard packs.

Clinical-Pharmacological Group

Antianemic drug

Pharmacotherapeutic Group

Iron preparation

Pharmacological Action

A drug for the treatment of iron deficiency conditions in the body, accompanied by folic acid deficiency. It is also used to cover the increased need for iron and folic acid during pregnancy.

Iron is necessary for the vital activity of the body: it is part of hemoglobin, myoglobin, various enzymes; reversibly binds oxygen and participates in a number of redox reactions; stimulates erythropoiesis.

The α-amino acid included in Aktiferrin compositum – d,l-Serine promotes more efficient absorption of iron and its entry into the systemic bloodstream, leading to a rapid restoration of its normal content in the body. This allows reducing the dose of iron, ensuring better tolerability and excluding the acute toxicity of the drug.

Pregnant women who took Aktiferrin compositum from the 22nd week of pregnancy, by the 30th week of pregnancy, have a higher iron content in the blood than pregnant women who did not take the drug. The iron content in the blood of newborns is also higher in cases where their mothers took Aktiferrin compositum during pregnancy.

Folic acid, which is part of Aktiferrin compositum, is involved in the synthesis of amino acids, nucleotides, nucleic acids; it is necessary for normal erythropoiesis. During pregnancy, it performs, to a certain extent, a protective function against the action of teratogenic factors.

Cyanocobalamin (vitamin B₁₂) is involved in the synthesis of nucleotides; it is an important factor for normal growth, hematopoiesis and the development of epithelial cells; it is necessary for the metabolism of folic acid and the synthesis of myelin. Vitamin B₁₂ deficiency leads to so-called pernicious anemia. Meeting the need for vitamin B₁₂ during pregnancy is crucial for the normal development of the child.

Pharmacokinetics

After oral administration, the iron contained in the drug is sufficiently completely absorbed from the gastrointestinal tract into the systemic bloodstream.

Indications

• Treatment of iron deficiency anemia with concomitant folic acid deficiency;
• Conditions accompanied by an increased need of the body for these substances, especially during pregnancy.

ICD codes

Dosage Regimen

Aktiferrin compositum capsules are taken orally during meals, without chewing and with a sufficient amount of water.

If the attending physician has not prescribed a different dosage, then the instructions below should be strictly followed.

Daily dose: 1 capsule. Depending on the severity of the disease, the dose can be increased to 2-3 capsules/day.

After achieving normal serum iron and hemoglobin levels, treatment with the drug is continued for at least another 4 weeks.

Adverse Reactions

The occurrence of side effects must be reported to the attending physician.

Aktiferrin compositum is usually well tolerated by patients of any age. Only in individual cases, especially with high dosages and long-term treatment, mild complaints from the gastrointestinal tract (flatulence, constipation, diarrhea) may be observed. When the dose is reduced, these phenomena usually disappear.

Very rarely, hypersensitivity reactions to folic acid may occur: skin redness, bronchial muscle spasms, nausea, irritability, excitability, sleep disorder with nightmares.

In patients with epilepsy, an increase in the frequency of seizures is possible.

In individual cases, loss of appetite, bitter taste in the mouth may be observed.

Contraindications

• Hemolytic and aplastic anemia;
• Hemosiderosis, hemochromatosis;
• Sideroblastic anemia, anemia in lead poisoning, thalassemia;
• Other types of anemia not caused by iron deficiency in the body;
• Hypersensitivity to folic acid.

Use in Pregnancy and Lactation

The use of Aktiferrin compositum during pregnancy and breastfeeding is considered justified and safe.

Special Precautions

Aktiferrin compositum capsules should not be taken with black tea, coffee, milk to avoid reduced iron absorption. Furthermore, reduced absorption can be caused by: solid food, bread, raw cereals, dairy products, eggs.

When taking Aktiferrin compositum, stool may turn black, which is not clinically significant.

Overdose

In case of accidental intake of particularly large doses of Aktiferrin compositum capsules (all capsules from one package), overdose phenomena may be observed.

Symptoms: abdominal pain, diarrhea, vomiting, cyanosis, confusion, hyperventilation symptoms.

Treatment: before specific therapy – intake of milk, raw egg. Specific therapy is carried out by prescribing deferoxamine (desferal) orally and parenterally. In case of acute poisoning, to bind iron that has not yet been absorbed from the gastrointestinal tract, 5-10 g of the drug is given orally by dissolving the contents of 10-20 ampoules in drinking water. To remove absorbed iron, deferoxamine is administered intramuscularly at 1-2 g every 3-12 hours.

In severe cases accompanied by the development of shock in patients, 1 g of the drug is administered intravenously by drip and symptomatic therapy is carried out.

Drug Interactions

Simultaneous use of Aktiferrin compositum and

• Tetracycline antibiotics causes mutual impairment of absorption;
• Antacids and cholestyramine prevents the absorption of iron;
• Oral contraceptives, anticonvulsants (phenytoin, primidone, barbiturates) and pyrimethamine leads to a decrease in blood folate levels;
• Chloramphenicol prevents the therapeutic effect of folic acid treatment;
• Colchicine, neomycin, biguanides, para-aminosalicylic acid and ethyl alcohol prevents the absorption of cyanocobalamin.

Storage Conditions

Store at a temperature not exceeding 25°C (77°F), in a place inaccessible to children.

Shelf Life

Shelf life – 4 years. Do not use after the expiration date.

Dispensing Status

The drug is dispensed by prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.