Krispofun Fe (Capsules) Instructions for Use

Marketing Authorization Holder

Artelar, LLC (Russia)

Manufactured By

VTF, LLC (Russia)

Dosage Form

Krispofun Fe

Capsules: 30 pcs.

Dosage Form, Packaging, and Product Composition

Capsules mass of 495 mg.

¹ % from recommended level of daily consumption according to TR TS 022/2011 “Food products in part of its labeling” (Appendix 2).
² % from adequate level of consumption according to “Unified sanitary-epidemiological and hygienic requirements for goods subject to sanitary-epidemiological surveillance (control)” (Appendix 5).
* does not exceed the upper permissible level of consumption according to “Unified sanitary-epidemiological and hygienic requirements for goods subject to sanitary-epidemiological surveillance (control)”.
Information on nutritional value of the product is determined by calculation method by average value of content of biologically active substance (BAS) in the product.

Composition Ascorbic acid, carrier (microcrystalline cellulose), gelatin capsule (gelatin, colorant titanium dioxide), iron pyrophosphate, rose hips extract, copper citrate, anti-caking agents (amorphous silicon dioxide, magnesium salt of stearic acid (magnesium stearate)), Folic acid, Cyanocobalamin.

15 pcs. – blisters (2) – carton packs.

Therapeutic Category

Dietary supplement – additional source of vitamins and microelements

Indications

• Krispofun Fe is a dietary supplement (not a medicine) intended as an additional source of iron, folic acid, ascorbic acid, cyanocobalamin, and copper.
• It is used to help compensate for dietary deficiencies of these micronutrients, which may be associated with an unbalanced diet, increased needs, or periods of physiological stress.
• The product may be particularly relevant for individuals with increased requirements for iron and B vitamins, such as women of childbearing age. However, any use during pregnancy or lactation should only be undertaken under strict medical supervision.
• Ascorbic acid (Vitamin C) included in the formulation is known to enhance the absorption of non-heme iron from the gastrointestinal tract, potentially increasing the efficacy of iron supplementation.

Contraindications

• Individual hypersensitivity (allergy) to any of the components of the dietary supplement, including the active ingredients or excipients such as gelatin or magnesium stearate.
• Conditions associated with iron overload (e.g., hemochromatosis, hemosiderosis) or conditions where iron accumulation is possible.
• Certain types of anemia not associated with iron deficiency, such as hemolytic anemia or anemia due to lead intoxication, where iron supplementation is not indicated and could be harmful.
• Patients with severe liver dysfunction or active peptic ulcer disease should avoid iron supplements unless specifically recommended and monitored by a physician.
• Concomitant use with certain medications, such as levodopa or penicillamine, as iron can impair their absorption. A significant time interval (at least 2-3 hours) between taking Krispofun Fe and these medications is required.

Dosage Regimen

The recommended dosage for adults is one capsule per day with meals. Taking the capsule with food can help minimize potential gastrointestinal discomfort.

The capsule should be swallowed whole with a sufficient amount of water (approximately 100-150 ml). Do not chew or crush the capsule. The duration of use is typically one month. If necessary, the course can be repeated after consulting a healthcare professional.

It is crucial to adhere to the recommended daily dose. Exceeding the stated dose is not recommended as it does not enhance the beneficial effects and may increase the risk of adverse reactions.

Before starting the supplement, especially for individuals with pre-existing chronic medical conditions (e.g., gastrointestinal diseases, liver or kidney disorders) or those taking other medications, a consultation with a doctor is mandatory.

Adverse Reactions

Adverse reactions to Krispofun Fe are generally mild and dose-related, primarily associated with the iron component. The most common reactions affect the gastrointestinal tract.

These may include nausea, epigastric pain or discomfort, constipation, diarrhea, or darkening of stools. Dark stools are a harmless and expected effect of unabsorbed iron and should not be a cause for alarm.

In rare cases, allergic reactions such as skin rash, itching, or urticaria may occur. If any signs of hypersensitivity appear, use of the supplement should be discontinued immediately.

Long-term intake of high doses of certain components can lead to other effects; for instance, excessive ascorbic acid can cause heartburn or diarrhea, while high copper intake can lead to gastrointestinal issues. Adherence to the recommended dosage minimizes these risks.

If any unusual or severe symptoms develop during the use of Krispofun Fe, you should stop taking it and seek medical advice.

Drug Interactions

Iron, contained in Krispofun Fe, can form insoluble complexes with several medications, significantly reducing their absorption and efficacy. A minimum interval of 2-3 hours is recommended between taking Krispofun Fe and the following drugs: tetracycline antibiotics, fluoroquinolones (e.g., ciprofloxacin, levofloxacin), levothyroxine, bisphosphonates (e.g., alendronate), and penicillamine.

Concomitant use with antacids containing aluminum, calcium, or magnesium, as well as with calcium supplements, can also impair iron absorption and should be taken at a different time.

Ascorbic acid enhances iron absorption but may increase the absorption of aluminum from aluminum-containing antacids, which is undesirable, especially in patients with renal impairment. It can also affect the excretion of other drugs by altering urinary pH.

Folic acid may reduce the efficacy of phenytoin (an anticonvulsant), and high doses can mask the symptoms of vitamin B12 deficiency (pernicious anemia), allowing neurological damage to progress. Patients should inform their doctor about all medications and supplements they are taking to avoid potential interactions.

Overdose

Accidental overdose of iron-containing products is dangerous and can be fatal, especially in children. Keep the product out of the reach of children. Symptoms of acute iron overdose typically occur in stages.

The initial stage (within 6 hours of ingestion) may include nausea, vomiting (sometimes bloody), abdominal pain, diarrhea, lethargy, and signs of dehydration. This may be followed by a period of apparent improvement. A subsequent, more severe stage can develop 12-48 hours later, featuring metabolic acidosis, hypoglycemia, coagulopathy, shock, liver necrosis, and multi-organ failure.

Chronic overdose (long-term intake of doses exceeding recommendations) can lead to iron overload (hemosiderosis), which can damage organs such as the liver and heart. If an overdose is suspected, immediate medical attention must be sought. Do not induce vomiting unless instructed by a medical professional. Treatment is symptomatic and may include gastric lavage, administration of chelating agents (e.g., deferoxamine), and supportive care.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

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.