Packaging and pharmaceutical form

30 ml oral suspension drops with graduated dropper along with patient information leaflet

Therapeutic effects and pharmacology:

Calcium is essential for maintaining bone health throughout life and is closely linked with vitamin D, as this vitamin facilitates calcium absorption in the intestines. Due to the physiological conditions during growth and the low vitamin D content in breast milk, infants and children have a high need for vitamin D, and deficiency is common during this period. Severe vitamin D3 deficiency in children can lead to rickets, while in adults it can cause osteomalacia. Additionally, in adults and the elderly, vitamin D levels are directly associated with the risk of bone fractures and osteoporosis. Vitamin D3 also supports immune system function, muscle activity, reduces the risk of various cancers, autoimmune diseases such as multiple sclerosis, prevents cardiovascular diseases (including heart failure and hypertension), and lowers the risk of diabetes and hyperlipidemia. The most common cause of anemia is iron deficiency. Iron is a mineral essential for growth and development. The body uses iron to produce hemoglobin (the protein in red blood cells that carries oxygen from the lungs to the rest of the body) and myoglobin (the protein that delivers oxygen to muscles). Iron is also required for the production of certain hormones. The need for iron increases in breastfed infants after four months of age, and iron supplementation is recommended alongside breast milk to meet this requirement. Long-term iron deficiency can lead to physical growth delays and impairments in neurological, cognitive, behavioral, and memory development in children. Liposomes are a type of drug delivery system in which the active ingredient is enclosed within very small lipid particles to form a liposomal molecule. This formulation allows easier absorption in the body and delivers more of the drug to the target area. Because liposomal iron is encapsulated, it does not come into direct contact with the digestive tract, oral tissues such as gums and teeth, or foods and medications, eliminating common side effects of iron supplementation such as metallic taste, gastrointestinal issues like constipation and abdominal pain, tooth and gum discoloration, and interactions with other drugs and foods such as dairy products. Another essential fat-soluble vitamin for growth, development, vision maintenance, and immune support is vitamin A. Its deficiency can lead to reduced resistance to infections, night blindness, and stunted growth. Zinc is an essential mineral for tissue growth and repair and plays a key role in the body. Zinc deficiency reduces the body’s ability to fight infections.

Side effects:

Zinc, iron, and vitamins A and D3 are generally well tolerated at recommended doses and do not cause significant side effects. Excessive zinc intake can lead to copper deficiency and sideroblastic anemia (a rare type of anemia affecting red blood cell production). Overconsumption of vitamin D may result in hyperphosphatemia, hypercalcemia, hypercalciuria (elevated calcium levels in urine), and hyperphosphaturia, which can potentially cause cardiovascular and kidney damage. Signs of vitamin D overdose include loss of appetite, fatigue, nausea and vomiting, constipation, diarrhea, weight loss, increased urination, bedwetting, sweating, headache, thirst, drowsiness, and dizziness. Common gastrointestinal side effects of iron, such as abdominal pain, constipation, diarrhea, nausea, and vomiting, are minimized in the liposomal form because the iron ions do not come into direct contact with the gastrointestinal mucosa.

Drug interactions:

This product does not have any specific drug interactions in the pediatric category. Due to the liposomal form of iron in this product, it does not interact with dairy products, milk, or other drugs and minerals such as zinc. However, because the product contains vitamin D, it may generally interact with other vitamin D and calcium supplements, thiazide diuretics, digoxin, antiepileptic drugs such as carbamazepine, phenobarbital, or phenytoin, cholestyramine, and paraffin. Therefore, consult a doctor or pharmacist if you are taking any of these medications simultaneously.

Precautions and warnings:

While using this product, the intake of fortified foods, dietary supplements, and other concurrently prescribed medications should be evaluated for their vitamin A, D, and iron content to prevent vitamin toxicity. Use the product according to your doctor's instructions or the recommended doses and avoid exceeding the maximum allowed amount. To ensure accurate dosing, use the graduated dropper provided in the package. If any severe side effects occur (especially signs of hypercalcemia) or allergic reactions develop, discontinue use and consult a doctor.

Contraindications:

Do not use this product if you have hemochromatosis, hemosiderosis, hemolytic anemia, hypercalcemia (high serum calcium), metastatic calcification, evidence of vitamin D toxicity, malabsorption syndrome, abnormal sensitivity to vitamin D, or impaired kidney function. Avoid this product if you have a known allergy to any of its ingredients. This product should not be administered to children undergoing treatment with acitretin or calcipotriol.

Storage conditions:

Store at a temperature below 25°C and away from light, moisture, frost and the reach of children.