این فرآورده فاقد گلوتن، رنگ مصنوعی، مواد نگهدارنده، قند و الکل است.

Each milliliter contains

Active Ingredients	Amount
Vitamin D3	12000 IU

Each drop contains

Active Ingredients	Amount
Vitamin D3	400 IU

This product is free from gluten, artificial colors, preservatives, sugar, and alcohol.

This product contains a high amount of vitamin D in drop form.

Consult a doctor before administration.

Packaging and Dosage Form:

15 ml oral drop with a graduated dropper, accompanied by a patient information leaflet.

Therapeutic and pharmacological effects:

Vitamin D is synthesized in the skin with sun exposure. It is recommended to take vitamin D supplements in people did not take direct sun exposure. Additionally, infants and children have a higher need for vitamin D because of the physiological demands during growth and development as well as the low vitamin D content in breast milk. As a result, deficiency of this vitamin is common during these stages. Severe and prolonged vitamin D3 deficiency in children leads to rickets, a bone-softening disease, while in adults it can cause osteomalacia. Among the elderly, it increases the risk of osteoporosis and bone fractures. Because calcium is a crucial mineral for maintaining bone health throughout life. On the other hand, vitamin D can help calcium absorption in the intestine; therefore, it impacts the homeostasis of calcium in the body. Vitamin D3 is also crucial for supporting immune function and muscle activity and may help lower the risk of various cancers and autoimmune diseases like multiple sclerosis (MS). Moreover, it may reduce the risk of heart conditions such as congestive heart failure (CHF) and high blood pressure (hypertension), as well as decrease the likelihood of diabetes and hyperlipidemia (high blood cholesterol).

Side effects:

Vitamin D3 is generally well-tolerated at the recommended doses and do not cause significant side effects.

Excessive intake of vitamin D3 can lead to hypercalcemia, which may cause gastrointestinal discomfort such as nausea, vomiting, constipation, and stomach pain, as well as symptoms like fatigue, dizziness, confusion, loss of appetite, excessive urination, kidney stones, kidney damage, and even kidney failure. It can also lead to high blood pressure, cardiac abnormalities, and dehydration.

Vitamin D toxicity may also lead to elevated cholesterol, increased liver enzyme levels, and higher nitrogen levels in blood and urine. Additionally, it can cause musculoskeletal issues and complications affecting the eyes, ears, kidneys, and mental health.

Drug interactions:

While taking vitamin D supplements, the content of vitamin D in fortified food, dietary supplements, and other medications should be monitored. Thiazide diuretics may increase the risk of hypercalcemia with vitamin D. Also, vitamin D may increase digoxin toxicity. Cholestyramine and paraffin may decrease vitamin D absorption. Anti-seizure medications such as carbamazepine, phenobarbital, or phenytoin increase the requirement of body for vitamin D.

Warnings and precautions:

This supplement contains a high dose of vitamin D. Please adhere carefully to the recommended dosage.

This supplement should be used with caution in patients with:

Hyperphosphatemia (due to the risk of metastatic calcification)

Obesity (BMI >30 may require higher doses of vitamin D and should be carefully monitored)

Renal impairment

In patients receiving therapeutic doses of vitamin D, there is a risk of elevated plasma calcium, which can lead to calcium deposits in soft tissues and may cause vascular or renal calcification. It is recommended to regularly monitor plasma calcium levels in these patients, especially at the beginning of treatment or if signs of toxicity observed.

Contraindications:

This product is contraindicated in individuals with hypersensitivity to vitamin D or patients with elevated serum levels of calcium or vitamin D.

Pregnancy and breastfeeding:

Breastfeeding:

Vitamin D is secreted in breast milk. Consuming appropriate doses (less than 4000 IU) by the mother is safe, but the serum calcium and vitamin D levels in a breastfeeding infant whose mother is taking vitamin D supplements should be monitored.

Pregnancy:

Oral consumption below the maximum allowable dose (equivalent to 4000 IU) is safe. Hypercalcemia during pregnancy due to excessive vitamin D intake may lead to adverse effects on the fetus.

Storage conditions:

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