Megadin Pronatal (Tablets) Instructions for Use

Marketing Authorization Holder

Mecom Saglik Urunleri, San. ve Tic. A.S. (Turkey)

Manufactured By

Abdi Ibrahim Ilac Sanayi ve Tic., A.S. (Turkey)

ATC Code

A11AA03 (Multivitamins and other minerals, including their combinations)

Dosage Form

Megadin Pronatal

Coated tablets: 30 pcs.

Dosage Form, Packaging, and Composition

Tablets, coated dark yellow color, oblong, biconvex, with an image of the company logo on one side.

Auxiliary substances : povidone, microcrystalline cellulose PH 102, lactose, magnesium stearate, sodium croscarmellose, talc.

Composition of the coating hypromellose E-5, polyethylene glycol 6000, talc, titanium dioxide, iron oxide yellow (III).

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

Clinical-Pharmacological Group

Multivitamins with macro- and microelements

Pharmacotherapeutic Group

Multivitamin agent + multimineral

Indications

• Preconception and Prenatal Care: Megadin Pronatal is specifically formulated to meet the increased nutritional demands of women during the preconception period, throughout pregnancy, and in the postpartum phase, particularly during lactation. It is intended to supplement the diet to prevent and correct deficiencies of vitamins and minerals.
• Nutritional Supplementation: Used for the prevention and treatment of vitamin and mineral deficiencies that may arise due to increased physiological needs, inadequate dietary intake, or conditions leading to malabsorption in women of childbearing age.
• Folic Acid Supplementation: The high dose of folic acid (800 mcg) is critical for the prevention of neural tube defects in the developing fetus when taken prior to conception and during the early stages of pregnancy. Adequate folic acid levels are essential for maternal tissue growth and red blood cell formation.
• Iron and Calcium Support: Provides substantial amounts of iron to help prevent iron-deficiency anemia, a common condition in pregnancy, and calcium to support the development of the fetal skeleton and maintain maternal bone mineral density.

Contraindications

• Hypersensitivity: Megadin Pronatal is contraindicated in patients with a known hypersensitivity (allergy) to any of the active substances or to any of the excipients listed in the composition. Reactions may include rash, urticaria, or more severe anaphylactic responses.
• Hypervitaminosis: The product is contraindicated in cases of hypervitaminosis A or D. Due to the presence of retinol (Vitamin A), which can be teratogenic in high doses, and ergocalciferol (Vitamin D), use in patients with pre-existing elevated levels of these vitamins is not recommended.
• Severe Renal Impairment: Contraindicated in patients with severe renal impairment or renal failure due to the risk of accumulation of minerals and electrolytes, which the kidneys may not be able to adequately excrete, potentially leading to hypercalcemia, hypermagnesemia, or other electrolyte imbalances.
• Hemochromatosis and Wilson’s Disease: Contraindicated in patients with hemochromatosis (iron overload disorder), hemosiderosis, or Wilson’s disease (copper accumulation disorder) due to the significant iron and copper content in the formulation, which could exacerbate these conditions.
• Hypercalcemia and Hypercalciuria: Contraindicated in conditions associated with hypercalcemia (elevated blood calcium) and hypercalciuria (elevated calcium in urine), as the calcium and vitamin D content may worsen these states.

Dosage Regimen

The standard dosage for adult women is one tablet taken orally once daily, unless otherwise directed by a physician.

The tablet should be swallowed whole with a full glass of water and should not be chewed or crushed. To enhance iron absorption and minimize potential gastrointestinal discomfort, it is generally recommended to take the tablet on an empty stomach, at least one hour before or two hours after a meal. If significant stomach upset occurs, the tablet may be taken with a small amount of food, although this may slightly reduce the absorption of iron.

For optimal prevention of neural tube defects, supplementation with folic acid should ideally begin at least one month prior to conception and continue through the first trimester. The entire formulation is intended for use throughout pregnancy and the postpartum period, especially during breastfeeding, as directed by a healthcare professional. It is important to adhere to the prescribed dosage and not to exceed it, as this can lead to toxic accumulation of fat-soluble vitamins (A, D, E, K) and minerals.

Adverse Reactions

Like all medicines, Megadin Pronatal can cause adverse reactions, although not everybody gets them. Adverse reactions are generally mild and transient in nature.

Gastrointestinal disorders are the most commonly reported. These may include nausea, vomiting, epigastric pain, abdominal discomfort, constipation, or diarrhea. These effects are often attributable to the high iron content and may be mitigated by taking the tablet with food, as previously mentioned, if tolerated.

Other, less frequent adverse reactions may involve allergic skin reactions such as rash, pruritus (itching), and urticaria (hives). In rare cases, hypersensitivity reactions including anaphylaxis may occur. Some individuals may experience headache or dizziness.

Long-term ingestion of doses exceeding the recommended daily intake can lead to hypervitaminosis. Symptoms of Vitamin A hypervitaminosis may include dry skin, desquamation, alopecia, bone and joint pain, fatigue, headache, and increased intracranial pressure. Chronic overdose of Vitamin D can result in hypercalcemia and hypercalciuria, manifesting as nausea, vomiting, constipation, weakness, and renal impairment. It is crucial to inform your doctor of any adverse effects experienced while taking this medication.

Drug Interactions

Concomitant use of Megadin Pronatal with other medicinal products should be done with caution and under medical supervision due to potential interactions.

The iron component can form insoluble complexes with tetracycline and fluoroquinolone antibiotics, levodopa, levothyroxine, methyldopa, and bisphosphonates (e.g., alendronate). This can significantly reduce the absorption and efficacy of both the iron and the co-administered drug. To avoid this, a dosing interval of at least 2-3 hours should be maintained between taking Megadin Pronatal and these medications.

Antacids, H2-receptor antagonists (e.g., ranitidine), and proton pump inhibitors (e.g., omeprazole) reduce gastric acidity, which can impair the absorption of iron. It is advisable to separate administration by several hours. The calcium in the formulation may also interfere with the absorption of tetracyclines and thyroid hormones.

Vitamin C (ascorbic acid) enhances the absorption of iron. While this is beneficial, it is a consideration if the patient is on other iron preparations. Vitamin K can antagonize the effect of oral anticoagulants like warfarin, potentially reducing their anticoagulant effect. Patients on such therapy should have their INR monitored closely. Folic acid may decrease the serum concentrations of certain antiepileptic drugs (e.g., phenytoin, phenobarbital), potentially reducing seizure control.

Overdose

In the event of an acute overdose, the clinical picture will be largely determined by the iron content, especially in young children, where iron toxicity can be severe and potentially fatal.

Symptoms of acute iron overdose may appear within hours and include nausea, vomiting (which may be bloody), abdominal pain, diarrhea, lethargy, metabolic acidosis, and hypovolemic shock. In severe cases, it can progress to hepatic necrosis, coagulopathy, coma, and death. Chronic overdose, as mentioned, leads to symptoms of hypervitaminosis A and D.

There is no specific antidote for a multivitamin/mineral overdose. Treatment is supportive and symptomatic. In case of suspected acute iron overdose, gastric lavage or induction of emesis may be considered if performed soon after ingestion. Serum iron levels and total iron-binding capacity should be measured. Chelation therapy with deferoxamine may be necessary in cases of severe iron intoxication. For hypercalcemia resulting from vitamin D overdose, treatment includes withdrawal of the supplement, a low-calcium diet, hydration, and possibly loop diuretics. It is imperative to seek immediate medical attention or contact a poison control center in case of suspected overdose.

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

Rx Only

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.