Europe — EMA
Hidroferol (Calcifediol Monohydrate)
Hidroferol (calcifediol monohydrate) is an OTC oral vitamin D supplement used for deficiency, bone health, and related conditions in the EU.
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What is Calcifediol Monohydrate?
Hidroferol is an oral vitamin D analog containing calcifediol monohydrate as its active ingredient. It is marketed in the European Union as an over‑the‑counter product for supplementation. The formulation provides calcifediol, the 25‑hydroxy form of vitamin D, in a readily absorbable oral dosage. The product is intended for adults who require additional vitamin D to maintain normal calcium metabolism and bone health, and it is supplied without a prescription.
What is Calcifediol Monohydrate used for?
Hidroferol is used to address conditions associated with insufficient vitamin D status.
- Treatment of documented vitamin D deficiency - Management of hypocalcemia due to inadequate vitamin D - Adjunct therapy for secondary hyperparathyroidism - Support of bone health in osteopenia or osteoporosis - Prevention of falls in elderly individuals at risk of fracture - Complementary treatment in chronic kidney disease with mineral‑bone disorder
What are the side effects of Calcifediol Monohydrate?
Adverse reactions to Hidroferol are generally dose‑related and may range from mild to serious.
Common: - Mild hypercalcemia (elevated blood calcium without symptoms) - Gastrointestinal discomfort such as nausea or constipation - Headache or fatigue - Dry mouth or mild skin rash
Serious: - Symptomatic hypercalcemia (e.g., polyuria, confusion, cardiac arrhythmia) - Nephrolithiasis (kidney stone formation) - Severe allergic reactions including anaphylaxis - Hyperphosphatemia with potential vascular calcification - Acute pancreatitis in rare cases
What precautions apply to Calcifediol Monohydrate?
Before using Hidroferol, consider the following safety points.
- Do not use in patients with known hypercalcemia or a history of renal calculi. - Caution in individuals with sarcoidosis, granulomatous diseases, or other conditions that can cause excess vitamin D activation. - Pregnancy category is unknown; discuss use with a healthcare professional before conception or during pregnancy. - Elderly patients may be more susceptible to hypercalcemia and should have serum calcium monitored. - Regular monitoring of serum 25‑hydroxyvitamin D and calcium levels is recommended during prolonged therapy. - Avoid concurrent use of multiple high‑dose vitamin D products to prevent toxicity. - Discontinue if signs of severe hypercalcemia or allergic reaction develop.
What does Calcifediol Monohydrate interact with?
Hidroferol may interact with other medicines that affect calcium balance or vitamin D metabolism.
Avoid: - Thiazide diuretics, which can increase calcium reabsorption and raise hypercalcemia risk. - Calcium-containing supplements or antacids taken in high doses. - High‑dose vitamin A preparations, which may potentiate vitamin D toxicity.
Use with caution: - Glucocorticoids, which can reduce vitamin D effectiveness. - Anticonvulsant drugs such as phenytoin or phenobarbital that accelerate vitamin D catabolism. - Patients who have undergone bariatric surgery, as absorption may be altered.



