GNH USA

Europe — EMA

Hidroferol

Hidroferol (calcifediol monohydrate) is an OTC oral vitamin D supplement used for deficiency, bone health, and related conditions in the EU.

Calcifediol Monohydrate

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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.

Frequently asked questions

What is the active ingredient in Hidroferol?+
Hidroferol contains calcifediol monohydrate, which is the 25‑hydroxy form of vitamin D.
How does calcifediol differ from vitamin D3 (cholecalciferol)?+
Calcifediol is already hydroxylated at the 25 position, so it is absorbed more rapidly and raises serum 25‑hydroxyvitamin D levels faster than vitamin D3, which requires two hydroxylation steps.
Who might benefit from taking Hidroferol?+
Adults with documented vitamin D deficiency, low calcium levels, secondary hyperparathyroidism, or those needing additional support for bone health such as osteopenia or osteoporosis may benefit.
Can I take Hidroferol during pregnancy?+
The pregnancy safety category for calcifediol is not established; pregnant or nursing individuals should consult a healthcare professional before use.
Do I need a prescription to buy Hidroferol in the EU?+
No, Hidroferol is classified as an over‑the‑counter (OTC) product in the European Union.
How should Hidroferol be taken?+
It is intended for oral administration; follow the product label or a healthcare provider’s guidance regarding timing and whether to take it with food.
What laboratory tests are recommended while using Hidroferol?+
Periodic measurement of serum 25‑hydroxyvitamin D and calcium levels helps ensure adequate supplementation and avoids toxicity.
What are common side effects of Hidroferol?+
Mild hypercalcemia, gastrointestinal discomfort, headache, fatigue, dry mouth, and occasional mild skin rash are among the more frequently reported effects.
When should I stop taking Hidroferol?+
If you develop symptoms of significant hypercalcemia, allergic reaction, or any serious adverse event, discontinue use and seek medical advice.
Can Hidroferol interact with other medications?+
Yes, it can interact with thiazide diuretics, calcium supplements, high‑dose vitamin A, glucocorticoids, and certain anticonvulsants, among others.
How should Hidroferol be stored?+
Store the product at room temperature, away from excess heat, moisture, and direct sunlight, and keep it out of reach of children.
Is Hidroferol suitable for people with kidney disease?+
Patients with chronic kidney disease may use Hidroferol under medical supervision, as vitamin D metabolism can be altered in this condition.
Information provided on this page is for educational use by procurement and clinical professionals. Always consult a licensed healthcare provider for medical advice and prescribing decisions. GNH USA supplies this product subject to applicable regulatory and licensing requirements.

Product details

Drug
Calcifediol Monohydrate
Route
Oral Use
Manufacturer
Faes Farma S.A.
Origin
EU

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