GNH USA

Europe — EMA

Hidroferol

Hidroferol (calcifediol monohydrate) is an oral vitamin D supplement for deficiency, bone health, and secondary hyperparathyroidism.

Calcifediol Monohydrate

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What is Calcifediol Monohydrate?

Hidroferol is an oral vitamin D analogue containing the active ingredient calcifediol monohydrate. The product is marketed in the European Union as an over‑the‑counter supplement, with the specific strength and dosage form not disclosed in the available data. Calcifediol is a pre‑hormone of vitamin D that helps maintain normal calcium and phosphate levels in the body.

What is Calcifediol Monohydrate used for?

Hidroferol is used to address conditions related to insufficient vitamin D activity. It is commonly recommended in the following situations:

- Vitamin D deficiency confirmed by laboratory testing - Secondary hyperparathyroidism associated with chronic kidney disease - Support of bone health in adults at risk of osteopenia - Adjunct therapy for patients with malabsorption syndromes affecting vitamin D - Prevention of hypocalcemia in individuals with limited sun exposure

What are the side effects of Calcifediol Monohydrate?

Adverse reactions to Hidroferol are generally uncommon but can occur. They are categorized by frequency and severity.

Common: - Mild gastrointestinal discomfort (nausea, abdominal pain) - Transient headache - Slight increase in serum calcium levels without symptoms - Fatigue or drowsiness - Skin rash or mild itching

Serious: - Hypercalcemia presenting with nausea, vomiting, polyuria, or cardiac arrhythmia - Severe allergic reaction (anaphylaxis, angioedema) - Persistent elevated serum phosphate levels - Renal impairment due to calcium deposition

What precautions apply to Calcifediol Monohydrate?

Before using Hidroferol, consider the following safety points:

- Assess baseline serum calcium, phosphate, and vitamin D levels to avoid overtreatment. - Use caution in patients with a history of hypercalcemia, kidney stones, or renal disease. - Monitor calcium and phosphate periodically during long‑term therapy. - Pregnant or breastfeeding individuals should consult a healthcare professional, as safety data are limited. - Individuals taking thiazide diuretics may be at increased risk of hypercalcemia. - Discontinue use and seek medical advice if symptoms of hypercalcemia develop.

What does Calcifediol Monohydrate interact with?

Hidroferol may interact with other medicines, affecting calcium balance or vitamin D metabolism.

Avoid: - High‑dose calcium supplements taken concurrently without monitoring. - Vitamin D analogues (e.g., calcitriol) that could lead to excess active vitamin D. - Certain anticonvulsants (e.g., phenobarbital, phenytoin) that increase vitamin D catabolism.

Use with caution: - Thiazide diuretics, which reduce urinary calcium excretion. - Corticosteroids, which may impair vitamin D activation. - Bisphosphonates, as combined effects on bone metabolism require monitoring. - Mineral oil or cholestyramine, which can reduce absorption of fat‑soluble vitamins.

Frequently asked questions

What is the active ingredient in Hidroferol?+
The active ingredient in Hidroferol is calcifediol monohydrate, a vitamin D analogue.
How does calcifediol differ from regular vitamin D supplements?+
Calcifediol is the 25‑hydroxy form of vitamin D, which is more rapidly converted to the active hormone calcitriol, allowing faster correction of low vitamin D status.
Can Hidroferol be used without a prescription?+
Yes, Hidroferol is classified as an over‑the‑counter (OTC) product in the European Union.
What conditions might a doctor recommend Hidroferol?+
Doctors may recommend Hidroferol for vitamin D deficiency, secondary hyperparathyroidism, and to support bone health in individuals at risk of osteopenia.
Is it safe to take Hidroferol during pregnancy?+
Safety data for use during pregnancy are limited; pregnant individuals should discuss potential benefits and risks with a healthcare professional before starting Hidroferol.
How should I store Hidroferol?+
Store the product at room temperature, away from direct sunlight and moisture, and keep it out of reach of children.
What laboratory tests are useful before starting Hidroferol?+
Baseline measurements of serum calcium, phosphate, and 25‑hydroxyvitamin D levels are helpful to guide therapy and avoid overtreatment.
Can I take Hidroferol with calcium supplements?+
Calcium supplements can be taken, but total calcium intake should be monitored to prevent hypercalcemia, especially if using high‑dose Hidroferol.
What are the signs of hypercalcemia while using Hidroferol?+
Symptoms may include nausea, vomiting, excessive thirst, frequent urination, muscle weakness, and irregular heartbeats. Seek medical attention if these occur.
Does Hidroferol interact with cholesterol‑lowering medications?+
There are no direct interactions reported with statins, but any medication affecting liver metabolism could theoretically influence vitamin D processing; consult a pharmacist if concerned.
How long does it take for Hidroferol to raise vitamin D levels?+
Calcifediol is absorbed quickly and typically raises serum 25‑hydroxyvitamin D concentrations within a few days, faster than cholecalciferol (vitamin D3).
Should I stop Hidroferol before surgery?+
There is no standard requirement to discontinue Hidroferol before surgery, but discuss all supplements with your surgeon or anesthesiologist.
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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