Europe — EMA
Hidroferol
Learn about Hidroferol (calcifediol monohydrate) – its uses, mechanism, side effects, precautions, and drug interactions for vitamin D supplementation.
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What is Calcifediol Monohydrate?
Hidroferol is an oral, over‑the‑counter product that contains calcifediol monohydrate as its active ingredient. It is supplied in tablet or capsule form (strength not specified) and is marketed in the European Union as a vitamin D analog for supplementation. Calcifediol is the 25‑hydroxy metabolite of vitamin D3, directly raising circulating 25‑hydroxyvitamin D levels in adults with low vitamin D status. It is available without a prescription and can be used under medical guidance.
What is Calcifediol Monohydrate used for?
Hidroferol is used to address conditions related to inadequate vitamin D status.
- Treatment of vitamin D deficiency in adults. - Management of secondary hyperparathyroidism, particularly in chronic kidney disease. - Support of bone mineralization in individuals at risk of osteomalacia. - Adjunct to calcium supplementation for maintaining normal serum calcium and phosphate concentrations. - Prevention of hypocalcemia in patients receiving long‑term glucocorticoid therapy.
What are the side effects of Calcifediol Monohydrate?
Adverse reactions to Hidroferol are generally related to excessive vitamin D activity.
Common: - Mild hypercalcemia (elevated serum calcium) - Nausea or vomiting - Constipation or abdominal discomfort - Headache - Fatigue
Serious: - Severe hypercalcemia with cardiac arrhythmia - Nephrolithiasis or renal impairment - Hypercalciuria leading to kidney stones - Allergic reactions such as rash or angioedema - Hyperphosphatemia in susceptible individuals
What precautions apply to Calcifediol Monohydrate?
Before using Hidroferol, consider the following precautions.
- Assess baseline serum calcium, phosphate, and 25‑hydroxyvitamin D levels. - Use cautiously in patients with a history of hypercalcemia, kidney stones, or renal disease. - Monitor for signs of hypercalcemia, especially when combined with calcium or vitamin D supplements. - Avoid use in individuals with known hypersensitivity to calcifediol or excipients. - Pregnant or breastfeeding women should consult a healthcare professional before use. - Adjust dosage in patients with malabsorption syndromes or liver impairment.
What does Calcifediol Monohydrate interact with?
Hidroferol may interact with several medications.
Avoid: - High‑dose calcium supplements or vitamin D preparations that could cause hypercalcemia. - Thiazide diuretics, which reduce urinary calcium excretion and increase hypercalcemia risk. - Certain antacids containing calcium or magnesium that may affect absorption.
Use with caution: - Corticosteroids, which can alter vitamin D metabolism. - Anticonvulsants (e.g., phenobarbital, phenytoin) that increase vitamin D catabolism. - Bisphosphonates, as altered calcium levels may affect their efficacy. - Loop diuretics, which increase calcium excretion and may require monitoring.
Frequently asked questions
What is the active ingredient in Hidroferol?+
How does Hidroferol differ from regular vitamin D3 supplements?+
Can Hidroferol be taken without a prescription in the EU?+
What conditions is Hidroferol commonly used for?+
Is it safe to use Hidroferol together with calcium supplements?+
What are the most frequent side effects of Hidroferol?+
Which serious adverse reactions should prompt medical attention?+
Should patients with kidney disease avoid Hidroferol?+
Can pregnant women use Hidroferol?+
What medications should be avoided while taking Hidroferol?+
How often should serum 25‑hydroxyvitamin D be measured while on Hidroferol?+
Is there a risk of overdose with Hidroferol?+
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