Leaflet: information for the user

Hidroferol 0.266 mg soft capsules

calcifediol monohydrate

Read this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only, and you must not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

1. What is Hidroferol 0.266 mg soft capsules and what it is used for

2. What you need to know before you start taking Hidroferol 0.266 mg soft capsules

3. How to take Hidroferol 0.266 mg soft capsules

4. Possible side effects

5. Storage of Hidroferol 0.266 mg capsules

6. Contents of the pack and additional information

It contains a form of vitamin D, calcifediol, which is used to treat vitamin deficiency and the problems that arise from it. Vitamin D acts in the human body, among other actions, by increasing calcium absorption.

Hidroferol 0,266 mg soft capsules is indicatedfor the treatment of vitamin D deficiency in adults and to prevent vitamin D deficiency in adults with identified risks such as patients with malabsorption syndrome, chronic kidney disease – mineral bone disease (CKD-MBD) or any other identified risk.

It is also used to treat bone loss (osteoporosis), in combination with other medications in patients with vitamin D deficiency or at risk of vitamin D deficiency.

Do not takeHydroferol 0.266 mg soft capsules

-if you are allergic to calcifediol or any of the other components of this medication (listed in section 6).

-if you have hypercalcemia (elevated levels of calcium in the blood) or hypercalciuria (elevated levels of calcium in the urine).

-if you have a history of kidney stone formation.

-if you have hypervitaminosis D (excess of vitamin D in the body).

Warnings and precautions

Consult your doctor before starting to takeHydroferol 0.266 mg soft capsules.

-Do not exceed the recommended daily doses of vitamin D supplements, such as this medication, as it may cause an overdose (see section 3, subsectionIf you take moreHydroferol 0.266 mg soft capsulesthan you should).

-Your doctor may recommend blood and urine tests to monitor your calcium, phosphorus, and other parameter levels while taking this medication.

-Patients with kidney disease require special caution and should be closely monitored by their doctor, with regular blood and urine tests.

-Patients with heart disease require special caution and should be closely monitored by their doctor for blood calcium levels, especially those taking cardiac glycosides (see this section, subsectionOther medications andHydroferol0.266 mg soft capsules).

-If you have hypoparathyroidism (insufficient parathyroid hormone function), the effect of this medication may be reduced.

-If you have a history of kidney stone formation, your doctor should monitor your blood calcium levels.

-Patients with prolonged immobilization may require lower doses of this medication.

-Patients with sarcoidosis (disease with nodules, usually on the skin), tuberculosis, or other diseases with nodules should exercise special caution with this medication, as they are at higher risk of experiencing adverse effects at lower doses. Regular blood and urine tests should be performed to monitor calcium levels.

Interference with diagnostic tests: Inform your doctor if you are to undergo any diagnostic tests (including blood, urine, skin tests using allergens, etc.) as this medication may affect the results. For example, in some cholesterol tests.

Children and adolescents

This medication has not been established as safe and effective in children and adolescents under 18 years of age. No data is available.

Other medications andHydroferol 0.266 mg soft capsules

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication, including those purchased without a prescription.

Some medications may affect the way this medication works. On the other hand, its active ingredient, calcifediol monohydrate, may affect the efficacy of other medications taken at the same time.

Therefore, interactions may occur with the following medications:

-Medications used to treat epilepsy (such as phenytoin, phenobarbital, and primidone) and other enzyme-inducing medications (which may decrease the effect of Hydroferol).

-Heart medications and/or high blood pressure medications, such as cardiac glycosides, thiazide diuretics, or verapamil.

-Colestiramine, colestipol (for cholesterol), orlistat (for obesity): Take these medications and calcifediol at least 2 hours apart.

-Mineral oil or paraffin (laxatives): Use another type of laxative or take these medications and calcifediol at different times.

-Some antibiotics (such as penicillin, neomycin, and chloramphenicol).

-Magnesium salts.

-Other products containing vitamin D.

-Calcium supplements.

-Corticosteroids (anti-inflammatory medications).

Hydroferol 0.266 mg soft capsules with food and beverages

Some foods and beverages are fortified with vitamin D. This should be taken into account as the effects of these foods may add to the effects of this medication and result in excessive levels.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

Do not take this medication during pregnancy.

Do not take this medication while breastfeeding your child.

Driving and operating machinery

This medicationdoes not affect your ability to drive vehicles or operate machinery.

Hydroferol 0.266 mg soft capsules contain ethanol, sorbitol (70%) (E-420), and yellow-orange colorant S (E-110).

This medication contains 5 mg of alcohol (ethanol) in each soft capsule. The amount in one capsule of this medication is equivalent to less than 1 ml of beer or 1 ml of wine. The small amount of alcohol in this medication has no perceptible effect.

This medication contains 22 mg of sorbitol in each soft capsule, equivalent to 0.03 mg/mg.

This medication may cause allergic reactions because it contains yellow-orange colorant S (E-110).

Follow exactly the administration instructions of this medication indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Do not take more medication or take it more frequently than indicated by your doctor (weekly, biweekly, or monthly). If you do, you may increase the risk of an overdose.

Recommended doses are:

Treatment of Vitamin D deficiency and prevention of Vitamin D deficiency in patients with identified risks: one capsule per month.

As a complement to specific medication for bone loss: one capsule per month.

There are high-risk populations for Vitamin D deficiency in which higher doses may be necessary. After the corresponding analysis of the degree of deficiency, your doctor may consider a dose of one capsule every two weeks or every week.

This medication should not be administered daily.

Your doctor should monitor your calcium and Vitamin D levels periodically, usually before starting treatment and at 3-4 months once treatment has begun. Depending on the indication, doses will be reduced or spaced out over time when symptoms improve or the deficiency of Vitamin D is corrected.Vitamin D deficiency.

Oral administration.

If you estimate that the effect of this medication is too strong or too weak, inform your doctor or pharmacist.

If you take moreHidroferol0.266 mg soft capsulesthan you should

If you take more than the indicated doses of this medication (overdose) and/or for a prolonged period, you may experience hypercalcemia (high levels of calcium in the blood) and the presence of phosphates in the blood, which may lead to kidney insufficiency. Some symptoms of toxicity may appear soon, and others may appear after some time. Initial symptoms include: weakness, fatigue, headache, loss of appetite, dry mouth, digestive disorders such as vomiting, abdominal cramps, constipation or diarrhea, increased thirst, increased urination, muscle pain.

After some time, you may experience: itching, weight loss, delayed growth in children, kidney disorders, intolerance to sunlight, conjunctivitis, increased cholesterol, increased transaminases, pancreatitis, calcification (deposit of calcium salts) in blood vessels and other tissues such as tendons and muscles, increased blood pressure, mental disorders, irregular heartbeats.

Overdose symptoms usually improve or disappear when treatment is stopped, but if the poisoning is severe, it may cause kidney or heart failure.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or go to a medical center, or call the Toxicology Information Service, Teléfono 91 562 04 20, indicating the medication and the amount ingested (or bring the medication with you).

If you forgot to takeHidroferol0.266 mg soft capsules

Do not take a double dose to compensate for the missed doses.

Take the missed dose as soon as possible; then return to your regular dosing schedule.

If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse..

Like all medications, this medication may produce adverse effects, although not all people may experience them.

Adverse effects may occur if excessive doses are taken or if treatments are prolonged beyond what the doctor has indicated, which may produce hypercalcemia (elevated levels of calcium in the blood) and hypercalciuria (elevated levels of calcium in the urine); see section 3 for a description of the symptoms.

Other adverse effects include allergic reactions such as itching, local swelling, difficulty breathing, and skin redness.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is possible adverse effects that do not appear in this prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging and blister after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Hidroferol 0.266 mg soft capsules

• The active ingredient is calcifediol monohydrate. Each soft capsule contains 0.266 mg of calcifediol monohydrate.

• The other components are: anhydrous ethanol, medium-chain triglycerides, and the capsule components: gelatin, glycerol, sorbitol (E-420), titanium dioxide (E-171), and yellow-orange S colorant (E-110).

Appearance of the product and contents of the packaging

Hidroferol 0.266 mg soft capsules are presented in orange-colored soft gelatin capsules containing a transparent, slightly viscous, and particle-free liquid in PVC/PVDC-Al blisters.

Hidroferol 0.266 mg soft capsules are available in blisters of 1, 2, 3, 5, or 10 capsules. Only some package sizes may be marketed.

The blisters are packaged in a cardboard box.

• Other presentations of Hidroferol:

Hidroferol 0.1 mg/ml oral drops in solution.

Hidroferol 0.266 mg oral solution.

Hidroferol Shock 3 mg oral solution.

Holder of the marketing authorization and responsible manufacturer

Faes Farma S.A.

Máximo Aguirre, 14

48940-Leioa (Bizkaia)

Spain

Last review date of this leaflet: August 2021

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/