HIDROFEROL 0.1 mg/ml ORAL DROPS IN SOLUTION

Introduction

Leaflet: information for the user

Hidroferol 0.1 mg/ml oral drops in solution

calcifediol monohydrate

Read the entire leaflet carefully before starting to take this medication, as it contains important information for you.

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

Contents of theleaflet

1. What Hidroferol 0.1 mg/ml oral drops in solution is and what it is used for.
2. What you need to know before starting to take Hidroferol 0.1 mg/ml oral drops in solution.
3. How to take Hidroferol 0.1 mg/ml oral drops in solution.
4. Possible side effects.
5. Storage of Hidroferol 0.1 mg/ml oral drops in solution.

Contents of the package and additional information.

1. What Hidroferol 0.1 mg/ml oral drops in solution is and what it is used for

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

Hidroferol 0.1 mg/ml oral drops in solution is indicated for 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), along with other medications, in patients with vitamin D deficiency or at risk of vitamin D deficiency.

In children, Hidroferol 0.1 mg/ml oral drops in solution is indicated for the treatment of vitamin D deficiency and rickets (bone disease).

2. What you need to know before starting to take Hidroferol 0.1 mg/ml oral drops in solution

Do not takeHidroferol0.1 mg/mloral drops in solution

• if you are allergic to calcifediol or any of the other components of this medication (listed in section 6).
• if you have hypercalcemia (high blood calcium levels) or hypercalciuria (high urine calcium levels).
• if you have kidney stone formation (calcium stones).
• if you have hypervitaminosis D (excess vitamin D in the body).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Hidroferol 0.1 mg/ml oral drops in solution.

• Do not exceed the recommended daily doses of vitamin D supplements, such as this medication, as this could lead to intoxication (see section 3, subsection If you take moreHidroferol 0.1 mg/ml oral drops in solution than you should).
• While taking this medication or before starting, your doctor may instruct you to have blood or urine tests to monitor your calcium, phosphorus, and other parameter levels.
• Patients with kidney disease require special caution and should be closely monitored by their doctor, with periodic tests.
• Patients with heart disease require special caution and should be frequently supervised by their doctor to monitor blood calcium levels, especially those undergoing treatment with cardiac glycosides (see section Other medications andHidroferol0.1 mg/ml oral drops in solution).
• If you have hypoparathyroidism (insufficient parathyroid hormone function), the action of this medication may be reduced.
• If you have 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 (a disease with nodules, usually on the skin), tuberculosis, or other nodule-forming diseases should be cautious when taking this medication, as they are at higher risk of adverse effects at lower than recommended doses. Periodic tests should be performed to monitor blood and urine calcium levels.

Interference with laboratory tests: if you are going to undergo any diagnostic tests (including blood tests, urine tests, skin tests using allergens, etc.), inform your doctor that you are taking this medication, as it may alter the results. For example, in some cholesterol tests.

Children and adolescents

When the medication is indicated, the doctor will prescribe the dose to be administered (see section 3, subsection Use in children and adolescents).

Other medications andHidroferol0.1 mg/ml oral drops in solution

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

Some medications may affect how this medication works. On the other hand, the 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 Hidroferol).
• Medications for the heart and/or hypertension, such as cardiac glycosides, thiazide diuretics, or verapamil.
• Colestyramine, colestipol (for cholesterol), orlistat (for obesity): the administration of these medications and calcifediol should be separated by at least 2 hours.
• Mineral oil or paraffin (laxatives): it is recommended to use another type of laxative or separate the administration of both medications.
• Some antibiotics (such as penicillin, neomycin, and chloramphenicol).
• Magnesium salts.
• Other products containing vitamin D.
• Calcium supplements.
• Corticosteroids (anti-inflammatory medications).

Taking Hidroferol 0.1 mg/ml oral drops in solution with food and beverages

Some foods and beverages are supplemented with vitamin D. This should be taken into account, as the effects of these foods may be added to the effects of this medication and become excessive.

Pregnancy, breastfeeding, and fertility

This medication will only be used during pregnancy if the vitamin D deficiency has been clinically diagnosed.

Hidroferol can be used during breastfeeding.

Calcifediol passes into breast milk. This should be considered when administering additional vitamin D to the breastfed infant.

There are no data on the effects of calcifediol on fertility. However, it is not expected that normal vitamin D levels will have adverse effects on fertility.

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

Driving and using machines

This medication does not affect the ability to drive vehicles or operate machines.

3. How to take Hidroferol 0.1 mg/ml oral drops in solution

Follow the administration instructions for this medication exactly as indicated by your doctor. If you have any doubts, consult your doctor or pharmacist again.

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

The recommended doses are:

Adults

• Treatment and prevention of vitamin D deficiency in patients with identified risks: 1 to 3 drops of calcifediol in solution per day.
• As a complement to medication for bone loss: 1 to 3 drops per day.

There are high-risk populations for vitamin D deficiency where higher doses may be necessary. After analyzing the degree of deficiency, the doctor may consider increasing the dose.

Use in children and adolescents

• Treatment of vitamin D deficiency:
• • Children under 11 years: 1 drop per day.
  • Children from 12 to 18 years: 2 drops per day.
• Rickets (bone disease) due to vitamin D deficiency: 1 to 2 drops per day.
• Resistant rickets: doses will be administered progressively based on test results, which may reach up to 65 drops per day or on alternate days, or higher doses if the doctor considers it necessary.

Your doctor should periodically monitor your calcium and vitamin D levels, usually before starting treatment and 3-4 months after starting treatment. According to the indication, doses will be reduced or spaced out over time when symptoms improve or the vitamin D deficiency is corrected.

Oral administration.

Shake before use.

The drops, measured with the dropper, can be taken alone or added to an empty glass and diluted with a little water, milk, or juice.

If you think the action of this medication is too strong or too weak, inform your doctor or pharmacist.

If you take moreHidroferol 0.1 mg/mloral drops in solution than you should

If you take more of this medication than the doses indicated by your doctor (overdose) and/or for a prolonged period, you may experience hypercalcemia (elevated blood calcium levels) and hyperphosphatemia (elevated phosphate levels in blood and urine), leading to possible kidney failure. Some symptoms of toxicity may appear soon, while 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.

Symptoms that appear after some time may include: itching, weight loss, growth retardation in children, kidney disorders, intolerance to sunlight, conjunctivitis, increased cholesterol, transaminases, pancreatitis, calcification (calcium deposits) in blood vessels and other tissues such as tendons and muscles, increased blood pressure, mental disorders, irregular heartbeats.

Symptoms of overdose usually improve or disappear when treatment is discontinued, but if the intoxication is severe, it could lead to 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, phone 91 562 04 20, indicating the medication and the amount ingested (or bring the medication with you).

If you forget to takeHidroferol0.1 mg/ml oral drops in solution

Do not take a double dose to make up for forgotten doses.

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

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Side effects may occur if excessive doses are taken or with a frequency higher than indicated by the doctor, which may cause hypercalcemia (elevated blood calcium levels) and hypercalciuria (elevated urine calcium levels); see section 3 for a description of the symptoms.

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

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: www.notificaram.es.

By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Hidroferol 0.1 mg/ml oral drops in solution

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

Do not use this medication after the expiration date shown on the packaging 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 wastewater or household waste. Deposit the packaging and unused medications in the SIGRE collection point at the pharmacy. If you have any doubts, ask your pharmacist how to dispose of the packaging and unused medications. This will help protect the environment.

6. Contents of the package and additional information

Composition ofHidroferol0.1 mg/ml oral drops in solution

• The active ingredient is calcifediol monohydrate.

1 ml of solution (25 drops) contains 0.1 mg (100 micrograms) of calcifediol monohydrate.

1 drop contains 4 micrograms of calcifediol monohydrate.

• The other components are: medium-chain triglycerides and alpha-tocopherol acetate.

Appearance of the product and package contents

This medication is presented as oral drops in solution; it is a clear, colorless or slightly yellowish, viscous liquid, free of visible impurities.

The packaging is a brown glass bottle with a pilfer-proof cap, which has an external dropper for dosing.

Contents: 10 or 20 ml of solution for oral administration.

• Other presentations of Hidroferol:

Hidroferol 0.266 mg oral solution.

Hidroferol Shock 3 mg oral solution.

Hidroferol 0.266 mg soft capsules

Marketing authorization holder

Faes Farma S.A.

Autonomia Etorbidea, 10

48940 Leioa (Bizkaia)

Spain

Manufacturer

Faes Farma, S.A.

Maximo Agirre Kalea, 14

48940 Leioa (Bizkaia)

Spain

Or

Faes Farma, S.A.

Parque Científico y Tecnológico de Bizkaia

Ibaizabal Bidea, Edificio 901

48160 Derio (Bizkaia)

Spain

Date of the last revision of this leaflet: November 2023

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): http://www.aemps.gob.es/