Label: information for the user

Hidroferol 0.1 mg/ml oral drops in solution

calcifediol monohydrate

Read this label carefully before starting to take this medicine, as it contains important information for you.

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

Contents of thelabel

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

Contents of the package andadditional information.

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

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

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 (elevated levels of calcium in the blood) or hypercalciuria (elevated levels of calcium in urine).
• if you have calcium stone formation.
• if you have hypervitaminosis D (excess of vitamin D in the body).

Warnings and precautions

Consult your doctor or pharmacist before starting to takeHidroferol 0,1 mg/ml oral drops in solution.

• 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 moreHidroferol 0,1 mg/ml oral dropsthan you should).
• While taking this medication or before starting, your doctor may instruct you to undergo 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 regular blood and urine tests.
• Patients with heart disease require special caution and should be frequently monitored by their doctor to control blood calcium levels, especially those taking cardiac glycosides (see this section, subsectionOther medications andHidroferol0,1 mg/ml oral drops in solution).
• If you have hypoparathyroidism (insufficient parathyroid hormone function), it may reduce the effect of this medication.
• 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 (disease with nodules, usually on the skin), tuberculosis, or other diseases with nodules should exercise special caution with this medication, as they have a higher risk of adverse effects at lower doses. Regular blood and urine tests should be performed to monitor calcium levels.

Interference with diagnostic tests:If you are to undergo any diagnostic test (including blood, urine, 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 indicated, your doctor will prescribe the dose to administer (see section 3, subsectionUse in children and adolescents).

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

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 how this medication works. On the other hand, its active ingredient, calcifediol monohydrate, may affect the efficacy of other medications taken simultaneously.

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 favor the decrease of Hidroferol's effect).
• 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 vitamin D products.
• 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 add to the effects of this medication and result in excessive effects.

Pregnancy, breastfeeding, and fertility

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

Hidroferol can be used during breastfeeding.

Calcifediol passes into breast milk. This should be taken into consideration when administering additional vitamin D to the 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, or if you think you may be pregnant, or if you plan to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

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

Follow exactly the administration instructions of this medication as 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. If you do, you may increase the risk of an overdose.

Recommended doses are:

Adults

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

There are high-risk populations for vitamin D deficiency in which it may be necessary to administer higher doses. After the corresponding analysis of 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 old: 1 drop per day.
  • Children 12 to 18 years old: 2 drops per day.
• Rickets (bone disorder) due to vitamin D deficiency: 1 to 2 drops per day.
• Resistant rickets: doses will be administered progressively according to results, controlled by analysis, and may reach 65 drops per day or in alternate days, or higher doses if the doctor deems necessary.

Your doctor should monitor your calcium and vitamin D levels periodically, usually before starting treatment and at 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 thedropper, can be taken alone or poured into an empty glass and diluted with a little water, milk, or juice.

If you estimate that the action ofthis medicationis 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 calcium levels in the blood) and phosphates in the blood and urine, leading to possible 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, gastrointestinal disturbances 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, transaminases, pancreatitis inflammation, calcification (calcium deposit) 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 intoxication 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, orcall 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 takeHidroferol0.1 mg/ml oral drops in solution

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 at a frequency higher than that indicated by your doctor, which may produce hypercalcemia (elevated levels of calcium in the blood) and hypercalciuria (elevated levels of calcium in urine); see section 3 for a description of symptoms.

Other adverse effects includeallergic 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 the Spanish System for Pharmacovigilance of Medicines 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 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 the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Hidroferol 0.1 mg/ml oral drops in solution

• The active principle 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 contents of the packaging

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

The packaging is a topaz-colored glass bottle with a pilfer-proof stopper , equipped with 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

Responsible for manufacturing

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

Last review date of this leaflet: November 2023

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