Label: information for the user

Hidroferol 0.266 mg oral solution

calcifediol monohydrate

Read this label carefully before starting to take this medication, because

it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only for you, 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 any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this label. See section 4.

Label content

1.What is Hidroferol 0.266 mg oral solution and for what it is used

2.What you need to know before starting to take Hidroferol 0.266 mg oral solution

3.How to take Hidroferol 0.266 mg oral solution

4.Possible adverse effects

5.Storage of Hidroferol 0.266 mg oral solution

6.Contents of the package and additional 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.

Hidroferol 0,266 mg oral solution is indicated for the treatment of vitamin D deficiency in adults and for preventing vitamin D deficiency in adults with identified riskssuch 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.

Do not takeHidroferol0,266mg oral 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 calcium levels in the blood) or hypercalciuria (elevated calcium levels in the urine).
• if you have calcium stone formation.
• if you have hypervitaminosis D (excess vitamin D in the body).

Warnings and precautions

Consult your doctor or pharmacist before starting to takeHidroferol 0,266mg oral 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 0,266mg oral solutionthan 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 regular blood and urine tests.
• Patients with heart disease require special caution and should be closely monitored by their doctor for calcium blood level control, especially those taking cardiac glycosides (seeinthissection, subsectionOther medications andHidroferol 0,266mgoral 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 calcium blood 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 adverse effects at lower doses. Regular blood and urine tests should be performed to monitor calcium levels.
• Interference with diagnostic tests: Inform your doctor that you are taking this medication if you are to undergo any diagnostic tests (including blood, urine, skin tests using allergens, etc.), as it may alter the results. For example, in some cholesterol tests.

Children and adolescents

The safety and efficacy of calcifediol in children and adolescents under 18 years have not been established. No data are available.

For use in children, there is a medication available in the market calledHidroferol 0,1mg/ml oral solution in solution, with a lower concentration of doses.

Other medications and Hidroferol 0,266mg oral 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 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 reduce the effect of Hidroferol).
• 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 0,266mg oral solution 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 effects.

Pregnancy, lactation, 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 the ability to drive vehicles or operate machinery.

Hidroferol 0.266 mg oral solution is EXCLUSIVELY for oral administration.

Hidroferol 0.266 mg oral solution MUST NOT be administered via intramuscular and/or intravenous routes..

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 Hidroferol 0.266 mg oral solution DAILY.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.

The recommended doses are:

• Treatment of vitamin D deficiency and prevention of vitamin D deficiency in patients with identified risks: one drinkable ampoule (0.266 mg of calcifediol monohydrate), once a month.
• As a complement to specific medication for bone mass loss: one drinkable ampoule (0.266 mg of calcifediol monohydrate), once a month.

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 the dose of one ampoule every two weeks or every week.

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, the doses will be reduced or spaced out over time when symptoms improve or the vitamin D deficiency is corrected.

Oral route.

The ampoule contents can be taken alone or diluted in a little water, milk, or juice.

The ampoule opening and use instructions are as follows:

Shake the ampoule before use.

Insert the glass ampoule head into the opening facilitator cylinder. Hold the ampoule body between the thumb and index finger with the white point upwards.

Place the index finger of the other hand under the cylinder covering the ampoule head, and the thumb above it, as indicated in the figure, so that the index fingers of both hands touch each other under the ampoule.

Hold the hand holding the ampoule still and press the head down with the thumb to open the ampoule with a dry movement.

Once the ampoule is opened, remove the ampoule head from the cylinder for subsequent reuse.

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 oral solution than you should

If you take more of this medication than the indicated dose 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, 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, transaminases, pancreatitis inflammation, calcification (deposit of calcium salts) in blood vessels and other tissues such as tendons and muscles, increased blood pressure, mental disorders, irregular heartbeats.

Toxicity 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, orcall the Toxicology Information Service, Telephone 91 562 04 20, indicating the medication and the amount ingested (or bring the medication with you).

If you forgot to takeHidroferol0.266 mg oral 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 the 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 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 the Spanish System of 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 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 medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Hidroferol 0.266 mg oral solution

• The active principle is calcifediol monohydrate. Each ampoule contains 0.266 mg of calcifediol monohydrate.
• The other components (excipients) are: medium-chain triglycerides and alpha-tocopherol acetate.

Aspect of the product and contents of the packaging

Hidroferol 0.266 mg is an oral solution; it is a transparent, colorless or slightly yellowish, viscous liquid, free of visible impurities; it is presented in glass ampoules.

Each package contains 10 drinkable ampoules.

Other presentations of Hidroferol:

Hidroferol 0.1 mg/ml oral drops in solution.

Hidroferol 0.266 mg soft capsules

Hidroferol Shock 3 mg oral solution.

Holder of the marketing authorization

Faes Farma, S.A.

Autonomia Etorbidea, 10

48940 Leioa (Bizkaia)

Spain

Responsible for manufacturing

Faes Farma Portugal, S.A.
Rua Elias Garcia, 28

Amadora-P-2700

Portugal

Date of the last review of this prospectus: November 2023

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