Hydroferol 0.1 mg/ml oral solution drops

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Hidroferol 0.1 mg/ml oral solution drops

calcifediol monohydrate

Read all of 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, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

Contents of the pack and other information.

1. What Hidroferol 0.1 mg/ml oral solution drops 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 conditions. Vitamin D acts in the human body, among other effects, by increasing calcium absorption.

Hidroferol 0.1 mg/ml oral solution drops is indicated for the treatment of vitamin D deficiency in adults and for the prevention of vitamin D deficiency in adults at identified risk, such as patients with malabsorption syndrome, chronic kidney disease–mineral and bone disorder (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.

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

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

Do not take Hidroferol 0.1 mg/ml oral solution drops

• if you are allergic to calcifediol or to any of the other ingredients of this medicine (listed in section 6).
• if you have hypercalcemia (high levels of calcium in the blood) or hypercalciuria (high levels of calcium in the urine).
• if you suffer from calcium stone (calculus) formation.
• if you have hypervitaminosis D (excess vitamin D in the body).

Warnings and precautions

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

• Do not exceed the recommended daily amounts of vitamin D supplements, such as this medicine, as this could lead to poisoning (see section 3, subsection If you take more Hidroferol 0.1 mg/ml oral solution drops than you should).
• While taking this medicine or before starting it, your doctor may recommend 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, including periodic testing.
• Patients with heart disease require special caution and should be frequently monitored by their doctor for blood calcium levels, especially those receiving cardiac glycosides (see this section, subsection Other medicines and Hidroferol 0.1 mg/ml oral solution drops).
• If you have hypoparathyroidism (insufficient parathyroid hormone function), the effect of this medicine may be reduced.
• If you suffer from kidney stone (calculus) formation, your doctor should monitor your blood calcium levels.
• Patients with prolonged immobilization may require lower doses of this medicine.
• Patients with sarcoidosis (a disease characterized by nodules, usually in the skin), tuberculosis, or other granulomatous diseases should use particular caution with this medicine, as they are at higher risk of adverse effects even at doses lower than recommended. Periodic blood and urine tests to monitor calcium levels should be performed.

Interference with laboratory tests: If you are scheduled to undergo any diagnostic tests (including blood and urine analyses, skin tests using allergens, etc.), inform your doctor that you are taking this medicine, as it may alter test results. For example, certain cholesterol tests may be affected.

Children and adolescents

When this medicine is indicated, the doctor will prescribe the appropriate dose (see section 3, subsection Use in children and adolescents).

Other medicines and Hidroferol 0.1 mg/ml oral solution drops

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.

Some medicines may affect how this medicine works. Conversely, its active ingredient, calcifediol monohydrate, may affect the effectiveness of other medicines taken simultaneously.

Therefore, interactions may occur with the following medicines:

• Medicines used to treat epilepsy (such as phenytoin, phenobarbital, and primidone) and other enzyme-inducing drugs (which may reduce the effect of Hidroferol).
• Medicines for heart conditions and/or high blood pressure, such as cardiac glycosides, thiazide diuretics, or verapamil.
• Cholestyramine, colestipol (for cholesterol), orlistat (for obesity): administration of these medicines should be separated from calcifediol by at least 2 hours.
• Mineral oil or paraffin (laxatives): it is recommended to use another type of laxative or to separate the administration times of both medicines.
• Certain antibiotics (such as penicillin, neomycin, and chloramphenicol).
• Magnesium salts.
• Other vitamin D-containing products.
• Calcium supplements.
• Corticosteroids (anti-inflammatory medicines).

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

Some foods and beverages are fortified with vitamin D. This should be taken into account, as the effects of these foods may add up to those of this medicine and become excessive.

Pregnancy, breast-feeding, and fertility

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

Hidroferol may be used during breast-feeding.

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

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

If you are pregnant, breast-feeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

This medicine does not affect the ability to drive or operate machinery.

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

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.

Do not take more of this medicine or take it more frequently than your doctor has indicated. Doing so may increase the risk of overdose.

Recommended doses:

Adults

• Treatment and prevention of vitamin D deficiency in patients with identified risk factors: 1 to 3 drops of calcifediol solution per day.
• As an adjunct to specific treatment for bone mass loss: 1 to 3 drops per day.

In high-risk populations for vitamin D deficiency, higher doses may be necessary. After appropriate assessment of the degree of deficiency, your 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 aged 12 to 18 years: 2 drops per day.
• Rickets (bone disorder) due to vitamin D deficiency: 1 to 2 drops per day.
• Resistant rickets: doses should be administered progressively according to monitored test results, and may reach up to 65 drops per day or on alternate days, or even higher doses if deemed necessary by the doctor.

Your doctor should periodically monitor your calcium and vitamin D levels, usually before starting treatment and again at 3–4 months after starting treatment. Depending on the clinical indication, doses will be reduced or spaced further apart over time once symptoms improve or vitamin D deficiency has been corrected.

Route of administration: Oral.

Shake well before use.

The drops, measured with the dropper, can be taken directly or added to an empty glass and diluted in a small amount of water, milk, or juice.

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

If you take more Hidroferol 0.1 mg/ml oral solution drops than you should

If you take more of this medicine than the dose prescribed by your doctor (overdose) and/or for a prolonged period, hypercalcemia (elevated blood calcium levels) may occur, along with increased phosphate levels in blood and urine, potentially leading to kidney failure. Some symptoms of toxicity may appear early, while others may develop after some time. Early 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.

Symptoms that may appear after a delay include: itching, weight loss, growth retardation in children, kidney disorders, photosensitivity, conjunctivitis, increased cholesterol and transaminase levels, pancreatic inflammation, calcification (calcium salt deposits) in blood vessels and other tissues such as tendons and muscles, increased blood pressure, mental disturbances, and irregular heartbeat.

Symptoms of overdose usually improve or disappear once treatment is discontinued; however, if poisoning is severe, it may lead to kidney or heart failure.

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

If you forget to take Hidroferol 0.1 mg/ml oral solution drops

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

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

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.

Adverse effects may occur if excessive doses are taken or if the medicine is taken more frequently than indicated by the physician, which may lead to hypercalcemia (high levels of calcium in blood) and hypercalciuria (high levels of calcium in 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 of adverse effects

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

By reporting adverse effects, you can help provide more information on the safety of this medicine.

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

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

No special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure how to dispose of containers and unused medicines, ask your pharmacist. This will help protect the environment.

6. Contents of the container and other information

Composition of Hidroferol 0.1 mg/ml oral drops solution

• The active substance 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-tocopheryl acetate.

Appearance of the medicine and contents of the container

This medicine is presented as an oral solution in drop form; it is a clear, colourless or slightly yellowish, viscous liquid free from visible impurities.

The container is an amber glass bottle with a tamper-evident cap, equipped with an external dropper for dosing.

Contents: 10 ml or 20 ml of oral solution.

• Other presentations of Hidroferol:

Hidroferol 0.266 mg oral solution.

Hidroferol Choque 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 latest revision of this package leaflet: November 2023

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