HIDROFEROL 0.266 mg SOFT GEL CAPSULES

Introduction

Package Leaflet: Information for the User

Hidroferol 0.266 mg Soft Capsules

calcifediol monohydrate

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What Hidroferol 0.266 mg Soft Capsules are and what they are used for
2. What you need to know before you take 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 Soft Capsules
6. Package Contents and Further Information

1. What Hidroferol 0.266 mg Soft Capsules are and what they are used for

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

Hidroferol 0.266 mg Soft Capsules are 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.

They are also used to treat bone loss (osteoporosis), along with other medications, in patients with vitamin D deficiency or at risk of vitamin D deficiency.

2. What you need to know before you take Hidroferol 0.266 mg Soft Capsules

Do not takeHidroferol 0.266 mg Soft Capsules

• if you are allergic to calcifediol or 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 have kidney stone formation (calcium stones).
• if you have hypervitaminosis D (excess vitamin D in the body).

Warnings and Precautions

Consult your doctor before starting to take Hidroferol 0.266 mg Soft Capsules.

• Do not exceed the recommended daily amounts of vitamin D supplements, such as this medicine, as this could lead to intoxication (see section 3, "If you take more Hidroferol 0.266 mg Soft Capsules than you should").
• While taking this medicine or before starting, your doctor may indicate that you undergo blood or urine tests to monitor your calcium, phosphorus, and other parameter levels.
• Patients with kidney disease require special caution and must be closely monitored by their doctor, with periodic tests.
• Patients with heart disease require special caution and must be frequently supervised by their doctor to monitor blood calcium levels, especially those being treated with cardiac glycosides (see section "Other medicines and Hidroferol 0.266 mg Soft Capsules").
• If you have hypoparathyroidism (insufficient parathyroid hormone function), the action of this medicine 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 medicine.
• Patients with sarcoidosis (a disease with nodules, usually on the skin), tuberculosis, or other diseases with nodules should be cautious with this medicine, 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 to undergo any diagnostic tests (including blood tests, urine tests, skin tests using allergens, etc.), inform your doctor that you are taking this medicine, 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 of age have not been established. No data are available.

Other Medicines and Hidroferol 0.266 mg Soft Capsules

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

Some medicines may affect how this medicine works. On the other hand, its active ingredient calcifediol monohydrate may affect the efficacy of other medicines taken at the same time.

Therefore, interactions may occur with the following medicines:

• Medicines used to treat epilepsy (such as phenytoin, phenobarbital, and primidone) and other enzyme-inducing medicines (which favor the decrease of Hidroferol's effect).
• Medicines for the heart and/or for high blood pressure, such as cardiac glycosides, thiazide diuretics, or verapamil.
• Colestyramine, colestipol (for cholesterol), orlistat (for obesity): the intake of these medicines 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 intake of both medicines.
• Some antibiotics (such as penicillin, neomycin, and chloramphenicol).
• Magnesium salts.
• Other products containing Vitamin D.
• Calcium supplements.
• Corticosteroids (anti-inflammatory medicines).

Taking Hidroferol 0.266 mg Soft Capsules with Food and Drinks

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

Pregnancy, Breast-feeding, and Fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Do not take this medicine during pregnancy.

Do not take this medicine while breast-feeding your child.

Driving and Using Machines

This medicine does not affect the ability to drive or use machines.

Hidroferol 0.266 mg Soft Capsules contain ethanol, sorbitol (70%) (E-420), and orange-yellow S colorant (E-110).

This medicine contains 5 mg of alcohol (ethanol) in each soft capsule. The amount in one capsule of this medicine is equivalent to less than 1 ml of beer or 1 ml of wine. The small amount of alcohol in this medicine does not produce any noticeable effect.

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

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

3. How to Take Hidroferol 0.266 mg Soft Capsules

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

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

The recommended doses are:

Treatment of vitamin D deficiency and prevention of vitamin D deficiency in patients with identified risks: one capsule once a month.

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

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

This medicine should not be administered daily.

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 vitamin D deficiency is corrected.

Oral route.

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

If you take more Hidroferol 0.266 mg Soft Capsules than you should

If you take more of this medicine than prescribed by your doctor (overdose) and/or for a prolonged period, you may suffer from hypercalcemia (high levels of calcium in the blood) and the presence of urine and phosphates in the blood, which may lead to kidney failure. 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.

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 salt 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 interrupted, 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, Telephone 91 562 04 20, indicating the medicine and the amount taken (or take the medicine with you).

If you forget to take Hidroferol 0.266 mg Soft Capsules

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 further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Side effects may occur if excessive doses are taken or if treatment is prolonged beyond what is indicated by the doctor, which may cause hypercalcemia (high levels of calcium in the blood) and hypercalciuria (high levels of calcium in the urine); see section 3 for a description of symptoms.

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

Reporting of Side Effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Hidroferol 0.266 mg Soft Capsules

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

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date is the last day of the month shown.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Package Contents and Further Information

Composition of Hidroferol 0.266 mg Soft Capsules

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

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

Appearance of the Product and Package Contents

Hidroferol 0.266 mg Soft Capsules are presented in orange-colored soft gelatin capsules containing a clear, slightly viscous liquid, free of particles, in PVC/PVDC-Al blisters.

Hidroferol 0.266 mg Soft Capsules are available in blisters of 1, 2, 3, 5, or 10 capsules. Not all pack sizes may be marketed.

The blisters are packaged in a cardboard box.

• Other presentations of Hidroferol:

Hidroferol 0.1 mg/ml oral solution in drops.

Hidroferol 0.266 mg oral solution.

Hidroferol Shock 3 mg oral solution.

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

Date of Last Revision of this Leaflet:August 2021

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