Hidroferol 0.266 mg soft capsules

Patient Information Leaflet

Introduction

Patient Information Leaflet

Hidroferol 0.266 mg soft capsules

calcifediol monohydrate

Read the entire leaflet carefully before you start taking this medicine, as 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 others, even if they have the same symptoms as you, since it may harm them.
• If you experience any adverse reactions, consult your doctor, pharmacist, or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet Contents

1. What Hidroferol 0.266 mg soft capsules are and what they are used for
2. What you need to know before taking Hidroferol 0.266 mg soft capsules
3. How to take Hidroferol 0.266 mg soft capsules
4. Possible side effects
5. How to store Hidroferol 0.266 mg soft capsules
6. Contents of the pack and other information

1. What Hidroferol 0.266 mg soft capsules are and what they are used for

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 effects, by increasing calcium absorption.

Hidroferol 0.266 mg soft capsules are 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.

2. What you need to know before taking Hidroferol 0.266 mg soft capsules

Do not take Hidroferol 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 calcium stone (calculi) formation.
• if you have hypervitaminosis D (excess vitamin D in the body).

Warnings and precautions

Talk to 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 poisoning (see section 3, section "If you take more Hidroferol 0.266 mg soft capsules than you should").
• While taking this medicine or before starting treatment, your doctor may recommend blood or urine tests to monitor your calcium, phosphorus, and other parameters.
• Patients with kidney disease require special caution and must 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 section below, "Other medicines and Hidroferol 0.266 mg soft capsules").
• If you have hypoparathyroidism (insufficient parathyroid hormone function), the effect of this medicine may be reduced.
• If you have kidney stones (calculi), 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 must use this medicine with special caution, as they are at higher risk of adverse effects even at doses below the recommended levels. Periodic blood and urine calcium tests should be performed.

Interference with diagnostic tests: If you are scheduled for any diagnostic tests (including blood and urine tests, 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.

Children and adolescents

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

Other medicines and Hidroferol 0.266 mg soft capsules

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 medicines (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 0.266 mg soft capsules 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, breastfeeding, and fertility

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

Do not take this medicine during pregnancy.

Do not take this medicine while breastfeeding.

Driving and using machines

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

Hidroferol 0.266 mg soft capsules contains ethanol, sorbitol (70%) (E-420), and the colouring agent Orange Yellow S (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 the colouring agent Orange Yellow S (E-110).

3. How to take Hidroferol 0.266 mg soft capsules

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

Do not take more of the medicine or take it more frequently than prescribed by your doctor (weekly, fortnightly, or monthly). If you do so, you may increase the risk of overdose.

The recommended doses are:

For the treatment and prevention of vitamin D deficiency in patients with identified risk factors: one capsule once a month.

As an adjunct to specific treatment for bone loss: one capsule once a month.

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

This medicine must not be administered daily.

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

For oral use.

If you think that the effect of this medicine is too strong or too weak, inform 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 the doses prescribed by your doctor (overdose) and/or for a prolonged period, you may develop hypercalcemia (high levels of calcium in the blood) and elevated levels of calcium and phosphates in blood and urine, which could lead to renal failure. Some symptoms of toxicity may appear early, while others may appear after a delay. 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 levels, elevated transaminases, pancreatic inflammation, calcification (calcium salt deposits) in blood vessels and other tissues such as tendons and muscles, increased blood pressure, mental disturbances, and irregular heartbeats.

Symptoms of overdose usually improve or disappear once treatment is discontinued, but if the poisoning is severe, it could 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 medicine and the amount ingested (or bring 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 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 produce adverse effects, although not everyone experiences them.

Adverse effects may occur if excessive doses are taken or if treatment lasts longer than indicated by the doctor, which may lead to hypercalcemia (increased calcium levels in blood) and hypercalciuria (increased calcium levels 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 Medicinal Products: www.notificaRAM.es. By reporting adverse 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 stated on the packaging and blister after EXP. The expiry date is the last day of the month indicated.

No special storage conditions are required.

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

6. Contents of the container and additional 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 components are: anhydrous ethanol, medium-chain triglycerides, and capsule components which are: gelatin, glycerol, sorbitol (E-420), titanium dioxide (E-171), and orange-yellow S dye (E-110).

Appearance of the product and contents of the package

Hidroferol 0.266 mg soft capsules are presented as orange-coloured soft gelatin capsules containing a clear, slightly viscous liquid free from particles, in PVC/PVDC-Al blisters.

Hidroferol 0.266 mg soft capsules are available in blisters containing 1, 2, 3, 5 or 10 capsules. Only certain package sizes may be marketed.

The blisters are packed in a cardboard box.

• Other presentations of Hidroferol:

Hidroferol 0.1 mg/ml oral drops solution.

Hidroferol 0.266 mg oral solution.

Hidroferol Choque 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

Or

Faes Farma, S.A.

Parque Científico y Tecnológico de Bizkaia

Ibaizabal Bidea, Edificio 901

48160 Derio (Bizkaia)

Spain

Date of latest review of this leaflet: August 2021

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/