HIDROFEROL SEMANAL 100 micrograms SOFT CAPSULES

Introduction

Leaflet: information for the user

Hydroferol weekly 100 micrograms soft capsules

calcifediol monohydrate

Read the entire leaflet carefully before starting to take 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, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed to you only, 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 side effects, consult your doctor, pharmacist, or nurse, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Hydroferol weekly 100 micrograms soft capsules are and what they are used for
2. What you need to know before taking Hydroferol weekly 100 micrograms soft capsules
3. How to take Hydroferol weekly 100 micrograms soft capsules
4. Possible side effects
5. Storage of Hydroferol weekly 100 micrograms soft capsules
6. Package contents and additional information

1. What Hydroferol weekly 100 micrograms soft capsules are and what they are used for

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

Hydroferol weekly 100 micrograms soft capsules are indicated for the treatment of vitamin D deficiency in adults and for the prevention of vitamin D deficiency in adults with identified risks.

They are also used to treat certain bone conditions, such as bone loss (osteoporosis) in adults.

2. What you need to know before taking Hydroferol weekly 100 micrograms soft capsules

Do not take Hydroferol weekly 100 micrograms soft capsules

• if you are allergic to calcifediol or any of the other components of this medicine (listed in section 6).
• if you have hypercalcemia (high blood calcium levels) or hypercalciuria (high urine calcium levels).
• 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 this medicine.

• Do not exceed the recommended daily amounts of vitamin D supplements, such as this medicine, as this could lead to intoxication (see section 3, subsection If you take more Hydroferol weekly 100 micrograms capsules than you should).
• While taking this medicine or before starting, your doctor may advise 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 periodic tests.
• Patients with heart disease require special caution and should be frequently supervised by their doctor to monitor blood calcium levels, especially those being treated with cardiac glycosides (see this section, subsection Other medicines and Hydroferol weekly 100 micrograms capsules).
• If you have hypoparathyroidism (insufficient parathyroid hormone function), the action of this medicine may be reduced.
• If you have kidney stone formation (calcium stones), 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 nodular diseases should be cautious when taking 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 analytical tests: if you are going to have 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 use of this medicine is not indicated in children and adolescents.

Other medicines and Hydroferol weekly 100 micrograms capsules

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines, including those obtained without a prescription.

Some medicines may affect how this medicine works. On the other hand, the 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 may decrease the effect of Hydroferol weekly).
• Medicines for the heart and/or high blood pressure, such as cardiac glycosides, thiazide diuretics, or verapamil.
• Colestyramine, colestipol (for cholesterol), orlistat (for obesity): take these medicines and calcifediol monohydrate at least 2 hours apart.
• Mineral oil or paraffin (laxatives): use another type of laxative or take these medicines at different times.
• Certain antibiotics (such as penicillin, rifampicin, isoniazid, neomycin, and chloramphenicol).
• Magnesium salts.
• Other vitamin D products.
• Calcium supplements.
• Corticosteroids (anti-inflammatory medicines).
• Verapamil (an antihypertensive medicine).
• Medicines that inhibit cytochrome P-450 (such as atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, and voriconazole).

Taking Hydroferol weekly 100 micrograms 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, breastfeeding, and fertility

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

This medicine is not recommended during pregnancy and breastfeeding.

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

There are no data on the effects of calcifediol on fertility.

Driving and using machines

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

Hydroferol weekly 100 micrograms capsules contain ethanol, sorbitol liquid (non-crystallizable) (E-420), and red allura colorant (E-129).

This medicine contains 2 mg of alcohol (ethanol) per soft capsule. The amount in each 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 11 mg of sorbitol (E-420) as non-crystallizable sorbitol liquid per soft capsule, equivalent to 0.04 mg/mg.

This medicine may cause allergic reactions because it contains red allura colorant (E-129).

3. How to take Hydroferol weekly 100 micrograms capsules

Follow your doctor's instructions for taking the medicine exactly. If you are unsure, consult your doctor or pharmacist again.

The recommended doses are:

• For the treatment of vitamin D deficiency and prevention of vitamin D deficiency in patients with identified risks: one capsule once a week.
• As a supplement to specific osteoporosis medication: one capsule once a week.

This medicine should not be taken daily.

Your doctor should monitor your calcium and vitamin D levels periodically, usually before starting treatment and 3-4 months after starting treatment.

Oral administration.

This medicine can be taken with or without food, should be swallowed whole, and can be taken with water, milk, or juice.

If you take more Hydroferol weekly 100 micrograms capsules than you should

If you take more of this medicine than your doctor has prescribed (overdose) and/or for a longer period, you may experience hypercalcemia (high blood calcium levels) and hypercalciuria (high urine calcium levels), which can lead to kidney failure. Some symptoms of toxicity may appear soon, while 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 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 stopped, 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, Phone 91 562 04 20, indicating the medicine and the amount taken (or bring the medicine with you).

If you forget to take Hydroferol weekly 100 micrograms 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 other questions about using this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

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

Side effects may occur if you take excessive doses or have longer treatments than prescribed by your doctor, which can cause hypercalcemia (high blood calcium levels) and hypercalciuria (high urine calcium levels); 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 side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are possible side effects not listed in this leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency's website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Hydroferol weekly 100 micrograms capsules

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

Do not use this medicine after the expiration date stated on the packaging and blister after CAD. The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the pharmacy's SIGRE collection point. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package contents and additional information

Composition of Hydroferol weekly 100 micrograms capsules

• The active ingredient is calcifediol monohydrate. Each soft capsule contains 100 micrograms of calcifediol monohydrate (equivalent to 96 micrograms of calcifediol).
• The other ingredients are: anhydrous ethanol, medium-chain triglycerides, and the capsule components, which are: gelatin, glycerol (E-422), non-crystallizable sorbitol liquid (E-420), titanium dioxide (E-171), and red allura colorant (E-129).

Appearance and package contents

Hydroferol weekly 100 micrograms are soft gelatin capsules, red, oval, with a longitudinal seam.

The capsules are packaged in PVC/PVDC//Al blisters containing 4, 12, 16, 24, or 48 capsules.

The blisters are packaged in a cardboard box.

Not all pack sizes may be marketed.

Marketing authorization holder

Faes Farma S.A.

Autonomia Etorbidea, 10

48940-Leioa (Bizkaia)

Spain

Manufacturer

Faes Farma S.A.

Máximo Aguirre, 14

48940-Leioa (Bizkaia)

Spain

Date of last revision of this leaflet: June 2024

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