HIDROFEROL SEMANAL 100 MICROGRAMS SOFT CAPSULES

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Hidroferol weekly 100 micrograms soft capsules

calcifediol monohydrate

Read the entire 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, since it could 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.

Contents of the leaflet

1. What Hidroferol weekly 100 micrograms soft capsules is and what it is used for
2. What you need to know before taking Hidroferol weekly 100 micrograms soft capsules
3. How to take Hidroferol weekly 100 micrograms soft capsules
4. Possible adverse effects
5. How to store Hidroferol weekly 100 micrograms soft capsules
6. Contents of the pack and other information

1. What Hidroferol Weekly 100 micrograms soft capsules is and what it is used for

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

Hidroferol Weekly 100 micrograms soft capsules is indicated for the treatment of vitamin D deficiency in adults and for the prevention of vitamin D deficiency in adults at identified risk.

It is also used to treat certain bone disorders, such as bone loss (osteoporosis) in adults.

2. What you need to know before taking Hidroferol Weekly 100 micrograms soft capsules

Do not take Hidroferol Weekly 100 micrograms 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 suffer from calcium stone (calculus) formation.
• if you have hypervitaminosis D (excess vitamin D in the body).

Warnings and precautions

Talk to 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 poisoning (see section 3, subsection If you take more Hidroferol Weekly 100 microgram 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 blood and urine tests.
• 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 subsection Other medicines and Hidroferol Weekly 100 microgram soft capsules in this section).
• If you have hypoparathyroidism (insufficient parathyroid hormone function), the effect of this medicine may be reduced.
• If you have a history of calcium-containing kidney stones, your doctor should monitor your blood calcium levels.
• Patients who are immobilized for prolonged periods 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 lower than recommended. Periodic blood and urine calcium monitoring is required.
• Interference with laboratory tests: if you are scheduled to undergo 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 may be affected.

Children and adolescents

The use of this medicine is not indicated in children and adolescents.

Other medicines and Hidroferol Weekly 100 microgram soft capsules

Inform your doctor or pharmacist if you are currently using, have recently used, or might need to use 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 Weekly).
• 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 monohydrate by at least 2 hours.
• Mineral oil or paraffin (laxatives): it is recommended to use an alternative laxative or separate the administration of both medicines.
• Some antibiotics (such as penicillin, rifampicin, isoniazid, neomycin, and chloramphenicol).
• Magnesium salts.
• Other vitamin D-containing products.
• Calcium supplements.
• Corticosteroids (anti-inflammatory medicines).
• Verapamil (an antihypertensive medicine).
• Medicines that inhibit cytochrome P-450 (e.g., atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole).

Taking Hidroferol Weekly 100 microgram soft capsules with food and drinks

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, breastfeeding, think you might be pregnant, or are planning 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 considered when additional vitamin D is administered to the infant.

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

Driving and using machines

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

Hidroferol Weekly 100 microgram soft capsules contain ethanol, liquid sorbitol (non-crystallizable) (E-420), and Allura Red dye (E-129).

This medicine contains 2 mg of alcohol (ethanol) in each soft capsule. The amount in each capsule is equivalent to less than 1 ml of beer or 1 ml of wine. The small amount of alcohol contained in this medicine does not produce any noticeable effect.

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

This medicine may cause allergic reactions because it contains Allura Red dye (E-129).

3. How to take Hidroferol weekly 100 micrograms soft capsules

Follow exactly the administration instructions for the medicine as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

The recommended doses are:

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

This medicine must not be taken daily.

Your doctor should monitor your calcium and Vitamin D levels periodically, usually before starting treatment and again 3–4 months after beginning treatment.

Oral use.

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

If you take more Hidroferol Weekly 100 micrograms capsules 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 (high levels of calcium in the blood) may occur, along with the presence of calcium and phosphates in the blood, 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, digestive disturbances such as vomiting, abdominal cramps, constipation or diarrhea, increased thirst, increased urination, muscle pain. Symptoms that may appear after a period of time include: itching, weight loss, growth retardation in children, kidney disorders, intolerance to sunlight, 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 stopped, 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 Weekly 100 micrograms soft capsules

Do not take a double dose to make up for forgotten 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 treatment is prolonged beyond the duration recommended by the doctor, which may lead to hypercalcemia (increased levels of calcium in blood) and hypercalciuria (increased 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 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 Weekly 100 microgram 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 refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their packaging to the SIGRE point at your pharmacy. If you are unsure, please ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Hidroferol Weekly 100 micrograms soft capsules

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

Appearance of the product and contents of the pack

Hidroferol Weekly 100 micrograms are red, oval-shaped, soft gelatin capsules with a longitudinal seam.

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

The blisters are packaged in a cardboard box.

Only certain pack sizes may be commercially available.

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 the most recent review of this leaflet: June 2024

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