Hidroferol Choque 3 mg oral solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Hidroferol Choque 3 mg oral solution

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 others, even if they have the same symptoms as you, because it could 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.

Leaflet contents

1. What Hidroferol Choque 3 mg oral solution is and what it is used for
2. What you need to know before taking Hidroferol Choque 3 mg oral solution
3. How to take Hidroferol Choque 3 mg oral solution
4. Possible side effects
5. How to store Hidroferol Choque 3 mg oral solution
6. Contents of the pack and other information

1. What Hidroferol Choque 3 mg oral solution is and what it is used for

It contains a form of vitamin D, calcifediol monohydrate, in very high doses, 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 Choque 3 mg oral solution is indicated for the treatment of vitamin D deficiency in adults, in those disorders requiring administration of very high doses.

2. What you need to know before taking Hidroferol Choque 3 mg oral solution

Do not take Hidroferol Choque 3 mg oral solution:

• 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 (calculi) formation.
• if you have hypervitaminosis D (excess vitamin D in the body).
• if you are pregnant or breastfeeding.
• if you have sarcoidosis (small lumps of abnormal tissue in certain organs of the body), tuberculosis, or other granulomatous diseases (similar to sarcoidosis).

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Hidroferol Choque 3 mg oral solution.

• 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 Choque 3 mg oral solution 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 levels.
• Your doctor should monitor your progress through regular visits to ensure this medicine does not cause unwanted effects.
• If symptoms such as nausea, vomiting, drowsiness, or any signs of overdose occur, inform your doctor immediately.
• 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 in this section, subsection Other medicines and Hidroferol Choque 3 mg oral solution).
• If you have hypoparathyroidism (insufficient parathyroid hormone function), the effect of this medicine may be reduced.
• If you are prone to kidney stone formation, your doctor should monitor your blood calcium levels.
• Patients with prolonged immobilization may require lower doses than those contained in this medicine.
• Your doctor should inform you and your family members and/or caregivers about the importance of taking the medicine at the prescribed doses, as well as dietary recommendations and calcium supplements, to avoid overdose.
• Interference with laboratory 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, in certain cholesterol tests.

Children and adolescents

Hidroferol Choque 3 mg must not be used in children under 18 years of age.

Other Hidroferol brand medicines with much lower dosage concentrations are available and authorized.

Other medicines and Hidroferol Choque 3 mg oral solution

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 in the treatment of epilepsy (such as phenytoin, phenobarbital, and primidone) and other enzyme-inducing medicines (which may reduce the effect of Hidroferol).
• Medicines for the heart and/or high blood pressure such as cardiac glycosides, thiazide diuretics, or verapamil.
• Cholestyramine, colestipol (for cholesterol), orlistat (for obesity): administration 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 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 Choque 3 mg oral solution 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 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.

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.

3. How to take Hidroferol Choque 3 mg oral solution

The Hidroferol Choque 3 mg oral solution ampoule is for ORAL USE ONLY.

Hidroferol Choque 3 mg oral solution must NOT be administered by intramuscular or intravenous route.

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

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

The recommended dose is:

Adults: a single dose of 1 ampoule of Hidroferol Choque (3 mg of monohydrate calcifediol).

After an interval of time (usually 2 or more months), if your doctor considers it necessary, a new dose may be prescribed to maintain adequate blood levels of calcifediol.

The interval between doses will vary depending on the initial blood vitamin D levels, the disorder being treated, and the response to treatment. This will be monitored regularly through blood and/or urine tests.

Oral use.

The contents of the ampoule can be taken alone or diluted in a small amount of water, milk, or juice.

Shake the ampoule before use.

Instructions for opening and using the ampoules are as follows:

1. Insert the glass ampoule's head into the opening aid cylinder. Hold the body of the ampoule between your thumb and index finger, with the white mark facing upwards.
2. Place the index finger of your other hand beneath the cylinder covering the ampoule's head, and your thumb above it, as shown in the figure, so that the index fingers of both hands touch each other beneath the ampoule.
3. Keep the hand holding the ampoule steady and press the head downwards with your thumb in a quick motion to break the ampoule open.
4. Once the ampoule is open, remove the head of the ampoule from the cylinder for future reuse.

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 Choque 3 mg oral solution than you should

If you take more of this medicine than the doses prescribed by your doctor (overdose) and/or for prolonged periods, hypercalcemia (elevated calcium levels in blood) may occur, along with increased phosphate levels in blood and urine, potentially leading to renal failure.

Some symptoms of toxicity may appear early, while others may appear 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 (urine output), muscle pain.

Symptoms that may appear after a delay include: itching, weight loss, 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 heartbeats.

Symptoms of overdose usually improve or disappear upon discontinuation of treatment, 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 take the medicine with you).

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 will experience them.

Adverse effects may occur if excessive doses are taken or if the medicine is taken more frequently than indicated by the doctor, 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 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 Choque 3 mg oral solution

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 empty containers and unused medicines at a SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Pack contents and additional information

Composition of Hidroferol Choque 3 mg oral solution

• The active substance is calcifediol monohydrate. Each ampoule contains 3 mg of calcifediol monohydrate.
• The other components are: medium-chain triglycerides, alpha-tocopheryl acetate.

Appearance of the product and pack contents

Hidroferol Choque is presented as an oral solution. In an amber glass ampoule with O.P.C. opening system and a polyethylene cylinder to facilitate opening, containing 1.5 ml of solution for oral administration.

The solution is a clear, slightly yellowish, viscous liquid, free from visible impurities.

Each pack contains 1 ampoule.

• Other presentations:

Hidroferol 0.1 mg/ml oral drops in solution.

Hidroferol 0.266 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 Portugal, S.A.

Rua Elias Garcia, 28

2700-327 Amadora

Portugal

Date of the most recent review of this leaflet: November 2023

Detailed 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/