Package Leaflet: Information for the Patient

Hidroferol Shock 3 mg Oral Solution

calcifediol monohydrate

Read this 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. Do not pass it on to others even if they have similar symptoms to you, as it may harm them.
• If you experience any side effects, talk to your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

1. What is Hidroferol Shock 3 mg Oral Solution and what it is used for

2. What you need to know before you start taking Hidroferol Shock 3 mg Oral Solution

3. How to take Hidroferol Shock 3 mg Oral Solution

4. Possible side effects

5. Storage of Hidroferol Shock 3 mg Oral Solution

6. Contents of the pack and additional information

It contains a form of vitamin D, calcifediol monohydrate, in very high doses, which is used to treat vitamin D deficiency and the problems that arise from it. Vitamin D acts in the human body, among other actions, by increasing calcium absorption.

Hidroferol Choque 3 mg oral solution is indicated for the treatment ofvitamin D deficiency in adults, in those disorders in which the administration of very high doses is required.

Do not take Hidroferol Choque 3 mg oral solution:

• if you are allergic to calcifediol or any of the other components of this medication (including those listed in section 6).
• if you have hypercalcemia (elevated levels of calcium in the blood) or hypercalciuria (elevated levels of calcium in the urine).
• if you have calcium stone formation.
• if you have hypervitaminosis D (excess of vitamin D in the body).
• if you are pregnant or breastfeeding a baby.
• if you have sarcoidosis (small abnormal tissue growths in certain organs of the body), tuberculosis, or other granulomatous diseases (similar to sarcoidosis).

Warnings and precautions

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

• Do not exceed the recommended daily doses of vitamin D supplements, such as this medication, as it may cause an overdose (see section 3, subsection If you take more Hidroferol Choque 3 mg oral solution than you should).
• Your doctor may instruct you to undergo blood or urine tests to monitor your calcium, phosphorus, and other parameter levels while taking this medication.
• Your doctor should monitor your progress through regular visits to ensure that this medication does not cause any adverse effects.
• If you experience symptoms such as nausea, vomiting, drowsiness, or any signs of overdose, inform your doctor immediately.
• Patients with kidney disease require special caution and should be closely monitored by their doctor, with regular blood and urine tests.
• Patients with heart disease require special caution and should be closely monitored by their doctor for blood calcium levels, especially those taking cardiac glycosides (see this section, subsection Other medications and Hidroferol Choque 3 mg oral solution).
• If you have hypoparathyroidism (insufficient parathyroid hormone function), it may reduce the effect of this medication.
• 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 medication.
• Your doctor should inform you and your family members or caregivers of the importance of taking the medication at the recommended doses, as well as recommendations for your diet and calcium supplement intake, to avoid overdose.
• Interference with diagnostic tests: Inform your doctor if you are to undergo any diagnostic tests (including blood, urine, skin tests using allergens, etc.) while taking this medication, as it may alter the results. For example, in some cholesterol tests.

Children and adolescents

Hidroferol Choque 3 mg oral solution should not be used in children under 18 years of age.

Other authorized medications from the Hidroferol brand with much lower dose concentrations are available.

Other medications and Hidroferol Choque 3 mg oral solution

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication, including those purchased without a prescription.

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

Therefore, interactions may occur with the following medications:

• Medications used to treat epilepsy (such as phenytoin, phenobarbital, and primidone) and other enzyme-inducing medications (which may reduce the effect of Hidroferol).
• Medications for the heart and/or high blood pressure, such as cardiac glycosides, thiazide diuretics, or verapamil.
• Colestiramine, colestipol (for cholesterol), orlistat (for obesity): Take these medications and calcifediol at least 2 hours apart.
• Mineral oil or paraffin (laxatives): Use another type of laxative or take these medications and calcifediol at different times.
• Some antibiotics (such as penicillin, neomycin, and chloramphenicol).
• Magnesium salts.
• Other vitamin D products.
• Calcium supplements.
• Corticosteroids (anti-inflammatory medications).

Taking Hidroferol Choque 3 mg oral solution with food and beverages

Some foods and beverages are fortified with vitamin D. This should be taken into account, as the effects of these foods may add to the effects of this medication and result in excessive effects.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

Do not take this medication during pregnancy.

Do not take this medication while breastfeeding your child.

Driving and operating machinery

This medication does not affect your ability to drive vehicles or operate machinery.

Hidroferol Choque 3 mg oral solution is EXCLUSIVELY for oral administration.

Hidroferol Choque 3 mg oral solution MUST NOT be administered via intramuscular or intravenous routes.

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

Do not take more of the medication or take it more frequently than indicated by your doctor. If you do, you may increase the risk of an overdose.

The recommended dose is:

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

After an interval of time (usually 2 or more months), if your doctor considers it necessary, they may prescribe a new dose to maintain an adequate concentration of calcifediol in the blood.

The interval between doses will vary depending on the initial concentration of vitamin D in the blood, the condition being treated, and the response to treatment. This will be monitored frequently through blood and/or urine analysis.

Oral route.

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.

The instructions for opening and using the ampoules are as follows:

1. Insert the glass ampoule head into the opener cylinder. Hold the ampoule body between the thumb and index finger with the white point upwards.
2. Place the index finger of the other hand under the cylinder covering the ampoule head, and the thumb above it, as indicated in the figure, so that the index fingers of both hands touch each other under the ampoule.
3. Hold the hand holding the ampoule still and press the head with the thumb downwards to open the ampoule with a dry movement.
4. Once the ampoule is opened, remove the head from the ampoule for subsequent reuse.

If you estimate that the action of this medication 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 medication than the doses indicated by your doctor (overdose) and/or for a prolonged period, you may experience hypercalcemia (elevated calcium levels in the blood) and phosphates in the blood and urine, leading to possible kidney insufficiency.

Some symptoms of toxicity may appear soon, and others may appear after a while. Initial 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.

After a while, you may experience: itching, weight loss, kidney problems, intolerance to sunlight, conjunctivitis, increased cholesterol, transaminases, pancreatitis inflammation, calcification (deposit of calcium salts) in blood vessels and other tissues such as tendons and muscles, increased blood pressure, mental disorders, irregular heartbeats.

Overdose symptoms usually improve or disappear when treatment is stopped, but if the poisoning is severe, it may cause 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, Teléfono 91 562 04 20, indicating the medication and the amount ingested (or bring the medication with you).

If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medications, this medication may produce adverse effects, although not all people may experience them.

Adverse effects may occur if excessive doses are taken or at a frequency higher than that indicated by the doctor, which may produce hypercalcemia (elevated calcium levels in the blood) and hypercalciuria (elevated calcium levels in the urine); see section 3 for a description of the symptoms.

Other adverse effects includeallergic reactions such as itching, local swelling, difficulty breathing, and skin redness.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is possible adverse effects that do not appear in this prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es

By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Hidroferol Shock 3 mg oral solution

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

Appearance of the product and content of the packaging

Hidroferol Shock is presented in oral solution. In a topaz glass ampoule with an O.P.C. opening system and a polyethylene cylinder for easy opening, containing 1.5 ml of oral solution for administration.

The solution is a transparent, slightly yellowish, viscous, and impurity-free liquid.

Each package 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

Holder of the marketing authorization

Faes Farma, S.A.

Autonomia Etorbidea, 10

48940 Leioa (Bizkaia)

Spain

Responsible for manufacturing

Faes Farma Portugal, S.A.

Rua Elias Garcia, 28

2700-327 Amadora

Portugal

Last review date of this leaflet:November 2023

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