HIDROFEROL CHOQUE 3 mg ORAL SOLUTION

Introduction

Package Leaflet: Information for the Patient

Hidroferol Shock 3 mg Oral Solution

calcifediol monohydrate

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication 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 package leaflet. See section 4.

Contents of the Package Leaflet

1. What Hidroferol Shock 3 mg Oral Solution is and what it is used for
2. What you need to know before 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. Package Contents and Additional Information

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

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

Hidroferol Shock 3 mg Oral Solution is indicated for the treatment of vitamin D deficiency in adults, in those disorders that require the administration of very high doses.

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

Do not take Hidroferol Shock 3 mg Oral Solution:

• if you are allergic to calcifediol or any other component of this medication (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).
• if you are pregnant or breastfeeding.
• if you have sarcoidosis (small abnormal tissue lumps in certain body organs), tuberculosis, or other granulomatous diseases (similar to sarcoidosis).

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Hidroferol Shock 3 mg Oral Solution.

• Do not exceed the recommended daily amounts of vitamin D supplements, such as this medication, as this could lead to intoxication (see section 3, subsection If you take more Hidroferol Shock 3 mg Oral Solution than you should).
• While taking this medication or before starting, your doctor may indicate that you undergo blood or urine tests to monitor your calcium, phosphorus, and other parameter levels.
• Your doctor should check your progress through regular visits to ensure that this medication does not cause unwanted effects.
• If symptoms such as nausea, vomiting, drowsiness, or any overdose symptom appear, inform your doctor immediately.
• Patient with kidney disease require special caution and should be closely monitored by their doctor, with periodic tests.
• Patient with heart disease require special caution and should be frequently supervised by their doctor to control blood calcium levels, especially those being treated with cardiac glycosides (see in thissection, subsection Other medications and Hidroferol Shock 3 mg Oral Solution).
• If you have hypoparathyroidism (insufficient parathyroid hormone function), the action of this medication may be reduced.
• If you are prone to kidney stone formation, your doctor should monitor your blood calcium levels.
• Prolonged immobilization patients may require lower doses than those contained in this medication.
• Your doctor should inform you and your family members/caregivers about the importance of taking the medication as indicated, as well as dietary recommendations and calcium supplement intake to avoid overdosing.
• Interference with analytical tests: if you are going to undergo any diagnostic test (including blood tests, urine tests, skin tests using allergens, etc.), inform your doctor that you are taking this medication, as it may alter the results. For example, in some cholesterol tests.

Children and Adolescents

Hidroferol Shock 3 mg should not be used in children under 18 years of age.

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

Other medications and Hidroferol Shock 3 mg Oral Solution

Inform your doctor or pharmacist if you are using, have recently used, 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 favor the decrease of Hidroferol's effect).
• Medications for heart conditions and/or high blood pressure, such as cardiac glycosides, thiazide diuretics, or verapamil.
• Colestyramine, colestipol (for cholesterol), orlistat (for obesity): the intake of these medications 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 separate the intake of both medications.
• Some antibiotics (such as penicillin, neomycin, and chloramphenicol).
• Magnesium salts.
• Other products containing Vitamin D.
• Calcium supplements.
• Corticosteroids (anti-inflammatory medications).

Taking Hidroferol Shock 3 mg Oral Solution 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 medication 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 medication.

Do not take this medication during pregnancy.

Do not take this medication while breastfeeding your child.

Driving and Using Machines

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

3. How to Take Hidroferol Shock 3 mg Oral Solution

The Hidroferol Shock 3 mg Oral Solution ampoule is EXCLUSIVELY for oral administration.

Hidroferol Shock 3 mg Oral Solution should NOT be administered intramuscularly or intravenously.

Follow your doctor's instructions for administering this medication exactly. If in doubt, consult your doctor or pharmacist again.

Do not take more 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 Shock (3 mg of calcifediol monohydrate).

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

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

Oral administration.

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

Shake the ampoule before use.

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

1. Insert the ampoule head into the opening facilitator cylinder. Hold the ampoule body between your thumb and index finger with the white dot facing up.
2. Place the index finger of your other hand under the cylinder covering the ampoule head and your thumb above it, as indicated in the figure, so that the index fingers of both hands touch each other below the ampoule.
3. Keep the hand holding the ampoule still and press the head down with your thumb to open the ampoule with a sharp movement.
4. Once the ampoule is open, remove the ampoule head from the cylinder for later reuse.

If you think the action of this medication is too strong or too weak, inform your doctor or pharmacist.

If you take more Hidroferol Shock 3 mg Oral Solutionthan 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 (high blood calcium levels) and high phosphate levels in blood and urine, leading to possible kidney failure.

Some toxicity symptoms 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, kidney disorders, intolerance to sunlight, conjunctivitis, increased cholesterol, transaminases, pancreatitis, calcification (calcium salt deposits) 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 discontinued, 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 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.

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

Side effects may occur if excessive doses are taken or with a frequency higher than indicated by the doctor, which can cause hypercalcemia (high blood calcium levels) and hypercalciuria (high urine calcium levels); see section 3 for a description of the symptoms.

Other side effects include allergic reactions such as itching, local swelling, difficulty breathing, and skin redness.

Reporting Side Effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: www.notificaRAM.es

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

5. Storage of Hidroferol Shock 3 mg Oral Solution

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

Do not use this medication after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and unused medications in the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and unused medications. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Hidroferol Shock 3 mg Oral Solution

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

Appearance of the Product and Package Contents

Hidroferol Shock is presented in an oral solution. In a brown glass ampoule with an 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 of visible impurities.

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.

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 Last Revision of this Package Leaflet:November 2023

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