CALCIFEDIOL NORMON 0.266 mg SOFT CAPSULES

Introduction

Package Leaflet: Information for the User

Calcifediol Normon 0.266 mg Soft Capsules EFG

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 or pharmacist.
• 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 or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Calcifediol Normon and what is it used for
2. What you need to know before taking Calcifediol Normon
3. How to take Calcifediol Normon
4. Possible side effects
5. Storage of Calcifediol Normon
6. Package Contents and Additional Information

1. What is Calcifediol Normon and what is it used for

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

Calcifediol Normon 0.266 mg soft capsules EFG are indicated for the treatment of vitamin D deficiency in adults and to prevent vitamin D deficiency in adults with identified risks, such as patients with malabsorption syndrome, chronic kidney disease - mineral bone disease (CKD-MBD) or any other identified risk.

It is also used to treat bone loss (osteoporosis), along with other medications in patients with vitamin D deficiency or at risk of vitamin D deficiency.

2. What you need to know before taking Calcifediol Normon

Do not take Calcifediol Normon

• If you are allergic to calcifediol or any of the other components 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).

Warnings and Precautions

Consult your doctor or pharmacist before starting to take calcifediol.

• Do not exceed the recommended daily amounts of vitamin D supplements, such as this medication, as this may cause intoxication (see section 3, subsection If you take more Calcifediol Normon 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.
• 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 monitored by their doctor to control blood calcium levels, especially those being treated with cardiac glycosides (see this section, subsection Other medications and Calcifediol Normon).
• If you have hypoparathyroidism (insufficient parathyroid hormone function), the action of this medication may be reduced.
• If you have kidney stone formation, your doctor should monitor your blood calcium levels.
• Prolonged immobilization patients may require lower doses of this medication.
• Patients with sarcoidosis (a disease with nodules, usually on the skin), tuberculosis, or other nodular diseases should be cautious with this medication, 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 undergo any diagnostic tests (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

The safety and efficacy of calcifediol in children and adolescents under 18 years of age have not been established. No data are available.

Other Medications and Calcifediol Normon

Inform your doctor or pharmacist if you are taking, have recently taken, or may take any other medication, including those purchased without a prescription.

Some medications may affect how this medication works or calcifediol, its active ingredient, 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 decrease the effect of calcifediol).
• Medications for heart conditions and/or high blood pressure, such as cardiac glycosides, thiazide diuretics, or verapamil.
• Colestyramine, 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.
• Certain antibiotics (such as penicillin, neomycin, and chloramphenicol).
• Magnesium salts.
• Other products containing vitamin D.
• Calcium supplements.
• Corticosteroids (anti-inflammatory medications).

Taking Calcifediol Normon 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 your ability to drive vehicles or operate machines.

Calcifediol Normon contains ethanol, sorbitol (70%), and yellow-orange colorant S (E-110)

This medication contains 5 mg of alcohol in each soft capsule, equivalent to 1% of the total weight of the soft capsule. The amount in one capsule of this medication is equivalent to less than 1 ml of beer or 1 ml of wine.

The small amount of alcohol in this medication does not produce any noticeable effect.

This medication contains 31.302 mg of sorbitol in each soft capsule, equivalent to 3.7% of the total weight of the soft capsule.

This medication may cause allergic reactions because it contains yellow-orange colorant S (E-110).

3. How to Take Calcifediol Normon

Follow your doctor's instructions for taking this medication exactly. If you have any doubts, consult your doctor or pharmacist again.

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

The recommended doses are:

Treatment of vitamin D deficiency and prevention of vitamin D deficiency in patients with identified risks: one capsule (0.266 mg of calcifediol) once a month.

As a supplement to specific medication for bone loss: one capsule (0.266 mg of calcifediol) once a month.

There are high-risk populations for vitamin D deficiency where higher doses may be necessary. After analyzing the degree of deficiency, your doctor may consider a dose of one capsule every two weeks or every week. This medication should not be taken daily.

Your doctor should periodically monitor your calcium and vitamin D levels, usually before starting treatment and 3-4 months after starting treatment. According to the indication, doses will be reduced or spaced out over time when symptoms improve or vitamin D deficiency is corrected.

Oral administration.

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

If you take more Calcifediol Normon than you should

If you take more calcifediol than the doses indicated by your doctor (overdose) and/or for a prolonged period, you may experience hypercalcemia (high blood calcium levels) and hypercalciuria (high urine calcium levels), which may 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 discontinued, but if the intoxication 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, phone 91 562 04 20, indicating the medication and the amount taken (or bring the medication with you).

If you forget to take Calcifediol Normon

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 the use of this medication, ask your doctor or pharmacist.

4. Possible Side Effects

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

Side effects may occur if you take excessive doses or for longer periods than indicated by your doctor, which may 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 not listed in this package 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 medication.

5. Storage of Calcifediol Normon

Do not store above 30°C.

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

Do not use this medication after the expiration date stated on the packaging after "EXP". The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Return the packaging and any unused medication to the pharmacy's SIGRE collection point. If you have any doubts, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Calcifediol Normon

• The active ingredient is calcifediol (in the form of monohydrate). Each capsule contains 0.266 mg of calcifediol monohydrate (15,960 IU of vitamin D).
• The other components (excipients) are: anhydrous ethanol and medium-chain triglycerides. The components of the capsule are: gelatin, glycerol, non-crystallizable sorbitol liquid (70%) (E-420), titanium dioxide (E-171), yellow-orange colorant S (E-110), and purified water.

Appearance of the Product and Package Contents

Calcifediol Normon 0.266 mg soft capsules EFG are presented in orange-colored soft gelatin capsules, which come in Al+PVC-PVDC blisters.

Packaging of 3, 5, and 10 soft gelatin capsules.

Marketing Authorization Holder

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Manufacturer

LABORATORIOS ALCALÁ FARMA, S.L.

Avenida de Madrid, 82 – 28802 Alcalá de Henares – Madrid (SPAIN)

Date of the Last Revision of this Package Leaflet: May 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/

You can access detailed and updated information about this medication by scanning the QR code included in the package leaflet and packaging with your smartphone. You can also access this information at the following internet address:

https://cima.aemps.es/cima/dochtml/p/88825/P_88825.html