CALCIFEDIOL NORMOGEN 0.266 mg SOFT GEL CAPSULES

Introduction

Package Leaflet: Information for the User

Calcifediol Normogen 0.266 mg Soft Capsules EFG

Calcifediol Monohydrate

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Calcifediol Normogen and what is it used for
2. What you need to know before you take Calcifediol Normogen
3. How to take Calcifediol Normogen
4. Possible side effects
5. Storage of Calcifediol Normogen
6. Contents of the pack and further information

1. What is Calcifediol Normogen 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 Normogen 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 you take Calcifediol Normogen

Do not take Calcifediol Normogen

• 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 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 medicine, as this could lead to intoxication (see section 3, subsection If you take more Calcifediol Normogen than you should).
• While taking this medicine 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 supervised by their doctor to monitor blood calcium levels, especially those being treated with cardiac glycosides (see this section, subsection Other medicines and Calcifediol Normogen).
• If you have hypoparathyroidism (insufficient parathyroid hormone function), the action of this medicine 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 medicine.
• Patients with sarcoidosis (a disease with nodules, usually on the skin), tuberculosis, or other nodular diseases should be cautious with this medicine, 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 test (including blood tests, urine tests, skin tests using allergens, etc.), inform your doctor that you are taking this medicine, 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 medicines and Calcifediol Normogen

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

Some medicines may affect how this medicine works or calcifediol, its active ingredient, may affect the efficacy of other medicines taken at the same time. Therefore, interactions may occur with the following medicines:

• Medicines used to treat epilepsy (such as phenytoin, phenobarbital, and primidone) and other enzyme-inducing medicines (which may decrease the effect of calcifediol).
• Medicines for the heart and/or high blood pressure, such as cardiac glycosides, thiazide diuretics, or verapamil.
• Cholestyramine, colestipol (for cholesterol), orlistat (for obesity): take these medicines and calcifediol at least 2 hours apart.
• Mineral oil or paraffin (laxatives): use another type of laxative or take these medicines 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 medicines).

Taking Calcifediol Normogen 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 medicine and become excessive.

Pregnancy, Breast-feeding, and Fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Do not take this medicine during pregnancy.

Do not take this medicine while breast-feeding your child.

Driving and using machines

This medicine does not affect the ability to drive or use machines.

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

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

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

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

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

3. How to take Calcifediol Normogen

Take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

Do not take more medicine than your doctor has told you or take it more often than prescribed (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 complement 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 medicine 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 route.

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

If you take more Calcifediol Normogen than you should

If you take more calcifediol than prescribed by your doctor (overdose) and/or for a prolonged period, you may experience hypercalcemia (high levels of calcium in the blood and urine) and phosphates in the blood, 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 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 medicine and the amount taken (or bring the medicine with you).

If you forget to take Calcifediol Normogen

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 further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Side effects may occur if you take higher doses or for longer periods than prescribed by your doctor, which may cause hypercalcemia (high levels of calcium in the blood) and hypercalciuria (high levels of calcium in the urine); 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 of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Spanish Medicines and Healthcare Products Agency (AEMPS) at www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Calcifediol Normogen

Do not store above 30°C.

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

Do not use this medicine after the expiry date which is stated on the packaging after ‘EXP’. The expiry date refers to the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Calcifediol Normogen

• 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 ingredients (excipients) are: anhydrous ethanol and medium-chain triglycerides. The ingredients 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 pack contents

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

Packs 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 last revision of this leaflet: May 2023

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