VITODE SEMANAL 75 micrograms SOFT CAPSULES

Introduction

Package Leaflet: Information for the User

Vitode Weekly 75 Micrograms Soft Capsules

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 Vitode Weekly 75 Micrograms Soft Capsules are and what they are used for
2. What you need to know before taking Vitode Weekly 75 Micrograms Soft Capsules
3. How to take Vitode Weekly 75 Micrograms Soft Capsules
4. Possible side effects
5. Storage of Vitode Weekly 75 Micrograms Soft Capsules
6. Package Contents and Additional Information

1. What Vitode Weekly 75 Micrograms Soft Capsules are and what they are used for

They contain a form of vitamin D, calcifediol, used to prevent and treat vitamin D deficiency and related problems. Vitamin D acts in the human body, among other actions, by increasing calcium absorption.

Vitode Weekly 75 Micrograms Soft Capsules are indicated for the treatment of vitamin D deficiency in adults and to prevent vitamin D deficiency in adults with identified risks.

They are also used to treat certain bone conditions, such as bone loss (osteoporosis) in adults.

2. What you need to know before taking Vitode Weekly 75 Micrograms Soft Capsules

Do not take Vitode Weekly 75 Micrograms Soft Capsules

• 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).

Warnings and Precautions

Consult your doctor before starting to take this medication.

• 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 Vitode Weekly 75 Micrograms Soft Capsules than you should).
• While taking this medication or before starting, your doctor may recommend 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 Vitode Weekly 75 Micrograms Soft Capsules).
• If you have hypoparathyroidism (insufficient parathyroid hormone function), the action of this medication may be reduced.
• If you have kidney stone formation (calcium stones), 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 nodule-forming 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 laboratory tests: if you are to undergo any diagnostic tests (including blood, urine, 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 use of this medication is not indicated in children and adolescents.

Other Medications and Vitode Weekly 75 Micrograms Soft Capsules

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. Additionally, 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 decrease the effect of Vitode Weekly).
• Medications for the heart 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 monohydrate at least 2 hours apart.
• Mineral oil or paraffin (laxatives): use another type of laxative or take these medications and calcifediol monohydrate at different times.
• Certain antibiotics (such as penicillin, rifampicin, isoniazid, neomycin, and chloramphenicol).
• Magnesium salts.
• Other vitamin D products.
• Calcium supplements.
• Corticosteroids (anti-inflammatory medications).
• Verapamil (anti-hypertensive medication).
• Medications that inhibit cytochrome P-450 (e.g., atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole).

Taking Vitode Weekly 75 Micrograms Soft Capsules 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, breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

This medication is not recommended during pregnancy and breastfeeding.

Calcifediol passes into breast milk. This should be taken into account when administering additional vitamin D to the breastfed infant.

There are no data on the effects of calcifediol on fertility.

Driving and Using Machines

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

Vitode Weekly 75 Micrograms Soft Capsules contain ethanol, non-crystallizing liquid sorbitol (E-420), and allura red colorant (E-129).

This medication contains 1 mg of alcohol (ethanol) per soft capsule. The amount in each 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 10 mg of sorbitol (E-420) as non-crystallizing liquid sorbitol per soft capsule, equivalent to 0.04 mg/mg.

This medication may cause allergic reactions because it contains allura red colorant (E-129).

3. How to Take Vitode Weekly 75 Micrograms Soft Capsules

Follow your doctor's instructions for taking the medication exactly. If you are unsure, consult your doctor or pharmacist again.

The recommended doses are:

• For the treatment of vitamin D deficiency and prevention of vitamin D deficiency in patients with identified risks: one capsule once a week.
• As a supplement to specific osteoporosis medication: one capsule once a 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 initiating treatment.

Oral administration.

This medication can be taken with or without food, swallowed whole, and taken with water, milk, or juice.

If you take more Vitode Weekly 75 Micrograms Soft Capsules than you should

If you take more of this medication than prescribed by your doctor (overdose) and/or for a longer period, you may experience hypercalcemia (high blood calcium levels) and hypercalciuria (high urine calcium levels), potentially leading 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 medication and the amount taken (or bring the medication with you).

If you forget to take Vitode Weekly 75 Micrograms Soft Capsules

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 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 will experience them.

Side effects may occur if excessive doses are taken or if the treatment is longer than prescribed by the doctor, potentially leading to 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 possible side effects not listed in this package leaflet. You can also report them directly through the Spanish Medicines 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 Vitode Weekly 75 Micrograms Soft Capsules

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

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

This medication does not require special storage conditions.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medication in the pharmacy's SIGRE collection point. If you are unsure, 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 Vitode Weekly 75 Micrograms Soft Capsules

• The active ingredient is calcifediol monohydrate. Each soft capsule contains 75 micrograms of calcifediol monohydrate (equivalent to 72 micrograms of calcifediol).
• The other ingredients are: anhydrous ethanol, medium-chain triglycerides, and the capsule components, which are: gelatin, glycerol (E-422), non-crystallizing liquid sorbitol (E-420), titanium dioxide (E-171), and allura red colorant (E-129).

Appearance of the Product and Package Contents

Vitode Weekly 75 Micrograms are soft gelatin capsules, pink, oval, with a longitudinal seam.

The capsules are packaged in PVC/PVDC//Al blisters containing 4, 12, 24, or 48 capsules.

The blisters are packaged in a cardboard box.

Only certain package sizes may be marketed.

Marketing Authorization Holder

Faes Farma S.A.

Autonomia Etorbidea, 10

48940-Leioa (Bizkaia)

Spain

Manufacturer

Faes Farma, S.A.

Maximo Agirre Kalea, 14

48940-Leioa (Bizkaia)

Spain

or

Faes Farma S.A.,

Parque Científico y Tecnológico de Bizkaia

Ibaizabal Bidea, Edificio 901

48160Derio (Bizkaia)

Spain

Date of the Last Revision of this Package Leaflet: June 2024

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/