VITODE SEMANAL 100 micrograms SOFT CAPSULES

Introduction

Package Leaflet: Information for the User

Vitode Weekly 100 micrograms Soft Capsules

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, pharmacist, or nurse.
• 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, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What Vitode Weekly 100 micrograms Soft Capsules is and what it is used for
2. What you need to know before you take Vitode Weekly 100 micrograms Soft Capsules
3. How to take Vitode Weekly 100 micrograms Soft Capsules
4. Possible side effects
5. Storage of Vitode Weekly 100 micrograms Soft Capsules
6. Contents of the pack and other information

1. What Vitode Weekly 100 micrograms Soft Capsules is and what it is used for

It contains a form of vitamin D, calcifediol, which is 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 100 micrograms Soft Capsules is indicated for the treatment of vitamin D deficiency in adults and to prevent vitamin D deficiency in adults with identified risks.

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

2. What you need to know before you take Vitode Weekly 100 micrograms Soft Capsules

Do not take Vitode Weekly 100 micrograms Soft Capsules

• 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 before starting to take this medicine.

• Do not exceed the recommended daily amounts of vitamin D supplements, such as this medicine, as this could lead to intoxication (see section 3, "If you take more Vitode Weekly 100 micrograms Soft Capsules than you should").
• While taking this medicine or before starting, your doctor may advise you to have 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, "Other medicines and Vitode Weekly 100 micrograms Soft Capsules").
• If you have hypoparathyroidism (insufficient parathyroid hormone function), the action of this medicine may be reduced.
• If you have kidney stone formation (calcium stones), your doctor should monitor your blood calcium levels.
• Patients with prolonged immobilization may require lower doses of this medicine.
• Patients with sarcoidosis (a disease with nodules, usually on the skin), tuberculosis, or other diseases with nodules 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 laboratory tests: if you are going to have any diagnostic tests (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 use of this medicine is not indicated in children and adolescents.

Other medicines and Vitode Weekly 100 micrograms Soft Capsules

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. On the other hand, its active ingredient calcifediol monohydrate 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 Vitode Weekly).
• Medicines 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 medicines and calcifediol monohydrate at least 2 hours apart.
• Mineral oil or paraffin (laxatives): use another type of laxative or take these medicines and calcifediol monohydrate at different times.
• Some antibiotics (such as penicillin, rifampicin, isoniazid, neomycin, and chloramphenicol).
• Magnesium salts.
• Other products containing Vitamin D.
• Calcium supplements.
• Corticosteroids (anti-inflammatory medicines).
• Verapamil (an anti-hypertensive medicine).
• Medicines that inhibit cytochrome P-450 (such as atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, and voriconazole).

Taking Vitode Weekly 100 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 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.

This medicine is not recommended during pregnancy and breast-feeding.

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

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

Driving and using machines

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

Vitode Weekly 100 micrograms Soft Capsules contains ethanol, sorbitol liquid (non-crystallizing) (E-420), and red allura colorant (E-129).

This medicine contains 2 mg of alcohol (ethanol) in each soft capsule. The amount in each 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 11 mg of sorbitol (E-420) as non-crystallizing sorbitol liquid in each soft capsule, equivalent to 0.04 mg/mg.

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

3. How to take Vitode Weekly 100 micrograms Soft Capsules

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

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 medicine should not be taken daily.

Your doctor should monitor your calcium and vitamin D levels periodically, usually before starting treatment and 3-4 months after starting treatment.

Oral use.

This medicine can be taken with or without food, swallow whole, and can be taken with water, milk, or juice.

If you take more Vitode Weekly 100 micrograms Soft Capsules than you should

If you take more of this medicine than your doctor has prescribed (overdose) and/or for a longer period, you may experience hypercalcemia (high levels of calcium in the blood) and hypercalciuria (high levels of calcium in the urine), which may lead to kidney failure. Some symptoms of toxicity may appear soon, and 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 stopped, 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, Telephone 91 562 04 20, indicating the medicine and the amount taken (or take the medicine with you).

If you forget to take Vitode Weekly 100 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 on the use of this medicine, ask your doctor, pharmacist, or nurse.

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 excessive doses or if the treatment is longer than indicated 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 the 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, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Vitode Weekly 100 micrograms Soft Capsules

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 carton and blister after EXP. The expiry date is the last day of the month stated.

This medicine does not require any special storage conditions.

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 other information

Composition of Vitode Weekly 100 micrograms Soft Capsules

• The active substance is calcifediol monohydrate. Each soft capsule contains 100 micrograms of calcifediol monohydrate (equivalent to 96 micrograms of calcifediol).
• The other ingredients are: anhydrous ethanol, medium-chain triglycerides, and the capsule ingredients are: gelatin, glycerol (E-422), sorbitol liquid (non-crystallizing) (E-420), titanium dioxide (E-171), and red allura colorant (E-129).

Appearance of the product and pack contents

Vitode Weekly 100 micrograms are soft gelatin capsules, red, oval, with a longitudinal joint.

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

The blisters are packaged in a cardboard box.

Not all pack sizes may be marketed.

Marketing Authorisation 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 last revision of this leaflet: June 2024

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