Prospect: information for the user

Vitamin D3Farmasierra 50,000 UI tablets

Colecalciferol (vitamin D3)

1.Vitamin D3Farmasierra and its use

2.What you need to know before starting to take Vitamin D3Farmasierra

3.How to take Vitamin D3Farmasierra

4.Adverse effects

5.Storage of Vitamin D3Farmasierra

6.Contents of the package and additional information

This medication contains vitamin D3that regulates the absorption and metabolism of calcium, as well as the incorporation of calcium into bone tissue.

Vitamina D3Farmasierrais indicated for the initial treatment of clinically relevant vitamin D deficiency in adults.

Do not take Vitamin D3Farmasierra

-if you are allergic to colecalciferol (vitamin D3) or any of the other components of this medication (listed in section 6)

-if you have hypercalcemia (elevated calcium levels in the blood) or hypercalciuria (elevated calcium levels in the urine)

-if you have vitamin D toxicity (elevated vitamin D levels in the blood)

-if you have kidney stones

-if you have severe kidney insufficiency (serious kidney problems)

If you have any of the above conditions, consult your doctor or pharmacist before taking this medication.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Vitamin D3:

-if you have sarcoidosis (a special type of connective tissue disease that affects the lungs, skin, and joints)

-if you have kidney problems or have had kidney stones

-if you have pseudohypoparathyroidism, a rare condition in which the body does not respond adequately to the parathyroid hormone produced by the body

-when using this medication simultaneously with other medications that contain vitamin D

Administration of Vitamin D3Farmasierra with food and beverages

Take Vitamin D3preferably with meals.

Children and adolescents

This medication is not suitable for use in children and adolescents under 18 years old.

Other medications and Vitamin DD3Farmasierra

Inform your doctor or pharmacist that you are taking, have taken recently, or may need to take any other medication, particularly:

-Thiazide diuretics (to treat high blood pressure)

-Cardiac glycosides (to treat heart conditions), e.g. digoxin

-Glucocorticoids (to treat inflammation)

-Cholestyramine or cholestipol hydrochloride (used to treat high cholesterol)

-Paraffin oil laxatives

-Orlistat (weight loss)

-Magnesium (found in some antacids)

-Phenytoin or barbiturates (used to treat epilepsy)

-Medications for the treatment of excess calcium (calcitonin, etidronate, gallium nitrate, pamidronate, or plicamycin)

-Rifampicin (antibiotic)

-Isoniazid (medication for tuberculosis)

-Actinomycin (chemotherapy)

-Imidazole (antifungal)

Pregnancy, lactation, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Vitamin D3will only be used during pregnancy if a clinical deficiency of vitamin D has been diagnosed. During pregnancy, the daily intake of vitamin D should not exceed 400 UI.

Vitamin D3can be used during lactation. Vitamin D3passes into breast milk. This should be taken into account when administering additional vitamin D to the infant.

There are no data on the effects of vitamin D3 on fertility. However, it is not expected that normal levels of vitamin D will have adverse effects on fertility.

Driving and operating machinery

Vitamin D3has no known effects on the ability to drive or operate machinery.

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Follow exactly the administration instructions for Vitamin D3Farmasierra indicated by your doctor. In case of doubts, consult your doctor or pharmacist again.

The dose must be established on an individual basis, depending on the degree of vitamin D supplementation required. Medical supervision is necessary since the dose requirements may vary depending on the patient's response.

The patient's dietary habits should be carefully evaluated and the vitamin D content of certain foods taken into account.

The tablets can be taken whole with water or crushed.You should take this medication preferably with a full meal so that your body can absorb the vitamin D3.

Use in Adults

Recommended dose:

25,000 UI per week. After the first month, the dose may be reduced.

High doses may be considered under medical supervision: 50,000 UI/week (single dose) for 6-8 weeks;

This initial treatment may be followed by a maintenance therapy, as indicated by your doctor.

Alternatively, follow the national dosing recommendations for the treatment of vitamin D deficiency.

Use in children

Vitamin D3Farmasierra is not intended for use in children and adolescents under 18 years old.

If you take more Vitamin D3Farmasierra than you should

If you have taken more of this medication than prescribed, or if a child has accidentally taken this medication, contact your doctor or emergency services to evaluate the existing risk.

An excess of vitamin D causes an alteration of the calcium cycle in the body. The following symptoms may occur: weakness, fatigue, headache, nausea, vomiting, diarrhea, excessive urine, calcium in urine, dry mouth, nocturia, proteinuria, intense thirst, loss of appetite, dizziness.

In case of overdose or accidental ingestion, consult the Toxicological Information Service, phone 91 562.04.20, indicating the medication and the amount used. It is recommended to bring the packaging and the medication leaflet to the healthcare professional..

If you forgot to take Vitamin D3Farmasierra

Do not take a double dose to compensate for the missed doses.

Take the missed dose as soon as possible; then return to your regular dosing schedule.

If it is almost time for the next dose, do not take the missed dose, just take the next dose normally.

If you interrupt the treatment with Vitamin D3Farmasierra

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medications, Vitamin D3can produce adverse effects, although not all people will experience them. If you consider that any of the adverse effects you are experiencing are severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

You must stop taking Vitamin D3immediately and consult your doctor if you experience severe allergic reaction symptoms, such as:

• Swelling of the face, lips, tongue, or throat
• Difficulty swallowing
• Hives and difficulty breathing.

Less common adverse effects(occur in fewer than 1 in 100 patients): Hypercalcemia (elevated calcium levels in the blood) and hypercalciuria (elevated calcium levels in the urine).

Rare adverse effects(occur in fewer than 1 in 1,000 patients): Itching, skin rash, and hives.

Reporting Adverse Effects

If you experienceany type of adverse effect, consult your doctor or pharmacist or nurse, even if it is apossibleadverse effect not listed in this prospectus.You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es.

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

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

Do not use this medication after the expiration date that appears on the packaging and on the bottle or blister after the abbreviation CAD. The expiration date is the last day of the month indicated.

Store the tablets in their original packaging to protect them from light.

Keep the bottle perfectly closed to protect it from moisture.

Do not store at a temperature above 25 °C.

Medications should not be thrown down the drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Composition of Vitamin D3Farmasierra

The active principle is colecalciferol 1250 micrograms, equivalent to 50,000 UI of vitamin D3.

The other components are refined palm oil, hydrogenated palm oil, butylhydroxytoluene E321, isomaltose, anhydrous colloidal silica, microcrystalline cellulose, sodium croscarmellose, magnesium stearate.

Appearance of Vitamin D3Farmasierra and contents of the packaging

Vitamin D3Farmasierra – oblong white-yellowish tablets with an aesthetic groove on one of the faces. The groove serves only to fracture and facilitate swallowing, but not to divide into equal doses

It is presented in a PVC/PVDC/PE-Al blister containing 4 tablets and packaged in a cardboard box.

Not all presentations may be marketed.

Holder of the Marketing Authorization

Farmasierra Laboratorios SL

Ctra de Irún km 26,200

28709 San Sebastián de los Reyes

Madrid

Spain

Responsible for manufacturing

Farmasierra Manufacturing SL

Ctra de Irún km 26,200

28709 San Sebastián de los Reyes

Madrid Spain

Revision date of this prospectus: June2022

The detailed and updated information of this medication is available on the website of the Spanish Agency for Medicines and Medical Devices AEMPS