Patient Information Leaflet

Vitamin D3Farmasierra 1000 UI Tablets

Colecalciferol (Vitamin D3)

1.What is Vitamin D3Farmasierra and what it is used for

2.What you need to know before taking Vitamin D3Farmasierra

3.How to take Vitamin D3Farmasierra

4.Possible side effects

5.Storage of Vitamin D3Farmasierra

6.Contents of the pack and additional information

This medication contains vitamin D3, which helps the body to absorb calcium and improves bone formation.

This medication is recommended in the following cases:

-Treatment of vitamin D deficiency in adults and adolescents.

-Prevention of vitamin D deficiency in adults with identified risk.

-With other medications to treat certain bone disorders, such as bone thinning (osteoporosis) in adult patients with vitamin D deficiency or at risk of vitamin D insufficiency.

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 renal insufficiency (serious kidney problems)

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 properly to the parathyroid hormone produced by the body

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

Taking Vitamin D3Farmasierra with food and drinks

Take Vitamin D3preferably with meals.

Children and adolescents

This medication is not recommended for use in children under 12 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 (contained 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, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you 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 breastfeeding. 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 D3on 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.

Warnings about excipients

If your doctor has told you that you are intolerant to certain sugars, consult with them before taking this medication.

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

The dose must be established individually based on the degree of vitamin D supplementation needed. Medical supervision is necessary since the dose requirements may vary depending on the patient's response.

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

The tablets can be taken whole with water or crushed. It is recommended to take this medication preferably with a large meal so that your body can absorb vitamin D3.

Use in adults

• Treatment of vitamin D deficiency:1000UI-4.000 UI/day (1-4 tablets/day)

After the first month, a lower maintenance dose should be considered.

• Prevention of vitamin D deficiency: 1000 UI/day (1 tablet/day).
• With other medications to treat certain bone conditions, such as bone loss (osteoporosis) in patients with vitamin D deficiency or risk of deficiency: 1000 UI/day (1 tablet/day).

Use in adolescents (12-18 years)

• Treatment of vitamin D deficiency: 1000 UI/day (1 tablet/day).

Higher doses should be considered based on medical criteria.

The initial treatment dose for vitamin D deficiency in adolescents should not exceed 4.000 UI/day (4 tablets/day)

Use in children

Vitamin D3Farmasierra is not intended for use in children under 12 years.

Administration form

The tablets can be taken whole with water or crushed.

If you take more Vitamina D3Farmasierra than you should

If you have taken a larger amount 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 Vitamina 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 Vitamina 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 with 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.

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

Do not use this medication after the expiration date that appears on the box or in the container 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.

Store below 25 °C.

Medications should not be disposed of through drains or in the trash. Deposit the containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Vitamin D3Farmasierra

The active principle is colecalciferol:

Each tablet contains 1000 UI of vitamin D3, equivalent to 25 micrograms.

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 D3 Farmasierra – round white-yellowish tablets.

It is presented in PVC/PVDC/PE blister packaging containing 30 tablets and conditioned in a cardboard box.

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

Last review date of this leaflet: September 2023

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices AEMPShttp://www.aemps.gob.es/.