VITAMIN D3 FARMASIERRA 1,000 I.U. TABLETS

Introduction

Package Leaflet: Information for the Patient

Vitamin D33Farmasierra 1000 IU Tablets

Colecalciferol (Vitamin D3)

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 or pharmacist.
• 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 or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet:

1. What is Vitamin D3 Farmasierra and what is it used for
2. What you need to know before taking Vitamin D3 Farmasierra
3. How to take Vitamin D3 Farmasierra
4. Possible side effects
5. Storage of Vitamin D3 Farmasierra
6. Package Contents and Additional Information

1. What is Vitamin D3 Farmasierra and what is it used for

This medication contains Vitamin D3, which helps the body 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 an identified risk.
• In combination with other medications to treat certain bone conditions, such as bone thinning (osteoporosis) in adult patients with Vitamin D deficiency or at risk of Vitamin D deficiency.

2. What you need to know before taking Vitamin D3 Farmasierra

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 hypervitaminosis D (elevated Vitamin D levels in the blood).
• if you have kidney stones.
• If you have severe kidney impairment (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 pseudo-hypoparathyroidism, a rare condition in which the body does not respond properly to the parathyroid hormone produced by the body
• when using other medications that contain Vitamin D simultaneously.

Taking Vitamin D3Farmasierra with Food and Drinks

Take Vitamin D3 preferably with meals.

Children and Adolescents

This medication is not recommended for use in children under 12 years of age.

Other Medications and Vitamin D3Farmasierra

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

• Thiazide diuretics (to treat high blood pressure).
• Cardiac glycosides (to treat heart conditions), e.g., digoxin.
• Glucocorticoids (to treat inflammation).
• Colestyramine or hydrochloride colestipol (used to treat high cholesterol).
• Laxatives containing paraffin oil.
• 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 (tuberculosis medication)
• Actinomycin (chemotherapy)
• Imidazole (antifungal)

Pregnancy, Breastfeeding, and Fertility

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

Vitamin D3 will only be used during pregnancy if the Vitamin D deficiency has been clinically diagnosed. During pregnancy, the daily intake of Vitamin D should not exceed 400 IU.

Vitamin D3 can be used during breastfeeding. Vitamin D3 passes into breast milk. This should be taken into consideration 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 Using Machines

Vitamin D3 has no known effects on the ability to drive or use machines.

Warnings about Excipients

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

3. How to Take Vitamin D3 Farmasierra

Follow the administration instructions indicated by your doctor exactly. 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, as dosage 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 should be taken into account.

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

Use in Adults

• Treatment of Vitamin D deficiency: 1000 IU-4000 IU/day (1-4 tablets/day)

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

• Prevention of Vitamin D deficiency: 1000 IU/day (1 tablet/day).
• In combination with other medications to treat certain bone conditions, such as bone thinning (osteoporosis) in patients with Vitamin D deficiency or at risk of Vitamin D deficiency: 1000 IU/day (1 tablet/day).

Use in Adolescents (between 12-18 years)

• Treatment of Vitamin D deficiency: 1000 IU/day (1 tablet/day).

Higher doses should be considered based on medical judgment.

The dose for the initial treatment of Vitamin D deficiency in adolescents should not exceed 4000 IU/day (4 tablets/day)

Use in Children

Vitamin D3 Farmasierra is not intended for use in children under 12 years of age.

Method of Administration

The tablets can be taken whole with water or crushed.

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 assess the existing risk.

An excess of Vitamin D causes an alteration of the calcium cycle in the body. The following symptoms may be experienced: weakness, fatigue, headache, nausea, vomiting, diarrhea, excessive urination, urinary calcium, 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 package leaflet of the medication to the healthcare professional.

If You Forget to Take Vitamin D3Farmasierra

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

If You Interrupt Treatment with Vitamin D3Farmasierra

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

4. Possible Side Effects

Like all medications, Vitamin D3 can cause side effects, although not everyone will experience them. If you think any of the side effects you are experiencing is serious or if you notice any side effect not mentioned in this package leaflet, inform your doctor or pharmacist.

You should stop taking Vitamin D3 immediately and consult your doctor if you experience symptoms of severe allergic reactions, such as:

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

Uncommon Side Effects(occurring in less than 1 in 100 patients): Hypercalcemia (elevated calcium levels in the blood) and hypercalciuria (elevated calcium levels in the urine).

Rare Side Effects(occurring in less than 1 in 1,000 patients): Itching, skin rash, and hives.

Reporting Side Effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: www.notificaRAM.es.

By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Vitamin D3 Farmasierra

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

Do not use this medication after the expiration date stated on the carton or bottle after the abbreviation EXP. 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 wastewater or household waste. Deposit the packaging and any unused medication in the SIGRE collection point at your pharmacy. If in doubt, 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 Vitamin D3Farmasierra

The active ingredient is colecalciferol:

Each tablet contains 1000 IU of Vitamin D3, equivalent to 25 micrograms.

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

Appearance of Vitamin D3Farmasierra and Package Contents

Vitamin D3 Farmasierra - white-yellowish round tablets.

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

Marketing Authorization Holder

Farmasierra Laboratorios SL

Ctra de Irún km 26,200

28709 San Sebastián de los Reyes

Madrid

Spain

Manufacturer

Farmasierra Manufacturing SL

Ctra de Irún km 26,200

28709 San Sebastián de los Reyes

Madrid Spain

Date of the Last Revision of this Package Leaflet: September 2023

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