Vitamin D3 Farmasierra 1.000 U.I. tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Vitamina D3 Farmasierra 1000 IU tablets

Colecalciferol (vitamin D3)

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Vitamina D3 Farmasierra is and what it is used for
2. What you need to know before taking Vitamina D3 Farmasierra
3. How to take Vitamina D3 Farmasierra
4. Possible side effects
5. How to store Vitamina D3 Farmasierra
6. Contents of the pack and other information

1. What is Vitamina D3 Farmasierra and what is it used for?

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

This medicine is recommended in the following cases:

• Treatment of vitamin D deficiency in adults and adolescents.
• Prevention of vitamin D deficiency in adults at identified risk.
• Along with other medicines to treat certain bone conditions, such as thinning of the bones (osteoporosis) in adult patients with vitamin D deficiency or at risk of vitamin D insufficiency.

2. What you need to know before starting to take Vitamin D3 Farmasierra

Do not take Vitamin D3 Farmasierra

• if you are allergic to colecalciferol (Vitamin D3) or to any of the other ingredients of this medicine (listed in section 6)
• if you have hypercalcemia (elevated calcium levels in blood) or hypercalciuria (elevated calcium levels in urine)
• if you suffer from hypervitaminosis D (excess vitamin D in blood)
• if you have kidney stones
• if you have severe renal insufficiency (severe kidney problems)

Warnings and precautions

Talk to your doctor or pharmacist before starting Vitamin D3:

• if you have sarcoidosis (a specific type of connective tissue disease affecting the lungs, skin, and joints)
• if you have kidney problems or have previously had kidney stones
• if you have pseudohypoparathyroidism, a rare condition in which the body does not respond properly to parathyroid hormone produced by the body
• when using other medicines containing vitamin D simultaneously

Taking Vitamin D3 Farmasierra with food and drinks

Take Vitamin D3 preferably with meals.

Children and adolescents

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

Other medicines and Vitamin D3 Farmasierra

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, especially:

• Thiazide diuretics (used to treat high blood pressure)
• Cardiac glycosides (used to treat heart conditions), e.g., digoxin
• Glucocorticoids (used to treat inflammation)
• Cholestyramine or colestipol hydrochloride (used to treat high cholesterol)
• Laxatives containing liquid paraffin
• Orlistat (weight loss)
• Magnesium (contained in some antacids)
• Phenytoin or barbiturates (used to treat epilepsy)
• Medicines for treating 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, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

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

Vitamin D3 may be used during breastfeeding. Vitamin D3 passes into breast milk. This should be taken into account when administering additional vitamin D to the infant.

There are no data regarding the effects of vitamin D3 on fertility. However, normal levels of vitamin D are not expected to have adverse effects on fertility.

Driving and using machines

Vitamin D3 has no known effects on the ability to drive or operate machinery.

Warnings about excipients

If your doctor has informed you of an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Vitamina D3 Farmasierra

Follow exactly the administration instructions given by your doctor. If in doubt, consult your doctor or pharmacist again.

The dose should be individually determined based on the required level of vitamin D supplementation. Medical supervision is necessary, as dosage requirements may vary depending on the patient's response.

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

The tablets can be taken whole with water or crushed. This medicine should preferably be taken with a substantial meal to ensure proper absorption of 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)
• With other medicines for treating certain bone conditions, such as bone loss (osteoporosis) in patients with vitamin D deficiency or at risk of vitamin D deficiency: 1000 IU/day (1 tablet/day)

Use in adolescents (12–18 years of age)

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

Higher doses may be considered according to medical judgment.

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

Use in children

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

Administration method

The tablets can be taken whole with water or crushed.

If you take more Vitamina D3 Farmasierra than you should

If you have taken more of this medicine than prescribed, or if a child has accidentally ingested it, contact your doctor or emergency services immediately to assess the potential risk.

Excess vitamin D causes disturbances in calcium metabolism. The following symptoms may occur: 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, contact the Toxicology Information Service at telephone 91 562.04.20, indicating the medicine and the amount taken. It is recommended to bring the medicine packaging and leaflet to the healthcare professional.

If you forget to take Vitamina D3 Farmasierra

Do not take a double dose to make up for missed doses.

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

If it is almost time for your next dose, do not take the missed dose; simply take the next dose as usual.

If you stop taking Vitamina D3 Farmasierra

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

4. Possible adverse effects

Like all medicines, Vitamin D3 may cause adverse effects, although not everyone experiences them. If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effect not listed in this leaflet, inform your doctor or pharmacist.

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

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

Uncommon adverse effects (occur in less than 1 in 100 patients): Hypercalcemia (increased calcium levels in blood) and hypercalciuria (increased calcium levels in urine).

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es.

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

5. Storage of Vitamina D3 Farmasierra

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the carton or container following the abbreviation EXP. The expiry date refers to the last day of the month indicated.

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

Store below 25 °C.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point in your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Vitamina D3 Farmasierra

The active substance is colecalciferol:

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

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

Appearance of Vitamina D3 Farmasierra and contents of the pack

Vitamina D3 Farmasierra – yellowish-white, round tablets.

Supplied in PVC/PVDC/PE-Al blisters containing 30 tablets, packed in a cardboard carton.

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 most recent revision of this leaflet: September 2023

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.