Vitamina D3 Farmasierra 10.000 U.I. tablets

Package leaflet: Information for the user

Introduction

Package Leaflet: Information for the Patient

Vitamina D3Farmasierra 10,000 IU Tablets

Cholecalciferol (Vitamin D3)

Package leaflet:

1. What Vitamin D3 Farmasierra is and what it is 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. How to store Vitamin 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 the active substance colecalciferol (vitamin D3). The main function of vitamin D is to regulate calcium absorption at the intestinal level, regulate its metabolism, and promote proper bone mineralization.

Vitamina D3 Farmasierra is indicated for the initial treatment of vitamin D deficiency in adults (serum levels of 25-hydroxycolecalciferol (25(OH)D) < 25 nmol/l).

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

Do not take Vitamina 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 (increased calcium levels in blood) or hypercalciuria (increased calcium levels in urine).
• If you have vitamin D intoxication (hypervitaminosis D).
• If you have kidney stones (nephrolithiasis) or calcium deposits in the kidneys (nephrocalcinosis).
• If you have severe renal insufficiency (severe kidney problems).

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

Warnings and precautions

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

• If you have sarcoidosis (a type of chronic multisystem inflammatory disease that can affect all organs).
• If you have kidney problems or are prone to developing kidney stones. Your doctor may need to monitor your calcium and phosphate levels in blood and urine.
• If you have severe renal insufficiency: in this case, other forms of vitamin D should be used.
• If you have pseudohypoparathyroidism, a rare condition in which the body does not respond appropriately to parathyroid hormone produced by the body.
• If you are being treated with medications containing vitamin D, or consume foods or milk fortified with vitamin D.

Children and adolescents

This medicine is not suitable for use in children under 18 years of age.

Other medicines and Vitamin D3Farmasierra

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

In particular, consult your doctor if you are taking the following medicines, as they may increase or reduce the effect of colecalciferol:

• Thiazide diuretics (used to treat high blood pressure).
• Cardiac glycosides (used to treat heart conditions), e.g. digoxin. Your doctor may monitor your heart with an electrocardiogram and measure calcium levels in blood and urine.
• Glucocorticoids (steroid hormones such as hydrocortisone or prednisolone), as they may reduce the effect of vitamin D3.
• Medicines used to lower blood fat levels such as colestipol, cholestyramine, and laxatives (such as paraffin oil), or orlistat. Do not take Vitamin D within two hours (before or after) of taking orlistat or vitamin D analogues.
• Antacids.
• Medicines used to treat epilepsy (anticonvulsants or barbiturates) such as phenytoin, phenobarbital, primidone.
• Medicines used to treat excess calcium (calcitonin, etidronate, gallium nitrate, pamidronate, or plicamycin).
• Medicines used to treat tuberculosis, such as rifampicin or isoniazid.
• Actinomycin (chemotherapy).
• Imidazole antifungals (e.g. clotrimazole and ketoconazole), which are medicines used to treat fungal infections. These medicines may interfere with the metabolism of vitamin D3 in the body.
• Phosphates.

Taking Vitamina D3Farmasierra with food and drink

Take Vitamina D3 preferably with meals.

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.

This medicine should not be used during pregnancy and breastfeeding. However, your doctor may decide that your clinical condition requires treatment with colecalciferol at lower doses.

Pregnancy

Your doctor will prescribe vitamin D during the first 6 months of pregnancy only if strictly necessary, due to the risk of harmful effects on the fetus (see section 3).

Vitamin D overdose should be avoided during pregnancy, as prolonged hypercalcemia may cause physical and mental developmental delays as well as congenital eye and heart disorders in the child.

However, since vitamin D deficiency is harmful to both the fetus and the mother, when necessary, your doctor may prescribe vitamin D during pregnancy at lower doses.

Breastfeeding

Vitamin D and its metabolites are excreted in breast milk. This should be taken into consideration when administering additional vitamin D3 to the infant. This medicine is not recommended, and a low dose should be used during breastfeeding. This does not replace the administration of vitamin D to the baby.

Driving and operating machinery

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

Warnings about excipients:

This medicinal product contains isomalt. If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.

This medicinal product contains less than 23 mg of sodium (1 mmol) per tablet;
this is, essentially “sodium-free”

3. How to take Vitamina D3 Farmasierra

Follow exactly the administration instructions for Vitamina D3 provided by your doctor. If in doubt, consult your doctor or pharmacist again.

The dose should be individually established depending on the required level of vitamin D3 supplementation. Medical supervision is necessary, as dosage requirements may vary depending on the patient's response. The recommended dose and duration of treatment will be assessed by your doctor based on your health condition.

Do not exceed the dose indicated by your doctor.

The patient's dietary habits should be carefully evaluated, and the vitamin D3 content of certain foods should be taken into account.

Take the dose orally.

The tablets can be taken whole with water or crushed. This medicine should preferably be taken with a meal.

The recommended dose is:

Initial treatment of vitamin D deficiency in adults (serum levels < 25 nmol/l or < 10 ng/ml): one or two tablets per week, according to the doctor's instructions.

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

Pediatric population

Vitamina D3 Farmasierra must not be used in children and adolescents under 18 years of age.

If you take more Vitamin D3Farmasierra than you should

If you have taken more of this medicine than prescribed, or if a child has accidentally taken this medicine, contact your doctor immediately or go to the nearest hospital to assess the risk involved.

Excess vitamin D3 causes disruption of calcium metabolism in the body. 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, constipation and dehydration, muscle and joint pain, muscle weakness, kidney stones, nephrocalcinosis and renal failure; in severe cases, you may notice irregular heartbeats.

Excessive chronic overdoses may lead to deposits of calcium salts in blood vessels and organs.

Taking too much vitamin D during the first 6 months of pregnancy may cause serious harm to the fetus and newborn.

In case of overdose or accidental ingestion, contact the Toxicology Information Service at telephone number 91.562.04.20, indicating the name of the medicine and the amount taken. It is recommended to bring the medicine package and leaflet to the healthcare professional.

If you forget to take Vitamina D3Farmasierra

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

If you forget to take your tablets, 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; just take your next dose as normal.

If treatment with Vitamina D3 Farmasierra is interrupted

Continue taking this medicine as long as your doctor has instructed you to do so. Do not stop taking this medicine just because you feel better.

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

4. Possible adverse effects

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

You must stop taking Vitamin D3 immediately 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 breathing difficulties.

The effects associated with the use of vitamin D are:

Uncommon adverse effects (may affect up to 1 in 100 people): Hypercalcemia (increased calcium levels in blood) and hypercalciuria (increased calcium levels in urine).

Rare adverse effects (may affect up to 1 in 1,000 people): Itching, skin rash, and urticaria.

Frequency not known (frequency cannot be estimated from available data): Hypersensitivity reactions such as angioedema or laryngeal edema.

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor, pharmacist, or nurse, even if these are possible adverse reactions not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es.

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

5. Storage of Vitamina D3 Farmasierra

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

Do not use this medicine after the expiry date stated on the carton and blister, 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. Keep the container tightly closed to protect it from moisture.

Store below 30 °C.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE Point in your pharmacy. If in doubt, ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the container and additional information

Composition of Vitamina D3 Farmasierra

The active substance is colecalciferol (vitamin D3). Each tablet contains 10,000 IU of colecalciferol (vitamin D3), equivalent to 250 micrograms of vitamin D3.

• The other components are: refined palm oil, hydrogenated palm oil, butylated hydroxytoluene (E321), isomalt (E953), anhydrous colloidal silica, microcrystalline cellulose, sodium croscarmellose, magnesium stearate.

Appearance of the product and contents of the package

Vitamina D3 Farmasierra 10,000 IU tablets are supplied in PVC/PVDC/PE-Al blisters packed in a cardboard carton. Each package contains 4 or 8 yellowish-white, round tablets, 7.4 mm in diameter.

Marketing Authorization Holder

Farmasierra Laboratorios, S.L.

Ctra de Irún km 26,200

28709 San Sebastián de los Reyes (Madrid)

Spain

Manufacturer

Farmasierra Manufacturing, S.L.

Ctra de Irún km 26,200

28709 San Sebastián de los Reyes (Madrid)

Spain

Date of the most recent review of this leaflet: November 2023

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/.