Patient Information Leaflet

Vitamin D3Farmasierra 10.000 UI tablets

Colecalciferol (vitamin D3)

Table of Contents:

1. What is Vitamin D3Farmasierra and for what it is used
2. What you need to know before starting to take Vitamin D3Farmasierra
3. How to take Vitamin D3Farmasierra
4. Possible adverse effects
5. Storage of Vitamin D3Farmasierra
6. Contents of the package and additional information

This medication contains the active ingredient colecalciferol (vitaminD3)The main function of vitamin D is to regulate calcium absorption at the intestinal level, regulate its metabolism, and promote adequate bone mineralization.

Vitamina D3Farmasierra is indicated for the initial treatment of vitamin D deficiency in adults (serum levels of 25-hydroxycolecalciferol (25 (OH) D) <25>

Do not take Vitamin D3Farmasierra

• If you are allergic to colecalciferol (vitamin D3) or any of the other components of thismedication (listed in section 6).
• If you have hypercalcemia (elevated levels of calcium in the blood) or hypercalciuria (elevated levels of calcium in the urine).
• If you have vitamin D toxicity (elevated levels of vitamin D in the blood).
• If you have kidney stones (nephrolithiasis) or calcium deposits in the kidneys (nephrocalcinosis).
• If you have severe kidney failure (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 type of chronic inflammatory multisystem disease that can affect all organs).
• If you have kidney problems orif you are prone to forming kidney stones.Your doctor may want to monitor your calcium and phosphate levels in the blood and urine.
• If you have severe kidney failure: 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 adequately to the parathyroid hormone produced by the body.
• If you are being treated with medications that contain vitamin D, or if you take foods or milk enriched with vitamin D.

Children and adolescents

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

Other medications and Vitamin D3Farmasierra

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

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

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

Taking Vitamin D3Farmasierra with food and drinks

Take Vitamin D3preferably with meals.

Pregnancy, breastfeeding, and fertility

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

This medication should not be used during pregnancy and breastfeeding. However, your doctor may decide that your medical conditions require a necessary treatment with colecalciferol at lower doses.

Pregnancy

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

Avoid vitamin D overdose during pregnancy, as prolonged hypercalcemia can cause physical and mental retardation, as well as congenital eye and heart diseases in the child.

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

Breastfeeding

Vitamin D and its metabolites pass into breast milk. This should beconsidered when administering additional vitamin D3to the infant. This medication is not recommended and should be used at a low dose during breastfeeding. This does not replace the administration of vitamin D to the baby.

Driving and operating machinery

VitaminD3has no known effects on the ability to drive or operate machinery.

Warnings about excipients:

This medication contains Isomalta. If your doctor has indicated that you have an intolerance to certain sugars, consult with him before taking this medication.

This medication contains less than 23 mg of sodium (1 mmol) per tablet;

it is essentially “sodium-free”

Follow exactly the administration instructions for Vitamin D3as indicated by your doctor.In case of doubt, consult your doctor or pharmacist again.

The dose must be established on an individual basis depending on the degree of vitamin D3supplementation required. Medical supervision is necessary since the dose requirements may vary depending on the patient's response.The recommended dose and treatment duration will be evaluated by your doctor based on your health conditions.

Do not exceed the doses indicated by your doctor.

The patient's dietary habits should be carefully evaluated and the vitamin D3content of certain foods should be taken into account.

Take the dose orally.

The tablets can be taken whole with water or crushed. You should take this medicationpreferably with a meal.

The recommended dose is:

Initial treatment of vitamin D deficiency in adults (serum levels <25

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

Pediatric population

Vitamin D3Farmasierrashould not be used in children and adolescents under 18 years old.

If you take more Vitamin 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 immediately or go to the nearest hospital to evaluate the existing risk.

An excess of vitamin D3causes an alteration of the calcium cycle in the body. You may experience the following symptoms: weakness, fatigue, headache, nausea, vomiting, diarrhea, excessive urine, calcium in urine, dry mouth, nocturia, proteinuria, intense thirst, loss of appetite, dizziness, constipation, and dehydration,muscle and joint pain, muscle weakness, kidney stones, nephrocalcinosis, and renal insufficiency, and in severe cases, you may notice irregular heartbeats.

Chronic excessive overdoses can lead to calcium deposits in blood vessels and organs.

The use of too much vitamin D in the first 6 months of pregnancy can cause severe damage to the fetus and newborn.

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.

If you forgot to take the tablets, 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

Continue taking this medication until your doctor tells you to. Do not stop taking this medication just because you feel better.

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

Like all medications, Vitamin D3may produce adverse effects, although not allpeople will experience them.If you consider that any of the adverse effects you experience are severe or if you notice any adverse effect not mentioned in this leaflet, inform your doctor or pharmacist.

You should 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.

The effects associated with the use of vitamin D are:

Less common adverse effects(may affect up to 1 in 100 people): Hypercalcemia (elevated calcium levels in the blood) and hypercalciuria (elevated calcium levels in the urine).

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

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

Reporting Adverse Effects

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

By reporting adverse effects, you can contribute to providing more information on 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 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 packaging perfectly closed to protect it from moisture.

Store below 30 °C.

Medicines should not be disposed of through drains or in the trash. Deposit the packaging and unusedmedicines at the SIGRE collection pointof the pharmacy. If in doubt, ask yourpharmacist how to dispose of the packaging and unused medicines.This will help protect the environment.

Vitamin CompositionD3Farmasierra

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

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

Appearance of the product and contents of the packaging

Vitamin D3Farmasierra 10,000 UI tabletsare presented in a PVC/PVDC/PE-Al blister packaged in a cardboard case. Each package contains 4 or 8round tablets, 7.4 mm in diameter, yellowish white in color.

Holder of the Marketing Authorization

Farmasierra Laboratorios, S.L.

Ctra de Irún km 26,200

28709 San Sebastián de los Reyes (Madrid)

Spain

Responsible for Manufacturing

Farmasierra Manufacturing, S.L.

Ctra de Irún km 26,200

28709 San Sebastián de los Reyes (Madrid)

Spain

Last review date of this leaflet: November 2023

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