VITAMIN D3 FARMASIERRA 10,000 I.U. TABLETS

Introduction

Patient Information Leaflet: Information for the Patient

Vitamin D3Farmasierra 10,000 IU Tablets

Colecalciferol (Vitamin D3)

Contents of the Leaflet:

1. What is Vitamin D3 Farmasierra and what is it used for
2. What you need to know before starting to take 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 the active ingredient colecalciferol (Vitamin D3). The main function of Vitamin D is to regulate calcium absorption in the intestine, regulate its metabolism, and promote adequate bone mineralization.

Vitamin 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).< p>

2. What you need to know before starting to take 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 (nephrolithiasis) or calcium deposits in the kidneys (nephrocalcinosis).
• If you have severe kidney failure (severe kidney problems).

If you have any of the above, 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 disease that can affect all organs).
• If you have kidney problems or tend to form kidney stones. Your doctor may want to monitor your calcium and phosphate levels in blood and urine.
• If you have severe kidney failure: in this case, other forms of Vitamin D should be used.
• If you have pseudohipoparathyroidism, a rare condition in which the body does not respond properly to the parathyroid hormone produced by the body.
• If you are taking medications that contain Vitamin D, or if you consume foods or milk enriched with Vitamin D.

Children and Adolescents

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

Other Medications and Vitamin D3Farmasierra

Tell your doctor or pharmacist that you are taking, have recently taken, 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 calcium levels in blood and urine.
• Glucocorticoids (steroid hormones such as hydrocortisone or prednisolone), as they may reduce the effect of Vitamin D3.
• Medications to reduce blood fat levels, such as colestipol, cholestyramine, and laxatives (such as paraffin oil), or orlistat. Do not take Vitamin D within 2 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, primidone.
• Medications used to treat excess 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 D3 preferably with meals.

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.

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

Pregnancy

Your doctor will prescribe Vitamin D during 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).

An overdose of Vitamin D during pregnancy should be avoided, as prolonged hypercalcemia can cause physical and mental retardation, as well as congenital eye and heart diseases in the child.

However, since the lack of Vitamin D 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 be taken into account when administering additional Vitamin D3 to the breastfed 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 Using Machines

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

Warnings about Excipients:

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

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

this is, essentially "sodium-free"

3. How to Take Vitamin D3 Farmasierra

Follow the instructions for administration of Vitamin D3 indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The dose should be established individually based on the degree of Vitamin D3 supplementation needed. Medical supervision is necessary, as the dose requirements may vary depending on the patient's response. The recommended dose and duration of treatment 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 D3 content 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 medication preferably 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 two tablets per week, as indicated by the doctor.< p>

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

Pediatric Population

Vitamin D3 Farmasierra should 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 medication than prescribed, or if a child has accidentally taken this medication, contact your doctor immediately or go to the nearest hospital to assess the existing risk.

An excess of Vitamin D3 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, constipation, and dehydration, muscle and joint pain, muscle weakness, kidney stones, nephrocalcinosis, and kidney failure, and in severe cases, irregular heartbeats may be noticed.

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

Taking too much Vitamin D in the first 6 months of pregnancy can cause serious harm to the fetus and the newborn.

In case of overdose or accidental ingestion, consult the Toxicology 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 Forget to Take Vitamin D3Farmasierra

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

If you forget to take the tablets, 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

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

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

4. Possible Side Effects

Like all medications, Vitamin D3 can cause side effects, although not everyone experiences 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 leaflet, tell 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.

The effects associated with the use of Vitamin D are:

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

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

Reporting Side Effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medication Pharmacovigilance System: 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 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.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of VitaminD3 Farmasierra

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

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

Appearance of the Product and Package Contents

Vitamin D3 Farmasierra 10,000 IU tablets are presented in a PVC/PVDC/PE-Al blister pack in a cardboard box. Each package contains 4 or 8 round tablets, 7.4 mm in diameter, white-yellowish in color.

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 Last Revision of this Leaflet: November 2023

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