VITAMIN D3 NM 3,200 IU SOFT GEL CAPSULES

Introduction

Package Leaflet: Information for the Patient

Vitamin D3NM 3,200 IU Soft Capsules

colecalciferol (vitamin D3)

Read this entire leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this 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 leaflet. See section 4.

Contents of the Package Leaflet

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

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

Vitamin D3 NM contains colecalciferol (vitamin D). Vitamin D helps the body absorb calcium and improves bone formation.

This medication is recommended for the treatment of vitamin D deficiency in adults and adolescents.

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

Do not take Vitamin D3 NM:

• If you are allergic to colecalciferol or any other ingredient in this medication (listed in section 6).

if you have high levels of calcium in the blood (hypercalcemia) or in the urine (hypercalciuria).

• If you have severe kidney problems (severe renal insufficiency).
• If you have high levels of vitamin D in the blood (hypervitaminosis D).
• If you have kidney stones or calcium deposits in the kidneys.

Warnings and Precautions

Do not take more Vitamin D3 NM than your doctor has prescribed, as an overdose may occur. Do not take other products containing vitamin D at the same time, except those prescribed by your doctor.

Consult your doctor or pharmacist before taking this medication:

• If you have a high tendency to form kidney stones.
• If you have cancer or any other condition that may have affected your bones.
• If you have a parathyroid hormone imbalance (pseudohypoparathyroidism).
• If you are being treated for heart disease.

If you have any of the following conditions, your doctor will monitor your blood calcium or phosphate levels, or your urine calcium levels:

If you are taking this medication long-term, if you have kidney problems, or if you have sarcoidosis, a disorder of the immune system that can affect your liver, lungs, skin, or lymph nodes.

• If you are taking this medication long-term.
• If you have kidney problems.
• If you have sarcoidosis, a disorder of the immune system that can affect your liver, lungs, skin, or lymph nodes.

Children and Adolescents

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

Other Medications and Vitamin D3 NM

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medications, especially:

• Medications for epilepsy, such as barbiturates or other anticonvulsants (e.g., carbamazepine, phenobarbital, phenytoin, primidone).

Other medications that contain vitamin D, including multivitamins.

• Medications to control heart rhythm (e.g., digoxin, digitoxin).

Diuretics, such as bendroflumethiazide.

• Calcium supplements.
• Medications to treat tuberculosis, such as rifampicin or isoniazid.
• Medications that cause fat malabsorption, such as orlistat, cholestyramine, or liquid paraffin.

Antifungal agents (for fungal infections), such as ketoconazole or itraconazole.

• Actinomycin (a medication used to treat some forms of cancer), as it may interfere with vitamin D metabolism.

Corticosteroids (steroid hormones, such as hydrocortisone or prednisolone).

Taking Vitamin D3 NM with Food and Drink

This medication can be taken with or without food.

Pregnancy, Breastfeeding, and Fertility

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

Pregnancy

Do not take this medication during pregnancy without a confirmed vitamin D deficiency and only if your doctor considers it absolutely necessary for you.

When there is a vitamin D deficiency, the recommended dose depends on national guidelines; however, the maximum recommended dose during pregnancy is 4,000 IU/day of vitamin D3.

This medication is not recommended for use during pregnancy for treatment at higher doses.

Breastfeeding

Vitamin D3 NM can be used during breastfeeding. Vitamin D passes into breast milk. This should be considered when administering additional vitamin D to the breastfed infant.

Fertility

There are no data on the effect of Vitamin D3 NM on fertility. However, it is not expected that normal levels of vitamin D will have adverse effects on fertility.

Driving and Using Machines

This medication has no known effects on the ability to drive or use machines.

3. How to Take Vitamin D3 NM

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

The dose must be individualized based on the degree of vitamin D supplementation needed.

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

Use in Adults

Medical supervision is necessary, as dosage requirements may vary depending on the patient's response.

Treatment of Vitamin D Deficiency:

800 IU-4,000 IU/day, depending on the severity of the disease and the patient's response to treatment.

After the first month, a lower maintenance dose should be considered, depending on the desired serum levels of 25-hydroxycolecalciferol (25(OH)D), the severity of the disease, and the patient's response to treatment.

The dose of 800 IU cannot be achieved with the 1,000 IU dose. In this case, and according to the available doses, alternative posological recommendations can be followed in the treatment of vitamin D deficiency.

Use in Children and Adolescents

Vitamin D3 NM 3,200 IU is not recommended for children under 12 years of age.

Treatment of Vitamin D Deficiency in Adolescents (12-18 years):

800 IU-4,000 IU/day, depending on the severity of the disease and the patient's response to treatment. It should only be administered under medical supervision. The daily dose should not exceed 4,000 IU/day.

Method of Administration

The capsules should be swallowed whole (without chewing) with water.

If You Take More Vitamin D3 NM Than You Should

If you have taken this medication more than you should, consult your doctor or pharmacist immediately. A daily intake of 25,000 IU of Vitamin D3 NM for a period of 6 months is generally considered toxic for a normal individual. However, lower doses may constitute an overdose, especially in children, who are one of the main risk groups. An excess of vitamin D causes an alteration of the calcium cycle in the body. You may experience the following symptoms: weakness, fatigue, headache, nausea, vomiting, diarrhea, excessive urine production, urinary calcium, dry mouth, nocturia, proteinuria, intense thirst, loss of appetite, dizziness.

In case of overdose or accidental ingestion, go to a medical center or call the Toxicology Information Service (Tel. 91 562 04 20), indicating the medication and the amount ingested.

If You Forget to Take Vitamin D3 NM

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. However, if it is almost time for your next dose, do not take the missed dose; just take the next dose as usual.

If You Stop Taking Vitamin D3 NM

This should only happen if you experience side effects. If you have any other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

You should stop taking the medication 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(occur in up to 1 in 100 people):

• Hypercalcemia (elevated calcium levels in the blood). You may feel sick, lose your appetite, have constipation, stomach pain, feel very thirsty, have muscle weakness, drowsiness, or confusion.

Hypercalciuria (elevated calcium levels in the urine).

Rare(occur in up to 1 in 1,000 people):

• Itching
• Rash
• Hives

Frequency Not Known(cannot be estimated from available data):

• Constipation
• Flatulence
• Nausea
• Abdominal pain
• Diarrhea
• Hypersensitivity reactions, such as angioedema or laryngeal edema

Reporting Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications (website: www.notificaRAM.es). By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Vitamin D3 NM

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

This medication does not require special storage conditions at room temperature. Store in the original packaging, protected from light.

Do not use this medication after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medication in the pharmacy's SIGRE collection point. If you are unsure, 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 D3 NM

The active ingredient is colecalciferol. Each capsule contains 80 micrograms of colecalciferol (vitamin D3, equivalent to 3,200 IU).

The other ingredients (excipients) are Butylhydroxytoluene (BHT), Medium-Chain Triglyceride Oil, Gelatin, Glycerol, Titanium Dioxide (E-171), Yellow Iron Oxide (E-172), and Purified Water.

Appearance of the Product and Package Contents

Soft, oval-shaped capsules, opaque yellow in color, size 6. The capsule measures approximately 13.6 mm x 8.4 mm. Each box contains a white, opaque PVC/PVDC/Aluminum blister pack with 7, 30, or 90 soft capsules.

Not all pack sizes may be marketed.

Marketing Authorization Holder

Nutrición Médica, S.L.

C/ Arequipa, 1

28043 - Madrid, Spain.

Manufacturer

GAP S.A.

Aghisilaou 46

173 41 Agios Dimitrios

Athens, Greece.

This medication is authorized in the Member States of the European Economic Area under the following names:

Spain: Vitamin D3 NM 3,200 IU Soft Capsules

Date of the Last Revision of this Leaflet:June 2025

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/