VITAMIN D3 NM 25,000 IU SOFT GEL CAPSULES

Introduction

Package Leaflet: Information for the Patient

Vitamin D3NM 25,000 IU Soft Capsules

colecalciferol (vitamin D3)

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

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, ask 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 package 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 initiating treatment of vitamin D deficiency in

adults.

Vitamin D3 NM 25,000 IU is indicated in adults.

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

Do not take VitaminD3NM:

• If you are allergic to colecalciferol or any of the other ingredients of 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, in addition to 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 (pseudo-hypoparathyroidism).
• If you are being treated for heart disease.

If you have any of the following conditions, your doctor will monitor your calcium

or phosphate levels in the blood, or your calcium levels in the urine:

• If you are taking this medication long-term.
• If you have kidney problems.
• If you suffer from "sarcoidosis", an immune system disorder that can affect your

liver, lungs, skin, or lymph nodes.

Other Medications and VitaminD3NM

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medication, 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.

Taking VitaminaD3NM with Food and Drink

This medication can be taken with or without food.

Children and Adolescents

Vitamin D3 NM 25,000 IU should not be used in children and adolescents (< 18 years).

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.

The use of Vitamin D3 NM 25,000 IU is not recommended during pregnancy.

Vitamin D passes into breast milk, so mothers should avoid taking high doses during breastfeeding.

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 should 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.

Initiation of Vitamin D Deficiency Treatment in Adults:

1 capsule of 20,000 IU/week for up to 4-5 weeks.

1 capsule of 25,000 IU/week for up to 4 weeks.

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

Alternatively, national dosage recommendations for the treatment of vitamin D deficiency can be followed. The duration of use is usually limited to the first month of treatment, as decided by the doctor.

Method of Administration

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

If You Take More VitaminaD3NM Than You Should

If you have taken this medication more than you should, consult your doctor or pharmacist immediately. A daily intake of 2 capsules of Vitamin D3 NM 25,000 IU 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. 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.

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 VitaminaD3NM

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 VitaminaD3NM

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 experiences 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 package leaflet. You can also report them directly through the Spanish Medicines Agency's 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.

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 VitaminaD3NM

The active ingredient is colecalciferol. Each capsule contains 0.625 milligrams of colecalciferol (Vitamin D3, equivalent to 25,000 IU).

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

Appearance of the Product and Package Contents

Soft, oval capsules, white opaque, size 3. The capsule measures approximately 11.3 mm x 6.9 mm. Each box contains a white opaque PVC/PVDC/Aluminum blister pack with 4, 6 (pharmacy use), 12, or 14 (hospital use) 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 25,000 IU soft capsules

Portugal: VITAMINA D3 NM 25,000 U.I soft capsules

Netherlands: Cholecalciferol INVOS 25,000 IE soft capsules

Greece: Cholecalciferol INVOS 25,000 IU

Austria: Colecalciferol Invos 25,000 IE soft capsules

Italy: Colecalciferolo INVOS 25,000 U.I. soft capsules

Germany: OsteoGalen D3 25,000 IE soft capsules

Date of the Last Revision of this Package Leaflet:August 2020

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/