VITAMIN D3 NM 800 IU SOFT GEL CAPSULES

Introduction

Package Leaflet: Information for the Patient

Vitamin D3800 IU Soft Capsules

colecalciferol (vitamin D3)

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What Vitamin D3 NM is and what it is used for
2. What you need to know before you take Vitamin D3 NM
3. How to take Vitamin D3 NM
4. Possible side effects
5. Storage of Vitamin D3 NM
6. Contents of the pack and other information

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

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

This medicine is recommended in the following cases:

• Treatment of vitamin D deficiency in adults and adolescents.
• Prevention of vitamin D deficiency in adults with an identified risk.
• With other medications to treat certain bone conditions, such as bone thinning (osteoporosis) in adult patients with vitamin D deficiency or at risk of vitamin D deficiency.

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

Do not take Vitamin D3 NM

• If you are allergic to colecalciferol or any of the other ingredients of this medicine (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 this may cause an overdose. Do not take other products that contain vitamin D at the same time, in addition to those prescribed by your doctor.

Consult your doctor or pharmacist before taking this medicine:

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

If you are on long-term treatment with this medicine.

• If you have kidney problems.
• If you suffer from "sarcoidosis"; an immune system disorder that can affect your liver, lungs, skin, or lymph nodes.

Children and adolescents

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

Other medicines and Vitamin D3 NM

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, in particular:

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

Other medicines that contain vitamin D, including multivitamins.

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

Diuretics such as bendroflumethiazide.

• Calcium supplements.
• Medicines to treat tuberculosis, e.g., rifampicin, isoniazid.
• Medicines that cause poor fat absorption, e.g., orlistat, cholestyramine, liquid paraffin.

Antifungal agents (for fungi), such as ketoconazole, itraconazole.

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

Glucocorticosteroids (steroid hormones such as hydrocortisone or prednisolone).

Taking Vitamin D3 NM with food and drink

This medicine can be taken with or without food.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Do not take this medicine during pregnancy without a confirmed vitamin D deficiency and 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.

For treatment during pregnancy at higher doses, Vitamin D3 NM is not recommended during pregnancy.

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

3. How to take Vitamin D3 NM

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are unsure, ask your doctor or pharmacist again.

The dose must be established individually 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 the 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.

Prevention of vitamin D deficiency:

800 IU – 1,000 IU/day.

The dose should be adjusted, depending on the desired serum levels of 25-hydroxycolecalciferol (25(OH)D), the severity of the disease, and the patient's response to treatment.

With other medications to treat certain bone conditions, such as bone thinning (osteoporosis) in patients with vitamin D deficiency or at risk of vitamin D deficiency:

800 IU – 1,000 IU/day.

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 may be followed in the treatment of vitamin D deficiency.

Use in children and adolescents

Vitamin D3 NM 800 IU is not recommended in 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 medicine more than you should, contact 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, 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 Toxicological Information Service (Tel. 91 562 04 20), indicating the medicine 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 medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

You must stop taking the medicine 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 (increased 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 (increased calcium levels in urine).

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

• Itching
• Rash
• Hives

Frequency not known(cannot be estimated from the available data):

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

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System (website: www.notificaRAM.es). By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Vitamin D3 NM

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

This medicine does not require any special storage conditions. Keep in the original packaging to protect from light.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date is the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Vitamin D3 NM

The active substance is colecalciferol. Each capsule contains 20 micrograms of colecalciferol (vitamin D3, equivalent to 800 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 pack contents

Soft capsules, oval, light yellow opaque, size 2. The capsule measures approximately 9.5 mm x 5.9 mm. Each box contains a white opaque PVC/PVDC/Aluminum blister pack with 28, 30, 80, 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 medicine is authorized in the Member States of the European Economic Area under the following names:

Spain: Vitamin D3 NM 800 IU soft capsules

Portugal: VITAMINA D3 NM 800 U.I soft capsules

Netherlands: Cholecalciferol INVOS 800 IE soft capsules

Greece: Cholecalciferol INVOS 800 IU

Date of last revision of this leaflet:January 2025

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS)

http://www.aemps.gob.es/