Prospecto: information for the patient

Vitamin D3NM 25.000 UI soft capsules

colecalciferol (vitamin D3)

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

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only to you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor or pharmacist, even if they do not appear in this prospect. See section 4.

1. What it isVitamin D3NMand its use

2. What you need to know before starting to takeVitamin D3NM

3. How to takeVitamin D3NM

4. Possible adverse effects

5. Storage ofVitamin D3NM

6. Contents of the package and additional information

VitaminD3NM contains colecalciferol (vitamin D). Vitamin D helps the body to absorb calcium and improves bone formation.

This medication is recommended to initiate the treatment of vitamin D deficiency in

adults.

VitaminD3NM 25.000 UI is indicated in adults.

Do not take Vitamin D3NM:

- If you are allergic to colecalciferol or any of the other ingredients in this

medication (listed in section 6).

- If you have high levels of calcium in the blood (hypercalcemia) or 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 D3NM than your doctor has prescribed, as this may

result in an overdose. 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 hormone parathyroid 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 calcium levels in the urine:

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

- If you have kidney problems.

- If you suffer from “sarcoidosis"; an immunological disorder that may affect your

liver, lungs, skin, or lymph nodes.

Other medications and Vitamin D3 NM

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to

take any other medication, particularly:

- Medications for epilepsy such as barbiturates or other anticonvulsants (for

example, carbamazepine, phenobarbital, phenytoin, primidone).

- Other medications containing vitamin D, including multivitamins.

- Medications to control heart rhythm (for example, digoxin, digitoxin).

- Diuretics such as bendroflumethiazide.

- Calcium supplements.

- Medications to treat tuberculosis, for example, rifampicin, isoniazid.

- Medications that cause poor fat absorption, for example, orlistat, cholestyramine,

paraffin liquid.

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

- Actinomycin (a medication used to treat certain types 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 drinks

This medication can be taken with or without food.

Children and adolescents

Vitamin D3NM 25,000 UI should not be used in children and adolescents (<18

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant, or plan to become

pregnant, consult your doctor or pharmacist before using this medication.

This medication is not recommended for use during pregnancy.

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

breastfeeding.

Driving and operating machinery

This medication has no known effects on the ability to drive or operate machinery.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Your doctor or pharmacist should be consulted in case of doubt.

The dose should be established on an individual basis according to the degree of vitamin D supplementation required.

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

Use in adults

Medical supervision is necessary since the dose requirements may vary depending on the patient's response.

The patient's response to treatment should be taken into account.

Initiation of treatment for vitamin D deficiency in adults:

1 capsule of 20,000 UI/week for 4-5 weeks.

1 capsule of 25,000 UI/week for 4 weeks.

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

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

Administration form

The capsules should be swallowed whole (not chewed) with water.

If taking more than the recommended dose of Vitamin D33NM

If you have taken this medication more than you should, consult your doctor or pharmacist immediately. A daily intake of 2 capsules of Vitamin D33NM 25,000 UI

for a period of 6 months is generally considered toxic for a normal individual.

However, lower doses can 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 occur: weakness, fatigue, headache, nausea, vomiting, diarrhea, excessive urine, calcium in urine, dry mouth, nocturia, proteinuria, intense thirst, loss of appetite, vertigo.

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 medication and the amount ingested.

If you forgot to take Vitamin D33NM

Do not take a double dose to compensate for the missed doses.

Take the missed dose as soon as possible; then return to your regular dosing schedule. However, if it is almost time to take the next dose, do not take the missed dose; only take the next dose normally.

If you interrupt treatment with Vitamin D33NM

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

Like all medications, this medication may produce adverse effects,

although not all people will experience them.

You should stop taking the medication immediately and consult with 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

Less Common Adverse 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, experience

muscle weakness, drowsiness, or confusion.

- Hypercalciuria (elevated calcium levels in urine).

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

- Pruritus

- Rash

- Urticaria

Unknown Frequency(cannot be estimated from available data):

- Constipation

- Flatulence

- Nausea

- Abdominal pain

- Diarrhea

- Hypersensitivity reactions such as angioedema or laryngeal edema

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist,

even if it is a possible adverse effect not listed in this prospectus. You can also

report them directly through the Spanish System for Pharmacovigilance of Medicines for

Human Use (website: 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.

Store in the original packaging to protect it from light.

Do not use this medication after the expiration date that appears on the packaging

after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the

packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt

ask your pharmacist how to dispose of the packaging and medications you no longer

need. By doing so, you will help protect the environment..

Vitamin D3 Composition

The active ingredient is colecalciferol. Each capsule contains 0.625 milligrams of

colecalciferol (Vitamin D3, equivalent to 25,000 UI).

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

Appearance of the product and content of the container

Soft, oval-shaped, white opaque capsules, size 3. The capsule dimensions are approximately 11.3 mm x 6.9 mm. Each box contains a white opaque PVC/PVDC/Aluminum blister with 4, 6 (pharmacy use), 12, 14 (hospital use) soft capsules.

The product may only be marketed in some container sizes.

Marketing Authorization Holder

Nutrición Médica, S.L.

C/ Arequipa, 1

28043- Madrid. Spain.

Responsible for manufacturing

GAP S.A.

Aghisilaou 46

173 41 Agios Dimitrios

Athens, Greece.

This medicinal product is authorized in the member states of the European Economic Area with the following names:

European Economic Area

Spain: Vitamin D3NM 25,000 UI 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

Last review date of this leaflet:August 2020

Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)

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