Vitamina D3 NM 25.000 UI soft capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Vitamina D3NM 25,000 IU soft capsules

colecalciferol (vitamin D3)

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

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

This medicine is recommended to initiate treatment of vitamin D deficiency in adults.

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

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

Do not take Vitamin D3 NM:

• If you are allergic to colecalciferol or to any of the other ingredients of this
  medicine (listed in section 6).

• If you have high levels of calcium in your blood (hypercalcemia) or in your urine (hypercalciuria).

• If you have severe kidney problems (severe renal insufficiency).

• If you have high levels of vitamin D in your 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 prescribed by your doctor, as 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 medicine:

• If you have a high tendency to form kidney stones.
• If you have cancer or any other condition affecting 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 calcium levels in the urine:

• If you are undergoing long-term treatment with this medicine.
• If you have kidney problems.
• If you have "sarcoidosis"; an immune system disorder that may affect your liver, lungs, skin, or lymph nodes.

Other medicines and Vitamin D3 NM

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

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

• Other medicines containing vitamin D, including multivitamins.

• Medicines to control heart rhythm (for example, digoxin, digitoxina).

• Diuretics such as bendroflumethiazide.

• Calcium supplements.

• Medicines for treating tuberculosis, for example, rifampicin, isoniazid.

• Medicines that cause poor fat absorption, for example, 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 may be taken with or without food.

Children and adolescents

Vitamin D3 NM 25,000 IU must 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 are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

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

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

Driving and using machines

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

3. How to take Vitamina D3 NM

Follow exactly the instructions for use of this medicine as given by your

doctor or pharmacist. If in doubt, please consult your doctor or pharmacist again.

The dose should be individually established depending on the degree of

vitamin D supplementation required.

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

Use in adults

Medical supervision is necessary, as dose requirements may vary

depending on the patient's response.

Initiation of treatment for vitamin D deficiency 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, consideration should be given to switching to a lower maintenance dose, based on desirable serum levels of

25-hydroxycholecalciferol (25(OH)D), severity of the condition, and the patient's response to treatment.

Alternatively, national dosage recommendations for the treatment of vitamin D deficiency may be followed. The duration of use is usually limited to the first month of treatment, according to the physician's decision.

Method of administration

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

If you take more Vitamina D3 NM than you should

If you have taken more of this medicine than you should, consult your doctor or pharmacist immediately.

A daily intake of 2 capsules of Vitamina 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. Excess vitamin D causes disruption of calcium metabolism in the body. The following symptoms may occur: weakness, fatigue, headache, nausea, vomiting, diarrhoea, 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 centre or call the Toxicology Information Service (Tel. 91 562 04 20), indicating the medicine and the amount ingested.

If you forget to take Vitamina D3 NM

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

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

If you stop taking Vitamina D3 NM

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

You should immediately stop taking the medicine 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 adverse effects (occur in up to 1 in 100 people):

• Hypercalcemia (increased levels of calcium in the blood). You may feel unwell, lose your appetite, have constipation, stomach pain, feel very thirsty, or experience muscle weakness, drowsiness, or confusion.
• Hypercalciuria (increased levels of calcium in urine).

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

• Pruritus
• Rash
• Urticaria

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

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines (website: www.notificaRAM.es). By reporting adverse 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.

Store in the original packaging, protected from light.

Do not use this medicine after the expiry date stated on the packaging.

after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the container and other information

Composition of VitaminaD3NM

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

The other components (excipients) are Butylated Hydroxytoluene (BHT), Medium-chain triglyceride oil, Gelatin, Glycerol, Titanium Dioxide (E-171), and Purified Water.

Appearance of the product and contents of the container

Soft capsules, oval-shaped, opaque white, size 3. The capsule measures approximately 11.3 mm x 6.9 mm. Each box contains an opaque white PVC/PVDC/Aluminum blister pack with 4, 6 (pharmacy use), 12, or 14 (hospital use) soft capsules.
Only certain pack sizes may be commercially available.

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 medicinal product is authorized in the Member States of the European Economic Area under the following names:

Spain: Vitamina D3 NM 25.000 UI cápsulas blandas
Portugal: VITAMINA D3 NM 25.000 U.I. cápsulas moles
Netherlands: Cholecalciferol INVOS 25.000 IE zachte capsules
Greece: Cholecalciferol INVOS 25.000 IU
Austria: Colecalciferol Invos 25.000 IE Weichkapseln
Italy: Colecalciferolo INVOS 25.000 U.I. capsule molli
Germany: OsteoGalen D3 25.000 IE Weichkapseln

Date of the most recent review of this summary: August 2020

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS):
http://www.aemps.gob.es/