Colecalciferol Normon 25.000 UI/2.5 ml oral solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Colecalciferol Normon 25,000 IU/2.5 ml oral solution

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 questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse, including any side effects not listed in this leaflet. See section 4.

Contents of this leaflet

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

1. What Colecalciferol Normon is and what it is used for

Colecalciferol Normon oral solution contains as its active substance colecalciferol (vitamin D3). Vitamin D3 can be found in certain foods and is produced by our body when the skin is exposed to sunlight. Vitamin D promotes calcium absorption in the kidneys and intestine, thereby aiding bone formation. Vitamin D deficiency is the main cause of rickets (deficient bone mineralization in children) and osteomalacia (inadequate bone mineralization in adults).

Colecalciferol Normon oral solution is used for the initial treatment of clinically relevant vitamin D deficiency in adults.

2. What you need to know before taking Colecalciferol Normon

Do not take Colecalciferol Normon

• If you are allergic to colecalciferol (vitamin D3) 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 kidney stones (renal calculi) or severe renal failure.
• If you have high levels of vitamin D in your blood (hypervitaminosis D).

Warnings and precautions

Talk to your doctor or pharmacist before taking Colecalciferol Normon:

• If you are being treated with certain medicines used for heart conditions (e.g., cardiac glycosides such as digoxin).
• If you have sarcoidosis (an autoimmune disease that may increase vitamin D levels in the body).
• If you are taking medicines containing vitamin D or consuming foods or milk fortified with vitamin D.
• If you are likely to be exposed to sunlight while using this medicine.
• If you are additionally taking supplements containing calcium. Your doctor should monitor your calcium levels to ensure they do not become too high during treatment with colecalciferol.
• If you have kidney disease or kidney damage. Your doctor should monitor your calcium levels in blood and urine.
• If your doctor needs to monitor your blood calcium levels through laboratory tests when your daily intake of vitamin D3 exceeds 1,000 IU for a prolonged period.
• If you have a disorder affecting parathyroid hormone function (pseudohypoparathyroidism).

Children and adolescents

The use of Colecalciferol Normon is not recommended in children and adolescents under 18 years of age.

Other medicines and Colecalciferol Normon

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

• Medicines used to treat heart or kidney conditions, such as cardiac glycosides (e.g., digoxin) or diuretics (e.g., bendroflumethiazide). When these medicines are used together with vitamin D3, they may cause a significant increase in calcium levels in blood and urine.

• Medicines containing vitamin D or foods rich in vitamin D, such as certain types of vitamin D-fortified milk.

• Actinomycin (a medicine used in the treatment of certain types of cancer) and imidazole antifungals (e.g., clotrimazole and ketoconazole, medicines used to treat fungal infections). These medicines may interfere with how your body processes vitamin D3.

• The following medicines, as they may interfere with the effect or absorption of vitamin D3:

  • Antiepileptic drugs (anticonvulsants), barbiturates.
  • Glucocorticoids (steroid hormones such as hydrocortisone or prednisolone), as they may reduce the effect of vitamin D3.
  • Medicines that lower cholesterol levels in the blood (such as cholestyramine or colestipol).
  • Some medicines used for weight loss by reducing fat absorption (e.g., orlistat).
  • Some laxatives (such as liquid paraffin).

Taking Colecalciferol Normon with food

You should preferably take colecalciferol during one of your main meals to help with the absorption of vitamin D3. You may take it alone or mix the solution with cold or lukewarm food. For more information, see section 3, How to take Colecalciferol Normon.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before taking this medicine.

This formulation of colecalciferol, due to its high vitamin D3 dose, is not recommended during pregnancy and breastfeeding.

Driving and using machines

Information regarding possible effects of this medicine on the ability to drive is limited. However, it is unlikely that your ability to drive or operate machinery will be affected.

3. How to take Colecalciferol Normon

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. In case of doubt, please consult your doctor or pharmacist again.

Shake before use.

Colecalciferol should preferably be taken with main meals.

This medicine has an olive oil flavour. Colecalciferol may be taken alone or mixed with a small amount of cold or lukewarm food immediately before intake. Make sure you take the full dose.

The amount of colecalciferol required will depend on your vitamin D levels and your response to treatment.

Use in adults

The recommended dose is 1 vial (25,000 IU) once weekly during the first month. Your doctor will adjust the dose after the first month of treatment.

Use in children and adolescents

Colecalciferol Normon 25,000 IU is not recommended for children and adolescents under 18 years of age.

Use in patients with kidney problems

Colecalciferol should not be used in patients with severe renal insufficiency, as vitamin D in the form of colecalciferol is not normally metabolized and other forms of vitamin D should be used.

Use in patients with liver problems

No dose adjustment is required.

Use in elderly patients

Special monitoring of serum and urinary calcium levels and renal function should be performed in elderly patients. Consult your doctor.

Pregnancy and breastfeeding

Colecalciferol Normon 25,000 IU is not recommended during pregnancy and breastfeeding.

If you take more Colecalciferol Normon than you should

Stop taking the medicine and consult your doctor or pharmacist immediately if you or your child take more of this medicine than prescribed. If you cannot contact a doctor, go to the nearest hospital and take the medicine package with you.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

The most frequent symptoms in case of overdose are: nausea, vomiting, excessive thirst, excessive urine production for about 24 hours, constipation and dehydration, elevated levels of calcium in blood and urine (hypercalcemia and hypercalciuria) in clinical tests.

If you forget to take Colecalciferol Normon

If you forget to take a dose of Colecalciferol Normon, take the next dose as soon as possible. Afterwards, take the following dose at the usual time. However, if it is almost time for your next dose, do not take the missed dose and instead take the next dose at the usual time.

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

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 will experience them.

Possible adverse effects may include:

Frequency not known: frequency cannot be estimated from the available data:

• Allergic reactions (hypersensitivity).
• Weakness, loss of appetite (anorexia), thirst.
• Drowsiness, confusion.
• Headache.
• Constipation, flatulence, abdominal pain, nausea, vomiting, diarrhea, metallic taste, dry mouth.
• Skin rash, itching, urticaria.
• Excessive calcium deposition in the kidneys (nephrocalcinosis), increased urine output, renal failure.
• High levels of calcium in the blood and urine.

Reporting of 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 leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Colecalciferol Normon

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

Do not use this medicine after the expiry date stated on the container after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage temperature conditions.

Store in the original packaging to protect it from light.

Do not use this medicine if the solution appears cloudy.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Colecalciferol Normon

• The active substance is colecalciferol (vitamin D3). Each 2.5 ml single-dose bottle of oral solution contains 0.625 mg of colecalciferol, equivalent to 25,000 IU of vitamin D3. Each ml of oral solution contains 0.25 mg of colecalciferol, equivalent to 10,000 IU of vitamin D3.
• The other components (excipients) are refined olive oil.

Appearance of the product and contents of the pack

Colecalciferol Normon 25,000 IU/2.5 ml oral solution is a clear oily solution, colourless to greenish-yellow, without visible solid particles and/or precipitates.

It is presented in amber glass bottles sealed with a plastic cap.

Each pack contains 1 or 4 single-dose bottles containing 2.5 ml of solution.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 - 28760 Tres Cantos - Madrid (SPAIN)

Date of the most recent revision of this leaflet: December 2024

Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.

You can access detailed and up-to-date information on this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You can also access this information at the following internet address:

https://cima.aemps.es/cima/dochtml/p/90024/P_90024.html