COLECALCIFEROL NORMON 25,000 IU/2.5 ML ORAL SOLUTION

Introduction

Package Leaflet: Information for the User

Colecalciferol Normon 25,000 IU/2.5 ml Oral Solution

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, consult your doctor, pharmacist, or nurse.
• 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, pharmacist, or nurse, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Colecalciferol Normon and what is it used for
2. What you need to know before taking Colecalciferol Normon
3. How to take Colecalciferol Normon
4. Possible side effects
5. Storage of Colecalciferol Normon
6. Package Contents and Additional Information

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

Colecalciferol Normon oral solution contains colecalciferol (Vitamin D3) as the active ingredient. Vitamin D3 can be found in some foods and is produced by our body when the skin is exposed to sunlight. Vitamin D promotes calcium absorption in the kidneys and intestines, helping to form bone. Vitamin D deficiency is the main cause of rickets (mineralization deficiency of bones in children) and osteomalacia (inadequate mineralization of bones 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 any of the other components of this medication (listed in section 6).
• If you have high levels of calcium in the blood (hypercalcemia) or urine (hypercalciuria).
• If you have kidney stones (renal calculi) or severe renal insufficiency.
• If you have high levels of vitamin D in the blood (hypervitaminosis D).

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Colecalciferol Normon:

• If you are being treated with certain medications for heart conditions (e.g., cardiac glycosides, such as digoxin).

• If you have sarcoidosis (an autoimmune disease that can cause increased levels of vitamin D in the body).
• If you are taking medications that contain vitamin D or consuming foods or milk enriched with vitamin D.
• If you are likely to be exposed to the sun while using this medication.
• If you are also taking calcium supplements. Your doctor should monitor your calcium levels to ensure they are not too high during your treatment with colecalciferol.
• If you have kidney disease. Your doctor should monitor your blood and urine calcium levels.
• If your doctor should monitor your blood calcium levels through laboratory tests if your daily intake of vitamin D3 exceeds 1,000 IU for an extended period.
• If you have a parathyroid hormone imbalance (pseudohypoparathyroidism).

Children and Adolescents

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

Other Medications and Colecalciferol Normon

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medication. This is especially important if you are taking:

• Medications for heart or kidney conditions, such as cardiac glycosides (e.g., digoxin) or diuretics (e.g., bendroflumethiazide). When these medications are used at the same time as vitamin D3, they can cause a significant increase in calcium levels in the blood and urine.
• Medications that contain vitamin D or foods rich in vitamin D, such as some types of milk enriched with vitamin D.
• Actinomycin (a medication used to treat certain types of cancer) and imidazole antifungals (e.g., clotrimazole and ketoconazole, medications used to treat fungal diseases). These medications can interfere with how your body processes vitamin D3.
• The following medications, as they may interfere with the effect or absorption of vitamin D3:

• Antiepileptic medications (anticonvulsants), barbiturics.
• Glucocorticoids (steroid hormones such as hydrocortisone or prednisolone), as they may reduce the effect of vitamin D3.
• Medications that lower cholesterol levels in the blood (such as cholestyramine or colestipol).
• Certain medications used to lose weight by reducing fat absorption (e.g., orlistat).
• Certain laxatives (such as liquid paraffin).

Taking Colecalciferol Normon with Food

You should take colecalciferol preferably with one of the main meals to help with the absorption of vitamin D3. You can 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 plan to become pregnant, consult your doctor or pharmacist before taking this medication.

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

Driving and Using Machines

Information on the possible effects of this medication on the ability to drive is limited. However, it is not expected that your ability to drive and use machines will be affected.

3. How to Take Colecalciferol Normon

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.

Shake before use.

Colecalciferol should be taken preferably with the main meals.

This medication has an olive oil flavor. Colecalciferol can be taken alone or mixed with a small amount of cold or lukewarm food immediately before ingestion. You must ensure that you take the complete dose.

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

Use in Adults

The recommended dose is 1 vial (25,000 IU) per week for 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 urine 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 medication and consult your doctor or pharmacist immediately if you or your child take more of this medication than prescribed by your doctor. If it is not possible to speak with your doctor, go to the nearest hospital and take the medication packaging with you.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

The most common symptoms in case of overdose are: nausea, vomiting, excessive thirst, excessive urine production for 24 hours, constipation, and dehydration, high levels of calcium in the 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. Subsequently, take the next dose at the usual time. However, if it is close to the time of the 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 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 will experience them.

Possible side effects may include:

Frequency Not Known: the 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.
• Rash, itching, urticaria.
• Too much calcium deposited in the kidneys (nephrocalcinosis), increased urine production, renal insufficiency.
• High levels of calcium in the blood and urine.

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 Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Colecalciferol Normon

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

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.

This medication does not require any special storage temperature.

Keep in the original packaging to protect from light.

Do not use this medication if the solution appears cloudy.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in your pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Colecalciferol Normon Composition

• The active ingredient is colecalciferol (Vitamin D3). Each 2.5 ml single-dose vial 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.

Product Appearance and Packaging Contents

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

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

Each package contains 1 or 4 single-dose vials 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 Last Revision of this Package Leaflet: December 2024

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.