Prospect: information for the user

Colecalciferol Normon 25,000 UI/2.5 ml oral solution

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, pharmacist, or nurse.
• This medication has been prescribed only to you, 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 adverse effects, consult yourdoctor, pharmacist, or nurse, even if they do not appear in this prospect. See section 4.

1. What isColecalciferol Normonand for what it is used

2. What you need to know before starting to takeColecalciferol Normon

3. How to takeColecalciferol Normon

4. Possible adverse effects

5. Storage ofColecalciferol Normon

6. Contents of the package and additional information

Colecalciferol Normon oral solution contains colecalciferol (vitamin D3) as the active ingredient. Vitamin D3can be found in some foods and is produced by the body when the skin is exposed to sunlight. Vitamin D promotes the absorption of calcium in the kidneys and intestines, aiding in bone formation. Vitamin D deficiency is the primary cause of rickets (inadequate mineralization 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.

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 your blood (hypercalcemia) or urine (hypercalciuria).
• If you have kidney stones (renal calculi) or severe kidney failure.
• If you have high levels of vitamin D in your 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 disease (e.g., cardiac glycosides, such as digoxin).

• If you have sarcoidosis (an autoimmune disease that can cause an increase in vitamin D levels in the body).
• If you are being treated with medications that contain vitamin D or take foods or milk enriched with vitamin D.
• If you are likely to be exposed to sunlight while taking this medication.
• If you are also taking supplements containing calcium. Your doctor should monitor your calcium levels to ensure they are not too high while you are taking colecalciferol.
• If you have kidney disease or renal damage. Your doctor should monitor your calcium levels in your blood and urine.
• If your doctor should monitor your calcium levels in your blood through laboratory tests if your daily intake of vitamin D3exceeds 1,000 UI for a prolonged 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 old.

Other medications and Colecalciferol Normon

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

• Medications used to treat heart or kidney disease, such as cardiac glycosides (e.g., digoxin) or diuretics (e.g., bendroflumetiazide). 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 imidazolic antifungals (e.g., clotrimazol and ketoconazol, 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), barbiturates.
• Glucocorticoids (steroid hormones such as hydrocortisone or prednisolone) as they may reduce the effect of vitamin D3.
• Medications that reduce cholesterol levels in the blood (e.g., cholestyramine or cholestipol).
• Some weight loss medications that reduce fat absorption (e.g., orlistat).
• Some laxatives (e.g., liquid paraffin).

Taking Colecalciferol Normon with food

You should take colecalciferol preferably with one of your 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, or think you may be 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 operating machinery

The information on possible effects of this medication on driving ability is limited. However, it is not expected that your ability to drive and operate machinery will be affected.

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

Shake before use.

Colecalciferol should be taken preferably with main meals.

This medication has a flavor of olive oil. Colecalciferol can be taken alone or by mixing the solution with a small amount of cold or lukewarm food immediately before ingestion. Make sure to take the complete dose.

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

Use in adults

The recommended dose is 1 bottle (25,000 UI) per week for the first month. Your doctor will adjust the dose after the first month of treatment.

Use in children and adolescents

Colecalciferol Normon25,000 UI is not recommended for children and adolescents under 18 years old.

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 does not metabolize normally 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 UI is not recommended during pregnancy and lactation.

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 than the prescribed amount of this medication. If it is not possible to speak with your doctor, go to the nearest hospital and bring the medication packaging with you.

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

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

If you forgot to take Colecalciferol Normon

If you forget to take a dose of Colecalciferol Normon, take the next dose as soon as possible. Then, take the next dose at the usual time. However, if you are very 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 compensate for missed doses.

If you have any other questions 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.

The possible adverse effects may include:

Unknown Frequency: the frequency cannot be estimated from the available data:

• Allergic reactions (hypersensitivity).
• Weakness, loss of appetite (anorexia), thirst.
• Drowsiness, state of 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 insufficiency.
• High levels of calcium in the blood and urine.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es.By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

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.

This medication does not require any special storage temperature.

Store in the original packaging to protect it from light.

Do not use this medication if the solution appears cloudy.

Medications should not be disposed of through drains or in the trash. Deposit the containers and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the containers and medications you no longer need. In this way, you will help protect the environment.

Composition of Colecalciferol Normon

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

Appearance of the product and contents of the packaging

Colecalciferol Normon 25,000 UI/ 2.5 ml oral solution is a transparent, colorless to yellowish-green oily solution, without visible solid particles and/or precipitates.

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

Each package contains 1 or 4 single-dose vials containing 2.5 ml of solution.

Holder of the marketing authorization and responsible for manufacturing

LABORATORIOS NORMON, S.A.

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

Last review date of this leaflet: December 2024

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