COLECALCIFEROL NORMON 10,000 IU/mL ORAL SOLUTION DROPS

Introduction

Package Leaflet: Information for the User

Colecalciferol Normon 10,000 IU/ml Oral Drops in Solution

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 further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this 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 you take Colecalciferol Normon
3. How to take Colecalciferol Normon
4. Possible side effects
5. Storage of Colecalciferol Normon
6. Contents of the pack and further information

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

Colecalciferol Normon oral drops in solution contain the active substance colecalciferol (vitamin D3). Vitamin D3 can be found in some foods and is produced by our body when the skin is exposed to sunlight. Vitamin D helps the absorption of calcium in the kidneys and intestines, helping to form bone. A deficiency of vitamin D is the main cause of rickets (mineralization deficiency of bones in children) and osteomalacia (inadequate mineralization of bones in adults).

Colecalciferol Normon oral drops in solution are used to prevent and treat vitamin D3 deficiency in adults, adolescents, and children with an identified risk of vitamin D3 deficiency.

Colecalciferol Normon oral drops in solution can also be used as an adjunct to specific medication for bone mass loss.

2. What you need to know before you take Colecalciferol Normon

Do not take Colecalciferol Normon

• if you are allergic to vitamin D3 or any of the other ingredients of this medicine (listed in section 6).
• if you have high levels of calcium in the blood (hypercalcemia) or in the urine (hypercalciuria).
• if you have kidney stones (renal calculi) or severe renal failure.
• if you have high levels of vitamin D in the blood (hypervitaminosis D).

Warnings and precautions

Consult your doctor or pharmacist before taking Colecalciferol Normon if:

• you are being treated with certain medications for heart conditions (e.g., cardiac glycosides, such as digoxin).
• you have sarcoidosis (an autoimmune disease that can cause increased levels of vitamin D in the body).
• you are being treated with medications that contain vitamin D or take foods or milk enriched with vitamin D.
• you are likely to be exposed to the sun while using this medication.
• you take other supplements that contain calcium. Your doctor should monitor your calcium levels to ensure they are not too high during your treatment with colecalciferol.
• you have kidney disease. Your doctor should monitor your blood and urine calcium levels.
• your doctor should monitor your blood calcium levels through laboratory tests if your daily intake of vitamin D3 exceeds 1,000 IU for a prolonged period.

Other medicines and Colecalciferol Normon

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

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

• antiepileptic medicines (anticonvulsants), barbiturics.
• 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).
• certain medicines used to lose weight by reducing fat absorption (e.g., orlistat).
• certain laxatives (such as liquid paraffin).

Taking Colecalciferol Normon with food, drinks, and alcohol

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 drops with cold or warm food. For more information, see section 3 "How to take Colecalciferol Normon".

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine. Colecalciferol Normon oral drops in solution should be taken during pregnancy and breastfeeding only under the recommendation of your doctor.

Overdoses of vitamin D should be avoided during pregnancy, as prolonged hypercalcemia can cause physical and mental developmental delays, supravalvular aortic stenosis, and retinopathy in the child.

Driving and using machines:

Information on the possible effects of this medicine 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 instructions for administration of this medicine 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 medicine has an olive oil flavor. Colecalciferol can be taken alone or by mixing the prescribed number of drops with a small amount of cold or warm food immediately before ingestion. You must ensure that you take the complete dose.

Use in adults

The recommended dose for vitamin D deficiency and as a supplement to specific medication for bone loss (osteoporosis) is 3-4 drops (600 IU - 800 IU) per day.

For the treatment of vitamin D deficiency, the dose is usually 4 drops (800 IU) per day. Higher doses should be adjusted depending on the desired serum levels of 25-hydroxycolecalciferol (25(OH)D), the severity of the disease, and the patient's response to treatment.

The daily dose should not exceed 4,000 IU (20 drops per day).

Use in children and adolescents

For the prevention of vitamin D deficiency in children (from 0 to 11 years) with an identified risk, the recommended dose is 2 drops (400 IU) per day. For prevention in adolescents (from 12 to 18 years) with an identified risk, the recommended dose is 3-4 drops (600-800 IU) per day.

For the treatment of vitamin D deficiency in children (from 0 to 11 years) and adolescents (from 12 to 18 years), the dose should be adjusted depending on the desired serum levels of 25-hydroxycolecalciferol (25(OH)D), the severity of the disease, and the patient's response to treatment. The daily dose should not exceed 1,000 IU per day for children under 1 year, 2,000 IU per day for children from 1 to 10 years, and 4,000 IU per day for adolescents.

In children, colecalciferol can be mixed with a small amount of baby food, yogurt, milk, cheese, or other dairy products. Do not add colecalciferol to baby bottles or other containers with food that the child will not consume completely and continuously, to avoid the child not taking the complete dose. You must ensure that the child takes the complete dose. In cases of children who have passed the breastfeeding stage, the prescribed dose should be administered with some main meal.

Do not store any product or food that contains colecalciferol for later use or in the next meal.

Use during pregnancy and breastfeeding

The recommended dose is 400 IU/day (2 drops). Higher doses may be needed after confirmation of vitamin D deficiency, but do not take more than your doctor recommends.

Instructions for use for the bottle with independent dosifier:

The pack contains a bottle and a dosifier. The bottle is closed with a child-resistant cap. The dosifier is protected by a plastic ring. To use the medicine, shake the bottle before use and follow the instructions below:

1. To open the bottle, press the cap down and turn it at the same time (see Figure 1).
2. Unscrew the plastic container that contains the dosifier (see Figure 2).
3. Insert the dosifier into the bottle to extract the contents. Put the prescribed number of drops into a spoon.
4. To close the bottle, remove the dosifier from the bottle and put the original cap back on the bottle (see Figure 3).
5. Carefully return the dosifier to its plastic container and screw it back on.
6. Place both the bottle and the dosifier in their original box.

If you take more Colecalciferol Normon than you should

Stop taking the medicine and contact your doctor or pharmacist immediately if you or your child take more of this medicine than prescribed by your doctor. If it is not possible to talk to your doctor, go to the nearest hospital and take the medicine pack 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 medicine and the amount taken.

The most frequent symptoms in case of overdose are: nausea, vomiting, excessive thirst, excessive urine production for 24 hours, constipation, and dehydration, and 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, take the next dose as soon as possible. Then, 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 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 on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The possible side effects associated with the use of colecalciferol may be:

Uncommon(affect 1 in 100 people):

• Excess calcium in the blood (hypercalcemia).
• Excess calcium in the urine (hypercalciuria).

Rare(affect 1 in 1,000 people):

• Skin rash (rash or skin eruption).
• Itching (pruritus).
• Urticaria.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Health Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side 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 which is stated on the pack after EXP. The expiry date is the last day of the month stated.

This medicine does not require any special storage temperature.

Store in the original package to protect from light.

After the first opening of the pack, the product can be stored for a maximum period of 6 months.

Do not use this medicine if you notice any visible signs of deterioration, such as turbidity in the solution.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and further information

Composition of Colecalciferol Normon

The active substance is colecalciferol (vitamin D3).

1 ml of oral solution (50 drops) contains 10,000 IU of colecalciferol (vitamin D3), equivalent to 0.25 mg. 1 drop contains 200 IU of colecalciferol (vitamin D).

The other ingredients (excipients) are: refined olive oil.

Appearance of the product and contents of the pack

Colecalciferol Normon 10,000 IU/ml oral drops in solution is a clear, colorless to yellow-green oral solution, without visible solid particles and/or precipitates.

It is presented in a 14 ml amber glass bottle with a child-resistant cap.

Each pack contains a 10 ml amber glass bottle containing 10 ml of solution (corresponding to 500 drops) and closed with a polypropylene child-resistant cap.

A polypropylene dosifier is included, protected with a plastic container.

Marketing authorization holder and manufacturer

LABORATORIOS NORMON, S.A.

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

Date of last revision of this leaflet: February 2024

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

You can access detailed and updated information on this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address:

https://cima.aemps.es/cima/dochtml/p/89368/P_89368.html