Leaflet: information for the user

Colecalciferol Normon 10.000 UI/ml oral drops in solution

vitamin D3

Read this leaflet carefully before starting to take this medicine, as it contains important information for you.

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

Colecalciferol Normon oral drops in solution contain colecalciferol (vitamin D3) as the active ingredient. Vitamin D3 can 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 drops in solution are used to prevent and treat vitamin D3 deficiency in adults, adolescents, and children with identified risk of vitamin D3 deficiency.

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

Do not take Colecalciferol Normon

• if you are allergic to 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 insufficiency.
• 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).
• you have sarcoidosis (an autoimmune disease that can cause an increase in vitamin D levels 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 take 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 while you are taking colecalciferol.
• you have kidney disease or renal damage. Your doctor should monitor your calcium levels in your blood and urine.
• your doctor should monitor your calcium levels in your blood through laboratory tests if your daily intake of vitamin D3 exceeds 1,000 IU for an extended period.

Other medications and Colecalciferol Normon

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

• medications used to treat heart or kidney diseases, such as cardiac glycosides (e.g., digoxin) or diuretics (e.g., bendroflumetazide). 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, which are medications used to treat diseases caused by fungi). These medications can interfere with the processing of vitamin D3 in the body.
• the following medications, as they may interfere with the effect or absorption of vitamin D3:

• anti-epileptic 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 cholestyramine).
• some medications used to lose weight by reducing fat absorption (e.g., orlistat);
• some laxatives (e.g., liquid paraffin).

Taking Colecalciferol Normon with food, drinks, and alcohol

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 by mixing the drops with cold or lukewarm food. For more information, see section 3 “How to take Colecalciferol Normon”.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor before using this medication. Colecalciferol Normon oral drops in solution should be taken during pregnancy and breastfeeding only under the recommendation of your doctor.

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

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 use machines will be affected.

Follow exactly the administration instructions of this medication as 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 taste of olive oil. Colecalciferol can be taken alone or by mixing the prescribed number of drops with a small amount of cold or lukewarm food immediately before ingestion. Make sure to take the complete dose.

Use in adults

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

For the treatment of vitamin D deficiency, the dose is usually 4 drops (800 UI) per day. Higher doses should be adjusted according to 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 UI (20 drops per day).

Use in children and adolescents

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

For the treatment of vitamin D deficiency in children (0 to 11 years) and adolescents (12 to 18 years), the dose should be adjusted according to 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 UI per day for children under 1 year, 2,000 UI per day for children 1 to 10 years old, and 4,000 UI per day for adolescents.

In children, colecalciferol can be mixed with a small amount of children's food, yogurt, milk, cheese, or other dairy products. Do not add colecalciferol to baby bottles with milk or other containers with food that the child will not consume completely uninterrupted, in order to avoid the child not taking the complete dose. Make sure the child takes the complete dose. In cases of children who have surpassed the lactation stage, the prescribed dose should be administered with some main food.

Do not store any product or food containing colecalciferol for later use or for the next meal.

Use during pregnancy and lactation

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

Instructions for use for the bottle with independent dosifier:

The container 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 medication, 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. Remove the plastic container that contains the dosifier (see Figure 2).
3. Insert the dosifier into the bottle to extract the content. 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 moreColecalciferol Normonthan you should

Stop taking the medication and immediately call your doctor or pharmacist if you or your child take more of this medication than prescribed by your doctor. If it is not possible to speak with the doctor, go to the nearest hospital and bring the container with the medication.

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 frequent symptoms in case of overdose are: nausea, vomiting, excessive thirst, excessive urine production for 24 hours, constipation, and dehydration, and 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, 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 the missed doses.

If you have any other doubts 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 associated with the use of colecalciferol may be:

Rarely Occurring(affect 1 in 100 people):

• Hypercalcemia (excess calcium in the blood).
• Hypercalciuria (excess calcium in the urine).

Uncommon(affect 1 in 1000 people):

• Cutaneous rash (skin rash or skin eruption).
• Pruritus (itching).
• Urticaria.

Reporting 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 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.

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

Do not use this medication if you observe any visible sign of deterioration, such as turbidity in the solution.

Medications should not be disposed of through drains or trash. Deposit the containers and themedications that you no longer need at the SIGREcollection point of the pharmacy. Ask your pharmacist howto dispose of the containers and the medications that you no longer need. In this way, you will help protect the environment.

Composition of Colecalciferol Normon

The active principle is colecalciferol (vitamin D 3 ).

1 ml of oral solution (50 drops) contains 10,000 UI of colecalciferol (vitamin D 3 ), equivalent to 0.25 mg. 1 drop contains 200 UI of colecalciferol (vitamin D ).

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

Appearance of the product and content of the container

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

It is presented in a topaz-colored glass bottle of 14 ml with a child-resistant cap.

Each container contains a topaz-colored glass bottle containing 10 ml of solution (corresponding to 500 drops) and closed with a polipropylene cap that is child-resistant.

A polipropylene dosifier protected with a plastic envelope is attached.

Holder of the marketing authorization and responsible for manufacturing

LABORATORIOS NORMON, S.A.

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

Date of the last review of this leaflet: February 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/ ).

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

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