Colecalciferol Normon 10.000 UI/mL oral solution in drops

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Colecalciferol Normon 10,000 IU/ml oral drops 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, as 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 and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any side effects, talk to your doctor, pharmacist or nurse, even if it is a side effect not listed in this leaflet. See section 4.

Leaflet contents

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 drops solution contains as the 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 intestines, thereby aiding bone formation. Vitamin D deficiency is the main cause of rickets (defective bone mineralization in children) and osteomalacia (inadequate bone mineralization in adults).

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

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

2. What you need to know before taking 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 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

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

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

Other medicines and Colecalciferol Normon

Inform 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 the body's processing of 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).
  • certain medicines used for weight loss by reducing fat absorption (e.g., orlistat);
  • certain laxatives (such as liquid paraffin).

Taking Colecalciferol Normon with food, drinks, and alcohol

You should preferably take colecalciferol during one of your main meals to help absorption of vitamin D3. You may take it alone or mix 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, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine. Colecalciferol Normon oral drops solution should be taken during pregnancy and breastfeeding only on the advice of your doctor.

Vitamin D overdosage should be avoided during pregnancy, as prolonged hypercalcemia may cause delayed physical and mental development, supravalvular aortic stenosis, and retinopathy in the child.

Driving and using machines:

Information on possible effects of this medicine on the ability to drive is limited. However, it is not expected that your ability to drive or operate machinery will be affected.

3. How to take Colecalciferol Normon

Follow exactly the instructions for administration of this medicine as given by your doctor or pharmacist. In case of doubt, 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 by mixing the prescribed number of drops with a small amount of cold or lukewarm food immediately before ingestion. You must ensure that the full dose is taken.

Use in adults

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

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

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

Use in children and adolescents

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

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

In children, colecalciferol may be mixed with a small amount of children's food, yoghurt, milk, cheese, or other dairy products. Do not add colecalciferol to bottles of milk or other food containers that the child may not consume completely in one sitting, to avoid the child not receiving the full dose. You must ensure that the child takes the complete dose. In children who have passed the breastfeeding stage, the prescribed dose should be administered with a main meal.

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

Use during pregnancy and breastfeeding

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

Instructions for use of the bottle with separate dosing device:

The package contains a bottle and a dosing device. The bottle is closed with a child-resistant cap. The dosing device 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 down on the cap while turning it at the same time (see Figure 1).
2. Unscrew the plastic container holding the dosing device (see Figure 2).
3. Insert the dosing device into the bottle to draw out the contents. Place the prescribed number of drops into a spoon.
4. To close the bottle, remove the dosing device from the bottle and replace the original cap on the bottle (see Figure 3).
5. Carefully return the dosing device to its plastic container and screw it back on.
6. Place both the bottle and the dosing device back into the 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. If you cannot speak to a doctor, go to the nearest hospital and take the medicine packaging 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 common symptoms in case of overdose are: nausea, vomiting, excessive thirst, excessive urine production over a 24-hour period, constipation and dehydration, and elevated 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 following dose at the usual time. However, if it is almost time for 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 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 experiences them. The possible adverse effects associated with the use of colecalciferol may include:

Uncommon (affect 1 in 100 people):

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

Rare (affect 1 in 1,000 people):

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

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 through the Spanish Pharmacovigilance System for Human Medicinal Products: 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 packaging after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage temperature.

Store in the original packaging to protect it from light.

After first opening the container, the product may 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 must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE Point in your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the container and other 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 components (excipients) are: refined olive oil.

Appearance of the product and contents of the container

Colecalciferol Normon 10,000 IU/ml oral drops solution is an oily, transparent oral solution, colourless to yellowish-green, without visible solid particles and/or precipitates.

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

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

A polypropylene dosing device is included, protected by a plastic container.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.
Ronda de Valdecarrizo, 6 - 28760 Tres Cantos - Madrid (SPAIN)

Date of the most recent review of this leaflet: February 2024

Detailed information on this medicinal product 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/89368/P_89368.html