COLECALCIFEROL GEBRO 25,000 IU ORAL SOLUTION

Introduction

Package Leaflet: Information for the User

Colecalciferol Gebro25,000UI oral solution

Colecalciferol Gebro50,000UI oral solution

Colecalciferol (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 pack

1. What is Colecalciferol Gebro and what is it used for
2. What you need to know before you take Colecalciferol Gebro
3. How to take Colecalciferol Gebro
4. Possible side effects
5. Storage of Colecalciferol Gebro
6. Contents of the pack and further information

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

Colecalciferol Gebro oral solution contains colecalciferol (Vitamin D3). Vitamin D3 can be found in certain foods, as well as being produced by the skin in the presence of sunlight. Vitamin D3 helps the kidneys and intestines absorb calcium and contributes to bone development. The lack of Vitamin D3 is the main cause of rickets (a defective mineralization of bones in children) and osteomalacia (an inadequate mineralization of bones in adults).

Colecalciferol Gebro oral solution is used:

for the initial treatmentof clinically relevantVitamin D3 deficiency in adults.

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

Do not take Colecalciferol Gebro:

• 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).
• If you have high levels of Vitamin D3 in the blood (hypervitaminosis D).
• If you have severe kidney failure.

Warnings and precautions

Consult your doctor or pharmacist before starting to take colecalciferol:

• If you are taking certain medicines used to treat heart disorders (e.g., cardiac glycosides, such as digoxin).
• If you have sarcoidosis (a disorder of the immune system that can cause an increase in Vitamin D levels in the body).
• If you are taking other medicines that contain Vitamin D, or if you take foods or milk enriched with Vitamin D.
• If you are likely to have high exposure to sunlight while taking this medicine.
• If you take additional calcium supplements, as you may develop kidney stones. Your doctor will monitor your blood calcium levels to ensure they are not too high while taking colecalciferol.
• If you are taking simultaneous calcium or phosphate supplements, as there is an increased risk of high blood calcium levels (hypercalcemia).
• If you have kidney problems or any kidney disease. Your doctor may want to measure your blood and urine calcium levels.

Your doctor should monitor your blood calcium level with laboratory tests if you take a dose equivalent to a daily dose of Vitamin D3 greater than 1,000 UI for a prolonged period.

Other medicines and Colecalciferol Gebro

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

• Medicines that act on the heart or kidneys, such as cardiac glycosides (e.g., digoxin) or diuretics (e.g., bendroflumethiazide). When taken at the same time as Vitamin D3, these medicines may cause a significant increase in blood and urine calcium levels.
• Medicines that contain Vitamin D or if you take foods rich in Vitamin D, such as some types of milk enriched with Vitamin D.
• Actinomycin (a medicine used to treat some forms of cancer) and imidazole antifungals (e.g., clotrimazole and ketoconazole, medicines used to treat fungal diseases). These medicines may affect how your body processes Vitamin D3.
• 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). These medicines may reduce the effect of Vitamin D3;
  • medicines that lower blood cholesterol levels (such as cholestyramine or colestipol);
  • certain weight loss medicines that reduce the amount of fat absorbed by the body (e.g., orlistat);
  • certain laxatives (such as liquid paraffin).

Using Colecalciferol Gebro with food, drinks, and alcohol

Preferably, you should take this medicine with a large meal to help your body absorb Vitamin D3. You can also mix the solution with cold or lukewarm food to help you take this medicine. For more information, see section 3 "How to take Colecalciferol Gebro".

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 is not recommended during pregnancy or breastfeeding due to the high dose of Vitamin D.

Driving and using machines

It has not been reported that Vitamin D3 has effects on the ability to drive and use machines.

3. How to take Colecalciferol Gebro

Follow exactly the administration instructions of this medicine given by your doctor. If you are unsure, ask your doctor or pharmacist.

Your doctor will define the necessary dose in your case.

Preferably, you should take colecalciferol with a large meal.

This medicine has a mild olive oil flavor. Colecalciferol can be taken alone or you can also mix the solution with a small amount of cold or lukewarm food immediately before taking it. Make sure to take the complete dose.

Do not store any food product or mixture that contains this medicine for later use or for the next meal.

The dose should be determined individually by your doctor depending on the necessary amount of Vitamin D supplementation.

Recommended dose:

25,000 UI every week.

After the first month, lower doses may be considered.

Higher doses may be considered under medical supervision:

• 50,000 UI per week (1 single dose) for 6-8 weeks.

Following this initial treatment, maintenance treatment with a dose determined individually by your doctor may be required.

Use in children and adolescents

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

Use in patients with renal impairment

Colecalciferol should not be used in patients with severe renal impairment, 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 hepatic impairment

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.

If you take more Colecalciferol Gebro than you should

If you or your child take more medicine than you should, stop taking this medicine and consult your doctor or pharmacist. If you cannot consult your doctor, go to the nearest emergency department and take the package with you.

The most frequent symptoms of an overdose are: nausea, vomiting, excessive thirst, production of large amounts of urine during 24 hours, constipation, and dehydration, as well as high blood and urine calcium levels (hypercalcemia and hypercalciuria) observed in laboratory tests.

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 ingested.

If you forget to take Colecalciferol Gebro

Do not take a double dose to make up for forgotten doses.

Take the forgotten dose as soon as possible and take the next doses on the correct day. However, if it is almost time for the next dose, do not take the forgotten dose; simply take the next dose as usual.

If you stop taking Colecalciferol Gebro

If you stop taking colecalciferol or stop it prematurely, your symptoms may worsen or reappear. Consult your doctor about this.

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.

Stop taking colecalciferol and seek medical attention immediately if you experience symptoms of a severe allergic reaction, such as:

• swelling of the face, lips, tongue, or throat,
• difficulty swallowing,
• hives and difficulty breathing.

Possible side effects may include:

Uncommon(affect less than 1 in 100 people)

• Too much calcium in the blood (hypercalcemia).
• Too much calcium in the urine (hypercalciuria).

Rare(affect less than 1 in 1,000 people)

• Skin rash.
• Itching.
• Hives.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Colecalciferol Gebro

Do not store above 30°C.

Keep this medicine in the outer packaging to protect it from light.

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 packaging after "EXP". The expiry date is the last day of the month shown.

Do not use this medicine if you notice that the solution is cloudy.

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

6. Contents of the pack and further information

Composition of Colecalciferol Gebro

• The active substance is colecalciferol.
• The other ingredients are tocopherol acetate, polyglycerol oleate, refined olive oil, sweet orange peel oil.

Appearance of the product and pack contents

PVC/PVDC/PE transparent blisters:

Colecalciferol Gebro is available in packs of 1, 2, 3, 4, 5, 6, 8, and 10 PVC/PVDC/PE blisters.

PVC/PVDC/PE transparent blisters in a transparent bag:

Colecalciferol Gebro is available in packs of 1, 2, 3, 4, 5, 6, 8, and 10 PVC/PVDC/PE blisters.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorios Gebro Pharma, S.A.

Avenida Tibidabo, 29

08022 Barcelona

Spain

Manufacturer

S.M.B Technology S.A.

39, rue du parc industriel

6900 Marche en Famenne

Belgium

This medicine is authorized in the Member States of the European Economic Area under the following names:

Spain: Colecalciferol Gebro 25,000 UI oral solution

Colecalciferol Gebro 50,000 UI oral solution

Austria: Vitavitan D 25,000 IU solution for oral administration

Vitavitan D 50,000 IU solution for oral administration

Date of last revision of this leaflet:December 2022

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/).