VIDESIL 50,000 IU ORAL SOLUTION

Introduction

Package Leaflet: Information for the User

Videsil 25,000UI Oral Solution

Videsil 50,000UI Oral Solution

Videsil 100,000UI 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 Videsil and what is it used for
2. What you need to know before you take Videsil
3. How to take Videsil
4. Possible side effects
5. Storage of Videsil
6. Contents of the pack and other information

1. What is Videsil and what is it used for

Videsil 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 intestine 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).

Videsil oral solution is used to:

Videsil 25,000UI

Prevent and treat Vitamin D3 deficiency in adults and adolescents (children ≥ 12 years).

Your doctor may prescribe this medicine as a supplement to a specific medication for bone loss.

Videsil 50,000UI Oral Solution and Videsil 100,000UI Oral Solution

Treat Vitamin D3 deficiency in adults and adolescents (children ≥ 12 years).

2. What you need to know before you take Videsil

Do not take Videsil:

• 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).

Warnings and precautions

Consult your doctor or pharmacist before taking Videsil:

• If you are taking certain medications 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 medications that contain Vitamin D, or if you take foods or milk enriched with Vitamin D.
• If you are likely to have high sun exposure 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 Videsil.
• 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 kidney disease. Your doctor may want to measure your blood and urine calcium levels.

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

Using Videsil with other medicines

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 can 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 can 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 can reduce the effect of Vitamin D;
  • 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 Videsil with food, drinks, and alcohol

Preferably, you should take this medicine with a large meal to help your body absorb Vitamin D. You can also mix the solution with cold or warm foods to help you take this medicine. For more information, see section 3 "How to take Videsil".

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.

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

Driving and using machines

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

3. How to take Videsil

Follow exactly the administration instructions of this medicine indicated by your doctor. If you are in doubt, ask your doctor or pharmacist.

Your doctor should define the necessary dose in your case.

Preferably, you should take Videsil with a large meal.

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

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

Use in adults and adolescents(children ≥ 12 years)

The recommended dose is one ampoule of 25,000 UI/month.

For the treatment of Vitamin D deficiency, the dose will be adjusted according to the level of Vitamin D in your blood (25(OH)D levels).

For the treatment of symptomatic Vitamin D deficiency, the recommended dose is one ampoule of 100,000 UI or 2 ampoules of 50,000 UI in one week. A maintenance dose of one ampoule of 25,000 UI/month may be considered.

Use in children

Videsil is not recommended in children under 12 years of age.

Use in patients with renal impairment

Videsil 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 Videsil than you should

If you or your child take more medicine than prescribed, 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 in 24 hours, constipation, and dehydration, as well as high blood and urine calcium levels (hypercalcemia and hypercalciuria) observed in laboratory tests.

You can also contact the Toxicology Information Service, phone 915620420, indicating the medicine and the amount taken.

If you forget to take Videsil

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 Videsil

If you stop taking Videsil 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 Videsil and seek medical help 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(affects less than 1 in 100 people)

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

Rare(affects 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 it is possible that 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 Videsil

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 indicated.

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 other information

Composition of Videsil

• The active substance is colecalciferol.
• The other ingredients are tocopherol acetate, polyglycerol oleate (E475), olive oil, refined sweet orange peel oil.

Appearance and packaging

Transparent PVC/PVDC/PE ampoules:

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

Transparent PVC/PVDC/PE ampoules in a transparent bag:

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

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

SMB 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:

Videsil: Spain, Portugal.

Date of last revision of this leaflet: August 2021

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