Videsil 50,000 IU oral solution

Package leaflet: Information for the user

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 the entire leaflet carefully before you start taking 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, ask your doctor, pharmacist or nurse.

• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, as it may harm them.

  • If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are possible adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Videsil is and what it is used for
2. What you need to know before taking Videsil
3. How to take Videsil
4. Possible side effects
5. How to store Videsil
6. Contents of the pack and other information

1. What Videsil is and what it is used for

Videsil oral solution contains colecalciferol (vitamin D3). Vitamin D3 can be found in certain foods and is also produced by the skin upon exposure to sunlight. Vitamin D3 helps the kidneys and intestines absorb calcium and contributes to bone development. A lack of vitamin D3 is the main cause of rickets (defective bone mineralization in children) and osteomalacia (inadequate bone mineralization in adults).

Videsil oral solution is used for:

Videsil 25,000 IU

Prevention and treatment of vitamin D3 deficiency in adults and adolescents (children aged ≥ 12 years).

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

Videsil 50,000 IU oral solution and Videsil 100,000 IU oral solution

Treatment of vitamin D3 deficiency in adults and adolescents (children aged ≥ 12 years).

2. What you need to know before taking Videsil

Do not take Videsil:

• If you are allergic to vitamin D3 or to 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).
• If you have high levels of vitamin D3 in your blood (hypervitaminosis D).

Warnings and precautions

Talk to your doctor or pharmacist before taking Videsil:

• If you are taking certain medicines used to treat heart conditions (e.g., cardiac glycosides such as digoxin).
• If you have sarcoidosis (an immune system disorder that can cause increased levels of vitamin D in the body).
• If you are taking other medicines containing vitamin D, or if you consume vitamin D–fortified foods or milk.
• If you are likely to have high exposure to sunlight while taking this medicine.
• If you are taking additional supplements containing calcium, as you may develop kidney stones. Your doctor will monitor your blood calcium levels to ensure they are not too high while you are taking Videsil.
• If you are taking additional calcium or phosphate supplements, as this increases the risk of high blood calcium levels (hypercalcemia).
• If you have kidney problems or any kidney disease. Your doctor may want to measure your blood or urine calcium levels.

Your doctor should monitor your blood calcium levels through blood tests if you take a dose equivalent to a daily vitamin D3 dose exceeding 1,000 IU over a prolonged period.

Taking Videsil with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. It is especially important to inform them if you are taking:

• Medicines acting on the heart or kidneys, such as cardiac glycosides (e.g., digoxin) or diuretics (e.g., bendroflumethiazide). When taken together with vitamin D3, these medicines may cause a significant increase in calcium levels in blood and urine.
• Medicines containing vitamin D or if you consume vitamin D–rich foods, such as certain types of vitamin D–fortified milk.
• 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), barbiturates;
  • glucocorticoids (steroid hormones such as hydrocortisone or prednisolone). These medicines may reduce the effect of vitamin D3;
  • medicines that lower cholesterol levels in the blood (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).

Use of Videsil with food, drinks and alcohol

It is preferable to take this medicine with a full meal to help your body absorb vitamin D3. You may also mix the solution with cold or lukewarm foods to help you take the medicine. For more information, see section 3 "How to take Videsil".

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine.

Videsil is not recommended during pregnancy or breast-feeding due to the high dose of vitamin D.

Driving and using machines

Vitamin D3 has not been reported to affect the ability to drive or use machinery.

3. How to take Videsil

Follow exactly the administration instructions for this medicine as given by your doctor. If in doubt, ask your doctor or pharmacist.

Your doctor will determine the required dose for your individual case.

Videsil should preferably be taken with a substantial meal.

This medicine has a mild olive oil taste. Videsil can be taken alone or may be mixed with a small amount of cold or lukewarm food immediately before taking it. Make sure you take the full dose.

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

Use in adults and adolescents (children aged ≥12 years)

The recommended dose is one 25,000 IU vial per month.

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

For the treatment of symptomatic vitamin D deficiency, the recommended dose is one 100,000 IU vial or two 50,000 IU vials within one week. A maintenance dose of one 25,000 IU vial per month may be considered.

Use in children

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

Use in patients with renal impairment

Videsil must 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 urinary 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 contact your doctor, go to the nearest emergency department and bring the package with you.

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

You may also contact the Toxicology Information Service at telephone number 915620420, indicating the medicine and the amount taken.

If you forget to take Videsil

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

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

If you stop taking Videsil

If you stop treatment with Videsil or discontinue it prematurely, your symptoms may worsen or reappear. Consult your doctor about this issue.

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 can cause adverse effects, although not everyone experiences them.

Stop taking Videsil and seek immediate medical attention 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 adverse 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 1000 people)

• Skin rash
• 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 can also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage instructions for 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 stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Do not use this medicine if the solution appears cloudy.

Medicines must not be disposed of via wastewater or household waste. Unused containers and medicines should be taken to a SIGRE collection point at your pharmacy. If in doubt, please ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Videsil

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

Appearance of the medicinal product and contents of the pack

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.

Only certain 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 medicinal product is authorized in the European Economic Area member states under the following names:

Videsil: Spain, Portugal.

Date of the most recent review of this leaflet: August 2021

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/