Leaflet: Information for the User

Videsil 25,000Oral Solution

Videsil 50,000Oral Solution

Videsil 100,000Oral Solution

Colecalciferol (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 doubts, consult your doctor, pharmacist, or nurse.

-This medicine has been prescribed for you only, and you must not give it to others 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 not listed in this leaflet. See section 4.

1.What is Videsil and what it is used for

2.What you need to know before starting to take Videsil

3.How to take Videsil

4.Possible adverse effects

5.Storage of Videsil

6.Contents of the pack and additional information

Videsil oral solution contains colecalciferol (vitamin D3). Vitamin D3can be found in certain foods, as well as produced by the skin in the presence of sunlight. Vitamin D3helps the kidneys and intestines absorb calcium and contributes to bone development. A lack of vitamin D3is 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 for:

Videsil 25.000UI

To prevent and treat vitamin D3deficiency in adults and adolescents (children ≥ 12 years old).

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

Videsil 50.000UI oral solution and Videsil 100.000UI oral solution

To treat vitamin D3deficiency in adults and adolescents (children ≥12years old).

Do not take Videsil:

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take 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 exposure to sunlight while taking this medication.
• If you take 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 taking Videsil.
• If you are taking simultaneous calcium or phosphate supplements, as there is an increased risk of developing 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 laboratory tests if you take a daily dose of vitamin D3 equivalent to more than 1,000 UI for a prolonged period.

Use of Videsil with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication. It is especially important to do so if you are taking:

• Medications that act on the heart or kidneys, such as cardiac glycosides (e.g., digoxin) or diuretics (e.g., bendroflumetiazide). When taken at the same time as vitamin D3, these medications can cause a significant increase in blood and urine calcium levels.
• Medications 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 medication used to treat certain types of cancer) and imidazole antifungals (e.g., clotrimazole and ketoconazole, medications used to treat fungal diseases). These medications can affect how your body processes vitamin D3.
• The following medications, as they may interfere with the effect or absorption of vitamin D3:
• • Antiepileptic medications (anticonvulsants), barbiturates;
  • Glucocorticoids (steroid hormones such as hydrocortisone or prednisolone). These medications can reduce the effect of vitamin D3;
  • Medications that reduce cholesterol levels in the blood (such as cholestyramine or cholestipol);
  • Certain weight loss medications 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 recommended that you take this medication with a full meal to help your body absorb the vitamin D3. You can also mix the solution with cold or lukewarm foods to help you take this medication. For more information, see section 3 "How to take Videsil".

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant or plan to become pregnant, consult your doctor before using this medication.

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

Driving and operating machinery

No adverse effects on the ability to drive and operate machinery have been described for vitamin D3.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, ask your doctor or pharmacist.

Your doctor must define the necessary dose in your case.

It is preferable to take Videsil with a generous meal.

This medication has a light olive oil flavor. Videsil can be taken alone or the solution can be mixed with a small amount of cold or lukewarm food immediately before taking it. Make sure to take the complete dose.

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

Use in adults and adolescents(children ≥12years)

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

The dose will be adjusted according to the level of vitaminD in your blood (25(OH)D levels) for the treatment of vitaminD deficiency.

For the treatment of symptomatic vitaminD deficiency, the recommended dose is one vial of 100,000UI or two vials of 50,000UI in one week. A maintenance dose of one vial of 25,000UI/month may be considered.

Use in children

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

Use in patients with renal insufficiency

Videsil should not be used in patients with severe renal insufficiency, as vitaminD in the form of colecalciferol does not metabolize normally and other forms of vitaminD should be used.

Use in patients with hepatic insufficiency

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 medication than prescribed, stop taking this medication and consult your doctor or pharmacist. If you cannot consult your doctor, go to the nearest emergency service and bring the packaging with you.

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

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

If you forget to take Videsil

Do not take a double dose to compensate for the missed doses.

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

If you interrupt treatment with Videsil

If you interrupt treatment with Videsil or stop it prematurely, it is possible that symptoms will worsen or reappear. Consult your doctor about this.

If you have any other questions 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.

Stop taking Videsil and seek immediate medical assistance if you experience severe allergic reaction symptoms, such as:

• Swelling in the face, lips, tongue, or throat
• Difficulty swallowing
• Hives and difficulty breathing

The possible adverse effects may include:

Rare(affect less than 1 in 100 people)

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

Very Rare(affect less than 1 in 1000 people)

• Skin rash
• Itching
• Hives

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 Medicines for Human Use:https://www.notificaram.es..By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Do not store at a temperature above 86°F (30°C).

Store this medication in the outer packaging to protect it from light.

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not use this medication if you observe that the solution is cloudy.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Videsil

• The active principle is colecalciferol.
• The other components are acetate of tocoferol, oleate of polyglycerol (E475), olive oil, refined orange peel oil.

Appearance of the product and contents of the packaging

Transparent PVC/PVDC/PE ampoules:

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

Transparent PVC/PVDC/PE ampoules in transparent pouch:

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

Only some sizes of packaging may be commercially marketed.

Holder of the marketing authorization and manufacturer

Holder of the marketing authorization

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 with the following names:

Videsil:Spain, Portugal.

Last review date of this leaflet: August 2021

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