Prospect: information for the user

Devik25.000UI/2,5ml oral solution

Colecalciferol

Read this prospect carefully before starting to use this medication, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only to you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor or pharmacist, even if they do not appear in this prospect. See section 4.

1. What is Devik and for what it is used

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

3. How to take Devik

4. Possible adverse effects

5. Conservation of Devik

6. Contents of the package and additional information

Devik oral solution contains colecalciferol (vitamin D3). Vitamin D3 can be found in certain foods, as well as produced by the skin in the presence of sunlight. Vitamin D3 helps the kidneys and intestines absorb calcium and contributes to bone development. Vitamin D3 deficiency is the main cause of rickets (inadequate bone mineralization in children) and osteomalacia (inadequate bone mineralization in adults).

Devik oral solution is used for the initial treatment of vitamin D deficiency in adults.

Your doctor may prescribe this medication as a complement to specific bone loss medication. Consult with your doctor or pharmacist if you have additional questions, and always follow their instructions.

Do not take Devik

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

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Devik:

• 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 Devik.
• If you take additional supplements containing calcium. Your doctor will monitor your blood calcium levels to ensure they are not too high while taking Devik.
• If you have kidney problems or any kidney disease. Your doctor may want to measure your blood calcium levels or urine calcium levels.
• Your doctor should monitor your blood calcium levels through laboratory tests if you take a daily dose of vitamin D3 exceeding 1,000 UI for a prolonged period.
• If you have a parathyroid hormone imbalance (pseudohypoparathyroidism).

Children and adolescents

Devik is not recommended for use in children and adolescents under 18 years of age.

Use of Devik 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 with vitamin D, these medications can cause a significant increase in blood and urine calcium levels.
• Medications that contain vitamin D or 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 D.
• Medications to treat tuberculosis, for example, rifampicin, isoniazid.
• The following medications, as they may interfere with the effect or absorption of vitamin D:

• Antiepileptic medications (anticonvulsants), barbiturates.
• Glucocorticoids (steroid hormones such as hydrocortisone or prednisolone). These medications can reduce the effect of vitamin D.
• Medications that reduce cholesterol levels in the blood (e.g., cholestyramine or cholestyramine).
• Certain weight loss medications that reduce the amount of fat absorbed by the body (e.g., orlistat).
• Certain laxatives (e.g., liquid paraffin).

Devik with food, drinks, and alcohol

You should take this medication preferably with a large meal to help your body absorb the vitamin D.This solution can also be mixed with cold or lukewarm foods to facilitate its intake. For more information, see section 3, How to take Devik.

Pregnancy, breastfeeding, and fertility

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

This highly concentrated formulation is not recommended for use during pregnancy and breastfeeding.

Driving and operating machinery

There is little information about the possible effects of this product on driving ability. However, it is not expected to affect your ability to drive or operate machinery.

Follow exactly the administration instructions for Devik as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

This medication has a flavor of olive oil with forest fruits. Devik should be taken preferably with a large meal. Devik can be taken directly from the package or the contents of a single-dose package of the oral solution can be mixed with a small amount of cold or lukewarm food immediately before taking it. Make sure to take the full dose.

The amount of colecalciferol will depend on your vitamin D levels and response to treatment.

Vitamin D Deficiency

Use in Adults

The recommended dose is 25,000 IU per week.

After the first month, the dose may be reduced.

If the doctor considers it necessary, the regimen of 50,000 IU/week (1 single dose) for 6-8 weeks may be considered.

This initial treatment may be followed by a maintenance therapy, as indicated by your doctor.

Alternatively, follow the national dosage recommendations for the treatment of vitamin D deficiency.

Use in Children

Devik is not suitable for use in children and adolescents under 18 years old.

Pregnancy and Breastfeeding

The use of Devik 25,000 UI/2.5 ml oral solution is not recommended in pregnant women or breastfeeding women.

Use in Patients with Kidney Problems

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

Use in Patients with Liver Problems

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 Devik Than You Should

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

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

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

If You Forget to Take Devik

If you forget to take a dose of Devik, take the missed dose as soon as possible and the next dose 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.

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

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 everyone will experience them.

You should discontinue colecalciferol intake and consult your doctor immediately if you experience severe allergic reaction symptoms, such as:

- Swelling of the face, lips, tongue, or throat.

- Difficulty swallowing.

- Urticaria and difficulty breathing

The possible adverse effects may include:

Rare (affect fewer than 1 in 100 people)

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, 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 Medicinal Products for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

This medication does not require special storage conditions.

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

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Devik

The active principle is colecalciferol. 2.5 ml of solution contain 0.625 mg of colecalciferol, equivalent to 25,000 UI of vitamin D3.

The other components are: refined olive oil, triacetate of glycerol, triethyl citrate, propylene glycol, and flavorings.

Appearance of Devik and content of the packaging

Devik is marketed in single-dose sachets containing 2.5 ml of oral solution.

This medication is available in packaging of 1, 2, 3, 4, 5, or 6 sachets in a cardboard box.

Only some packaging sizes may be marketed.

Holder of the marketing authorization

Kern Pharma, S.L.

Venus, 72 – Pol. Ind. Colón II

08228 Terrassa – Barcelona

Spain

Responsible for manufacturing

Zinereo Pharma, S.L.U.

A Relva s/n, O Porriño

36410 Pontevedra

Spain

This medication is authorized in the member states of the European Economic Area with the following names:

Spain: Devik 25,000 UI/2.5 ml oral solution

Portugal: Devik 25,000 UI/2.5 ml oral solution

Date of the last review of this prospectus: November 2022

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