DEVIK 50,000 IU/5 mL ORAL SOLUTION IN SACHET

Introduction

Package Leaflet: Information for the User

Devik 50,000UI/5 ml Oral Solution in Sachet

Colecalciferol

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.

• This medication has been prescribed to you only, 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 side effects, consult your doctor, pharmacist, or nurse, even if they are possible side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Devik and what is it used for
2. What you need to know before taking Devik
3. How to take Devik
4. Possible side effects
5. Storage of Devik
6. Package Contents and Additional Information

1. What is Devik and what is it used for

Devik oral solution in sachet 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. Vitamin D deficiency is the main cause of rickets (inadequate bone mineralization in children) and osteomalacia (inadequate bone mineralization in adults)

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

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

2. What you need to know before taking Devik

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 the blood (hypercalcemia) or in the urine (hypercalciuria).
• If you have kidney stones (renal calculi) or severe renal failure.
• If you have high levels of vitamin D3 in the blood (hypervitaminosis D).

Warnings and Precautions

Consult your doctor or pharmacist 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 (an immune system disorder 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 consume foods or milk enriched with vitamin D.
• If you are likely to have high sun exposure while taking Devik.
• If you take additional supplements that contain 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 or urine calcium levels.
• Your doctor should monitor your blood calcium level through laboratory tests if you take a daily dose of vitamin D3 greater than 1,000 UI for a prolonged period.
• If you have a parathyroid hormone imbalance (pseudo-hypoparathyroidism).

Use of Devik with other medications

Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medication. It is especially important that you 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., bendroflumethiazide). 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 consume foods rich in vitamin D, such as some types of vitamin D-enriched milk.
• Actinomycin (a medication used to treat some forms 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.
• Medications for treating tuberculosis, such as rifampicin and isoniazid
• The following medications, as they may interfere with the effect or absorption of vitamin D3:

• antiepileptic medications (anticonvulsants), barbiturics;
• glucocorticoids (steroid hormones such as hydrocortisone or prednisolone). These medications can reduce the effect of vitamin D3;
• medications that lower blood cholesterol levels (such as cholestyramine or colestipol);
• 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 Devik with food, beverages, and alcohol

Preferably, you should take this medication with a large meal to help your body absorb vitamin D3. You can also mix the solution with cold or warm foods to facilitate intake. For more information, see section 3 "How to take Devik".

Pregnancy, breastfeeding, and fertility

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

The use of this highly concentrated formulation is not recommended during pregnancy.

Driving and using machines

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

3. How to take Devik

Follow your doctor's instructions for taking this medication exactly. If you are unsure, ask your doctor or pharmacist.

This medication has an olive oil flavor with forest fruits. Devik should be taken preferably with a large meal. Devik can be taken directly from the sachet or mixed with a small amount of cold or warm food immediately before taking. Make sure to take the complete dose.

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

Use in adults

The recommended dose is 25,000 UI per week.

After the first month, the dose may be reduced

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

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

Alternatively, national posology recommendations for the treatment of vitamin D deficiency may be followed.

Use in children

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

Use in patients with kidney problems

Devik should not be used in patients with severe renal failure, 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 liver problems

No dose adjustment is required.

Use in elderly patients

Special monitoring of blood and urine calcium levels and renal function is required 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 or pharmacist. If you cannot consult your doctor, go to the nearest emergency room and bring the package with you.

The most common symptoms of an overdose are: nausea, vomiting, excessive thirst, production of large amounts of urine over 24 hours, constipation, and dehydration, as well as high 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 Devik

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 interrupt treatment with Devik

If you have any further questions about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

You should stop taking colecalciferol and consult your doctor immediately if you experience symptoms of severe allergic reactions, 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). Symptoms include nausea, vomiting, loss of appetite, constipation, stomach pain, bone pain, excessive thirst, frequent urination, muscle weakness, drowsiness, and confusion.
• Too much calcium in the urine (hypercalciuria)

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

• Skin rash
• Itching
• Hives

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Devik

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 shown on the package after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packages and medications you no longer need at the SIGRE collection point in your pharmacy. If you have any questions, ask your pharmacist how to dispose of packages and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Devik

The active ingredient is colecalciferol. 5 ml of solution contain 1,250 mg of colecalciferol, equivalent to 50,000 UI of vitamin D3.

The other components are: refined olive oil and forest fruit flavor (contains glycerol triacetate, triethyl citrate, propylene glycol, and flavorings).

Appearance of the product and package contents

Devik is marketed in single-dose sachets containing 5 ml of oral solution.

This medication is available in packages of 1 or 4 sachets in a cardboard box.

Marketing Authorization Holder

Kern Pharma, S.L.

Venus, 72 – Pol. Ind. Colón II

08228 Terrassa – Barcelona

Spain

Manufacturer

Zinereo Pharma, S.L.U.

A Relva s/n, O Porriño

36410 Pontevedra

Spain

Date of the last revision of this package leaflet: September 2021

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