DEVIK 25,000 IU/2.5 ML ORAL SOLUTION

Introduction

Package Leaflet: Information for the User

Devik25,000UI/2.5ml oral solution

Colecalciferol

Read this package leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any 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 you take Devik
3. How to take Devik
4. Possible side effects
5. Storage of Devik
6. Contents of the pack and other information

1. What is Devik and what is it used for

Devik 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. A deficiency of vitamin D3 is the main cause of rickets (a mineralization defect of bones in children) and osteomalacia (a mineralization defect of bones in adults).

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

Your doctor may prescribe this medicine as a supplement to specific bone loss medication. If you have any further questions, consult your doctor or pharmacist, and always follow their instructions.

2. What you need to know before you take Devik

Do not take Devik

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

Warnings and precautions

Consult your doctor, pharmacist, or nurse before taking Devik:

• If you are taking certain medicines 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 medicines 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 Devik.
• If you take additional calcium supplements. 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 with 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 (pseudohypoparathyroidism).

Children and adolescents

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

Using Devik with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines. It 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 D, these medicines can cause a significant increase in blood and urine calcium levels.
• Medicines that contain vitamin D or foods rich in vitamin D, such as some types of vitamin D-enriched 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 can affect how your body processes vitamin D.
• Medicines for treating tuberculosis, such as rifampicin and isoniazid.
• The following medicines, as they may interfere with the effect or absorption of vitamin D:

• 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).

Devik with food, drinks, and alcohol

You should take this medicine preferably with a large meal to help your body absorb vitamin D. You can also mix the solution with cold or lukewarm food 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 or pharmacist before using this medicine.

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

Driving and using machines

There is little 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 use machines.

3. How to take Devik

Follow the administration instructions of Devik indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

This medicine has an olive oil flavor with forest fruits. You should take Devik preferably with a large meal. Devik can be taken directly from the sachet or you can mix the contents of a single-dose sachet of the oral solution with a small amount of cold or lukewarm food immediately before taking it. Make sure to take the complete 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 UI once a 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.

Pregnancy and breastfeeding

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

Use in patients with kidney problems

Devik should not be used in patients with severe kidney 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 kidney function should be performed in elderly patients. Consult your doctor.

If you take more Devik than you should

If you take more medicine than prescribed, stop taking this medicine and consult your doctor. 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 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 medicine 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 for the next dose, do not take the missed dose; simply take the next dose as usual.

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

If you have any further questions about 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.

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 of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this package leaflet. You can also report them 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 Devik

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

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date which is stated on the package after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of the package and any unused medicine in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the package and any unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition of Devik

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

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

Appearance of Devik and contents of the pack

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

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

Not all pack sizes may be marketed.

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

This medicine is authorized in the Member States of the European Economic Area under the following names:

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

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

Date of the last revision of this package leaflet:November 2022

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/