Leaflet: information for the user

Devik 50,000UI/5 ml oral solution in sachet

Colecalciferol

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 side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

1.What Devik is and what it is used for

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

3.How to take Devik

4.Possible side effects

5.Storage of Devik

6.Contents of the pack and additional information

Devik oral solution in a blister pack 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 to absorb calcium and contributes to bone development.Vitamin D deficiency is the main cause of rickets (inadequate mineralization of bones in children) and osteomalacia (inadequate mineralization of bones in adults)

Devikis 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 the 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 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 (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 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).

Use of Devikwithother 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., clotrimazol and ketoconazol, medications used to treat fungal diseases). These medications can affect how your body processes vitamin D3.
• Medications to treat tuberculosis, for example, rifampicin, isoniazid
• 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 Devikwith foods, beverages, and alcohol

It is recommended to 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 make it easier to take. 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.

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

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 of this medication as indicated by your doctor. In case of doubt, ask your doctor or pharmacist.

This medication has a flavor of olive oil with forest fruits. Devik should be taken preferably with a generous meal. Devik can be taken directly from the package or it can also be mixed with the contents of a single-dose package 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 the response to treatment.

Use in adults

The recommended dose is 25,000 UI per week.

After the first month, the dose may be considered to be reduced.

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

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 usein children and adolescents under 18 years old.

Use in patients with kidney problems

Devik 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 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 or pharmacist. 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 over 24 hours, 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 Devik

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 Devik

If you have any other doubts 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)

• Too much calcium in the blood (hypercalcemia). Symptoms include nausea, vomiting, loss of appetite, constipation, stomach pain, bone pain, extreme thirst, need to drink water more frequently, muscle weakness, drowsiness, and confusion.
• Too much calcium in the urine (hypercalciuria).

Very rare (affect fewer than 1 in 1,000 people)

• Skin rash.
• Itching.
• Urticaria.

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 theSpanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting adverse effects, you can contribute to providing more information about 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 unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition of Devik

The active principle is colecalciferol. 5 ml of solution contain1,250mg of colecalciferol, equivalent to 50,000 UI of vitamin D3.

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

Appearance of the product and contents of the packaging

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

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

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

Last review date of this leaflet: September 2021

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