User Information: Package Insert

Devik®10,000 IU/mL Oral Drops in Solution

Colecalciferol (Vitamin D3)

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

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you and should not be given 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 or pharmacist, even if they are not listed in this package insert. See section 4.

Devik contains colecalciferol (vitamin D3). Vitamin D3, which is liposoluble, can be found in some foods and is produced by the body when the skin is exposed to sunlight. Vitamin D promotes the absorption of calcium in the kidneys and intestines, aiding in bone formation.Vitamin D deficiency is the primary cause of rickets (inadequate mineralization of bones in children) and osteomalacia (inadequate mineralization of bones in adults).

Devik is indicated to prevent and treat vitamin D deficiency, due to inadequate intake, lack of exposure to sunlight, or intestinal fat absorption alteration; in adults, adolescents, and children with identified risk of vitamin D deficiency.

It can also be used as an adjunct in the prevention and treatment of bone mass loss (osteoporosis).

Do not take Devik

• if you areallergicto vitamin D3or 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 D in your blood (hypervitaminosis D).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Devik if,

• you are being treated with certain medications for heart disease (e.g., cardiac glycosides, such as digoxin).
• you have sarcoidosis (an autoimmune disease that can cause an increase in vitamin D levels in the body).
• you are being treated with medications that contain vitamin D or take foods or milk enriched with vitamin D.
• you are likely to be exposed to sunlight while using this medication.
• you are taking other supplements that contain calcium. Your doctor should monitor your calcium levels to ensure they are not too high while you are taking Devik.
• you have kidney disease or renal damage. Your doctor should monitor your calcium levels in your blood and urine.
• you have high levels of lipids (fats) in your blood
• Your doctor should monitor your calcium levels in your blood through laboratory tests if your daily intake of vitamin D3exceeds 1,000 IU for an extended period.

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. This is especially important if you are taking:

• medications used to treat heart or kidney disease, such as cardiac glycosides (e.g., digoxin) or diuretics (e.g., bendroflumetazide). When these medications are used at the same time as vitamin D3, they can cause a significant increase in calcium levels in the blood and urine.
• 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, which are medications used to treat fungal diseases). These medications can interfere with the processing of vitamin D3in the body.
• 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), as they may reduce the effect of vitamin D3.
• medications that lower cholesterol levels in the blood (e.g., cholestyramine or cholestipol).
• some weight loss medications that reduce fat absorption (e.g., orlistat).
• some laxatives (e.g., liquid paraffin).

Use of Devik with food, drinks, and alcohol

You should take Devik preferably with one of your main meals to help with the absorption of vitamin D3. You can take it alone or mix the drops with cold or lukewarm food. For more information, see section 3 “How to take Devik”.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant, consultyour doctor before using this medication.

Devik should only be taken during pregnancy and breastfeeding under the recommendation of your doctor.

Prolonged hypercalcemia should be avoided during pregnancy, as it can cause physical and mental developmental delays, aortic constriction leading to decreased blood flow, and eye disease in the child (retinopathy).

Driving and operating machinery

The information on possible effects of this medication on driving ability is limited. However, it is not expected to affect driving ability and the use of machinery.

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

The packaging contains a bottle and a dosing pipette. The bottle is closed with a child-resistant plastic cap. The dosing pipette is protected by a plastic tube that screws on.

To use the medication, shake the bottle before use and follow the instructions below:

1. To open the bottle, press the cap down and turn it at the same time. Do not throw away the plastic cap, you will use it to close it.
2. Before using the pipette, unscrew the plastic tube that protects it. Do not throw away the tube, you will use it to store it after each use.
3. Insert the pipette into the bottle to extract the contents, pressing the rubber at the top. Put the number of drops prescribed in a spoon.
4. Close the bottle with its original cap, absorb any remaining oil that may be left in the tip of the pipette with a paper towel and store the pipette in the plastic tube. Do not wash with water.
5. Make sure both are well closed. Store the bottle and the dosing pipette in the original packaging.

Devik should be taken preferably with main meals.

This medication has a taste of olive oil. Devik can be taken alone or by mixing the prescribed number of drops with a small amount of cold or lukewarm food immediately before ingestion. Make sure to take the full dose.

Use in adults

The recommended dose forthedeficiency of vitamin Dand as a complement to specific medication for bone loss (osteoporosis) is 3-4 drops (600 IU - 800 UI) per day.

For the treatment of vitamin D deficiency, the dose is usually 4 drops (800 UI) per day. Higher doses should be adjusted depending on the desired serum levels of 25-hydroxyvitamin D (25 (OH) D), the severity of the disease, and the patient's response to treatment.

The daily dose should not exceed 4,000 UI (20 drops per day).

Use in children and adolescents

For the prevention of vitamin D deficiency in children (0 to 11 months) at risk, the recommended dose is 2 drops (400 UI) per day. For prevention in children and adolescents (1 to 18 years) at risk, the recommended dose is 3-4 drops (600-800 UI) per day.

For the treatment of vitamin D deficiency in children and adolescents, the dose should be adjusted depending on the desired serum levels of 25-hydroxyvitamin D (25 (OH) D), the severity of the disease, and the patient's response to treatment. The daily dose should not exceed 1,000 UI per day for children under 1 year, 2,000 UI per day for children 1 to 10 years old, and 4,000 UI per day for adolescents 11 years and older.

Devik can be mixed with a small amount of children's food, yogurt, milk, cheese, or other dairy products. Do not add Devik to baby bottles or other containers with food that the child will not consume completely uninterrupted, in order to avoid the child not taking the full dose. Make sure the child takes the full dose. In cases of children who have passed the lactation stage, the prescribed dose should be administered with some main meal.

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

Special populations

This medication should not be used in patients with severe renal insufficiency.

Use during pregnancy and lactation

The recommended dose is 600 UI/day (3 drops). Higher doses may be needed after confirming vitamin D deficiency, but do not take more than your doctor recommends. The maximum daily dose for pregnant and lactating women is 2,000 UI/day – 10 drops.

If you take more Devik than you should

Vitamin D toxicity is characterized by hypercalcemia (high levels of calcium in the blood).The most common symptoms in case of overdose are: loss of appetite (anorexia), nausea, vomiting, diarrhea, excessive thirst, excessive urine production for 24 hours, weakness, nervousness, itching, and dehydration, and elevated levels of calcium in the blood and urine (hypercalcemia and hypercalciuria) in clinical tests.

Severe vitamin D toxicity can also cause more serious disorders (cardiac, vascular, etc.).

Moderate cases of vitamin D toxicity can be treated by simply reducing or stopping vitamin D consumption. In cases of more severe hypercalcemia, glucocorticoids or calcitonin may be administered to reduce plasma calcium levels.

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or go to a medical center immediately, or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

Stop taking the medication and call your doctor or pharmacist immediately if you or your child take more of this medication than prescribed by your doctor. If you cannot speak with your doctor, go to the nearest hospital and bring the packaging with the medication.

If you forgot to take Devik

If you forget to take a dose of Devik, take the next dose as soon as possible. Then, take the next dose at the usual time. However, if you are very close to the time of the next dose, do not take the missed dose and instead take the next dose at the usual time.

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

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

Like any other medication, Devik can produce adverse effects, although not all people may experience them. The possible adverse effects associated with the use of Devik may be:

Rarely Occurring(affect 1 in 100 people):

-Hypercalcemia (excess calcium in the blood)

-Hypercalciuria (excess calcium in the urine)

Uncommon(affect 1 in 1000 people):

-Cutaneous rash (skin eruption or hives)

-Pruritus (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 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 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.

Do not dispose of medications through drains or 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 (vitamin D3). 1 ml of oral solution (50 drops) contains 10,000 UI of colecalciferol (vitamin D3), equivalent to 0.25 mg.

1 drop contains 200 UI of colecalciferol (vitamin D3), equivalent to 0.005 mg.

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

Appearance of Devik and contents of the packaging

Devikis a clear yellowish oily liquid.

It is presented in amber glass vials of 10 ml sealed with a metal capsule. The product is accompanied by a low-density polyethylene pipette to dispense the product and a protective cover for the dispenser tube.

Holder of the marketing authorization and responsible for manufacturing

Kern Pharma, S.L.

Venus, 72 - Pol. Ind.Colón II

08228 Terrassa - Barcelona

Spain

Last review date of this leaflet: October 2021

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