DEVIK 10,000 IU/mL ORAL DROPS IN SOLUTION

Introduction

Package Leaflet: Information for the User

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

Colecalciferol (Vitamin D3)

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this 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 further information

1. What is Devik and what is it used for

Devik contains colecalciferol (Vitamin D3). Vitamin D3, which is fat-soluble, can be found in some foods and is produced by the body when the skin is exposed to sunlight. Vitamin D promotes calcium absorption in the kidneys and intestine, helping to form bone. Vitamin D deficiency is the main cause of rickets (mineralization deficiency of bones in children) and osteomalacia (inadequate mineralization of bones in adults).

Devik is indicated for the prevention and treatment of vitamin D deficiency, due to lack of intake, lack of exposure to sunlight, or alteration of intestinal fat absorption; in adults, adolescents, and children with an identified risk of vitamin D deficiency.

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

2. What you need to know before you take Devik

Do not take Devik

• if you are allergic to Vitamin D3 or any of the other components of this medicine (listed in section 6).
• if you have high levels of calcium in the blood (hypercalcemia) or in urine (hypercalciuria).
• if you have kidney stones (renal calculi) or severe renal insufficiency.
• if you have high levels of vitamin D in the 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 diseases (e.g., cardiac glycosides, such as digoxin).
• you have sarcoidosis (an autoimmune disease that can cause increased levels of vitamin D 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 sunbathe while using this medicine.
• you take other supplements that contain calcium. Your doctor should monitor your calcium levels to ensure they are not too high during your treatment with Devik.
• you have kidney disease. Your doctor should monitor your blood and urine calcium levels.
• if you have high levels of lipids (fats) in the blood.
• your doctor should monitor your blood calcium levels through laboratory tests if your daily intake of vitamin D3 exceeds 1,000 IU for a prolonged period.

Using Devik with Other Medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines. This is especially important if you are taking:

• medicines used to treat heart or kidney diseases, such as cardiac glycosides (e.g., digoxin) or diuretics (e.g., bendroflumethiazide). When these medicines are used at the same time as vitamin D3, they can cause a significant increase in calcium levels in the blood and urine.
• medicines that contain vitamin D or foods rich in vitamin D, such as some types of milk enriched with vitamin D.
• actinomycin (a medicine used to treat certain types of cancer) and imidazole antifungals (e.g., clotrimazole and ketoconazole, which are medicines used to treat fungal diseases). These medicines can interfere with the processing of vitamin D3 in the body.
• the following medicines, as they may interfere with the effect or absorption of vitamin D3:

• antiepileptic medicines (anticonvulsants), barbiturics.
• glucocorticoids (steroid hormones such as hydrocortisone or prednisolone), as they may reduce the effect of vitamin D3.
• medicines that reduce cholesterol levels in the blood (such as cholestyramine or colestipol).
• certain medicines used to lose weight by reducing fat absorption (e.g., orlistat).
• certain laxatives (such as liquid paraffin).

Using Devik with Food, Drinks, and Alcohol

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

Pregnancy, Breast-feeding, and Fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.

Devik should be taken during pregnancy and breast-feeding only under the recommendation of your doctor.

Overdoses of vitamin D should be avoided during pregnancy, as prolonged hypercalcemia can cause physical and mental developmental delays, narrowing of the aorta leading to decreased blood flow, and eye disease in the child (retinopathy).

Driving and Using Machines

Information on the possible effects of this medicine on the ability to drive is limited. However, it is not expected to affect the ability to drive and use machines.

3. How to Take Devik

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

The pack 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 medicine, shake the bottle before use and follow these instructions:

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 plastic tube, you will use it to store the pipette after each use.
3. Insert the pipette into the bottle to extract the contents, pressing the rubber bulb at the top end. Place the prescribed number of drops in a spoon.
4. Close the bottle with its original cap, absorb any remaining oil that may be on 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 pack.

Devik should be taken preferably with the main meals.

This medicine has an olive oil flavor. Devik can be taken alone or mixed with a small amount of cold or lukewarm food immediately before ingestion. You must ensure that you take the complete dose.

Use in Adults

Recommended doses for vitamin D deficiency and as a complement to specific medication for bone loss (osteoporosis) are 3-4 drops (600 IU - 800 IU) per day.

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

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

Use in Children and Adolescents

For the prevention of vitamin D deficiency in children (from 0 to 11 months) with an identified risk, the recommended dose is 2 drops (400 IU) per day. For prevention in children and adolescents (from 1 to 18 years) with an identified risk, the recommended dose is 3-4 drops (600-800 IU) 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-hydroxycolecalciferol (25(OH)D), the severity of the disease, and the patient's response to treatment. The daily dose should not exceed 1,000 IU per day for children under 1 year, 2,000 IU per day for children from 1 to 10 years, and 4,000 IU per day for adolescents from 11 years.

In children, Devik can be mixed with a small amount of baby 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 and continuously, to avoid the child not taking the complete dose. You must ensure that the child takes the complete dose. In cases of children who have passed the breastfeeding stage, the prescribed dose should be administered with some main meal.

Do not store any product or food that contains Devik for later use or in the next meal.

Special Populations

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

Use During Pregnancy and Breast-feeding

The recommended dose is 600 IU/day (3 drops). Higher doses may be needed after confirmation of vitamin D deficiency, but do not take more than your doctor recommends. The maximum daily dose for pregnant and breast-feeding women is 2,000 IU/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 frequent 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 high levels of calcium in the blood and urine (hypercalcemia and hypercalciuria) in clinical tests.

Hypervitaminosis D can also cause more serious disorders (cardiac, vascular, among others).

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

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

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

If You Forget 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 it is close to the time of the next dose, do not take the missed dose and 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 medicine, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medicines, Devik can cause side effects, although not everybody gets them. The possible side effects associated with the use of Devik may be:

Uncommon(affect 1 in 100 people):

-Excess calcium in the blood (hypercalcemia)

-Excess calcium in the urine (hypercalciuria)

Rare(affect 1 in 1,000 people):

-Skin rash (rash or skin eruption)

-Itching (pruritus)

-Urticaria

Reporting of Side Effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this 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 special storage conditions.

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the Pack and Further Information

Composition of Devik

The active substance is colecalciferol (Vitamin D3). 1 ml of oral solution (50 drops) contains 10,000 IU of colecalciferol (Vitamin D3), equivalent to 0.25 mg.

1 drop contains 200 IU of colecalciferol (Vitamin D3), equivalent to 0.005 mg.

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

Appearance of Devik and Contents of the Pack

Devik is a clear, light yellow, oily liquid.

It is presented in 10 ml amber glass bottles, sealed with a metal cap. The product comes with a low-density polyethylene dosing pipette to dispense the product and a protective cover for the dispensing tube.

Marketing Authorization Holder and Manufacturer

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Date of Last Revision of this Leaflet: October 2021

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