VITAMIN D3 KERN PHARMA 2,000 IU/ml ORAL SOLUTION

Introduction

Package Leaflet: Information for the User

Vitamin D3Kern Pharma 2,000 IU/ml Oral Solution

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.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• 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 or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What Vitamin D3 Kern Pharma is and what it is used for
2. What you need to know before taking Vitamin D3 Kern Pharma
3. How to take Vitamin D3 Kern Pharma
4. Possible side effects
5. Storage of Vitamin D3 Kern Pharma
6. Contents of the pack and further information

1. What Vitamin D3 Kern Pharma is and what it is used for

Vitamin D3 Kern Pharma oral solution 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 intestines, helping to form bone. Vitamin D deficiency is the main cause of rickets (inadequate mineralization of bones in children) and osteomalacia (inadequate mineralization of bones in adults).

Vitamin D3 Kern Pharma is indicated for the prevention and treatment of vitamin D deficiency, due to lack of intake, lack of sun exposure, or altered intestinal absorption of fats; 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) in patients with inadequate vitamin D and/or calcium intake.

2. What you need to know before taking Vitamin D3 Kern Pharma

Do not take Vitamin D3 Kern Pharma

• if you are allergic to vitamin D or any of the other components of this medication (listed in section 6),
• if you have hypercalcemia (high levels of calcium in the blood), hypercalciuria (high levels of calcium in the urine),
• if you have hypervitaminosis D (high levels of vitamin D in the blood),
• if you have kidney stones (renal calculi) or severe renal insufficiency,
• if you have renal osteodystrophy with hyperphosphatemia.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Vitamin D3 Kern Pharma if:

• you are being treated with certain medications for heart conditions (e.g., cardiac glycosides, such as digoxin),
• you have sarcoidosis (an autoimmune disease that can cause increased levels of vitamin D in the body, which can manifest with nodules, usually on the skin),
• you are being treated with medications that contain vitamin D or take foods or milk enriched with vitamin D, or plan to sunbathe while using this medication,
• you are also taking supplements that contain calcium. Your doctor should monitor your calcium levels to ensure they are not too high during your treatment with vitamin D,
• you have kidney disease. Your doctor should monitor your calcium and phosphate levels in blood and urine,
• if you have high levels of lipids (fats) in the blood,
• in case of liver disease, the absorption of the medication may be altered,
• 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.

Other medications and Vitamin D3 Kern Pharma

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medication. This is especially important if you are taking:

• medications for heart conditions or blood pressure, such as cardiac glycosides (e.g., digoxin) or thiazide diuretics;

when these medications are used at the same time as vitamin D, 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 infections). These medications can interfere with the processing of vitamin D in the body,
• the following medications, as they may interfere with the effect or absorption of vitamin D:

• antiepileptic medications (anticonvulsants), barbiturics,
• glucocorticoids (steroid hormones such as hydrocortisone or prednisolone), as they may reduce the effect of vitamin D,
• medications that lower cholesterol levels in the blood (such as cholestyramine or colestipol),
• certain medications used for weight loss by reducing fat absorption (e.g., orlistat),
• certain laxatives (such as liquid paraffin).
• tocofersolan (a form of vitamin E), increases the absorption of fat-soluble vitamins, such as vitamin D.

Using Vitamin D3 Kern Pharma with food and drinks

You should take Vitamin D3 Kern Pharma preferably with one of the 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 Vitamin D3 Kern Pharma".

Pregnancy and breastfeeding

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

Vitamin D3 Kern Pharma should be taken during pregnancy 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, aortic narrowing leading to decreased blood flow, and eye disease in the child (retinopathy).

Vitamin D3 passes into breast milk. When vitamin D3 is prescribed to a breastfeeding infant, the doctor should take into account the additional dose of vitamin D that the mother is taking.

Driving and using machines

The influence of Vitamin D3 Kern Pharma 2,000 IU/ml oral solution on the ability to drive and use machines is negligible or non-existent.

3. How to take Vitamin D3 Kern Pharma

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

Vitamin D3 Kern Pharma should be taken preferably with the main meals.

This medication has an olive oil flavor. Vitamin D3 Kern Pharma can be taken alone or by mixing the prescribed number of drops with a small amount of cold or lukewarm food immediately before ingestion. You must ensure that you take the complete dose.

The recommended doses are:

Equivalence Table:

This medication can be administered using two administration devices (dropper or dosing syringe).

To correctly administer the medication, pay special attention to the quantities indicated in the following table depending on whether you use a dropper or a dosing syringe.

Adults:

Recommended doses for vitamin D deficiencyand as a complement to specific treatment for bone loss (osteoporosis) are 9-12 drops (600 UI - 800 UI) per day.

For the treatment of vitamin D deficiency, the recommended dose is 12 drops (800 UI) per day. Higher doses should be adjusted depending on the desired serum levels of 25-hydroxycolecalciferol (25(OH)D), the patient's condition, and response to treatment.

The daily dose should not exceed 4,000 UI (60 drops per day or 2 ml 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 6 drops (400 UI) per day. For prevention in children and adolescents (from 12 months to 18 years) with an identified risk, the recommended dose is 9 drops (600 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-hydroxycolecalciferol (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 from 1 to 10 years, and 4,000 UI per day for adolescents from 11 years onwards.

In children, Vitamin D3 Kern Pharma can be mixed with a small amount of baby food, yogurt, milk, cheese, or other dairy products. Do not add Vitamin D3 Kern Pharma 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. 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 Vitamin D3 Kern Pharma for later use or in the next meal.

Special populations

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

Instructions for use

Oral route.

Bottle, 10 ml dropper bottle:

The package contains a dropper bottle with a protected cap and a metal closure.

1. Unscrew the cap of the dropper bottle to break the metal closure.
2. Place the bottle in a vertical position with the opening facing down. If the solution does not drip immediately, shake it or tap it lightly with your hand or invert it several times.
3. Administer directly or dilute with yogurt, milk, cheese, or other dairy products.

30 ml bottle:

The package contains a bottle with a child-resistant closure and a 1 ml oral syringe. Measure the prescribed ml with the dosing syringe.

1. To open the bottle, press the plastic cap down and turn it at the same time.

2. Insert the oral syringe, pressing into the perforated hole in the cap.

3. Invert the bottle and withdraw the necessary dose.

4. Administer directly or dilute with yogurt, milk, cheese, or other dairy products.

5. Absorb any remaining oil that may be left on the tip of the syringe with absorbent paper. Do not wash with water.

If you take more Vitamin D3 Kern Pharma than you should

Toxicity due to excess vitamin D 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 over 24 hours, weakness, nervousness, itching, and dehydration, and high levels of calcium in the blood and urine (hypercalcemia and hypercalciuria) in clinical analyses.

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

Moderate cases of hypervitaminosis 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 blood 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 medication and the amount ingested.

If you forget to take Vitamin D3 Kern Pharma

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

If you forget to take a dose of Vitamin D3 Kern Pharma, take the next dose as soon as possible. Subsequently, take the next dose at the usual time. However, if it is close to the time of the next dose, do not take the forgotten dose and instead take the next dose at the usual time.

If you have any other 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 will experience them.

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)

• Cutaneous rash (rash or skin eruption)
• Pruritus (itching)
• Urticaria (hives)

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for human use: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Vitamin D3 Kern Pharma

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

This medication does not require special storage conditions.

Once opened, this medication can be consumed until the expiration date shown on the packaging.

Do not use this medication after the expiration date shown on the packaging after "EXP". The expiration date is the last day of the month indicated.

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

6. Contents of the pack and further information

Composition of Vitamin D3 Kern Pharma 2,000 IU/ml oral solution drops

• The active ingredient is colecalciferol. Each ml of solution (approx. 30 drops) contains 2,000 IU of colecalciferol (vitamin D3), equivalent to 0.05 mg.

Each drop contains 66 IU of colecalciferol (vitamin D3).

• The other components are: refined olive oil and forest fruit flavor.

Appearance of the product and packaging contents

Vitamin D3 Kern Pharma is a clear, colorless to yellowish oral solution, without visible solid particles and/or precipitates.

It is presented in a 10 ml dropper bottle and a 30 ml bottle with a dosing syringe.

Marketing authorization holder and manufacturer

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Date of the last revision of this package leaflet:September 2020.

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