Prospect: Information for the User

Vitamin D3Kern Pharma 2.000 UI/ml Oral Solution

Colecalciferol

Read this prospect carefully before starting to take this medication, because

it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed to you alone, and you must not give it to other people, 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 prospect. See section 4.

Vitamin D3Kern Pharma oral solution 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.The deficiency of vitamin D is the main cause of rickets (deficient mineralization of bones in children) and osteomalacia (inadequate mineralization of bones in adults).

Vitamin D3Kern Pharma 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 adjuvant in the prevention and treatment of bone mass loss (osteoporosis) in patients with inadequate intake of vitamin D and/or calcium.

Do not take Vitamin D3Kern 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 (elevated levels of calcium in the blood), hypercalciuria (elevated levels of calcium in the urine),
• if you have a vitamin D overdose (elevated levels of vitamin D in the blood),
• if you have kidney stones (renal calculi) or severe kidney insufficiency,
• if you have renal osteodystrophy with hyperphosphatemia.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Vitamin D3Kern Pharma 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 elevated levels of vitamin D in the body, which can manifest as skin nodules),
• you are being treated with medications that contain vitamin D or take foods or milk enriched with vitamin D, or are going to take the sun 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 while you are taking vitamin D,
• you have kidney disease or renal damage. Your doctor should monitor your calcium and phosphate levels in the blood and urine,
• if you have elevated 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 calcium levels through laboratory tests if your daily intake of vitamin D3exceeds 1,000 IU for a prolonged period.

Other medications and Vitamin D3Kern Pharma

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 indicated for the treatment of heart disease or for hypertension, 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 diseases caused by fungi). 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), barbiturates,
• glucocorticoids (steroid hormones such as hydrocortisone or prednisolone), as they may reduce the effect of vitamin D,
• medications that reduce cholesterol levels in the blood (such as cholestyramine or colestipol),
• some medications used to lose weight by reducing fat absorption (e.g., orlistat),
• some laxatives (such as liquid paraffin).
• tocopherol succinate (a form of vitamin E), increases the absorption of fat-soluble vitamins, such as vitamin D.

Use of Vitamin D3 Kern Pharma with foods and beverages

You should take Vitamin D3Kern Pharma preferably with one of the main meals to help absorb the vitamin D3. You can take it alone or by mixing the drops with cold or lukewarm food. For more information, see section 3 “How to take Vitamin D3Kern Pharma”.

Pregnancy and breastfeeding

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

Vitamin D3Kern Pharma should be taken during pregnancy only under the recommendation of your doctor.

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

Vitamin D3passes to breast milk. When prescribing vitamin D3to a breastfeeding infant, the doctor should take into account the additional dose of vitamin that the mother is taking.

Driving and operating machinery

The influence of Vitamin D3Kern Pharma 2,000 IU/ml oral solution on the ability to drive and operate machinery is negligible or insignificant.

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

Vitamin D3Kern Pharma should be taken preferably with main meals.

This medication has a taste of olive oil. Vitamin D3Kern 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. Make sure to take the complete dose.

Recommended doses are:

Equivalence table:

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

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

Adults:

Recommended doses for vitamin D deficiency and as a complement to specific treatment for bone loss (osteoporosis) is 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-hydroxyvitamin D (25 (OH) D), the patient's condition, and the patient's 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 (0-11 months) at risk, the recommended dose is 6 drops (400 UI) per day. For prevention in children and adolescents (12 months-18 years) at 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-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 1-10 years, and 4,000 UI per day for adolescents 11 years and older.

Vitamin D3Kern Pharma can be mixed with a small amount of children's food, yogurt, milk, cheese, or other dairy products. Do not add Vitamin D3Kern Pharma 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 complete dose. Make sure the child takes the complete 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 Vitamin D3Kern Pharma for later use or for the next meal.

Special populations

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

Usage instructions

Oral route.

Bottle, 10 ml dropper:

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

1. Unscrew the dropper cap 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 gently tap it with your hand or invert it several times.

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

Bottle of 30 ml:

The package contains a bottle with a child-resistant cap and an oral syringe of 1 ml. Measure the prescribed ml with the oral syringe.

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

2.- Insert the oral syringe, pressing it into the perforated cap.

3.- Invert the bottle and remove the required dose.

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

5.- Absorb the remaining oil that may be left in the syringe tip with a paper towel. Do not wash with water.

If you take more Vitamin D3Kern Pharma 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.

Vitamin D overdose can also cause more serious disorders (cardiac, vascular, etc.).

Moderate vitamin D toxicity cases can be treated by simply reducing or stopping vitamin D consumption. 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 medication and the amount ingested.

If you forget to take Vitamin D3Kern Pharma

Do not take a double dose to compensate for the missed doses.

If you forget to take a dose of Vitamin D3Kern Pharma, take the next dose as soon as possible. Then, take the next dose at the usual time. However, if you find yourself 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.

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

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Infrequent(affect 1 in 100 people)

- Hypercalcemia (excess calcium in the blood)

- Hypercalciuria (excess calcium in the urine)

Rare(affect 1 in 1000 people)

- Cutaneous rash (hives or skin eruption)

- Pruritus (itching)

- Urticaria (hives)

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is an 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:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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 up to the expiration date that appears on the packaging.

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.

Vitamin D Composition3Kern Pharma 2,000 UI/ml oral drops in solution

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

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

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

Product appearance and packaging content

Vitamin D3Kern Pharma is a transparent, colorless to yellowish, oily oral solution without visible solid particles or precipitates.

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

Marketing authorization holder and responsible manufacturer

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Last review date of this leaflet:September 2020.

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