Vitamin D3 Kern Pharma 2.000 UI/ml oral solution

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

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

Colecalciferol

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

• Keep this leaflet as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

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. How to store Vitamin D3 Kern Pharma
6. Contents of the pack and other information

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

Vitamina D3 Kern Pharma oral solution contains colecalciferol (vitamina D3). Vitamina D3 is fat-soluble, can be found in certain foods, and is produced by the body when the skin is exposed to sunlight. Vitamina D promotes calcium absorption in the kidneys and intestine, thereby aiding bone formation. Vitamina D deficiency is the main cause of rickets (deficient bone mineralization in children) and osteomalacia (inadequate bone mineralization in adults).

Vitamina D3 Kern Pharma is indicated for the prevention and treatment of vitamina D deficiency due to inadequate dietary intake, lack of sunlight exposure, or impaired intestinal fat absorption; in adults, adolescents, and children identified at risk of vitamina D deficiency.

It may also be used as an adjunct in the prevention and treatment of bone mass loss (osteoporosis) in patients with inadequate intake of vitamina D and/or calcium.

2. What you need to know before starting to take Vitamina D3 Kern Pharma

Do not take Vitamina D3 Kern Pharma

• if you are allergic to vitamin D or to any of the other ingredients of this medicine (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 (excess vitamin D in the blood),
• if you have kidney stones (renal calculi) or severe renal failure,
• if you have renal osteodystrophy with hyperphosphatemia.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Vitamina D3 Kern Pharma if:

• you are being treated with certain medicines used for heart conditions (e.g., cardiac glycosides such as digoxin),
• you have sarcoidosis (an autoimmune disease that may increase vitamin D levels in the body, possibly manifesting with nodules, usually in the skin),
• you are taking medicines containing vitamin D, or consuming vitamin D–enriched foods or milk, or if you are exposed to sunlight while using this medicine,
• you are additionally taking supplements containing calcium. Your doctor should monitor your calcium levels to ensure they do not become too high during vitamin D treatment,
• you have kidney disease or kidney damage. Your doctor should monitor your blood and urine levels of calcium and phosphate,
• if you have high levels of lipids (fats) in the blood,
• if you have liver disease, as this may affect the absorption of the medicine,
• your doctor should monitor your blood calcium levels through laboratory tests if your daily intake of vitamin D3 exceeds 1,000 IU over a prolonged period.

Other medicines and Vitamina D3 Kern Pharma

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This is especially important if you are taking:

• medicines used to treat heart conditions or high blood pressure, such as cardiac glycosides (e.g., digoxin) or thiazide diuretics;

when these medicines are used together with vitamin D, they may cause a significant increase in calcium levels in the blood and urine,

• medicines containing vitamin D or vitamin D–rich foods, such as certain types of vitamin D–fortified milk,

• actinomycin (a medicine used in the treatment of certain types of cancer) and imidazole antifungals (e.g., clotrimazole and ketoconazole, medicines used to treat fungal infections). These medicines may interfere with the body's processing of vitamin D,

• the following medicines, as they may interfere with the effect or absorption of vitamin D:

• antiepileptic medicines (anticonvulsants), barbiturates,

• glucocorticoids (steroid hormones such as hydrocortisone or prednisolone), as they may reduce the effect of vitamin D,

• medicines that lower cholesterol levels in the blood (such as cholestyramine or colestipol),

• some medicines used for weight loss by reducing fat absorption (e.g., orlistat),

• some laxatives (such as liquid paraffin).

• tocopherol (a form of vitamin E), which increases the absorption of fat-soluble vitamins such as vitamin D.

Taking Vitamina D3 Kern Pharma with food and drink

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

Pregnancy and breastfeeding

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

Vitamina D3 Kern Pharma should only be taken during pregnancy under the recommendation of your doctor.

Vitamin D overdosage must be avoided during pregnancy, as prolonged hypercalcemia may cause delayed physical and mental development, narrowing of the aorta leading to reduced blood flow, and eye disease in the child (retinopathy).

Vitamin D3 passes into breast milk. When prescribing vitamin D3 to a breastfeeding infant, the doctor must consider the additional dose of vitamin the mother is receiving.

Driving and using machines

The influence of Vitamina D3 Kern Pharma 2,000 IU/ml oral solution on the ability to drive and use machines is none or negligible.

3. How to take Vitamina D3 Kern Pharma

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, please consult your doctor or pharmacist again.

Vitamina D3 Kern Pharma should preferably be taken with main meals.

This medicine has an olive oil flavour. Vitamina D3 Kern Pharma may 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 full dose.

Recommended doses are:

Equivalence table:

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

For correct administration of the medicine, you must pay special attention to the quantities indicated in the following table, depending on whether you are using a dropper or a dosing syringe.

Adults:

Recommended doses for vitamin D deficiency and as a supplement to specific treatment for bone loss (osteoporosis) are 9–12 drops (600 IU – 800 IU) per day.

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

The daily dose must not exceed 4,000 IU (60 drops per day or 2 mL per day).

Use in children and adolescents

For prevention of vitamin D deficiency in infants (0 to 11 months) at identified risk, the recommended dose is 6 drops (400 IU) per day. For prevention in children and adolescents (12 months to 18 years) at identified risk, the recommended dose is 9 drops (600 IU) per day.

For treatment of vitamin D deficiency in children and adolescents, the dose should be adjusted according to desired serum levels of 25-hydroxycholecalciferol (25 (OH) D), disease severity, and the patient’s response to treatment.

The daily dose must not exceed 1,000 IU per day in children under 1 year of age, 2,000 IU per day in children aged 1 to 10 years, and 4,000 IU per day in adolescents from age 11 onwards.

In children, Vitamina D3 Kern Pharma may be mixed with a small amount of infant food, yogurt, milk, cheese, or other dairy products. Do not add Vitamina D3 Kern Pharma to bottles of milk or other food containers if the child is not expected to consume the entire content at once, to avoid incomplete dosing. Ensure that the child takes the full prescribed dose. In children who have passed the breastfeeding stage, the prescribed dose should be administered with a main meal.

Do not store any product or food containing Vitamina D3 Kern Pharma for later use or for the next meal.

Special populations

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

Instructions for use

Oral use.

10 mL dropper bottle:

The package contains a dropper bottle with a cap protected by a metal seal.

1. Unscrew the cap of the dropper bottle to break the metal seal.
2. Hold the bottle upright with the opening facing downward. If the solution does not drip immediately, shake or tap it gently 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 safety cap and a 1 mL oral dosing syringe. Use the dosing syringe to measure the prescribed mL.

1. To open the bottle, press down on the plastic cap while turning it at the same time.

2. Insert the oral syringe through the pierced opening in the cap.

3. Invert the bottle and withdraw the required dose.

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

5. Absorb any remaining oil on the tip of the syringe with a tissue. Do not wash with water.

If you take more Vitamina D3 Kern 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 over a 24-hour period, weakness, nervousness, itching, dehydration, and elevated calcium levels in blood and urine (hypercalcemia and hypercalciuria) in clinical tests.

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

Cases of moderate hypervitaminosis may be managed simply by reducing or discontinuing vitamin D intake. In cases of more severe hypercalcemia, glucocorticoids or calcitonin may be administered to reduce plasma calcium levels.

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

If you forget to take Vitamina D3 Kern Pharma

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

If you forget to take a dose of Vitamina D3 Kern Pharma, take the next dose as soon as possible. Then, take the following dose at the usual time. However, if it is almost time for the next dose, do not take the missed dose and instead take the next dose at the regular time.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

Uncommon (affect 1 in every 100 people)

• Excess calcium in the blood (hypercalcemia)
• Excess calcium in urine (hypercalciuria)

Rare (affect 1 in every 1000 people)

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if these adverse effects are not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Vitamin D3 Kern Pharma

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

This medicine does not require any special storage conditions.

After opening, this medicine may be used until the expiry date stated on the packaging.

Do not use this medicine after the expiry date which is stated on the packaging after "EXP". The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Empty containers and unused medicines should be returned to the SIGRE point at your pharmacy. If you are unsure, please ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Package contents and other information

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

• The active substance 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 flavouring.

Appearance of the medicinal product and contents of the container

Vitamina D3 Kern Pharma is an oily, transparent oral solution, colorless to slightly yellow, without visible solid particles and/or precipitates.

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

Marketing Authorization Holder and Manufacturer

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Date of the most recent revision of this package leaflet: September 2020.

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