Vitamin D3 Krka

Leaflet attached to the packaging: patient information

Vitamin D3 Krka, 500 IU, tablets

Cholecalciferol

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

• 1. What is Vitamin D3 Krka and what is it used for
• 2. Important information before taking Vitamin D3 Krka
• 3. How to take Vitamin D3 Krka
• 4. Possible side effects
• 5. How to store Vitamin D3 Krka
• 6. Contents of the packaging and other information

1. What is Vitamin D3 Krka and what is it used for

Vitamin D3 Krka contains the active substance cholecalciferol, which is a form of vitamin D that plays an essential role in the absorption and utilization of calcium in the body, as well as its incorporation into bone tissue.
Vitamin D3 Krka is used in:

• Preventing vitamin D deficiency in children and adults.
• Preventing diseases in cases where there is an increased risk of vitamin D deficiency in children and adults.
• Preventing rickets (softening of bones during growth) and osteomalacia (softening of bones) in children and adults.
• Supportive treatment in osteoporosis (a disease characterized by a decrease in bone density, which can lead to an increased risk of fractures) in adults.

The active substance of the medicine is the same as cholecalciferol that occurs naturally in humans.
Vitamin D is produced in the skin under the influence of sun exposure and can also be supplied to the body with food. Vitamin D deficiency may occur if the diet and lifestyle do not provide enough of it, or if the need for vitamin D is increased.

2. Important information before taking Vitamin D3 Krka

When not to take Vitamin D3 Krka

• if the patient is allergic to vitamin D or any of the other ingredients of this medicine (listed in section 6)
• if the patient has a high level of vitamin D in the blood (hypervitaminosis D)
• if the patient has a high level of calcium in the blood (hypercalcemia) or in the urine (hypercalciuria)
• if the patient has kidney stones or calcium deposits in the kidneys (nephrocalcinosis)
• if the patient has severe kidney dysfunction (since the body is unable to use vitamin D)
• if the patient has pseudo-hypoparathyroidism (disorders of parathyroid hormone secretion)

Warnings and precautions

Before starting treatment with Vitamin D3 Krka, the patient should discuss it with their doctor or pharmacist.
The risk of increased calcium levels in the blood or urine (hypercalcemia and hypercalciuria) may occur in patients:

• with mild to moderate kidney dysfunction,
• with a tendency to form kidney stones,
• taking thiazide diuretics (medicines that help produce urine),
• immobilized,
• suffering from sarcoidosis (an immune system disorder that can affect the liver, lungs, skin, or lymph nodes), as the action of Vitamin D3 Krka may be too strong for them.

The doctor will monitor the patient's calcium levels in the blood and urine during treatment to ensure they are not too high.
Patients with pseudo-hypoparathyroidism should not take Vitamin D3 Krka, as their need for vitamin D is different and they may be at risk of long-term overdose. The doctor may prescribe a different medicine with a similar mechanism of action.
No other medicines, dietary supplements, or products containing vitamin D or other metabolites or analogs (e.g., cholecalciferol, ergocalciferol, or calcitriol) or calcium should be taken unless the doctor advises otherwise. In such cases, the doctor will monitor the patient's calcium levels in the blood and urine.
Long-term use of doses exceeding 1000 IU per dayrequires monitoring of calcium levels in the blood and urine, as well as kidney function. This is especially important in patients who:

• take digitalis glycosides (medicines used to treat certain heart diseases),
• have an increased tendency to form kidney stones,
• are elderly. If elevated calcium levels in the blood or urine occur, or if there are signs of kidney dysfunction, the doctor may decide to reduce the dose of Vitamin D3 Krka or discontinue treatment.

Do not exceed the recommended daily doseof the medicine, as this may lead to overdose.

Children

Whole tablets of Vitamin D3 Krka should not be given to infants or children under 6 years of age. The tablet should be dissolved before administration to children in this age group. Follow the instructions provided in section 3 "How to take Vitamin D3 Krka".
Caution should be exercised when administering the medicine to children between 6 and 12 years of age, as they may not be able to swallow the whole tablet.
Consider the vitamin D content in milk and vitamin-rich foods given to children. If in doubt, consult a doctor to determine whether this type of food can be given simultaneously with Vitamin D3 Krka.

Vitamin D3 Krka and other medicines

Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines they plan to take.
The action of vitamin D may be reduced by the following medicines:

• phenytoin(used to treat epilepsy),
• barbiturates(medicines used to facilitate sleep),
• glucocorticosteroids(medicines with anti-allergic, anti-inflammatory, and immunosuppressive effects, e.g., prednisolone),
• rifampicinor isoniazid(medicines used to treat tuberculosis).

Particular caution should be exercised when taking Vitamin D3 Krka with the following medicines:

• thiazide diuretics(medicines that help produce urine), e.g., hydrochlorothiazide: may reduce calcium excretion in the urine and consequently increase its levels in the blood. During long-term treatment, calcium levels in the blood and urine should be monitored.
• digitalis glycosides(medicines used to treat heart diseases), e.g., digoxin: may increase the risk of heart rhythm disorders (arrhythmia). The doctor will monitor calcium levels in the blood and urine, as well as heart function in an ECG. If necessary, the levels of digitalis glycosides in the blood should also be monitored.
• medicines similar to vitamin D(e.g., calcitriol), as their concurrent use is only possible in exceptional cases under medical supervision and requires monitoring of calcium levels in the blood.
• medicines containing aluminum or magnesium(used to treat heartburn): prolonged use of these medicines should be avoided, as aluminum/magnesium levels in the blood may increase.
• cholestyramine, orlistat(used to lower blood lipid levels) or laxatives(used to treat constipation), such as paraffin oil: may reduce vitamin D absorption. Remember to take Vitamin D3 Krka at least 2 hours before or 4 hours after taking such medicines.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.

Pregnancy

In pregnant women, women of childbearing age, and those planning pregnancy, it is essential to have adequate vitamin D intake. Usually, in pregnant women and those planning pregnancy, the same dose can be taken as recommended for the general adult population (see section 3 "How to take Vitamin D3 Krka").
Before taking Vitamin D3 Krka, consult a doctor, as a dose change may be necessary. The doctor may decide to monitor vitamin D levels in the blood.

Breastfeeding

Vitamin D3 Krka passes into breast milk, which should be considered if the child is receiving vitamin D from other sources. No symptoms of overdose have been observed in breastfed infants whose mothers took vitamin D.

Driving and using machines

Vitamin D3 Krka has no or negligible influence on the ability to drive and use machines.

Vitamin D3 Krka contains sucrose and sodium

Sucrose

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking this medicine.

Sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to take Vitamin D3 Krka

This medicine should always be taken exactly as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.

If the doctor does not advise otherwise, the following dosing schedule should be followed:

Adults and the elderly

The recommended daily dose is two tablets of Vitamin D3 Krka 500 IU (equivalent to 1000 IU of vitamin D or 25 µg of cholecalciferol).
Without medical supervision, the medicine should not be taken for a long time or in doses higher than recommended.
Supportive treatment in osteoporosis
Treatment should be started after consulting a doctor.
Usually, the recommended daily dose is two tablets of Vitamin D3 Krka 500 IU (equivalent to 1000 IU of vitamin D or 25 µg of cholecalciferol). The attending physician may prescribe higher doses, depending on the patient's needs.

Children and adolescents

The recommended daily dose is one tablet of Vitamin D3 Krka 500 IU (equivalent to 500 IU of vitamin D or 12.5 µg of cholecalciferol). The doctor may recommend a different dosage; in such cases, follow the doctor's instructions.
The medicine should not be taken in newborns, infants, and young children without medical supervision.

Method of administration

Vitamin D3 Krka should be taken during the main meal.

Adults, the elderly, and children over 6 years of age

Tablets should be swallowed with a sufficient amount of water.
Caution should be exercised when administering the product to children between 6 and 12 years of age, as they may have problems swallowing the whole tablet.
In case of difficulties with swallowing, the tablet(s) can be dissolved on a teaspoon or in a small transparent container (e.g., a small glass) using a small amount of water (at least 10 mL). The entire contents of the teaspoon or container should be taken. Dissolving the tablet may take a little time (about 2 minutes), so this process can be accelerated by gently shaking the teaspoon or container. Be careful not to spill any of the liquid due to too vigorous shaking of the teaspoon or container. The entire contents should be drunk.
Any remaining residue left in the glass should be rinsed with a small amount of water and then drunk.

Infants, toddlers, and children under 6 years of age

The tablet should be dissolved on a spoon with water and then given to the child directly into the mouth.
Alternatively, a small transparent container (such as a glass) and a small amount of water (at least 10 mL) can be used to dissolve the tablet. Dissolving the tablet may take a little time (about 2 minutes), so this process can be accelerated by gently shaking the spoon or container. Be careful not to spill any of the liquid due to too vigorous shaking of the spoon or container. Ensure the child drinks the entire contents. Any remaining residue left in the glass should be rinsed with a small amount of water and then drunk. In this age group, it is recommended to use a spoon to administer the medicine.
Before administering the medicine to the child, ensure the tablet has completely disintegrated and formed a uniform suspension.
It is not recommended to add the dissolved tablet to the child's food (bottle with milk or finely chopped food), as it cannot be guaranteed that the entire amount of the medicine will be taken.
If the tablet is to be given with food, it should be pre-boiled and then cooled. Be careful to ensure the entire dose of the medicine is taken.

Duration of treatment

The duration of treatment depends on the patient's condition and may be long-term. Discuss the required treatment duration with a doctor.

Using a higher dose of Vitamin D3 Krka than recommended

If the patient accidentally takes one tablet more than recommended, no symptoms will occur.
If too many tablets are taken, contact a doctor immediately.
Symptoms of vitamin D overdose are atypical and may include: nausea, vomiting, diarrhea, constipation, loss of appetite, weight loss, fatigue, headache, excessive thirst, drowsiness, dizziness, increased urine output, or sweating. Calcium levels in the blood and urine may rise, and soft tissue calcification may occur, which can lead to kidney damage, blood vessel damage, and heart damage. In severe cases, heart rhythm disorders may occur, and very high calcium levels in the blood can cause coma or even death. Infants and children are more susceptible to the toxic effects of vitamin D.

Missing a dose of Vitamin D3 Krka

If a dose is missed, take it as soon as possible, and then take the next dose at the usual time, as directed by the doctor. If it is almost time for the next dose, do not take the missed dose. Wait and take the next dose at the usual time.

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

If you have any further doubts about taking this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Vitamin D3 Krka can cause side effects, although not everybody gets them.
Side effects related to the use of Vitamin D3 Krka tablets may include:
Frequency not known(frequency cannot be estimated from the available data)

• high levels of calcium in the blood (hypercalcemia) or urine (hypercalciuria)
• nausea
• abdominal pain, constipation, gas (bloating), diarrhea
• allergic reactions, such as rash, itching, or hives

Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, inform a doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Aleje Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of this medicine.

5. How to store Vitamin D3 Krka

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "EXP".
The expiry date refers to the last day of the month.
Do not store above 25°C.
Store in the original packaging to protect from light.
Medicines should not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Vitamin D3 Krka contains

• The active substance of the medicine is cholecalciferol (vitamin D). Each tablet contains 5 mg of cholecalciferol powder, which corresponds to 0.0125 mg (500 IU) of cholecalciferol (vitamin D).
• Other ingredients are: mannitol, sodium carboxymethylcellulose (type A), corn starch, microcrystalline cellulose (type 102), talc, magnesium stearate, colloidal anhydrous silica, sodium ascorbate, all-rac-α-tocopherol, modified starch, sucrose, medium-chain triglycerides. See section 2 "Vitamin D3 Krka contains sucrose and sodium".

What Vitamin D3 Krka looks like and what the packaging contains

White or almost white, round, slightly convex tablets with beveled edges, with the inscription "1 D" on one side. Tablet diameter: 6 mm.
Vitamin D3 Krka is available in packages containing: 30, 50, 60, 90, 100, or 200 tablets in a blister pack.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
For more detailed information, contact the local representative of the marketing authorization holder:
Krka - Polska Sp. z o.o.
ul. Równoległa 5
02-235 Warsaw
phone: +48 22 573 75 00

Date of last revision of the leaflet: