VITAMIN D3 1000 IU Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. Vitamin D3 Krka, 1000 IU, tablets
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
3. What is Vitamin D3 Krka and what is it used for
4. Important information before taking Vitamin D3 Krka
   1. When not to take Vitamin D3 Krka
   2. Warnings and precautions
   3. Children
   4. Vitamin D3 Krka and other medicines
   5. Pregnancy and breastfeeding
   6. Pregnancy
   7. Breastfeeding
   8. Driving and using machines
   9. Vitamin D3 Krka contains sucrose and sodium
   10. Sucrose
   11. Sodium
5. How to take Vitamin D3 Krka
   1. If the doctor does not recommend otherwise, the following dosing schedule should be followed:
   2. Adults and the elderly
   3. Children aged 6 years and older and adolescents
   4. Method of administration
   5. Duration of treatment
   6. Taking a higher dose of Vitamin D3 Krka than recommended
   7. Missing a dose of Vitamin D3 Krka
6. Possible side effects
   1. Reporting side effects
7. How to store Vitamin D3 Krka
8. Contents of the pack and other information
   1. What Vitamin D3 Krka contains
   2. What Vitamin D3 Krka looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. Date of last revision of the leaflet:

Leaflet attached to the packaging: patient information

Vitamin D3 Krka, 1000 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, you may need to read it again.
• 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 pack 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 for:

• Prevention of vitamin D deficiency in children aged 6 years and older and adults.
• Prevention of diseases in cases where there is an increased risk of vitamin D deficiency in children aged 6 years and older and adults.
• Prevention of rickets (softening of bones during growth) and osteomalacia (softening of bones) in children aged 6 years and older 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.

A deficiency of vitamin D may occur when the diet and lifestyle do not provide sufficient amounts of it, or when 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 utilize vitamin D)
• if the patient has pseudohypoparathyroidism (a disorder 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 effect 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 pseudohypoparathyroidism 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 recommends 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 cardiac glycosides (medicines used to treat certain heart diseases)
• have an increased tendency to form kidney stones
• are elderly

In case of elevated calcium levels in the blood or urine, or signs of kidney dysfunction, the doctor may decide to reduce the dose of Vitamin D3 Krka or discontinue treatment.

The recommended daily dose of the medicine should not be exceeded, as this may lead to overdose.

Children

Vitamin D3 Krka should not be used in infants and children under 6 years of age, as this pharmaceutical form does not allow for adequate dose adjustment.

Caution should be exercised when administering the medicine to children aged 6 to 12 years, as they may have difficulty swallowing the tablet whole.

Vitamin D3 Krka and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

The effect 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)

Special 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
• cardiac glycosides(medicines used to treat heart diseases), e.g., digoxin: may increase the risk of heart rhythm disorders (arrhythmia)
• 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): should be avoided for long-term use, 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

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 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, the patient should consult their doctor, as a dose adjustment 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 taken into account if the infant is receiving vitamin D from other sources.

No symptoms of overdose have been observed in breastfed infants whose mothers were taking 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 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 the doctor or pharmacist.

In case of doubt, the patient should consult their doctor or pharmacist.

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

Adults and the elderly

The recommended daily dose is one Vitamin D3 Krka 1000 IU tablet (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 one Vitamin D3 Krka 1000 IU tablet (equivalent to 1000 IU of vitamin D or 25 µg of cholecalciferol).

The doctor may prescribe higher doses, depending on the patient's needs.

Children aged 6 years and older and adolescents

The recommended dose is one Vitamin D3 Krka 1000 IU tablet every other day (equivalent to 500 IU of vitamin D or 12.5 µg of cholecalciferol per day).

The doctor may recommend a different dosing schedule; in such cases, the patient should follow the doctor's recommendations.

Method of administration

Vitamin D3 Krka should be taken during the main meal.

The tablets should be swallowed with a sufficient amount of water.

Caution should be exercised when administering the medicine to children aged 6 to 12 years, as they may have difficulty swallowing the tablet whole.

If there are difficulties with swallowing, the tablet can be dissolved in a teaspoon or a small transparent container (e.g., a small glass) with 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 some time (about 2 minutes), and this process can be accelerated by gently shaking the teaspoon or container.

However, caution should be exercised not to spill any of the liquid due to excessive shaking of the teaspoon or container.

The entire contents should be consumed.

Any remaining residue in the glass should be rinsed with a small amount of water and then consumed.

Duration of treatment

The duration of treatment depends on the patient's condition and may be long-term.

The patient should discuss the required treatment duration with their doctor.

Taking a higher dose of Vitamin D3 Krka than recommended

If the patient accidentally takes one tablet more than recommended, no symptoms will occur.

In case of taking too many tablets, the patient should contact their 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 increase, 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

In case of missing a dose, the patient should take it as soon as possible and then take the next dose at the usual time, as recommended by the doctor.

If it is almost time for the next dose, the patient should not take the missed dose.

The patient should wait and take the next dose at the usual time.

The patient should not take a double dose to make up for the missed dose.

In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Vitamin D3 Krka can cause side effects, although not everybody gets them.

Side effects associated with Vitamin D3 Krka may include:

Frequency not known(frequency cannot be estimated from the available data)

• high calcium levels 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 the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should inform their 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:

Jerozolimskie Avenue 181C, 02-222 Warsaw

Tel.: +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.

By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Vitamin D3 Krka

The medicine should be stored out of sight and reach of children.

This medicine should not be taken after the expiry date stated on the packaging after "EXP".

The expiry date refers to the last day of the month stated.

The medicine should not be stored above 25°C.

The medicine should be stored in the original packaging to protect it from light.

Medicines should not be disposed of via wastewater or household waste.

The patient should ask their pharmacist how to dispose of medicines that are no longer needed.

This will help protect the environment.

6. Contents of the pack and other information

What Vitamin D3 Krka contains

• The active substance of the medicine is cholecalciferol (vitamin D3). Each tablet contains 10 mg of cholecalciferol powder, equivalent to 0.025 mg (1000 IU) of cholecalciferol (vitamin D3).
• The other ingredients are: mannitol, sodium carboxymethylcellulose (type A), corn starch, microcrystalline cellulose (type 102), talc, magnesium stearate, colloidal silica anhydrous, 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 contents of the pack

White or almost white, round, biconvex tablets with beveled edges, with the inscription "2 D" on one side.

Tablet diameter: 8 mm.

Vitamin D3 Krka is available in packs containing: 30, 50, 60, 90, 100, or 200 tablets in blisters.

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 information, the patient should contact the local representative of the marketing authorization holder:

Krka - Polska Sp. z o.o.

Równoległa 5

02-235 Warsaw

Phone: +48 22 573 75 00

Date of last revision of the leaflet: