Vitamin D3 Krka

Leaflet attached to the packaging: patient information

Vitamin D3 Krka, 30,000 IU, tablets
Cholecalciferol

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Vitamin D3 Krka, 30,000 IU, tablets and what is it used for
• 2. Important information before taking Vitamin D3 Krka, 30,000 IU, tablets
• 3. How to take Vitamin D3 Krka, 30,000 IU, tablets
• 4. Possible side effects
• 5. How to store Vitamin D3 Krka, 30,000 IU, tablets
• 6. Contents of the pack and other information

1.

What is Vitamin D3 Krka, 30,000 IU, tablets and what is it used for
Vitamin D3 Krka, 30,000 IU, tablets 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,
and its incorporation into bone tissue.
Vitamin D3 Krka, 30,000 IU, tablets is used for:

• Prevention of vitamin D deficiency (low or suboptimal vitamin D levels in the body) in adults with a confirmed high risk of deficiency.
• Treatment of vitamin D deficiency in adults.
• As a supplement to specific treatment of osteoporosis (a disease in which bone density is reduced, leading to an increased risk of fractures) in adults with vitamin D deficiency or confirmed high risk of vitamin D deficiency.

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 it can also be supplied
to the body with food.
Vitamin D deficiency may occur if the diet and lifestyle do not provide sufficient amounts of it or if the demand for vitamin D is increased.

2.

Important information before taking Vitamin D3 Krka, 30,000 IU, tablets
When not to take Vitamin D3 Krka, 30,000 IU, tablets

• 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 high levels of vitamin D in the blood (hypervitaminosis D),
• if the patient has high levels of calcium in the blood (hypercalcemia) or in the urine (hypercalciuria),
• if the patient has kidney stones or calcium deposits in the kidneys,
• if the patient has severe kidney dysfunction (because the body is not able to use vitamin D).

Warnings and precautions

Before starting treatment with Vitamin D3 Krka, 30,000 IU, tablets, discuss it with
your 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 (a disorder of the immune system that can affect the liver, lungs, skin, or lymph nodes), as the effect of Vitamin D3 Krka, 30,000 IU, tablets may be too strong for them.

During treatment, your doctor may recommend monitoring calcium levels in the blood and urine to ensure
that these values are not too high.
Patients with alleged hypoparathyroidism (parathyroid hormone disorders) should not take Vitamin D3 Krka,
as the demand for vitamin D is variable over time and they may be at risk of long-term overdose. Your doctor may
recommend another medicine with a similar mechanism of action.
Do not take any other medicines or dietary supplements containing vitamin D or calcium, unless your doctor recommends otherwise. In such cases, your doctor may decide to monitor calcium levels in the blood and urine.

Long-term use of doses exceeding 30,000 IU per month or weekly doses

of Vitamin D3 Krka, 30,000 IU, tablets requires 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 symptoms of kidney dysfunction occur, your doctor may decide to reduce the dose of Vitamin D3 Krka or stop treatment.

Do not exceed the recommended daily dose of the medicine, as this may lead to its
overdose.

Children and adolescents

Vitamin D3 Krka, 30,000 IU, tablets is not intended for use in children and adolescents under 18 years of age.

Vitamin D3 Krka and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or 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),
• cholestyramineor orlistat(used to lower blood lipid levels),
• laxatives(used to treat constipation), such as paraffin oil.

Be careful when taking Vitamin D3 Krka, 30,000 IU, tablets 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, monitor calcium levels in the blood and urine.
• digitalis glycosides(medicines used to treat heart diseases), e.g., digoxin: may increase the risk of heart rhythm disorders (arrhythmia). Your doctor will monitor calcium levels in the blood and urine, as well as heart function in an ECG. If necessary, also monitor the levels of heart medicines in the blood.
• medicines similar to vitamin D(e.g., calcitriol), as they should only be used together in exceptional cases and with monitoring of calcium levels in the blood.
• aluminum-containing medicines(used to treat heartburn): avoid long-term use of these medicines, as aluminum levels in the blood may increase.
• products containing high doses of calciummay increase the risk of high calcium levels in the blood. Monitoring of its levels in the blood may be required.
• products containing high doses of phosphorusmay increase the risk of low calcium levels in the blood or high phosphate levels in the blood. Monitoring of their levels in the blood may be required.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Vitamin D3 Krka, 30,000 IU, tablets is not recommended in pregnant or breastfeeding women due to its high vitamin D content.

Driving and using machines

Vitamin D3 Krka, 30,000 IU, tablets has no or negligible influence on the ability to drive and use machines.
Vitamin D3 Krka, 30,000 IU, tablets contains sucrose and sodium
If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially 'sodium-free'.

3.

How to take Vitamin D3 Krka, 30,000 IU, tablets
Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

If your doctor has not recommended otherwise, use the following dosing schedule:

• Prevention of vitamin D deficiency in adults with a confirmed high risk of deficiency:The recommended dose is 1 to 2 tablets (30,000 IU to 60,000 IU of vitamin D or 750-1500 micrograms of cholecalciferol) once a month. The dosage should be determined individually by the treating doctor, depending on the scope of necessary vitamin D supplementation.
• The dosage is 750-1500 micrograms of cholecalciferol, taken once a month.
• Treatment of vitamin D deficiency in adultsThe recommended initial dose (for 6 to 12 weeks) is 1 to 2 tablets (30,000 IU to 60,000 IU of vitamin D or 750-1500 micrograms of cholecalciferol) once a week. The dosage should be determined individually by the treating doctor, depending on the scope of necessary vitamin D supplementation.

The recommended maintenance dose is 2 tablets (60,000 IU of vitamin D or 1500 micrograms of cholecalciferol) once a month.

• As a supplement to specific treatment of osteoporosis in adults with vitamin D deficiency or confirmed high risk of vitamin D deficiency.1 tablet (30,000 IU or 750 micrograms of cholecalciferol) once a month. Ensure adequate calcium intake from the diet, if possible.

Based on specific needs, your doctor may decide to prescribe a different dose than described above. In such cases, follow your doctor's instructions. Consider national guidelines for the treatment of vitamin D deficiency.
Patient with liver function disorders and elderly patients
No dose adjustment is necessary in patients with liver disease or in elderly patients with normal kidney function.
Patient with kidney function disorders
If you have mild or moderate kidney disease, talk to your doctor before taking Vitamin D3 Krka, 30,000 IU, tablets. Patients with severe kidney disease should not take this medicine.

Method of administration

Swallow the tablet whole, with a small amount of water.
Vitamin D3 Krka, 30,000 IU, tablets can be taken with or without food.
If you take more than the recommended dose of Vitamin D3 Krka, 30,000 IU, tablets
If you accidentally take one more tablet than recommended, you will probably not experience any symptoms. If you accidentally take too many tablets, contact your doctor immediately.
Symptoms of vitamin D overdose are atypical and may include: nausea, vomiting, diarrhea, constipation, loss of appetite, weight loss, muscle weakness, 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.
If you miss a dose of Vitamin D3 Krka, 30,000 IU, tablets
If you miss a dose, take it as soon as possible, and then take the next dose at the usual time, as recommended by your 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 questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Vitamin D3 Krka, 30,000 IU, tablets can cause side effects, although not everybody gets them.
Side effects related to the use of Vitamin D3 Krka, 30,000 IU, tablets may include:
Frequency not known(frequency cannot be estimated from the available data)

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

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5.

How to store Vitamin D3 Krka, 30,000 IU, tablets
Keep this medicine out of the 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 30°C.
Store in the original blister pack to protect from light and moisture.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Vitamin D3 Krka, 30,000 IU, tablets contains

• The active substance is cholecalciferol (vitamin D). Each tablet contains 30,000 IU (equivalent to 750 micrograms) of cholecalciferol (vitamin D).
• The other ingredients (excipients) are: mannitol, sodium croscarmellose, microcrystalline cellulose (type 112), talc, colloidal anhydrous silica, magnesium stearate, sodium ascorbate, all-rac-α-tocopherol, modified corn starch, sucrose, medium-chain triglycerides. See section 2 "Vitamin D3 Krka, 30,000 IU, tablets contains sucrose and sodium".

What Vitamin D3 Krka, 30,000 IU, tablets looks like and contents of the pack
White or light yellow, oval, biconvex tablets, with the marking "4" on one side of the tablet and a wide dividing line on the other side of the tablet.
The dividing line on the tablet is only to facilitate breaking the tablet to make it easier to swallow, and not to divide it into equal doses.
Tablet dimensions: approximately 16 mm x 8 mm.
Vitamin D3 Krka, 30,000 IU, tablets is available in packs of: 2, 4, 6, 8, and 12 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

This medicine is authorized in the Member States of the European Economic Area under the following names:

To obtain 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: 22 573 75 00

Date of last revision of the leaflet: