Vitamin d3 krka

Package leaflet: Information for the patient

Vitamin D3 Krka, 1000 IU, tablets
Cholecalciferolum
Please read this leaflet carefully before taking this medicine because it contains important information for you.
This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor or pharmacist.

• Keep this leaflet so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement or if you feel worse, you should consult your doctor.

Table of contents

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

Vitamin D3 Krka contains the active substance cholecalciferol, a form of vitamin D that plays an important role in the absorption and utilization of calcium in the body, as well as in 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 disorders in cases of increased risk of vitamin D deficiency in children aged 6 years and older and adults.
• Prevention of rickets (impaired bone mineralization during growth) and osteomalacia (bone softening) in children aged 6 years and older and adults.
• Adjunctive treatment in osteoporosis (a disease characterized by reduced bone density, leading to an increased risk of fractures) in adults.

The active substance in this medicine is identical to the cholecalciferol naturally present in humans.
Vitamin D is produced in the skin upon exposure to sunlight and can also be supplied to the body through diet.
Vitamin D deficiency may occur when dietary intake and lifestyle do not provide sufficient amounts, or when the body's requirement for vitamin D is increased.

2. Important information before using Vitamin D3 Krka

When not to use 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 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 (nephrocalcinosis)
• if the patient has severe kidney function impairment (because the body cannot utilise vitamin D)
• if the patient has pseudohypoparathyroidism (a disorder of hormone secretion from the parathyroid glands)

Warnings and precautions
Before starting treatment with Vitamin D3 Krka, 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 function impairment,
• prone to developing calcium kidney stones,
• taking thiazide diuretics (medicines that promote urine production),
• immobilised,
• suffering from sarcoidosis (an immune system disorder that may affect the liver, lungs, skin or lymph nodes), as the effect of Vitamin D3 Krka may be too strong for them.

Your doctor will monitor calcium levels in your blood and urine during treatment to ensure these values are not too high.
Patients with pseudohypoparathyroidism (parathyroid hormone secretion disorders) should not take Vitamin D3 Krka, as their requirement for vitamin D is different and they may be at risk of long-term overdose. Your doctor may prescribe another medicine with a similar mechanism of action.
Do not take any other medicines, dietary supplements or other products containing vitamin D or other metabolites or analogues (e.g. cholecalciferol, ergocalciferol or calcitriol) or calcium, unless otherwise advised by your doctor. In such cases, your doctor will monitor calcium levels in blood and urine.
Long-term use of doses exceeding 1000 IU per day requires monitoring of calcium levels in blood and urine and kidney function. This is particularly important for patients who:

• are taking cardiac glycosides (medicines used in the treatment of certain heart diseases),
• have an increased tendency to form kidney stones,
• are elderly.

If elevated calcium levels in blood or urine or symptoms of kidney dysfunction occur, your doctor may decide to reduce the dose of Vitamin D3 Krka or discontinue treatment.
Do not exceed the recommended daily dose, 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 appropriate dose adjustment.
Exercise caution when administering the medicine to children aged 6 to 12 years, as they may not be able to swallow the whole tablet.

Vitamin D3 Krka and other medicines
Tell your doctor or pharmacist about all medicines you are currently 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 help sleep),
• glucocorticoids (medicines with antiallergic, anti-inflammatory and immunosuppressive effects, e.g. prednisolone),
• rifampicin or isoniazid (medicines used to treat tuberculosis).

Exercise particular caution when taking Vitamin D3 Krka together with the following medicines:

• thiazide diuretics (medicines that promote urine production), e.g. hydrochlorothiazide: may reduce calcium excretion in urine and consequently increase its blood concentration. Calcium levels in blood and urine should be monitored during long-term treatment.
• cardiac 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 blood and urine and heart function via ECG. If necessary, blood levels of cardiac glycosides should also be monitored.
• medicines similar to vitamin D (e.g. calcitriol), as their concomitant use is possible only in exceptional cases under medical supervision and requires monitoring of blood calcium levels.
• medicines containing aluminium or magnesium (used to treat heartburn): avoid long-term use of these medicines, as blood levels of aluminium/magnesium may increase.
• cholestyramine, orlistat (used to lower blood lipid levels) or laxatives (used to treat constipation), such as paraffin oil: may reduce the absorption of vitamin D. Remember to take Vitamin D3 Krka at least 2 hours before or 4 hours after taking such medicines.

Pregnancy and breastfeeding
If you are pregnant, breastfeeding, think you may be pregnant or are planning to have a baby, consult your doctor or pharmacist before using this medicine.

Pregnancy
Adequate vitamin D intake is important for women who are pregnant or planning pregnancy. Usually, women who are pregnant or planning pregnancy can take the same dose as recommended for the general adult population (see section 3 "How to use Vitamin D3 Krka"). Before taking Vitamin D3 Krka, consult your doctor, as a dose adjustment may be necessary. Your doctor may decide to monitor vitamin D levels in blood.

Breastfeeding
Vitamin D3 Krka passes into breast milk, which should be considered if the infant 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 effect or a negligible effect on the ability to drive and operate machinery.

Vitamin D3 Krka contains sucrose and sodium
Sucrose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

Sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Vitamin D3 Krka

This medicine should always be used exactly as directed by a physician or pharmacist. If in doubt,
consult a physician or pharmacist.
If the physician has not advised otherwise, the following dosing regimen should be followed:
Adults and elderly patients
The recommended daily dose is one tablet of Vitamin D3 Krka 1000 IU (corresponding to 1000 IU
of vitamin D or 25 µg of cholecalciferol).
This medicine should not be used long-term or in doses higher than recommended without medical
supervision.
Supportive treatment in osteoporosis
Treatment should be initiated after consultation with a physician.
The usual recommended daily dose is 1 tablet of Vitamin D3 Krka 1000 IU (corresponding to 1000 IU
of vitamin D or 25 µg of cholecalciferol). The treating physician may prescribe higher doses,
depending on the patient's needs.
Children aged 6 years and older and adolescents
The recommended dose is one tablet of Vitamin D3 Krka 1000 IU every other day (corresponding to
500 IU of vitamin D or 12.5 µg of cholecalciferol per day). The physician may recommend a different
dose; in such a case, follow the physician's instructions.
Method of administration
Vitamin D3 Krka tablets should be taken during a main meal.
The tablets should be swallowed with a sufficient amount of water.
Caution should be exercised when administering this medicinal product to children aged 6 to 12
years due to the possibility of difficulty swallowing the whole tablet.
If swallowing is difficult, the tablet may be dissolved on a teaspoon or in a small transparent
container (e.g. a small glass) using a small amount of water (not less than 10 mL). The entire
contents of the spoon or container should be consumed. Dissolving the tablet may take some time
(approximately 2 minutes), so the process can be accelerated by gently shaking the spoon or
container. Care should be taken not to spill any of the liquid due to excessive shaking. The entire
contents must be consumed.
Any residue left 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 prolonged. Discuss with
the physician the required duration of treatment.
Use of a higher than recommended dose of Vitamin D3 Krka
If a patient accidentally takes one tablet too many, no symptoms will occur.
If an excessive number of tablets is taken, contact a physician immediately.
Symptoms of vitamin D overdose are uncommon and may include: nausea, vomiting, diarrhoea,
constipation, loss of appetite, weight loss, fatigue, headache, excessive thirst, drowsiness, dizziness,
increased urine output, or sweating. Blood and urine calcium levels may increase, and soft tissue
calcification may occur, potentially leading to kidney, blood vessel, or heart damage. In severe
cases, cardiac arrhythmias may develop, and very high calcium levels in the blood may lead to
coma or even death. Infants and children are more susceptible to the toxic effects of vitamin D.
Missed dose of Vitamin D3 Krka
If a dose is missed, take it as soon as possible, then take the next dose at the usual time, according
to the physician's instructions. If the next dose is due soon, 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 there are any further doubts regarding the use of this medicine, consult a physician or
pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Adverse reactions associated with the use of Vitamin D3 Krka tablets may include:
Frequency unknown (frequency cannot be estimated from the available data)

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

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: + 48 22 49 21 301
Faks: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Vitamin D3 Krka

Keep the 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 stated 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 your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Vitamin D3 Krka contains

• The active substance is cholecalciferol (vitamin D). Each tablet contains 10 mg of cholecalciferol powder, equivalent to 0.025 mg (1000 IU) of cholecalciferol (vitamin D).
• The other ingredients are: mannitol, sodium carboxymethyl starch (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 contents of the pack
White or almost white, round, biconvex tablets with bevelled edges,
imprinted with the code “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 blister packs.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
For more detailed information, please contact the local representative of the Marketing Authorisation Holder:
Krka - Polska Sp. z o.o.
Równoległa 5 Street
02-235 Warsaw, Poland
telephone: +48 22 573 75 00