Vitamin d3 krka

Package leaflet: Information for the patient

Vitamin D3 Krka, 30,000 IU, tablets
Cholecalciferolum
Please read all of this leaflet carefully before 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 further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Vitamin D3 Krka, 30,000 IU, tablets is and what it is 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 Vitamin D3 Krka, 30,000 IU, tablets is and what it is used for

Vitamin D3 Krka, 30,000 IU, tablets contains the active substance cholecalciferol, which is a form of vitamin D that plays an important role in calcium absorption and utilization in the body, as well as in the incorporation of calcium 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 identified as being at high risk of deficiency.
• Treatment of vitamin D deficiency in adults.
• As an adjunct to specific treatment of osteoporosis (a disease characterized by reduced bone density, leading to an increased risk of fractures) in adults with vitamin D deficiency or at high risk of vitamin D deficiency.

The active substance in this medicine is identical to the cholecalciferol naturally produced in the human body.
Vitamin D is synthesized in the skin upon exposure to sunlight and can also be supplied through the diet.
Vitamin D deficiency may occur when diet and lifestyle do not provide sufficient amounts, or when the body's requirement 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 (hypercalcaemia) or in the urine (hypercalciuria),
• if the patient has kidney stones or calcium deposits in the kidneys,
• if the patient has severe kidney function impairment (because the body is unable to utilise vitamin D).

Warnings and precautions
Before starting treatment with Vitamin D3 Krka, 30,000 IU, tablets, discuss this with your
doctor or pharmacist.
The risk of increased calcium levels in the blood or urine (hypercalcaemia and hypercalciuria) may
occur in patients:

• with mild to moderate kidney function impairment,
• with a tendency to form calcium kidney stones,
• taking thiazide diuretics (medicines that promote urine production),
• who are immobilised,
• suffering from sarcoidosis (an immune system disorder that may affect the liver, lungs, skin or lymph nodes), because 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 blood and urine to ensure
these values are not too high.
Patients with pseudohypoparathyroidism (disorders of parathyroid hormone secretion) should not
take Vitamin D3 Krka, because their vitamin D requirements vary over time and they may be at risk of
long-term overdose. Your doctor may recommend another medicine with a similar mode of action.
Do not take any other medicines or dietary supplements containing vitamin D or calcium unless
your doctor advises otherwise. In such cases, your doctor may decide to monitor calcium levels in
blood and urine.
Long-term use of doses exceeding 30,000 IU per month or weekly dosing of Vitamin D3 Krka,
30,000 IU, tablets requires monitoring of calcium levels in blood and urine, as well as kidney function.
This is particularly important for patients who:

• are taking cardiac glycosides (medicines used to treat certain heart conditions),
• have an increased tendency to develop kidney stones,
• are elderly.
  If elevated calcium levels in blood or urine occur, or if symptoms of kidney dysfunction appear, 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 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 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),
• glucocorticosteroids (medicines with antiallergic, anti-inflammatory and immunosuppressive effects, e.g. prednisolone),
• rifampicin or isoniazid (medicines used to treat tuberculosis),
• cholestyramine or orlistat (used to lower blood lipid levels),
• laxatives (used to treat constipation), such as liquid paraffin.

Exercise particular caution when taking Vitamin D3 Krka, 30,000 IU, tablets 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. During long-term treatment, calcium levels in blood and urine should be monitored.
• cardiac glycosides (medicines used to treat heart conditions), e.g. digoxin: may increase the risk of heart rhythm disorders (arrhythmia). Your doctor will monitor calcium levels in blood and urine, as well as heart function via ECG. If necessary, blood levels of cardiac glycosides may also be monitored.
• medicines similar to vitamin D (e.g. calcitriol), because they should only be used together in exceptional cases and calcium levels in blood must be monitored.
• medicines containing aluminium (used to treat heartburn): avoid long-term use, as blood aluminium levels may increase.
• products containing high doses of calcium may increase the risk of high blood calcium levels. Monitoring of blood calcium levels may be required.
• products containing high doses of phosphorus may increase the risk of low blood calcium levels or high blood phosphate levels. Monitoring of their blood concentrations may be required.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become
pregnant, she should consult her doctor or pharmacist before using this medicine.
Vitamin D3 Krka, 30,000 IU, tablets is not recommended for use in pregnant or breastfeeding women due to its high vitamin D content.
Driving and operating machinery
Vitamin D3 Krka, 30,000 IU, tablets has no effect or negligible effect on the ability to drive and operate machinery.
Vitamin D3 Krka, 30,000 IU, tablets contains sucrose and sodium
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should
consult a doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered “sodium-free”.

3. How to take Vitamin D3 Krka 30,000 IU tablets

This medicine should always be taken as directed by your doctor or pharmacist. If you have any
doubts, consult your doctor or pharmacist.
If your doctor has not advised otherwise, the following dosing regimen should be followed:

• Prevention of vitamin D deficiency in adults at confirmed high risk of deficiency: The recommended dose is 1 to 2 tablets (30,000 IU to 60,000 IU vitamin D or 750–1500 micrograms cholecalciferol) taken once a month. Dosing should be individually determined by the treating physician depending on the required extent of vitamin D supplementation.

• Treatment of vitamin D deficiency in adults: The recommended initial dose (for 6 to 12 weeks) is 1 to 2 tablets (30,000 IU to 60,000 IU vitamin D or 750–1500 micrograms cholecalciferol) taken once a week. Dosing should be individually determined by the treating physician depending on
  the required extent of vitamin D supplementation.
  The recommended maintenance treatment dose is 2 tablets (60,000 IU vitamin D or
  1500 micrograms cholecalciferol) taken once a month.

• As an adjunct to specific treatment of osteoporosis in adults with vitamin D deficiency or at confirmed high risk of vitamin D deficiency: 1 tablet (30,000 IU or 750 micrograms cholecalciferol) taken once a month. Adequate calcium intake should be ensured, preferably through diet.

Depending on individual needs, your doctor may decide to prescribe a dose different from that
described above. In such a case, follow your doctor's instructions. National guidelines for the
treatment of vitamin D deficiency should be taken into account.
Patients with hepatic impairment and elderly patients
Dose adjustment is not necessary in patients with liver disease or in elderly patients with normal
renal function.
Patients with renal impairment
If the patient has mild or moderate kidney disease, consult a doctor before taking Vitamin D3 Krka 30,000 IU tablets. Patients with severe kidney disease should not take this medicine.
Method of administration
The tablet should be swallowed whole with a small amount of water.
Vitamin D3 Krka 30,000 IU tablets may be taken with or without food.
Taking more than the recommended dose of Vitamin D3 Krka 30,000 IU tablets
If a patient accidentally takes one extra tablet, symptoms are unlikely to occur. In case of accidental
intake of too many tablets, contact a doctor immediately.
Symptoms of vitamin D overdose are nonspecific and may include: nausea, vomiting, diarrhoea,
constipation, loss of appetite, weight loss, muscle weakness, fatigue, headache, excessive thirst,
drowsiness, dizziness, increased urine output, or sweating. Serum and urinary calcium levels may
increase, and soft tissue calcification may occur, potentially leading to kidney, cardiovascular, or
heart damage. In severe cases, cardiac arrhythmias may develop, and very high serum calcium levels
may lead to coma or even death. Infants and children are more susceptible to the toxic effects of
vitamin D.
Missing a dose of Vitamin D3 Krka 30,000 IU tablets
If a dose is missed, take it as soon as possible, then continue with the next dose at the usual time as
directed by your doctor. If the next scheduled dose is approaching, do not take the missed dose. Wait
and take the next dose at the regular 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, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
Adverse reactions associated with the use of Vitamin D3 Krka, 30,000 IU, tablets may include:
Frequency unknown (frequency cannot be estimated from the available data)

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

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

5. How to store Vitamin D3 Krka 30,000 IU tablets

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging following: EXP.
The expiry date refers to the last day of the stated month.
Do not store above 30°C.
Store in the original blister pack to protect from light and moisture.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the packaging 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 maize 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, marked with "4" on one side of the tablet and a broad division line on the other side.
The division line on the tablet is intended only to facilitate breaking for easier swallowing and does not ensure division into equal doses.
Tablet dimensions: approximately 16 mm x 8 mm.
Vitamin D3 Krka, 30,000 IU, tablets are available in packs of: 2, 4, 6, 8 and 12 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
This medicinal product is authorised in the Member States of the European Economic Area under the following names:

For more detailed information, please contact the local representative of the responsible entity:
KRKA-POLSKA Sp. z o.o.
Równoległa 5 Street
02-235 Warsaw
Tel.: 22 573 75 00