Vitamin d3 krka

Package leaflet: Information for the user

Vitamin D3 Krka, 500 IU, tablets
Cholecalciferolum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as directed by
the 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 adverse reactions not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If your symptoms do not improve or if you feel worse, consult your doctor.

Contents of the leaflet

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:

• Preventing vitamin D deficiency in children and adults.
• Preventing disorders in cases of increased risk of vitamin D deficiency in children and adults.
• Preventing rickets (impaired bone hardening during growth) and osteomalacia (softening of the bones) in children and adults.
• Adjunctive treatment of 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 occurring in humans.
Vitamin D is produced in the skin upon exposure to sunlight and can also be supplied through food.
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 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 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, discuss this 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,
• with a tendency to form calcium kidney stones,
• taking thiazide diuretics (medicines that promote urine production),
• who are immobilized,
• 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 the 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 vitamin D requirements are different 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, dietary supplements, or other products containing vitamin D or other metabolites or analogs (e.g. cholecalciferol, ergocalciferol, or calcitriol) or calcium, unless otherwise advised by your doctor. In such cases, your doctor will monitor calcium levels in the 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 to treat certain heart conditions),
• have an increased tendency to form kidney stones,
• are elderly.
  If elevated calcium levels in blood or urine, or symptoms of impaired kidney function occur, your doctor may decide to reduce the dose of Vitamin D3 Krka or discontinue treatment.

Do not exceed the recommended daily dose of this medicine, as this may lead to overdose.
Children
Do not give the whole tablet 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".
Exercise caution when giving this medicine to children aged 6 to 12 years, as they may not be able to swallow the whole tablet.
Consider the vitamin D content in milk and vitamin-fortified foods given to children. If in doubt, consult your doctor whether these foods can be given simultaneously with Vitamin D3 Krka.
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 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 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 aluminum or magnesium (used to treat heartburn): avoid long-term use, as blood levels of aluminum/magnesium may increase.
• cholestyramine, orlistat (used to lower blood lipid levels), or laxatives (used to treat constipation), such as liquid paraffin: 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 or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine.
Pregnancy
Adequate intake of vitamin D is important for pregnant women, women of childbearing age, and those planning pregnancy. Generally, pregnant women and those planning pregnancy can take the same dose as recommended for the general adult population (see section 3 "How to take 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 the 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 operating machinery
Vitamin D3 Krka has no effect or 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 their 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 as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
If the doctor has not advised otherwise, follow this dosing regimen:
Adults and elderly people
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).
This medicine should not be used long-term or in higher than recommended doses without medical supervision.
Supportive treatment in osteoporosis
Treatment should be initiated after consultation with a doctor.
The usual 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 treating 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). A doctor may recommend a different dosage; in such cases, follow the doctor's instructions.
This medicine should not be used in newborns, infants, and young children without medical supervision.
Method of administration
Vitamin D3 Krka should be taken during a main meal.
Adults, elderly people, and children above 6 years of age
Tablets should be swallowed with sufficient water.
Exercise caution when administering the medicine to children aged 6 to 12 years due to the possible risk of difficulty swallowing the whole tablet.
If difficulty swallowing occurs, the tablet(s) 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 liquid due to excessive shaking. The entire contents must be consumed.
Any residue remaining in the glass should be rinsed with a small amount of water and then consumed.
Newborns, infants, and children under 6 years of age
The tablet should be dissolved in water on a spoon and then administered directly into the child's mouth.
Alternatively, a small transparent container (such as a glass) and a small amount of water (not less than 10 mL) may be used to dissolve the tablet. 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 liquid due to excessive shaking. Ensure that the child consumes the entire contents. Any residue remaining in the glass should be rinsed with a small amount of water and then consumed. A spoon is recommended for administering the medicine in this patient age group.
Before administering the medicine to a child, ensure that the tablet has completely disintegrated and a uniform suspension has formed.
It is not recommended to add the dissolved tablet to infant food (e.g., a bottle of milk or gently mashed food), as it cannot be guaranteed that the full dose will be consumed.
However, if the tablet must be administered with food, the food should first be boiled and then cooled. Care must be taken to ensure that the entire dose of medicine is consumed.
Duration of treatment
The duration of treatment depends on the patient's condition and may be prolonged. Discuss with your doctor the required duration of treatment.
Taking more Vitamin D3 Krka than recommended
If a patient accidentally takes one tablet too many, no symptoms will occur.
If an excessive number of tablets is taken, contact a doctor 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 volume, or sweating. Blood and urine calcium levels may rise, and soft tissue calcification may occur, potentially leading to kidney, cardiovascular, and heart damage. In severe cases, cardiac rhythm disturbances may occur, 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.
If a dose of Vitamin D3 Krka is missed
If a dose is missed, take it as soon as possible, then take the next dose at the usual time, as directed by the doctor. 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 doctor or pharmacist.

4. Possible adverse reactions

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

• high level 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 urticaria

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, tell your doctor or pharmacist. Adverse reactions can be
reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for 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.
By reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store Vitamin D3 Krka

Keep this 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 stated month.
Do not store above 25 °C.
Store in the original packaging to protect from light.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Such measures 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 5 mg of cholecalciferol powder, equivalent to 0.0125 mg (500 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, slightly biconvex tablets with bevelled edges, printed with the mark “1 D” on one side. Tablet diameter: 6 mm.
Vitamin D3 Krka is available in blister packs containing: 30, 50, 60, 90, 100 or 200 tablets.
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 further information, contact the local representative of the Marketing Authorisation Holder:
Krka - Polska Sp. z o.o.
ul. Równoległa 5
02-235 Warszawa
telephone: +48 22 573 75 00