Vitamin D3 Krka

Leaflet accompanying the packaging: patient information

Vitamin D3 Krka, 7000 IU, tablets
Cholecalciferol

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Vitamin D3 Krka, 7000 IU, tablets and what is it used for
• 2. Important information before taking Vitamin D3 Krka, 7000 IU, tablets
• 3. How to take Vitamin D3 Krka, 7000 IU, tablets
• 4. Possible side effects
• 5. How to store Vitamin D3 Krka, 7000 IU, tablets
• 6. Contents of the packaging and other information

1.

What is Vitamin D3 Krka, 7000 IU, tablets and what is it used for
Vitamin D3 Krka, 7000 IU, tablets contain 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, 7000 IU, tablets are 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 osteoporosis treatment (a disease in which bone density is reduced, leading to an increased risk of fractures) in adults with vitamin D deficiency or a 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 can also be supplied to the body through food.
A deficiency of vitamin D may occur if the diet and lifestyle do not provide sufficient amounts of it or if the need for vitamin D is increased.

2.

Important information before taking Vitamin D3 Krka, 7000 IU, tablets
When not to take Vitamin D3 Krka, 7000 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 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,
• if the patient has severe kidney dysfunction (since the body is unable to use vitamin D).

Warnings and precautions

Before starting to take Vitamin D3 Krka, 7000 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 (an immune system disorder that can affect the liver, lungs, skin, or lymph nodes), as the action of Vitamin D3 Krka, 7000 IU, tablets may be too strong for them.

During treatment, the doctor may recommend monitoring calcium levels in the blood and urine to ensure that these values are not too high.
Patients with suspected hypoparathyroidism (parathyroid hormone disorders) should not take Vitamin D3 Krka, as their need for vitamin D may vary over time and they may be at risk of long-term overdose. The doctor may recommend another medicine with a similar mechanism of action.
No other medicines or dietary supplements containing vitamin D or calcium should be taken, unless the doctor recommends otherwise. In such cases, the doctor may decide to monitor calcium levels in the blood and urine.
Long-term use of doses exceeding 1000 IU per day or 7000 IU per week
requires monitoring of calcium levels in the blood and urine, as well as kidney function. This is especially important for 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 symptoms of kidney dysfunction, the doctor may decide to reduce the dose of Vitamin D3 Krka or discontinue treatment.

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

Children and adolescents

Vitamin D3 Krka, 7000 IU, tablets are 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 action 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.

Particular caution should be exercised when taking Vitamin D3 Krka, 7000 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 level in the blood. During long-term treatment, calcium levels in the blood and urine should be monitored.
• digitalis glycosides(medicines used to treat heart diseases), e.g., digoxin: may increase the risk of heart rhythm disorders (arrhythmia). The doctor will monitor calcium levels in the blood and urine, as well as heart function in an ECG. If necessary, the levels of heart medicines in the blood should also be monitored.
• medicines similar to vitamin D(e.g., calcitriol), as they should only be used together in exceptional cases and calcium levels in the blood should be monitored.
• aluminum-containing medicines(used to treat heartburn): should be avoided for long-term use, 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 level 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.
Pregnancy
Vitamin D3 Krka, 7000 IU, tablets are not recommended for pregnant women due to their high vitamin D content.
Breastfeeding
Vitamin D3 Krka, 7000 IU, tablets may be used in breastfeeding mothers if deemed necessary by the doctor. The doctor will prescribe a dose based on the patient's needs and response to treatment.
Vitamin D passes into breast milk. This should be taken into account if the baby is also receiving vitamin D supplements.

Driving and using machines

Vitamin D3 Krka has no or negligible influence on the ability to drive and use machines.
Vitamin D3 Krka, 7000 IU, tablets contain sucrose and sodium
If you have been diagnosed with intolerance to some sugars, consult 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, 7000 IU, tablets
Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, consult your doctor or pharmacist.

If the doctor has not prescribed otherwise, the following dosing schedule should be followed:

• Prevention of vitamin D deficiency in adults with a confirmed high risk of deficiency:

The recommended dose is 1 to 2 tablets (7000 IU to 14000 IU of vitamin D or 175-350 micrograms of cholecalciferol) taken once a week. The dosage should be determined individually by the doctor based on the extent of necessary vitamin D supplementation.

• The initial dose (for 6 to 12 weeks) is 1 tablet (7000 IU of vitamin D or 175 micrograms of cholecalciferol) taken once a day. Taking into account the patient's preferences and needs, the doctor may decide to administer the medicine once a week. In such cases, the patient may take 7 tablets (49000 IU of vitamin D or 1225 micrograms of cholecalciferol) once a week.

The recommended maintenance dose is 2 tablets (14000 IU of vitamin D or 350 micrograms of cholecalciferol) taken once a week.

• As a supplement to specific osteoporosis treatment (a disease in which bone density is reduced, leading to an increased risk of fractures) in adults with vitamin D deficiency or a confirmed high risk of vitamin D deficiency.1 tablet (7000 IU or 175 micrograms of cholecalciferol) taken once a week. Ensure adequate calcium intake, preferably from the diet.

Based on specific needs, the doctor may decide to prescribe a different dose than described above. In such cases, follow the doctor's instructions.
Patients with liver dysfunction and elderly patients
No dose adjustment is necessary for patients with liver disease or elderly patients with normal kidney function.
Patients with kidney dysfunction
If the patient has mild or moderate kidney disease, consult the doctor before taking Vitamin D3 Krka, 7000 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, 7000 IU, tablets can be taken with or without food.
Taking a higher dose of Vitamin D3 Krka, 7000 IU, tablets than recommended
If you accidentally take one tablet more than recommended, you are unlikely to experience any symptoms. If you accidentally take too many tablets, contact your doctor immediately.
Symptoms of vitamin D overdose are uncommon and may include: nausea, vomiting, diarrhea, constipation, loss of appetite, weight loss, muscle weakness, fatigue, headache, excessive thirst, drowsiness, dizziness, or excessive 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, 7000 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, 7000 IU, tablets can cause side effects, although not everybody gets them.
Side effects related to the use of Vitamin D3 Krka, 7000 IU, tablets 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 you experience any side effects, including any side effects not listed in this leaflet, tell your 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:
Aleje 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.
Reporting side effects will help to gather more information on the safety of this medicine.

5.

How to store Vitamin D3 Krka, 7000 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 stated.
Store in the original blister to protect from light.
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 packaging and other information

What Vitamin D3 Krka, 7000 IU, tablets contain

• The active substance is cholecalciferol (vitamin D). Each tablet contains 7000 IU (equivalent to 175 micrograms) of cholecalciferol (vitamin D).
• The other ingredients (excipients) are: mannitol, sodium carmellose, microcrystalline cellulose (type 112), talc, colloidal silica, magnesium stearate (E470b), sodium ascorbate, all-rac-α-tocopherol, modified corn starch, sucrose, medium-chain triglycerides. See section 2 "Vitamin D3 Krka, 7000 IU, tablets contain sucrose and sodium".

What Vitamin D3 Krka, 7000 IU, tablets look like and contents of the pack
White or almost white, oval, biconvex tablets, with the marking "3" on one side of the tablet. Tablet dimensions: approximately 11 mm x 6 mm.
Vitamin D3 Krka, 7000 IU, tablets are available in packs of: 4, 6, 8, 12, 16, 18, 20, 24, 28, 30, 32, 36, 40, or 42 tablets in a blister pack, in a cardboard box.
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: +48 22 573 75 00
Date of last revision of the leaflet:10.05.2024