Ibuvit D3 2000 Iu

Leaflet attached to the packaging: patient information

Ibuvit D 2000 IU, soft capsules

Cholecalciferol

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

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

• 1. What is Ibuvit D 2000 IU and what is it used for
• 2. Important information before taking Ibuvit D 2000 IU
• 3. How to take Ibuvit D 2000 IU
• 4. Possible side effects
• 5. How to store Ibuvit D 2000 IU
• 6. Contents of the packaging and other information

1. What is Ibuvit D 2000 IU and what is it used for

Ibuvit D 2000 IU (International Units) contains the active substance vitamin D (cholecalciferol), which plays an important role in bone formation and immune system support.
Cholecalciferol is identical to the vitamin D produced in the human body.
Vitamin D increases calcium absorption from the intestines and reduces its excretion through the kidneys, which helps build bones.
In vitamin D deficiencies, there are disorders of bone calcification (rickets - impaired mineralization of bones in children) or loss of calcium from bones (osteomalacia - inadequate mineralization of bones in adults) and weakened immune system. Long-term vitamin D deficiency can lead to more serious disorders, such as osteoporosis and bone deformity.
Ibuvit D 2000 IU is used:

• for the prevention of conditions related to vitamin D deficiency in adults with normal body weight and children and adolescents with normal body weight aged 11 and over;
• as adjunctive treatment in osteoporosis in adults;
• for the prevention of vitamin D deficiency in women planning pregnancy, during pregnancy, and breastfeeding, in agreement with a doctor.

Vitamin D is found in some food products and is also produced in the body when the skin is exposed to sunlight.
Preventive intake of vitamin D is recommended during months of insufficient sun exposure (from October to April).
During months of high sun exposure in the summer (from May to September), it is recommended to periodically discontinue vitamin D intake.

2. Important information before taking Ibuvit D 2000 IU

When not to take Ibuvit D 2000 IU:

• if the patient is allergic to cholecalciferol or any other component of this medicine (listed in section 6);
• if the patient has elevated blood calcium levels (hypercalcemia) or urine calcium levels (hypercalciuria);
• if the patient has severe kidney failure, kidney stones (nephrolithiasis), or a tendency to form kidney stones;
• if the patient has elevated blood levels of vitamin D (hypervitaminosis D);
• in children under 11 years of age.

Warnings and precautions

Before starting treatment with Ibuvit D 2000 IU, the patient should discuss it with their doctor or pharmacist:

• if the patient is taking certain heart medications (e.g., cardiac glycosides, such as digoxin);
• if the patient has sarcoidosis (an immune system disease that can increase vitamin D levels in the body);
• if the patient is taking other medicines and/or dietary supplements containing vitamin D or foods rich in vitamin D, as additional doses of vitamin D can only be taken under medical supervision;
• if the patient is taking additional calcium doses;
• if there is a likelihood that the patient will be exposed to a large amount of sunlight during treatment with Ibuvit D 2000 IU (sufficient sun exposure - see section 1.);
• if the patient has damaged or diseased kidneys;
• if vitamin D treatment is long-term, as the doctor should monitor the patient's blood calcium levels and kidney function, measuring serum creatinine levels.

Ibuvit D 2000 IU with food and drink

This medicine is best taken with the main meal to facilitate vitamin D absorption.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Ibuvit D 2000 IU should be used during pregnancy and breastfeeding in agreement with a doctor.
Administration of vitamin D during pregnancy in a dose of 2000 IU per day has a beneficial effect on pregnant women and their newborns.
During pregnancy, women should follow their doctor's recommendations, as their needs may vary depending on the degree of deficiency and response to treatment.

Driving and using machines

Ibuvit D 2000 IU does not affect the ability to drive and use machines.

3. How to take Ibuvit D 2000 IU

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist.

Prevention of vitamin D deficiency and related conditions in adults and children and adolescents aged 11 and over

The recommended dose is usually 2000 IU (1 capsule) per day for patients with normal body weight, from October to April or throughout the year if effective skin synthesis of vitamin D is not ensured during the summer months.

Adjunctive treatment in osteoporosis in adults

The recommended dose is usually 2000 IU (1 capsule) per day, regardless of the time of year.

Prevention of vitamin D deficiency in women planning pregnancy, during pregnancy, and breastfeeding, in agreement with a doctor

The recommended dose is usually 2000 IU (1 capsule) per day, regardless of the time of year, unless the doctor recommends a different dosing regimen.

Do not take other medicines, dietary supplements, or foods containing vitamin D (cholecalciferol), calcitriol, or other vitamin D metabolites and analogs without medical supervision.

Method of administration

Capsules should be swallowed whole, with water, preferably during the main meal.

Overdose of Ibuvit D 2000 IU

If the patient accidentally takes one capsule more than recommended, the occurrence of overdose symptoms is unlikely.
In case of overdose, the patient should inform their doctor or pharmacist, or contact the nearest hospital emergency department for further advice. If possible, the patient should bring the package and this leaflet to show the doctor.

Missed dose of Ibuvit D 2000 IU

Do not take a double dose to make up for a missed dose.
In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Ibuvit D 2000 IU can cause side effects, although not everybody gets them.

Some side effects may be serious and may require immediate medical attention

Medical attentionis required immediately if the patient experiences symptoms of angioedema, such as:

• swelling of the face, tongue, or throat (larynx)
• difficulty swallowing
• hives and difficulty breathing.

Other side effects related to Ibuvit D 2000 IU include:
Uncommon(occurring in less than 1 in 100 patients)

• elevated blood calcium levels (hypercalcemia)
• elevated urine calcium levels (hypercalciuria)

Rare(occurring in less than 1 in 1000 patients)

• rash
• itching
• hives

Frequency not known(cannot be estimated from available data)

• constipation
• gas (bloating)
• nausea
• abdominal pain
• diarrhea.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should inform their 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.
Reporting side effects will help gather more information on the safety of this medicine.

5. How to store Ibuvit D 2000 IU

The medicine should be stored out of sight and reach of children.
Do not store above 30°C. Store in the original packaging to protect from light.
Do not use this medicine after the expiry date stated on the carton and blister after EXP.
The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of unused medicines. This will help protect the environment.

6. Contents of the packaging and other information

What Ibuvit D 2000 IU contains

• The active substance is cholecalciferol. Each capsule contains 50 micrograms of cholecalciferol, equivalent to 2000 IU of vitamin D.
• Other ingredients are: capsule content: purified cottonseed oil capsule shell: gelatin, glycerol, purified water, medium-chain triglycerides.

What Ibuvit D 2000 IU looks like and contents of the packaging

Ibuvit D 2000 IU is a light yellow, oval, soft capsule (shorter diameter approximately 6 mm) with a seam in the middle, filled with a light yellow, oily liquid.
The packaging contains 30, 60, 90, 120, or 150 capsules in PVC/PVDC/Aluminum blisters in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder

Zakłady Farmaceutyczne POLPHARMA S.A.
Pelplińska 19, 83-200 Starogard Gdański
phone: +48 22 364 61 01

Manufacturer

Zakłady Farmaceutyczne POLPHARMA S.A.
Medana branch in Sieradz
Władysława Łokietka 10, 98-200 Sieradz

Date of last revision of the leaflet: