Ibuvit D3 4000 Iu

Package Leaflet: Information for the Patient

Ibuvit D 4000 IU, Soft Capsules

Cholecalciferol

Read the package 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 package leaflet or as directed by your doctor or pharmacist.

• Keep this package leaflet, you may need to read it again.
• If you need advice or further information, ask your pharmacist.
• If you experience any side effects, including those not listed in this package leaflet, tell your doctor or pharmacist. See section 4.
• If you do not feel better or if you feel worse, contact your doctor.

Table of Contents of the Package Leaflet

• 1. What is Ibuvit D 4000 IU and what is it used for
• 2. Important information before taking Ibuvit D 4000 IU
• 3. How to take Ibuvit D 4000 IU
• 4. Possible side effects
• 5. How to store Ibuvit D 4000 IU
• 6. Contents of the package and other information

1. What is Ibuvit D 4000 IU and what is it used for

Ibuvit D 4000 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 by the kidneys, which supports bone growth.
Vitamin D deficiency can lead to bone mineralization disorders (rickets - impaired bone mineralization in children) or loss of calcium from bones (osteomalacia - inadequate bone mineralization 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 4000 IU is used:

• for the prevention of vitamin D deficiency and conditions resulting from vitamin D deficiency in adults with obesity (body mass index (BMI) ≥ 30 kg/m).

Vitamin D is found in some foods 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 periods of high sun exposure in summer months (from May to September), it is recommended to periodically discontinue vitamin D intake.

2. Important information before taking Ibuvit D 4000 IU

When not to take Ibuvit D 4000 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 and adolescents under 18 years of age;
• in pregnant women.

Warnings and precautions

Before starting treatment with Ibuvit D 4000 IU, discuss it with your doctor or pharmacist:

• if the patient is taking certain heart medications (e.g., digitalis 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 or dietary supplements containing vitamin D or foods rich in vitamin D, as additional doses of vitamin D should only be taken under medical supervision;
• if the patient is taking additional calcium supplements;
• if there is a likelihood that the patient will be exposed to large amounts of sunlight during treatment with Ibuvit D 4000 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 4000 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 she may be pregnant, or plans to have a child, she should consult her doctor or pharmacist before taking this medicine.
Ibuvit D 4000 IU is contraindicated in pregnant women.
Ibuvit D 4000 IU is not intended for breastfeeding women.

Driving and using machines

Ibuvit D 4000 IU does not affect the ability to drive or operate machines.

3. How to take Ibuvit D 4000 IU

This medicine should always be taken exactly as described in the package leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Prevention of vitamin D deficiency and conditions resulting from vitamin D deficiency in adults with obesity

The recommended dose is 4000 IU (1 capsule) per day, from October to April or throughout the year if skin synthesis of vitamin D is not effective during summer months.

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

Children and adolescents
Ibuvit D 4000 IU is contraindicated in children and adolescents under 18 years of age.

Method of administration

Swallow the capsules whole with water, preferably during the main meal.

Overdose of Ibuvit D 4000 IU

If the patient accidentally takes one capsule more than recommended, the risk of overdose symptoms is low.
In case of overdose, tell your doctor or pharmacist or contact the nearest hospital emergency department for further advice. If possible, take the package and this package leaflet with you to show the doctor.

Missed dose of Ibuvit D 4000 IU

Do not take a double dose to make up for a missed dose.
If you have any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Ibuvit D 4000 IU can cause side effects, although not everybody gets them.

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

Seek medical attention immediatelyif you experience symptoms of angioedema, such as:

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

Other side effects associated with Ibuvit D 4000 IU include:
Uncommon(affecting less than 1 in 100 patients)

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

Rare(affecting less than 1 in 1,000 patients)

• rash
• itching
• hives

Frequency not known(cannot be estimated from available data)

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

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, tell your 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. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ibuvit D 4000 IU

Keep the medicine out of sight and reach of children.
Do not store above 30°C. Store in the original package to protect from light.
Do not use this medicine after the expiry date stated on the package 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. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the package and other information

What Ibuvit D 4000 IU contains

• The active substance is cholecalciferol.
• Each capsule contains 100 micrograms of cholecalciferol, equivalent to 4000 IU of vitamin D.
• Other ingredients are: capsule content: purified cottonseed oil capsule shell: gelatin, glycerol, purified water, medium-chain triglycerides.

What Ibuvit D 4000 IU looks like and contents of the package

Ibuvit D 4000 IU is a light yellow, oval, soft capsule (shorter diameter approximately 7 mm) with a seam in the middle, filled with a light yellow, oily liquid.
The package 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.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. +48 22 364 61 01

Manufacturer

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

Date of last revision of the package leaflet: