Ibuvit d3 4000 iu

Package leaflet: Information for the patient

Ibuvit D 4000 IU, soft capsules
Cholecalciferolum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.
This medicine should always be used exactly as described in this patient leaflet or as advised by
your 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 not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If your symptoms do not improve or if you feel worse, consult your doctor.

Table of contents

1. What Ibuvit D 4000 IU is and what it is 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 pack and other information

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

Ibuvit D 4000 IU (international units) contains as its active substance vitamin D (cholecalciferol), which plays an important role in bone formation and in supporting immunity.
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, thereby supporting bone formation.
Vitamin D deficiency leads to disturbances in bone calcification (rickets – impaired bone mineralization in children) or loss of calcium from bones (osteomalacia – inadequate bone mineralization in adults) and weakened immune function.
Prolonged vitamin D deficiency may lead to more serious disorders, such as the development of osteoporosis and bone deformities.
Ibuvit D 4000 IU is indicated:

• for the prevention of vitamin D deficiency and conditions resulting from vitamin D deficiency in adults with obesity [body mass index (BMI) ≥ 30 kg/m²].

Vitamin D is present in certain food products and is also produced in the body when the skin is exposed to sunlight.
Prophylactic intake of vitamin D is recommended during months with insufficient sunlight exposure (from October to April).
During periods of high sunlight exposure in the summer months (from May to September), it is recommended to temporarily discontinue vitamin D supplementation.

2. Important information before using Ibuvit D 4000 IU

When not to use Ibuvit D 4000 IU:

• if the patient is allergic to cholecalciferol or to any of the other ingredients of this medicine (listed in section 6);
• if the patient has elevated calcium levels in blood (hypercalcemia) or in urine (hypercalciuria);
• if the patient has severe kidney failure, kidney stones (nephrolithiasis), or a tendency to develop kidney stones;
• if the patient has elevated vitamin D levels in blood (hypervitaminosis D);
• in children and adolescents under 18 years of age;
• if the patient is pregnant.

Warnings and precautions
Before starting treatment with Ibuvit D 4000 IU, discuss the following with your doctor or pharmacist:

• if the patient is taking certain medicines used for heart conditions (e.g. cardiac glycosides such as digoxin);
• if the patient has sarcoidosis (an immune system disorder which may increase vitamin D levels in the body);
• if the patient is taking other medicines and/or dietary supplements containing vitamin D or consuming foods rich in vitamin D, because additional doses of vitamin D should be taken only under medical supervision;
• if the patient is taking additional calcium supplements;
• if the patient is likely to be exposed to significant sunlight during treatment with Ibuvit D 4000 IU (adequate sun exposure – see section 1.);
• if the patient has damaged or diseased kidneys;
• if vitamin D treatment is long-term, as in such cases the doctor should monitor serum and urinary calcium levels and assess kidney function by measuring blood creatinine levels.

Ibuvit D 4000 IU and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
This is particularly important if the patient is taking:

• medicines affecting the heart or kidneys, such as cardiac glycosides (e.g. digoxin) or thiazide diuretics (e.g. bendroflumethiazide). Concomitant use with vitamin D may cause a significant increase in blood and urinary calcium levels;
• medicines containing vitamin D, calcitriol, or other vitamin D metabolites and analogs, as well as foods rich in vitamin D;
• actinomycin (a medicine used in the treatment of certain types of cancer) and imidazole antifungal agents (e.g. clotrimazole and ketoconazole, used to treat fungal infections);
• anticonvulsant (antiepileptic) medicines;
• barbiturates (sleeping or anticonvulsant medicines);
• glucocorticoids (steroid hormones such as hydrocortisone or prednisolone);
• cholesterol-lowering medicines (such as cholestyramine or colestipol);
• certain medicines used to treat obesity that reduce fat absorption (e.g. orlistat);
• certain laxatives (such as liquid paraffin);
• medicines used in hypercalcemia (elevated blood calcium levels), such as calcitonin, etidronate, pamidronate;
• antacids containing magnesium or aluminium (used for heartburn and indigestion);
• medicines used to treat tuberculosis (e.g. rifampicin, isoniazid).

Ibuvit D 4000 IU with food and drink
This medicine should be taken with a main meal to facilitate absorption of vitamin D.
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.
Ibuvit D 4000 IU is contraindicated during pregnancy.
Ibuvit D 4000 IU is not intended for use in breastfeeding women.
Driving and operating machinery
Ibuvit D 4000 IU has no influence on the ability to drive or operate machinery.

3. How to use Ibuvit D 4000 IU

This medicine should always be used exactly as described in this patient information leaflet or as advised by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Prevention of vitamin D deficiency and conditions resulting from vitamin D deficiency in adults with obesity
The usual recommended dose is 4000 IU (1 capsule) daily, from October to April, or throughout the year if effective cutaneous synthesis of vitamin D is not ensured during summer months.

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

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

Method of administration
The capsules should be swallowed whole with water, preferably during a main meal.

Use of a higher than recommended dose of Ibuvit D 4000 IU
If a patient accidentally takes one extra capsule, symptoms of overdose are unlikely.

In case of overdose, inform your doctor or pharmacist or contact the nearest hospital emergency department for further advice. If possible, bring the pack and this leaflet along 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 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 not everyone experiences them.
Some adverse reactions may be serious and may require immediate medical attention.
You should immediately consult a doctor if symptoms of angioedema occur, such as:

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

Other adverse reactions associated with the use of Ibuvit D 4000 IU include:
Not very common (occur in less than 1 in 100 patients)

• elevated calcium levels in blood (hypercalcaemia)
• elevated calcium levels in urine (hypercalciuria)

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

• rash
• itching
• urticaria

Frequency not known (cannot be estimated from available data)

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

Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warszawa
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 the medicine Ibuvit D 4000 IU

Keep the medicine 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 pack after EXP.
The expiry date refers to the last day of the stated month.
Medicines must 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 pack 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.
• The other ingredients are: capsule contents: purified crocus oil; capsule shell composition: gelatin, glycerol, purified water, medium-chain triglycerides.

What Ibuvit D 4000 IU looks like and contents of the pack
Ibuvit D 4000 IU is in the form of light yellow, oval soft capsules (shorter diameter approx. 7 mm) with a central seam, filled with a light yellow oily liquid.
The pack contains 30, 60, 90, 120 or 150 capsules in PVC/PVDC/Aluminium blisters, packed in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
Pelplińska 19, 83-200 Starogard Gdański
tel. +48 22 364 61 01

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