Ibuvit d3

Package leaflet: information for the patient

Ibuvit D, 15,000 IU/ml, oral drops, solution
Cholecalciferolum
Please read carefully the entire leaflet before taking this 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
the physician or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If your condition does not improve or if you feel worse, contact your doctor.

Table of contents

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

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

Ibuvit D contains cholecalciferol (vitamin D) as the active substance.
Vitamin D is found in certain foods and is also produced in the body when the skin is exposed to sunlight.
Vitamin D enhances calcium absorption from the intestines and reduces its excretion by the kidneys, thus supporting bone formation, maintaining proper muscle tone, nerve conduction, and blood clotting. Vitamin D deficiency may lead, among other conditions, to rickets (impaired bone mineralization in children).
Vitamin D also plays a key role in the intestinal absorption of phosphates, mineral transport, and contributes to the proper functioning of the immune system.
Ibuvit D is used:

• for the prevention of vitamin D deficiency and conditions resulting from vitamin D deficiency (e.g. rickets);
• for the prevention of vitamin D deficiency in women planning pregnancy, during pregnancy, and while breastfeeding.

Prophylactic intake of vitamin D is important during months with insufficient sunlight exposure, from October to April, or throughout the year if effective cutaneous synthesis of vitamin D is not ensured during summer months.
In Poland, sufficient sunlight exposure is possible only from May to September, provided that individuals stay outdoors between 10:00 and 15:00 with forearms and lower legs uncovered and without using UV-filter creams, for at least:

• 15–30 minutes for children aged 4–10 years
• 30–45 minutes for adolescents and adults.

Due to age-related limitations on sun exposure, infants, newborns, and children up to 4 years of age should receive vitamin D supplementation throughout the year.
In newborns and infants, this medicine should be administered under medical supervision.

2. Important information before using Ibuvit D

When not to use Ibuvit D:

• if the patient is allergic to cholecalciferol or any of the other ingredients of this medicine (listed in section 6);
• if the patient has hypervitaminosis D (disease symptoms caused by excess vitamin D in the body);
• if the patient has increased calcium levels in blood and urine;
• if the patient has kidney stones (nephrolithiasis) or a tendency to form kidney stones;
• if the patient has sarcoidosis (an immune system disorder);
• if the patient has severe renal insufficiency.

Warnings and precautions
Before starting treatment with Ibuvit D, consult a doctor or pharmacist if:

• the patient is immobilized;
• the patient is taking thiazide diuretics;
• the patient has kidney stones;
• the patient has heart disease;
• the patient is taking cardiac glycosides (digitalis);
• the patient is pregnant or breastfeeding;
• the patient is simultaneously taking high doses of calcium;
• if the patient is using other medicines or dietary supplements containing vitamin D, calcitriol, or other vitamin D metabolites or analogs, or consuming foods rich in vitamin D.

During treatment, the doctor may recommend periodic monitoring of calcium and phosphate levels in blood and urine.
Children
The daily requirement and method of administration of vitamin D in children are determined individually by the doctor and verified at each regular check-up, especially during the first months of life.
Administration of vitamin D in newborns and infants should be under medical supervision.
Special caution should be exercised in infants who have a small anterior fontanelle size from birth.

Ibuvit D and other medicines
Inform the doctor or pharmacist about all medicines currently used or recently used, as well as any medicines the patient plans to take.

• Antiepileptic drugs, especially phenytoin and phenobarbital, as well as rifampicin, reduce the absorption of vitamin D.
• Concomitant use of vitamin D with thiazide diuretics increases the risk of hypercalcemia (elevated calcium levels in blood).
• Concurrent administration with cardiac glycosides may enhance their toxicity (increased risk of cardiac arrhythmias).
• Simultaneous use with antacids containing aluminum and magnesium may lead to toxic effects of aluminum on bones and hypermagnesemia in patients with renal insufficiency.
• Concurrent use with vitamin D analogs (e.g. calcitriol) carries a risk of toxic effects.
• Products containing high doses of calcium or phosphorus increase the risk of

hyperphosphatemia.

• Ketoconazole may inhibit both biosynthesis and catabolism of 1,25(OH)2-cholecalciferol.
• Vitamin D may act antagonistically to drugs used in hypercalcemia such as calcitonin, etidronate, pamidronate.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she might be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Ibuvit D should be used during pregnancy only under medical supervision.
During pregnancy, women should follow the recommendations of their attending physician, as their requirements may vary depending on the degree of deficiency and response to treatment.
Excess vitamin D intake should be avoided during pregnancy, because prolonged hypercalcemia (elevated calcium levels in blood) may lead to delayed physical and mental development, congenital heart defects, and retinal disorders in the child.
Ibuvit D should be used during breastfeeding only under medical supervision.

Driving and operating machinery
Ibuvit D has no influence on the ability to drive vehicles or operate machinery.

3. How to use Ibuvit D

This medicine should always be used exactly as described in this patient leaflet or as directed by a
physician or pharmacist. If in doubt, consult a physician or pharmacist.
Warning: 1 drop contains approximately 500 IU of vitamin D. The abbreviation IU (from English International Unit)
denotes international unit, which is used to express the activity of vitamin D.
Prevention of vitamin D deficiency and conditions resulting from vitamin D deficiency
In patients with normal body weight, during the months from October to April or throughout the year
if effective cutaneous synthesis of vitamin D is not ensured during summer months (see section 1.).
Newborns and infants (up to 1 year of age)

• 500 IU (1 drop)

Ibuvit D should be used in newborns and infants under medical supervision.
Children aged 1 to 4 years

• 500 IU (1 drop)

Children aged 4 to 10 years

• 500 - 1000 IU (1 - 2 drops)

Adolescents (aged 11 to 18 years)

• 1000 - 2000 IU (2 - 4 drops)

Adults

• 1000 - 2000 IU (2 - 4 drops)

Elderly patients

• aged 65 to 75 years: 1000 - 2000 IU (2 - 4 drops)
• aged over 75 years: 2000 - 4000 IU (4 - 8 drops)

Adults with obesity and children and adolescents with overweight
Adults with obesity (body mass index [BMI] ≥30) and children and adolescents with overweight
(body mass index [BMI] >90th percentile appropriate for age and sex) require a double dose of vitamin D
compared to the dose recommended for peers with normal body weight.
Prevention of vitamin D deficiency in women planning pregnancy, during pregnancy and breastfeeding,
in consultation with a physician:
The usual recommended dose is 2000 IU (4 drops) daily, regardless of the time of year, unless the physician
recommends otherwise.
During pregnancy, women should follow the advice of their attending physician, as their vitamin D requirements
may vary depending on the body's vitamin D stores.
Do not use this medicine for longer than recommended or in higher doses. Do not simultaneously use other
medicines, dietary supplements, or other food products containing vitamin D (cholecalciferol), calcitriol, or other
vitamin D metabolites and analogues without consulting a physician. The physician may recommend measuring
serum 25(OH)D concentration.
Method of administration
Oral use.
To facilitate accurate measurement of drops, the bottle should be held vertically.
Ibuvit D is best taken during a meal.
Do not mix Ibuvit D with milk in a bottle or with soft foods in containers, as the child may not consume the entire
portion and thus will not receive the full dose of the medicine. Ensure the entire dose is administered.
Due to the risk of overdose, do not administer the medicine directly from the bottle into the child's mouth.
The solution should be dosed onto a spoon.
Accidental ingestion of more than the recommended dose of Ibuvit D
If a patient accidentally takes one extra drop, the occurrence of overdose symptoms is unlikely.
If an excessive dose has been taken, inform a physician or pharmacist or contact the nearest hospital emergency
department for further advice. If possible, bring the package and this leaflet to show the physician.
Missed dose of Ibuvit D
Do not take a double dose to make up for a missed dose.
If you have any further doubts about the use of this medicine, consult your physician or pharmacist.

4. Possible adverse reactions

Like any medicinal product, this medicine may cause adverse reactions, although not everyone experiences them.
Adverse reactions practically do not occur when the recommended doses are used.
However, in rare cases of hypersensitivity to vitamin D or after administration of excessively high doses over a prolonged period, vitamin D poisoning known as hypervitaminosis D may occur. Symptoms of hypervitaminosis D include:

• cardiac rhythm disturbances;
• headache, lethargy;
• conjunctivitis, photophobia;
• loss of appetite, nausea, vomiting, constipation;
• uremia, polyuria;
• muscle and joint pain, muscle weakness;
• hypercholesterolemia, weight loss, excessive thirst, profuse sweating, pancreatitis;
• arterial hypertension;
• skin itching;
• increased aminotransferase activity;
• decreased libido, depression, psychotic disorders;
• watery nasal discharge;
• hyperthermia;
• dryness of the oral cavity;
• increased calcium concentration in blood and/or in urine;
• nephrolithiasis;
• tissue calcifications.

Reporting of adverse reactions
If any adverse reactions occur, including any 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 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions may also be reported to the marketing authorization holder.
Reporting adverse reactions enables better assessment of the safety profile of the medicine.

5. How to store the medicine Ibuvit D

Keep the medicine out of the sight and reach of children.
Do not store above 25°C. Store in the original packaging to protect from light.
Do not use this medicine after the expiry date stated on the carton and bottle following the abbreviation EXP. The expiry date refers to the last day of the stated month.
Once the package has been opened, use within 12 months.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What the medicine Ibuvit D contains:

• The active substance is cholecalciferol. Each ml (approximately 30 drops) of solution contains 15,000 IU of cholecalciferol. Each drop contains approximately 500 IU of vitamin D.
• The other ingredient is: medium-chain triglycerides.

What Ibuvit D looks like and contents of the pack
Ibuvit D is a clear, colourless to pale yellow solution.
The pack contains a 10 ml amber glass bottle (type III), closed with an HDPE screw cap and a dropper made of LDPE, placed in a cardboard box.
Marketing Authorisation Holder
POLPHARMA Pharmaceutical Works S.A.
Pelplińska Street 19, 83-200 Starogard Gdański
tel. +48 22 364 61 01
Manufacturer
POLPHARMA Pharmaceutical Works S.A.
Medana Branch in Sieradz
Władysława Łokietka Street 10, 98-200 Sieradz