Ibuvit D3

Package Leaflet: Information for the Patient

Ibuvit D, 15,000 IU/ml, Oral Drops, Solution

Cholecalciferol

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

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

• Keep this leaflet, you may need to read it again.
• If you need advice or further information, consult your pharmacist.
• If you experience any side effects, including those not listed in this 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 Leaflet

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

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

Ibuvit D contains the active substance cholecalciferol (vitamin D3). Vitamin D is found in some foods and is also produced in the body when the skin is exposed to sunlight. Vitamin D increases calcium absorption from the intestines and reduces its excretion by the kidneys, which supports bone construction, maintains proper muscle tension, nerve stimulation, and blood clotting. A deficiency of vitamin D can cause, among other things, rickets (disrupted bone mineralization in children). Vitamin D also plays a crucial role in the absorption of phosphates from the intestines, the transport of mineral salts, and participates in 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 breastfeeding.

Prophylactic intake of vitamin D is essential during months of insufficient sun exposure, from October to April, or throughout the year if effective skin synthesis of vitamin D is not ensured during the summer months. In Poland, sufficient sun exposure is possible only from May to September, provided that you stay in the sun between 10:00 and 15:00, with uncovered forearms and lower legs, without using UV filters, for at least:

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

In newborns, infants, and children up to 4 years old, due to age-related limitations on sunbathing, it is recommended to take vitamin D throughout the year. In newborns and infants, the medicine should be used 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 an excess of vitamin D in the body);
• if the patient has elevated calcium levels in the blood and urine;
• if the patient has kidney stones (nephrolithiasis) or a tendency to form kidney stones;
• if the patient has sarcoidosis (a disease of the immune system);
• if the patient has severe kidney failure.

Warnings and precautions

Before starting to use Ibuvit D, discuss it with your 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 digitalis glycosides;
• the patient is pregnant or breastfeeding;
• the patient is taking large doses of calcium;
• if the patient is using other medicines or dietary supplements containing vitamin D, calcitriol, or other metabolites or analogs of vitamin D, or is consuming foods rich in vitamin D.

During treatment, your doctor may recommend periodic monitoring of calcium and phosphate levels in the blood and urine.

Children

In children, the daily requirement and method of administration of vitamin D are determined individually by the doctor and verified each time during periodic examinations, especially in the first months of life. The use of vitamin D in the group of newborns and infants should be carried out under medical supervision. Particular caution should be exercised in infants in whom small anterior fontanelle sizes are found from birth.

Ibuvit D and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have recently taken, as well as any medicines you plan to take.

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

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine. Ibuvit D should be used during pregnancy in agreement with your doctor. During pregnancy, women should follow the recommendations of their attending physician, as their need for vitamin D may vary depending on the degree of deficiency and response to treatment. During pregnancy, it is necessary to avoid overdosing on vitamin D, as prolonged hypercalcemia (elevated calcium levels in the blood) may lead to delayed physical and mental development, as well as congenital heart defects and retinal disorders in the child. Ibuvit D should be used during breastfeeding in agreement with your doctor.

Driving and using machines

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

3. How to use Ibuvit D

This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist. Note: 1 drop contains approximately 500 IU of vitamin D. The abbreviation IU (International Unit) denotes the activity of vitamin D. Prevention of vitamin D deficiency and conditions resulting from vitamin D deficiencyIn 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 (see section 1).

Newborns and infants (up to 1 year of age)

• 500 IU (1 drop)

In newborns and infants, the medicine should be used 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)
• over 75 years: 2000 IU - 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 for age and sex) require a double dose of vitamin D compared to the recommended dose for peers with normal body weight. 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 (4 drops) per day, regardless of the time of year, unless the doctor recommends a different dosing regimen. During pregnancy, women should follow the recommendations of their attending physician, as their need for vitamin D may vary depending on their body's vitamin D stores. Do not use the medicine for longer than recommended or in larger doses, and do not use other medicines, dietary supplements, or food products containing vitamin D (cholecalciferol), calcitriol, or other metabolites and analogs of vitamin D without consulting a doctor. The doctor may recommend measuring the 25(OH)D level in the serum. Method of administration Oral administration. To facilitate easier dosing, hold the bottle 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 if the child does not consume the entire portion, they will not receive the full dose of the medicine. Ensure that the entire dose of the medicine is taken. 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 a larger dose of Ibuvit D

If a patient accidentally takes one drop too many, the occurrence of overdose symptoms is unlikely. If you have taken too much of the medicine, tell your doctor or pharmacist or contact the nearest hospital emergency department for further advice. If possible, take the package and this leaflet with you to show the doctor.

Missing a dose of Ibuvit D

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

4. Possible side effects

Like all medicines, Ibuvit D can cause side effects, although not everybody gets them. Side effects practically do not occur when used in recommended doses. In the case of rare hypersensitivity to vitamin D or when using too high doses for a long time, there may be an overdose known as hypervitaminosis D. Symptoms of hypervitaminosis D include:

• heart rhythm disturbances;
• headaches, lethargy;
• conjunctivitis, photophobia;
• loss of appetite, nausea, vomiting, constipation;
• polyuria, polydipsia;
• muscle and joint pain, muscle weakness;
• hypercholesterolemia, weight loss, excessive thirst, excessive sweating, pancreatitis;
• hypertension;
• skin itching;
• elevated aminotransferase activity;
• decreased libido, depression, psychotic disorders;
• runny nose;
• hyperthermia;
• dry mouth;
• increased calcium levels in the blood and/or urine;
• kidney stones;
• calcification of tissues.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Post-Marketing Surveillance of Medicinal Products, Medical Devices, and Biocidal Products, ul. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +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

Keep the medicine out of the sight and reach of children. Do not store above 25°C. Store in the original package to protect from light. Do not use this medicine after the expiry date stated on the carton and bottle after the EXP. expiry date. The expiry date refers to the last day of the month stated. Once opened, the package should be used within 12 months. 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 pack and other information

What Ibuvit D contains:

• The active substance is cholecalciferol. Each ml (approximately 30 drops) of the 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, colorless to light yellow solution. The pack contains a 10 ml glass bottle, type III, with a HDPE screw cap and a LDPE dropper, in a cardboard box.

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 Division in Sieradz, ul. Władysława Łokietka 10, 98-200 Sieradz

Date of last revision of the leaflet: