Ibuvit d3 baby

Patient Information Leaflet

Ibuvit D Baby, 2,667 IU/ml, oral drops, solution
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 directed 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 side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If your condition does not improve or worsens, consult your doctor.

Contents of this leaflet

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

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

Ibuvit D Baby contains as the active substance vitamin D (cholecalciferol), which plays an
important role in bone formation and in supporting the immune system.
Cholecalciferol is identical to the vitamin D produced naturally in the human body.
Vitamin D is found in certain foods and is also synthesized 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, thereby supporting bone development. Vitamin D deficiency is a cause of rickets (impaired bone mineralization in children) and weakened immune function.
Ibuvit D Baby 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 during breastfeeding, in consultation with a doctor.

Prophylactic use of vitamin D is recommended during periods of insufficient sunlight exposure, from October to April, or throughout the year if effective cutaneous synthesis of vitamin D is not ensured during summer months.

2. Important information before using Ibuvit D3 Baby

When not to use Ibuvit D3 Baby:

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

Warnings and precautions
Before starting treatment with Ibuvit D3 Baby, consult your doctor or pharmacist:

• if the patient is taking certain medications used for heart conditions (e.g. cardiac glycosides such as digoxin) or thiazide diuretics (e.g. hydrochlorothiazide);
• 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 only be taken 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 D3 Baby (adequate sun exposure - see section 1.);
• if the patient has impaired or diseased kidneys;
• if vitamin D treatment is long-term, in which case the doctor should monitor serum and urinary calcium levels and assess kidney function by measuring blood creatinine levels.

Children
In premature infants, the daily requirement and method of vitamin D administration should be individually determined and regularly reviewed by the physician during routine check-ups, especially during the first months of life.
Intake of vitamin D from dietary supplements and food sources exceeding 1000 IU per day carries a risk of vitamin D overdose, particularly in newborns with a birth weight below 1000 g.

Ibuvit D3 Baby and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient intends to take.
This is especially important if the patient is taking:

• medications affecting the heart or kidneys, such as cardiac glycosides (e.g. digoxin) or thiazide diuretics (e.g. hydrochlorothiazide). Concomitant use with vitamin D may cause a significant increase in blood and urinary calcium levels;
• medications containing vitamin D, calcitriol, or other vitamin D metabolites and analogs, as well as foods rich in vitamin D;
• actinomycin (a drug 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) drugs;
• barbiturates (sedatives, anticonvulsants);
• glucocorticosteroids (steroid hormones, such as hydrocortisone or prednisolone);
• lipid-lowering agents (such as cholestyramine or colestipol);
• certain anti-obesity drugs that reduce fat absorption (e.g. orlistat);
• certain laxatives (e.g. liquid paraffin);
• antacids containing magnesium or aluminum (used for heartburn and indigestion);
• drugs used in the treatment of tuberculosis (e.g. rifampicin, isoniazid).

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 D3 Baby should be used during pregnancy and breastfeeding only under medical supervision.
Administration of vitamin D during pregnancy at a dose of 2000 IU per day may have beneficial effects for both pregnant women and their newborns.
During pregnancy, women should follow the advice of their attending physician, as individual requirements may vary depending on the degree of deficiency and response to treatment.

Driving and operating machinery
Ibuvit D3 Baby has no influence on the ability to drive or operate machinery.

3. How to use Ibuvit D3 Baby

This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Note: 1 dose (1 drop) contains 400 IU of vitamin D. The abbreviation IU (from English International Unit) refers to international units, which are used to express the biological activity of vitamin D.

Prevention of vitamin D deficiency and conditions resulting from vitamin D deficiency
For patients with normal body weight, during the months from October to April, or throughout the entire year if effective cutaneous synthesis of vitamin D is not ensured during summer months (see section 1).

Typical recommended daily doses:
Premature infants:
Ibuvit D3 Baby should be used in preterm infants only under medical supervision and as directed by a physician. The usual dose is 400–800 IU (1–2 drops), depending on the infant's health status, body weight, and gestational week at birth. Dosage must be determined by the treating physician.

Newborns and infants (up to 1 year of age):

• 400 IU (1 drop)
  Ibuvit D3 Baby should be administered according to the physician's recommendations.

Children aged 1 to 3 years:

• 400 IU (1 drop)

Children aged 4 to 10 years:

• 800 IU (2 drops)

Children with overweight
Children 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
The usual recommended daily dose is 2000 IU (5 drops), regardless of the time of year, unless otherwise advised by a physician.
During pregnancy, women should follow the advice of their physician, as their vitamin D requirements may vary depending on individual vitamin D stores.
Do not use Ibuvit D3 Baby for longer than recommended or in higher doses than indicated. Do not simultaneously use other medicines, dietary supplements, or fortified foods containing vitamin D (cholecalciferol), calcitriol, or other vitamin D metabolites or analogues without consulting a physician. Your doctor may recommend measuring serum 25(OH)D concentration.

Method of administration
Oral use.
Ibuvit D3 Baby is best taken during a meal.

Do not mix Ibuvit D3 Baby with milk in a bottle or with soft foods in containers, as the child may not consume the entire portion and thus may not receive the full dose. Ensure the complete dose is administered.

The solution must not be poured or pumped directly into the mouth from the bottle or dosing pump. Use the pump to measure the dose onto a spoon.

Instructions for preparing and using the medicine
Before first use, attach the dosing pump to the bottle. To remove the cap, unscrew it counterclockwise and then remove it (Fig. 1).

Attaching the dosing pump to the bottle:
Insert the plastic tube of the dosing pump carefully into the bottle. Hold the dosing pump firmly against the bottle neck and screw it on clockwise until tight (Fig. 2). The dosing pump should be attached only once, before first use. Do not unscrew or remove it afterward.

Preparing the dosing pump:
At first use, the dosing pump does not deliver the correct amount of oral solution. Therefore, it must be primed by pressing the pump head fully down five consecutive times (Fig. 3).

Discard any solution that leaks out of the pump. After this preparation, the next full compression of the dosing pump (corresponding to one pump activation) will deliver the correct dose (1 dose, equivalent to one full pump press, delivers 0.15 ml of oral solution and contains 400 IU of vitamin D; Fig. 4).

Correct use of the dosing pump:
Place the bottle upright on a flat, horizontal surface, such as a table. Place a spoon under the nozzle of the dosing pump and press the pump head firmly but steadily (not too slowly) until resistance is felt (Fig. 5).

Then release the pump head. The pump is now ready to deliver the next dose.
The dosing pump is intended solely for administering doses of Ibuvit D3 Baby from the supplied bottle. The pump must not be used to dose other substances or attached to other containers.
Store and transport the bottle with the attached dosing pump in an upright position only.

Accidental overdose of Ibuvit D3 Baby
If a patient accidentally takes one extra dose, symptoms of overdose are unlikely.
In case of overdose, inform a doctor or pharmacist or contact the nearest hospital emergency department for further advice. If possible, bring the package and this leaflet to show the doctor.

Missed dose of Ibuvit D3 Baby
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 Baby include:
Uncommon (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 1000 patients)

• rash
• itching
• urticaria

Frequency not known (cannot be estimated from available data)

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

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

5. How to store Ibuvit D Baby

Keep this medicine out of sight and reach of children.
Do not store above 25°C. Store in the outer packaging to protect from light.
Do not use this medicine after the expiry date stated on the carton and bottle. The expiry date refers to the last day of the stated month.
Once opened, use within 3 months.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What the medicine Ibuvit D Baby contains:

• The active substance is cholecalciferol. Each drop, which constitutes 1 dose, contains 400 IU of cholecalciferol (vitamin D).
• The other ingredient is: medium-chain triglycerides.

What Ibuvit D Baby looks like and contents of the pack
Ibuvit D Baby is a clear, colourless to pale yellow solution.
The container is an amber glass bottle (type III), with a PE cap with tamper-evident ring, equipped with a PP/LDPE dosing pump, packed in a cardboard box.
The pack contains 10 ml of solution.

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

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