Boncel 25 000 i.m.

LEAFLET INCLUDED IN THE PACKAGING

Leaflet included in the packaging: information for the patient

Boncel, 25,000 IU, oral solution

Boncel, 100,000 IU, oral solution

Cholecalciferol

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What is Boncel and what is it used for

Boncel is a vitamin medicine.
Boncel 25,000 IU
Boncel contains 0.625 mg of cholecalciferol (vitamin D), which corresponds to 25,000 IU.
Boncel 100,000 IU
Boncel contains 2.5 mg of cholecalciferol (vitamin D), which corresponds to 100,000 IU.
IU (International Unit) means international units.
Boncel, 25,000 IU or 100,000 IU is intended for the initial symptomatic treatment of vitamin D deficiency in adults.

2. Important information before taking Boncel

When not to take Boncel

• if the patient is allergic to cholecalciferol or any of the other ingredients of this medicine (listed in section 6);
• if the patient is under 18 years old;
• if the patient has hypercalcemia (elevated calcium levels in the blood) and (or)
• if the patient has hypercalciuria (excessive excretion of calcium in the urine);
• if the patient has pseudohypoparathyroidism (a disorder of parathyroid hormone metabolism), as the need for vitamin D may be reduced due to periods of normal sensitivity to vitamin D, leading to the risk of prolonged overdose. In such cases, vitamin D derivatives are available, whose concentration is easier to control;

in patients with impaired renal function taking Boncel, the effect on calcium and phosphate balance should be monitored.
In case of exposure to intense sunlight while taking Boncel, the dose of vitamin D in Boncel should be taken into account.
Additional calcium supplementation should only be carried out under medical supervision. In this case, calcium and phosphate levels in the blood and urine should be monitored.
Oral administration of high doses of vitamin D (500,000 IU in a single annual bolus) leads to an increased risk of fractures in the elderly, with the greatest increase in risk occurring within the first 3 months after administration.
During long-term treatment with Boncel, calcium levels in the blood and urine, as well as kidney function, should be monitored by measuring serum creatinine levels. This control is particularly important for elderly patients, in case of concomitant use of cardiac glycosides (stimulating heart muscle function) or diuretics. In case of hypercalcemia or signs of impaired renal function, the dose should be reduced or treatment discontinued. Reduction of the dose or discontinuation of treatment is recommended when the calcium content in the urine is higher than 7.5 mmol/24 h (300 mg/24 h).

Children and adolescents

Boncel should not be used in children and adolescents under 18 years old.

Boncel and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Rifampicin (an antibiotic), isoniazid (an antibiotic), phenytoin (used to treat epilepsy) or barbiturates (used to treat epilepsy, sleep disorders, and for anesthesia) may weaken the effect of vitamin D.
Thiazide diuretics (e.g., benzothiadiazine derivatives) are medicines that stimulate urine excretion and may lead to hypercalcemia due to reduced excretion of calcium by the kidneys. Therefore, during long-term treatment, calcium levels in the blood and urine should be monitored.
Concomitant administration of glucocorticoids (used to treat certain allergic diseases) may weaken the effect of vitamin D.
The risk of side effects may increase when taking cardiac glycosides (used to stimulate heart function) concomitantly, due to increased calcium levels in the blood during vitamin D treatment (risk of cardiac arrhythmias). The patient's ECG and calcium levels in the blood and urine should be monitored.
It is recommended to avoid combining Boncel with vitamin D metabolites or analogs. Concomitant treatment with ion-exchange resins such as cholestyramine or laxatives such as paraffin oil may reduce the absorption of vitamin D in the gastrointestinal tract.
Actinomycin (used to treat certain types of cancer) and imidazole antifungal medicines (such as clotrimazole and ketoconazole, used to treat fungal diseases) may affect vitamin D metabolism.
All other medicines taken recently by the patient should be considered.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
This medicine is highly potent and is not recommended for use in pregnant or breastfeeding women.

Driving and using machines

No special precautions are necessary.

3. How to take Boncel

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist.
The dose should be determined individually by the treating doctor. If not otherwise specified, a single total dose of 100,000 IU is usually administered over one week.
One ampoule of Boncel 100,000 IU can be administered in a single dose or 4 ampoules of Boncel 25,000 IU over the course of a week (100,000 IU).
Method of administration
Drops should be taken or administered according to the dosing instructions.
Adults should take Boncel with a spoonful of liquid.

Taking a higher dose of Boncel than recommended

Overdose symptoms
Ergocalciferol (vitamin D) and cholecalciferol (vitamin D) have a relatively low therapeutic index. The threshold for vitamin D poisoning is between 40,000 and 100,000 IU per day for 1 to 2 months in adults with normal parathyroid function. Infants and young children may react strongly to much lower doses. Therefore, caution is advised against taking vitamin D without medical supervision.
Overdose leads to an increase in phosphate levels in the blood and urine, as well as hypercalcemia, and consequently contributes to the formation of calcium deposits in tissues, particularly in the kidneys (kidney stones and kidney calcification) and blood vessels.
Overdose symptoms are non-specific and manifest as nausea, vomiting, initially diarrhea, then constipation, loss of appetite, fatigue, headache, muscle pain, joint pain, muscle weakness, excessive sleepiness, azotemia (elevated nitrogen levels in the blood), increased thirst, increased need to urinate, and finally dehydration. Typical laboratory test results show hypercalcemia (elevated calcium levels in the blood), hypercalciuria (elevated calcium levels in the urine), and elevated 25-hydroxycholecalciferol levels in the serum.
Treatment of overdose
Overdose requires measures to treat hypercalcemia (elevated calcium levels in the blood), often persistent and potentially life-threatening.
The first step is to discontinue vitamin D administration; the disappearance of hypercalcemia due to vitamin D poisoning takes several weeks.
Depending on the degree of hypercalcemia, treatment includes a calcium-free diet or a diet low in calcium, high fluid intake, increased urine excretion with furosemide, and administration of glucocorticoids (used to treat certain allergic diseases) and calcitonin (a hormone regulating calcium levels in the blood).
If kidney function is sufficient, blood calcium levels can be lowered by infusion of isotonic sodium chloride solution (3-6 liters over 24 hours) with added furosemide, and in some cases also 15 mg/kg body weight/hour of disodium edetate (a calcium-chelating agent), with continuous monitoring of calcium levels and ECG. If urine excretion is limited, hemodialysis with a calcium-free dialysate is recommended.
There is no specific antidote.
The patient should ask their doctor about overdose symptoms of vitamin D.

Missing a dose of Boncel

A double dose should not be taken to make up for a missed dose.

Stopping Boncel treatment

If treatment is discontinued or stopped prematurely, the patient's symptoms may worsen or recur.
The patient should discuss this with their doctor.
If the patient has any further doubts about the use of this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Boncel can cause side effects, although not everybody gets them.
Vitamin D may cause the following side effects, particularly in case of overdose.
The patient should stop taking Boncel and seek medical help immediately if they experience any symptoms of a severe allergic reaction, such as:

• swelling of the face, lips, tongue, or throat;
• difficulty swallowing;
• hives and difficulty breathing.

Metabolic and nutritional disorders:
Excessive calcium levels in the blood and urine (hypercalcemia, hypercalciuria).
Gastrointestinal disorders:
Constipation, bloating, nausea, abdominal pain, stomach pain, diarrhea.
Skin and subcutaneous tissue disorders
Itching, rash (pruritus/urticaria).
The frequency of the above side effects is not known (cannot be estimated from the available data).

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their 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
Jerozolimskie Avenue 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, more information can be gathered on the safety of the medicine.

5. How to store Boncel

Do not store above 30°C.
Store in the original packaging to protect from light.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after: EXP.
The expiry date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Boncel contains

• The active substance of Boncel is cholecalciferol. Each 1 ml ampoule contains 0.625 mg or 2.5 mg of cholecalciferol (vitamin D), which corresponds to 25,000 IU or 100,000 IU
• The other ingredients are: tocopherol acetate, polyglyceryl oleate (E 475), purified olive oil, sweet orange peel oil.

What Boncel looks like and contents of the packaging

Transparent PVC/PVDC/PE ampoules.
Boncel is available in cardboard boxes containing 1, 2, 3, or 4 ampoules of 1 ml PVC/PVDC/PE.
Boncel 25,000 IU is also available in a packaging containing 48 ampoules of 1 ml PVC/PVDC/PE for hospital use.
Transparent PVC/PVDC/PE ampoules in a transparent bag:
Boncel is available in cardboard boxes containing 1, 2, 3, or 4 ampoules of 1 ml PVC/PVDC/PE.
Boncel 25,000 IU is also available in a packaging containing 48 ampoules of 1 ml PVC/PVDC/PE for hospital use.

Marketing authorization holder and manufacturer

Marketing authorization holder
UAB "Orivas"

• J. Jasinskio g. 16B LT-03163 Vilnius, Lithuania Tel: +370 525 265 70

Manufacturer
SMB Technology S.A.
rue du parc industriel 39
6900 Marche-en-Famenne
Belgium
This medicine is authorized in the Member States of the European Economic Area under the following names:
Germany:
HELIODREI 25,000/100,000 IU
Belgium:
D-CURE FORTE 100,000 IU
Cyprus:
LECALCIF 25,000/100,000 IU
Greece:
LECALCIF 25,000/100,000 IU
Luxembourg:
D-CURE FORTE 100,000 IU
Netherlands:
D-CURA 25,000/100,000 IU
Poland:
Boncel 25,000/100,000 IU
Portugal:
D MED AZEVEDOS 25,000/100,000 IU

Date of last revision of the leaflet: 05/2024