Boncel 100 000 j.m.

PACKAGE LEAFLET

Package leaflet: Information for the patient

Boncel, 25,000 IU, oral solution
Boncel, 100,000 IU, oral solution
Cholecalciferolum
Please read carefully all the information in this leaflet before taking the medicine, as it contains important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

1. What Boncel is and what it is 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 package and other information

1. What Boncel is and what it is used for

Boncel is a vitamin preparation.
Boncel 25,000 IU
Boncel contains 0.625 mg of cholecalciferol (vitamin D), equivalent to 25,000 IU.
Boncel 100,000 IU
Boncel contains 2.5 mg of cholecalciferol (vitamin D), equivalent to 100,000 IU.
IU (International Unit) refers to international units.
Boncel 25,000 IU or 100,000 IU is intended for 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 to any of the other ingredients of this medicine (listed in section 6);

• if the patient is under 18 years of age;

• if the patient has hypercalcaemia (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), because the requirement for vitamin D may be reduced due to periods of normal
  sensitivity to vitamin D, leading to the risk of chronic overdose. In such cases,
  vitamin D derivatives are available whose concentrations are easier to control;

• if the patient is prone to forming calcium-containing kidney stones;

• if the patient has severe kidney dysfunction;

• if the patient has hypervitaminosis D;

• if the patient is taking other medicines containing vitamin D.

Warnings and precautions
High-concentration vitamin D solutions may easily lead to vitamin D poisoning in case of incorrect dosing. Therefore, severe cases of hypercalcaemia have been reported after administration of high doses of vitamin D.
Before starting to take Boncel, discuss the following with your doctor or pharmacist:

• if the patient has impaired excretion of calcium and phosphates by the kidneys;
• if the patient is being treated with benzothiadiazine derivatives (used to stimulate urine excretion);
• if the patient is immobilized, as immobilized patients are at risk of developing hypercalcaemia (increased blood calcium levels) and hypercalciuria (increased urinary calcium levels);
• if the patient has sarcoidosis, because there is a risk of enhanced conversion of vitamin D into its active form. In this case, calcium and phosphate levels in blood and urine should be monitored;
• if the patient develops symptoms resembling overdose symptoms (see section 3) shortly after starting treatment, even if the patient follows the recommended dosage. In such a case, contact a doctor immediately, as this may be due to an undiagnosed inherited metabolic disorder (idiopathic infantile hypercalcaemia).

In patients with impaired kidney function receiving Boncel, the effect on calcium and phosphate balance should be monitored.
In case of exposure to intense sunlight during treatment with Boncel, the vitamin D content of Boncel should be taken into account.
Additional calcium supplementation should be administered only under medical supervision. In such cases, calcium and phosphate levels in blood and urine should be monitored.
Oral administration of high doses of vitamin D (500,000 IU as a single annual bolus) increases the risk of fractures in elderly individuals, with the highest risk increase occurring within the first 3 months after administration.
During long-term treatment with Boncel, serum calcium levels and urinary calcium excretion should be monitored, and kidney function should be checked by measuring serum creatinine. This monitoring is particularly important for elderly patients and when Boncel is used concomitantly with cardiac glycosides (used to stimulate heart muscle function) or diuretics. If hypercalcaemia or signs of kidney dysfunction occur, the dose should be reduced or treatment discontinued. Dose reduction or treatment interruption is recommended when urinary calcium excretion exceeds 7.5 mmol/24 h (300 mg/24 h).

Children and adolescents
Boncel must not be used in children and adolescents under 18 years of age.

Boncel and other medicines
Tell your doctor or pharmacist about any other medicines the patient is currently taking, has recently taken, or plans to take.
Rifampicin (an antibiotic), isoniazid (an antibiotic), phenytoin (used in the treatment of epilepsy), or barbiturates (used in the treatment of epilepsy, sleep disorders, and for anaesthesia) may reduce the effectiveness of vitamin D.
Thiazide diuretics (e.g. benzothiadiazine derivatives) are medicines that stimulate urine production and may lead to hypercalcaemia due to reduced renal calcium excretion. Therefore, during long-term treatment, calcium levels in blood and urine should be monitored.
Concomitant use of glucocorticoids (used in the treatment of certain allergic conditions) may reduce the effectiveness of vitamin D.
The risk of adverse effects may increase when cardiac glycosides (used to stimulate heart muscle function) are taken concurrently, due to elevated blood calcium levels during vitamin D treatment (risk of cardiac arrhythmias). ECG, as well as calcium levels in blood and urine, should be monitored.
Combining Boncel with vitamin D metabolites or analogues should be avoided. Concurrent treatment with ion-exchange resins such as cholestyramine or laxatives such as liquid paraffin may reduce gastrointestinal absorption of vitamin D.
Actinomycin (used in the treatment of certain types of cancer) and imidazole antifungal agents (such as clotrimazole and ketoconazole, used in the treatment of fungal infections) may affect vitamin D metabolism.
All other medicines recently taken by the patient should be taken into consideration.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a 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 operating machinery
No special precautions are necessary.

3. How to take Boncel

This medicine should always be taken according to the recommendations of a doctor or pharmacist. If you have any doubts,
you should consult a doctor or pharmacist.
The dose should be individually determined by the treating physician. Unless otherwise indicated,
the usual dose is a single total dose of 100,000 IU administered within one week.
One ampoule of Boncel 100,000 IU may be given as a single dose, or four ampoules of Boncel 25,000 IU
may be administered during the week (100,000 IU).
Method of administration
The drops should be taken or administered according to the dosing recommendations.
Adults should take Boncel with a spoonful of liquid.
Taking more Boncel than recommended
Symptoms of overdose
Ergocalciferol (vitamin D_) and cholecalciferol (D_) have a relatively low therapeutic index. The toxic threshold
for vitamin D 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 significantly lower doses. Therefore, vitamin D should not be taken
without medical supervision.
Overdose leads to increased levels of phosphorus in blood and urine, as well as to hypercalcemia,
and consequently contributes to calcium deposits in tissues, particularly in the
kidneys (kidney stones and nephrocalcinosis) and blood vessels.
Symptoms of poisoning are nonspecific and include nausea, vomiting, initially also diarrhea, later constipation,
loss of appetite, fatigue, headache, muscle pain, joint pain, muscle weakness, excessive drowsiness, azotemia (elevated blood nitrogen levels), increased thirst, increased need to urinate, and in the final stage, dehydration.
Typical laboratory findings show hypercalcemia (elevated calcium levels in blood), hypercalciuria
(elevated calcium levels in urine), and increased plasma concentration of 25-hydroxycholecalciferol.
Treatment of overdose
Overdose requires measures to treat hypercalcemia (elevated calcium levels in blood), which may persist
and in certain circumstances may be life-threatening.
The first step is to discontinue vitamin D intake; resolution of hypercalcemia (elevated calcium levels in blood)
due to vitamin D poisoning may take several weeks.
Depending on the severity of hypercalcemia (elevated calcium levels in blood), management includes a calcium-free or low-calcium diet, adequate fluid intake, increased urine excretion using furosemide, and administration of glucocorticoids (used in the treatment of certain allergic diseases) and calcitonin (a hormone regulating blood calcium levels).
If kidney function is adequate, blood calcium levels may be reduced by infusion of isotonic sodium chloride solution (3–6 liters within 24 hours) supplemented with furosemide, and in certain circumstances also with 15 mg/kg body weight/hour of sodium edetate (a calcium-binding 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.
You should consult your doctor regarding symptoms of vitamin D overdose.
Missing a dose of Boncel
Do not take a double dose to make up for a missed dose.
Stopping Boncel treatment
If treatment is interrupted or prematurely discontinued, the patient's symptoms may worsen or recur.
You should discuss this with your doctor.
If you have any further doubts concerning 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 will experience them.
Vitamin D may cause the following adverse reactions, especially in case of overdose.
Discontinue taking Boncel and seek immediate medical help if any symptoms of a severe allergic reaction occur, such as:

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

Metabolism and nutrition disorders:
Excess calcium in the blood and urine (hypercalcaemia, hypercalciuria).
Gastrointestinal disorders:
Constipation, bloating, nausea, abdominal pain, stomach pain, diarrhoea.
Skin and subcutaneous tissue disorders:
Itching, rash (pruritus/urticaria).
The frequency of occurrence of the above-mentioned adverse reactions is not known (cannot be estimated from the available data).
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 of the 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 the medicine.

5. How to store Boncel 25 000 j.m.

Do not store above 30°C.
Keep in the original packaging to protect from light.
Keep the medicine out of the 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 stated month.
Medicines must not be disposed of via wastewater. 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 Boncel contains

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

What Boncel looks like and contents of the pack
Clear PVC/PVDC/PE ampoules.
Boncel is available in cardboard boxes containing 1, 2, 3 or 4 ampoules of 1 ml
with PVC/PVDC/PE.
Boncel 25,000 IU is also available in a pack containing 48 ampoules of 1 ml with
PVC/PVDC/PE for hospital use.
Clear PVC/PVDC/PE ampoules in a transparent pouch:
Boncel is available in cardboard boxes containing 1, 2, 3 or 4 ampoules of 1 ml
with PVC/PVDC/PE.
Boncel 25,000 IU is also available in a pack containing 48 ampoules of 1 ml with
PVC/PVDC/PE for hospital use.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
UAB "Orivas"
J. Jasinskio g. 16B
LT-03163 Vilnius
Lithuania
Tel: +37052526570

Manufacturer
SMB Technology S:A.
rue du parc industriel 39
6900 Marche-en-Famenne
Belgium

This medicinal product is authorised in the European Economic Area countries 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