bonevum

PATIENT INFORMATION LEAFLET: USER INFORMATION

bonevum
calcium + cholecalciferol
600 mg + 400 IU, coated tablets

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

This medicine should always be taken exactly as described in the patient information leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse after a month, they should contact their doctor.

Table of contents of the leaflet:

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

1. WHAT IS BONEVUM AND WHAT IS IT USED FOR

This is a combination medicine containing calcium (in the form of calcium carbonate) and cholecalciferol (vitamin D).
The medicine is recommended for elderly people to prevent and treat calcium and vitamin D deficiency, substances necessary for bone formation and normal bone metabolism.
It is also recommended as a supplement to specific osteoporosis treatment in patients who are at high risk of calcium and vitamin D deficiency.

2. IMPORTANT INFORMATION BEFORE TAKING BONEVUM

When not to take Bonevum:

• if the patient is allergic to the active substances or any of the other ingredients of this medicine (listed in section 6);
• if the patient has kidney stones;
• if the patient has kidney failure or impaired kidney function;
• if the patient has an excessive amount of vitamin D in the blood;
• if the patient has a chronically elevated calcium level in the urine;
• Bonevum contains hydrogenated soybean oil. If the patient is allergic to soy or peanuts, this medicine should not be taken.

Warnings and precautions

Before taking Bonevum, the patient should discuss it with their doctoror pharmacist:

• if the patient has kidney disease or impaired kidney function;
• if the patient has sarcoidosis (an inflammatory disease of unknown origin, characterized by the formation of cell clusters in various locations);
• if the patient has a tendency to form kidney stones;
• if the patient is immobilized and has osteoporosis.

The doctor should decide whether calcium and/or vitamin D can be administered in these cases.
If the patient takes the medicine without a doctor's recommendation, they should always consult a doctor if they take it for more than one month.
If the patient is to receive Bonevum for osteoporosis treatment, the doctor may check the calcium level in the blood before starting treatment with Bonevum.
During long-term treatment, the doctor may regularly check the calcium level in the blood and kidney function. Depending on the results, the doctor may reduce the dose or decide to stop the treatment.

Children and adolescents

Bonevum is not intended for use in children and adolescents.

Bonevum and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, including those available without a prescription.
The patient should consult their doctor if they are taking:

• other medicines containing vitamin D or calcium, as taking these medicines with Bonevum may lead to a significant increase in calcium levels in the blood and cause side effects. During Bonevum treatment, the patient should not take any other medicines containing calcium or vitamin D without consulting their doctor;
• thiazide diuretics;
• systemic corticosteroids (anti-inflammatory medicines taken orally or intravenously);
• digitalis glycosides (used to treat heart failure).

The patient should be particularly careful if they are taking:

• ion exchange resins, such as cholestyramine, or laxatives like paraffin oil, as these medicines may reduce the absorption of vitamin D from the gastrointestinal tract;
• medicines containing tetracyclines (antibiotics), as calcium carbonate may interfere with their absorption. Therefore, medicines containing tetracyclines should be taken at least two hours before or four to six hours after taking Bonevum;
• medicines called bisphosphonates (used to treat osteoporosis) or sodium fluoride. If these medicines are taken with Bonevum, they should be taken at least three hours before taking Bonevum;
• the absorption of quinolone antibiotics may be limited if taken with calcium. Quinolone antibiotics should be taken at least 2 hours before or at least 6 hours after taking a calcium-containing medicine;
• rifampicin (used to treat tuberculosis), phenytoin (a medicine used to treat epilepsy), and barbiturates (medicines used to treat epilepsy or as sedatives), as they may reduce the effectiveness of vitamin D;
• estramustine (a medicine used in chemotherapy), thyroid hormones, or medicines containing iron, zinc, or strontium, as their absorption may be reduced. They should be taken at least 2 hours before or after taking Bonevum.

Bonevum with food and drink

Oxalic acid (found in spinach, sorrel, and rhubarb) and phytic acid (found in whole grain cereals) may inhibit calcium absorption. After consuming foods high in oxalic acid or phytic acid, the patient should not take Bonevum for 2 hours.

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 taking this medicine.
During pregnancy, the daily intake of calcium should not exceed 1500 mg of calcium and 600 IU (international units) of vitamin D. Pregnant women should avoid overdosing on calcium and vitamin D, as prolonged hypercalcemia may have a negative effect on fetal development.
Bonevum can be used during pregnancy in recommended doses only in case of calcium and vitamin D deficiency. Otherwise, the daily dose of Bonevum should not exceed one tablet.
Bonevum can be used during breastfeeding, but the doctor should inform the patient that calcium and vitamin D pass into breast milk. This should be taken into account when additionally administering vitamin D to the child.
There is no data on the effect of Bonevum on fertility.

Driving and using machines

There is no data on the effect of the medicine on the ability to drive and use machines.

Bonevum contains soybean oil and sucrose.

• Bonevum contains hydrogenated soybean oil. If the patient is allergic to soy or peanuts, this medicine is not recommended.
• Bonevum contains sucrose. If the patient has been previously informed of intolerance to some sugars, they should contact their doctor before starting treatment with this medicine.

3. HOW TO TAKE BONEVUM

Bonevum should always be taken as directed in this leaflet or as advised by a doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist.
Usually, the recommended dose for adults and the elderly is one coated tablet twice a day.
It is recommended to swallow the coated tablets 1-1.5 hours after a meal, with a glass of water or juice, without chewing. If necessary, the tablet can be broken in half.
Bonevum should be taken continuously during the period of the indicated physiological condition or disease (osteoporosis). The patient should consult their doctor at least once a year during Bonevum treatment if it is used as a supplement in osteoporosis treatment.

Use in children and adolescents

The Bonevum coated tablet is not intended for children and adolescents.

Taking a higher dose of Bonevum than recommended

Taking a higher dose than recommended may cause an overdose of calcium and vitamin D.
Symptoms of calcium overdose: loss of appetite, thirst, nausea, vomiting, constipation, stomach pain, bone pain, excessive thirst, frequent urination, muscle weakness, fatigue, mental disorders, or increased calcium excretion in the urine (hypercalciuria).
Very severe calcium overdose can lead to coma and death. Persistent high calcium levels in the blood can cause irreversible kidney failure and soft tissue calcification.
Treatment: the patient should stop taking Bonevum and consult their doctor.

Missing a dose of Bonevum

The patient should not take a double dose to make up for a missed tablet, as there is a risk of overdose.
The patient should continue taking the medicine according to the previous schedule.
If the patient has any further doubts about taking the medicine, they should consult their doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Bonevum can cause side effects, although not everybody gets them.
The following side effects are listed by system organ class and frequency:

• uncommon: (affects 1 to 10 in 1000 patients)
• rare: (affects 1 to 10 in 10,000 patients)
• very rare: (affects less than 1 in 10,000 patients)

Uncommon: elevated calcium levels in the blood (hypercalcemia) – symptoms include: nausea, vomiting, loss of appetite, constipation, stomach pain, bone pain, excessive thirst, frequent urination, muscle weakness, drowsiness, disorientation, or increased calcium excretion in the urine (hypercalciuria).
Rare: constipation, bloating, nausea, stomach pain, diarrhea, itching, rash, hives.
Very rare: "milk-alkali" syndrome (mainly in case of overdose).

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should consult 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, Al. 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.
Reporting side effects will help to gather more information on the safety of the medicine.

5. HOW TO STORE BONEVUM

Do not store above 25°C. Store in the original package to protect from moisture. Store out of sight and reach of children.
Do not use Bonevum after the expiry date stated on the package (EXP).
The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. 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 PACK AND OTHER INFORMATION

What Bonevum contains

Active substances:400 IU cholecalciferol (which corresponds to 10 micrograms) (+10% stability surplus), 600 mg calcium (in the form of 1500 mg calcium carbonate) in each coated tablet.
Also contains:
Core: magnesium stearate, crospovidone (type A), copovidone (K value: 25.2 – 30.8),
microcrystalline cellulose, sucrose, gelatin, all-rac-α-tocopherol (E 307), hydrogenated soybean oil,
corn starch.
Coating: iron oxide yellow (E 172), hypromellose (15 mPa s), titanium dioxide (E 171), macrogol 3350, talc.

What Bonevum looks like and contents of the pack

The coated tablet is ochre-colored, oval-shaped, with a dividing line on one side.
The break line surface is white. The dividing line is intended to facilitate breaking the tablet to make it easier to swallow, not to divide the tablet into equal parts.
The carton contains 10 coated tablets packaged in transparent and colorless blisters (PCV/Alu) of 3, 6, or 9 pieces.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:
US Pharmacia Sp. z o.o.
ul. Ziębicka 40
50-507 Wrocław

Manufacturer:

Béres Pharmaceuticals Ltd.
H-5000 Szolnok, Nagysándor József út 39
Hungary
To obtain more detailed information about this medicine, the patient should contact the representative of the marketing authorization holder:
USP Zdrowie Sp. z o.o., ul. Poleczki 35, 02-822 Warsaw, tel.: +48 (22) 543 60 00.

This medicinal product is authorized in the Member States of the European

Economic Area under the following names:
Poland:
bonevum
Bulgaria, Hungary:
CalciviD
Czech Republic:
Videmel
Estonia:
CalciviD 600 mg/400 IU
Latvia:
CalciviD 600 mg/400 SV apvalkotā tablete
Romania:
Calcium Colecalciferol Béres 600 mg/400 IU comprimat filmat
Slovakia:
Kalcizen

Date of last revision of the leaflet: