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BONECOLE 1000 IU FILM-COATED TABLETS

Active substance(s): CHOLECALCIFEROL / CHOLECALCIFEROL CONCENTRATE (POWDER FORM)

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Package leaflet: Information for the user
BONECOLE 800 IU Film-coated Tablets
BONECOLE 1 000 IU Film-coated Tablets
BONECOLE 7 000 IU Film-coated Tablets
BONECOLE 30 000 IU Film-coated Tablets
cholecalciferol (vitamin D3)

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or
pharmacist.
• This medicine has been prescribed for you only. Do
not pass it on to others. It may harm them, even if
their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet.
What is in this leaflet
1. What BONECOLE Film-coated Tablets are and what
they are used for
2. What you need to know before you take BONECOLE
Film-coated Tablets
3. How to take BONECOLE Film-coated Tablets
4. Possible side effects
5. How to store BONECOLE Film-coated Tablets
6. Contents of the pack and other information
1. What BONECOLE Film-coated Tablets are and
what they are used for
The active substance of BONECOLE Film-coated
Tablets is vitamin D3.
Vitamin D helps the body to absorb calcium and enhances bone formation and decreases the level of parathyroid hormone (PTH).
This medicine is recommended in the following cases:
• For certain bone conditions, such as thinning of the
bone (osteoporosis), when it will be given to you
with other medicines.
• To prevent or treat vitamin D deficiency. Vitamin D
deficiency may occur when your diet or lifestyle
does not provide you enough vitamin D or when
your body requires more vitamin D (e.g. when you
are pregnant).
BONECOLE is used in adults, the elderly and adolescents
2. What you need to know before you take
BONECOLE Film-coated Tablets
Do not take BONECOLE Film-coated Tablets if:
• if you are allergic to vitamin D or any of the other ingredients of this medicine (listed in section 6),
• if you have high levels of calcium in your blood or
urine,
• if you have kidney stones or calcium deposits in
your kidneys,
• if you have severe renal impairment
• if you are already taking additional doses of vitamin
D (e.g. multivitamins or food supplements containing vitamin D).
Warnings and precautions
If any of the following applies to you, please tell your
doctor:
• You have a high tendency to kidney stone formation
• You have cancer or any other condition that may
have affected your bones
• You have parathyroid hormone imbalance (pseudohypoparathyroidism)
If you have any of the following conditions, your doctor will monitor the levels of calcium or phosphate in
your blood, or the level of calcium in your urine:
• If you are on long term treatment with this medicine.
• If you have kidney problems,
• If you suffer from “sarcoidosis”; an immune system
disorder which may affect your liver, lungs, skin or
lymph nodes.

BONECOLE BT ENG 160x360.indd 1

Other medicines and BONECOLE Film-coated Tablets
Tell your doctor if you are taking, have recently taken
or might take any other medicines, including medicines
obtained without a prescription.
In par ticular, tell your doctor if you are taking any of
the following medicines:
• diuretics (water tablets) – your blood calcium levels
will be monitored regularly;
• cor ticosteroids (‘steroids’ e.g. prednisolone, dexamethasone) – your dose of Vitamin D may need to
be increased;
• cholestyramine (a cholesterol lowering medicine) or
laxatives (e.g. paraffin oil) – they reduce vitamin D
absorption;
• heart medicines (cardiac glycosides) – you should
be monitored by a physician and possibly your ECG
and your blood calcium levels will be monitored,
• anticonvulsants (for the treatment of epilpsy), sleeping medicines (e.g. hydantoin, barbiturates) or primidone – these reduce the effect of vitamin D;
• calcitonin, etidronate, gallium nitrate, pamidronate or
plicamycin – these decrease blood calcium levels;
• calcium containing products in high doses: these increase the risk of high blood calcium levels;
• magnesium containing products (e.g. antacids) –
these should not be used during treatment with vitamin D because of the risk of high magnesium levels;
• phosphorus containing products in large doses –
these increase the risk of high phosphate blood levels.
Pregnancy and breast-feeding
If you are pregnant, think you may be pregnant or are
planning to have a baby, or breast-feeding, ask your
doctor for advice before taking this medicine.
If you are breast-feeding, your doctor will monitor the
levels of calcium or phosphate in your blood, or the
level of calcium in your urine.
Driving and using machines
There is no known effect on your ability to drive or use
machines.
BONECOLE Film-coated Tablets contain lactose and
sucrose
If your doctor has previously told you that you have an
intolerance to certain sugars, talk to your your doctor
before taking this medicine.
3. How to take BONECOLE Film-coated Tablets
Always take this medicine exactly as your doctor has
told you. Check with your doctor or pharmacist if you
are not sure.
The tablets can be taken with or without food.
Dosage
800 IU and 1000 IU Film-coated Tablets:
Your doctor will usually prescribe 1 tablet daily. In severe vitamin D deficiency for the adult and the elderly,
the amount will depend on your vitamin D levels and
on the response given to the treatment.
7000 IU Film-coated Tablets:
Your doctor will usually prescribe 1 tablet weekly. In
severe vitamin D deficiency for the adult and the elderly, the amount will depend on your vitamin D levels and
on the response given to the treatment.
30000 IU Film-coated Tablets:
Your doctor will usually prescribe 1 tablet monthly. In
severe vitamin D deficiency for the adult and the elderly, the amount will depend on your vitamin D levels and
on the response given to the treatment.

Színforrás Kft. – Gergely Attila

2016.02.03. 13:06:23

Patients with kidney problems
Your doctor may arrange regular blood and/or urine
tests for you.
Children
BONECOLE is not suitable for children under 12 years.
If you take more BONECOLE Film-coated Tablets
than you should
You may develop the following symptoms: loss of appetite, thirst, nausea, vomiting, constipation, abdominal pain, muscle weakness, tiredness, confusion, having to pass more urine than usual, bone pain, kidney
problems, and in severe cases, irregular hear tbeat,
coma or even death.
If you take too many tablets, contact your doctor immediately or go to the emergency depar tment of the
nearest hospital. Take the packet and any remaining
tablets with you.
If you have any fur ther questions on the use of this
medicine, ask your doctor or pharmacist.

BONECOLE 7000 IU Film-coated Tablets: each filmcoated tablet contains 70 mg cholecalciferol concentrate (powder form) (equivalent to 175 µg cholecalciferol = 7000 IU vitamin D3).
BONECOLE 30000 IU Film-coated Tablets: each filmcoated tablet contains 300 mg cholecalciferol concentrate (powder form) (equivalent to 750 µg cholecalciferol = 30000 IU vitamin D3).
The other ingredients:
-- Tablet core: cellactose 80 (lactose monohydrate
and powdered cellulose (E460 (ii)) modified starch,
maize starch, croscarmellose sodium (E468), sucrose, colloidal anhydrous silica (E551), colloidal
hydrous silica (E551), magnesium stearate (E572),
sodium ascorbate (E301), medium chain triglycerides, DL-alpha-tocopherol (E307).
-- Coating: Opadry II Yellow 85F 32659 consisting of
polyvinyl alcohol (E1203), titanium dioxide (E171),
macrogol, talc (E553b), quinoline yellow aluminum
lake (E104), yellow iron oxide (E172).
What BONECOLE Film-coated Tablets look like and
contents of the pack

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking BONECOLE and seek immediate medicinal
help if you experience symptoms of serious allergic reactions, such as:
• swollen face, lips, tongue or throat
• difficult to swallow
• hives and difficulty breathing.
Uncommon side effects (may affect up to 1 in 100
people):
• too much calcium in your blood (hypercalcaemia) –
symptoms include nausea, vomiting, lack of appetite, constipation, stomach ache, bone pain, extreme
thirst, a need to pass more water than usual, muscle
weakness, drowsiness and confusion.
• too much calcium in your urine (hypercalciuria).
Rare side effects (may affect up to 1 in 1,000 people):
• Pruritus, rash and urticaria
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also repor t side effects directly via the Yellow Card Scheme at: www.mhra.gov.
uk/yellowcard. By reporting side effects you can help
provide more information on the safety of this medicine.
5. How to store BONECOLE Film-coated Tablets
Keep this medicine out of the sight and reach of children.
Store below 25 °C.
Store in the original package in order to protect from
light.
Do not use this medicine after the expiry date which is
stated on the carton. The expiry date refers to the last
day of that month.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures
will help protect the environment.

BONECOLE 800 IU Film-coated Tablets:
yellow coloured, round, 6 mm diameter film-coated
tablets with smooth convex surface on both sides.
Pack sizes: 30, 60 or 90 film-coated tablets in opaque
PVD/PVdC-Alu blisters and box.
BONECOLE 1000 IU Film-coated Tablets:
yellow coloured, round, 7 mm diameter film-coated
tablets with smooth convex surface on both sides and
‘D’ embossed on one side.
Pack sizes: 30, 60 or 90 film-coated tablets in opaque
PVD/PVdC-Alu blisters and box.
BONECOLE 7000 IU Film-coated Tablets:
yellow coloured, round, 7 mm diameter film-coated
tablets with smooth convex surface on both sides and
‘W’ embossed on one side.
Pack sizes: 4, 8 or 12 film-coated tablets in opaque
PVD/PVdC-Alu blisters and box.
BONECOLE 30000 IU Film-coated Tablets:
yellow coloured, round, 13 mm diameter film-coated
tablets with smooth convex surface on both sides.
Pack sizes: 1, 2 or 3 film-coated tablets in opaque
PVD/PVdC-Alu blisters and box.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Radaydrug Kft.
Rózsavölgy u.151.
4225 Debrecen
Hungary
+36 52 537 432
+36 52 537 433
info@radaydrug.com
Manufacturer
ExtractumPharma zrt.
6413 Kunfehértó, IV. körzet 6.
Hungary
This leaflet was last revised in 01/2016

6. Contents of the pack and other information
What BONECOLE Film-coated Tablets contains
The active substance of the product is cholecalciferol
(vitamin D3)
BONECOLE 800 IU Film-coated Tablets: each filmcoated tablet contains 8 mg cholecalciferol concentrate (powder form) (equivalent to 20 µg cholecalciferol = 800 IU vitamin D3).
BONECOLE 1000 IU Film-coated Tablets: each filmcoated tablet contains 10 mg cholecalciferol concentrate (powder form) (equivalent to 25 µg cholecalciferol = 1000 IU vitamin D3).

BONECOLE BT ENG 160x360.indd 2

Színforrás Kft. – Gergely Attila

2016.02.03. 13:06:23

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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