BONEFOS 800 Milligram Film Coated Tablet
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
19-01-2016
Summary of Product characteristics
(SPC)
19-01-2016
Active ingredient:
CLODRONATE DISODIUM TETRAHYDRATE
Available from:
Bayer Limited
ATC code:
M05BA02
INN (International Name):
CLODRONATE DISODIUM TETRAHYDRATE
Dosage:
800 Milligram
Pharmaceutical form:
Film Coated Tablet
Prescription type:
Product subject to prescription which may be renewed (B)
Therapeutic area:
Bisphosphonates
Authorization status:
Authorised
Authorization date:
2007-09-21
Patient Information leaflet
Bayer Limited
The Atrium
Blackthorn Road
Dublin 18
Telephone:
+353 1 2999313
Fax:
+353 1 2061456
Copyright reserved
15260
BONEFOS 800MG
FILM-COATED TABLETS
SODIUM CLODRONATE
PACKAGE LEAFLET – INFORMATION
FOR THE USER
READ ALL OF THIS LEAFLET CAREFULLY
BEFORE YOU START TAKING THIS
MEDICINE.
•
Keep this leaflet. You may need
to read it again.
•
If you have more questions, ask
your doctor or pharmacist.
•
This medicine has been
prescribed for you. Do not pass it
on to others. It may harm them,
even if their symptoms are the
same as yours.
•
If any of the side effects gets
serious, or if you notice any side
effectsnot listed in this leaflet,
please tell your doctor or
pharmacist.
IN THIS LEAFLET:
1. WHAT BONEFOS TABLETS ARE AND
WHAT THEY ARE USED FOR
2. BEFORE YOU TAKE BONEFOS
TABLETS
3. HOW YOU TAKE BONEFOS TABLETS
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE BONEFOS TABLETS
6. FURTHER INFORMATION
1. WHAT BONEFOS TABLETS ARE AND
WHAT THEY ARE USED FOR
Bonefos Tablets contain sodium
clodronate which belongs to a group
of medicines called bisphosphonates.
These medicines help prevent the
loss of calcium from bones.
Bonefos Tablets are used to help
manage bone diseases, particularly
those associated with cancer.
Bonefos Tablets also help maintain
normal levels of calcium in your
blood.
2. BEFORE YOU TAKE BONEFOS
TABLETS
DO NOT TAKE BONEFOS TABLETS IF:
•
you are ALLERGIC to the active
ingredient (sodium clodronate),
or to any of the other ingredients.
The ingredients are
Read the complete document
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Bonefos 800 mg film-coated tablets.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains sodium clodronate 800 mg (as tetrahydrate).
Each tablet contains sodium 128 mg.
For full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
White, oval, scored, tablets marked ‘L134’ on one side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of hypercalcaemia due to malignancy.
Treatment of osteolysis due to malignancy.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Clodronate is mainly eliminated via the kidneys. Therefore, adequate fluid intake must be maintained during clodronate
treatment.
•
Children
Safety and efficacy in paediatric patients have not been established.
•
Elderly
There are no special dosage recommendations for the elderly. Clinical trials have included patients over 65 years and
no adverse effects specific to this age group have been reported.
A Bonefos 800 mg tablet may be divided into two to ease swallowing, but the halves have to be taken at the same time
of administration. Bonefos tablets should not be crushed or dissolved before intake.
A daily dose of 1600 mg may be taken as a single dose. When higher daily doses are used, the part of the dose
exceeding 1600 mg should be taken separately (as a second dose) as recommended below.
The single daily dose and the first dose of two (in the case of twice daily dosing) should preferably be taken in the
morning on an empty stomach together with a glass of water. The patient should then refrain from eating, drinking
(other than plain water), or taking any other oral drugs for one hour.
When twice daily dosing is used, the first dose should be taken as recommended above. The second dose s
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