Bonefos 400mg capsule

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

CLODRONATE DISODIUM

Available from:

Bayer Public Limited Company 400 South Oak Way, Reading Berkshire RG2 6AD, United Kingdom

ATC code:

M05BA02

INN (International Name):

CLODRONATE DISODIUM 400 mg

Pharmaceutical form:

HARD CAPSULE

Composition:

CLODRONATE DISODIUM 400 mg

Prescription type:

POM

Therapeutic area:

DRUGS FOR TREATMENT OF BONE DISEASES

Authorization status:

Withdrawn

Authorization date:

2005-05-30

Patient Information leaflet


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Summary of Product characteristics

Page 1 of 11
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1.3.1
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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF MEDICINAL PRODUCT
Bonefos 400 mg capsules.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 500 mg sodium clodronate tetrahydrate,
equivalent to
400 mg anhydrous sodium clodronate.
Excipients with known effect
Each capsule contains 41.5mg lactose (as monohydrate)
, see section 4.4.
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Pale yellow, hard gelatin capsules printed 'BONEFOS' in black for oral
use.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Bonefos capsules are indicated for the management of osteolytic
lesions, hypercalcaemia and bone pain associated with skeletal
metastases in patients with carcinoma of the breast or multiple
myeloma.
Bonefos capsules are also indicated for the maintenance of clinically
acceptable serum calcium levels in patients with hypercalcaemia of
malignancy initially treated with an intravenous bisphosphonate.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults_
A daily dose of 1600 mg should 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.
_Paediatric population_
Bonefos has not been evaluated in children.
_Elderly_
There are no special dosage recommendations in the elderly. Clinical
trials have included patients over 65 years and no adverse reactions
specific to this age group have been reported.
Page 2 of 11
v021_0
1.3.1
2
_Renal impairment_
Clodronate is eliminated mainly via the kidneys. Therefore, it should
be used with caution in patients with renal failure; daily doses
exceeding 1600mg should not be used continuously.
It is recommended that the clodronate dosage be reduced as follows:
DEGREE OF RENAL
FAILURE
CREATININE CLEARANCE,
ML/MIN
DOSE
Mild
50-80 ml/min
1600 mg daily (no dose
reduction recommended)
Moderate
30- <50 ml/min
1200 mg/daily
Severe
10 - ˂30 ml/min
800 mg/daily
Method of administration
Adequate fluid intake should