Bonefos 400mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Sodium clodronate

Available from:

Lexon (UK) Ltd

ATC code:

M05BA02

INN (International Name):

Sodium clodronate

Dosage:

400mg

Pharmaceutical form:

Oral capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 06060200

Patient Information leaflet


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Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE 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.
_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 be maintained during treatment.
The single d