Bonefos 400mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Sodium clodronate

Available from:

Bayer Plc

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; GTIN: 5016703008811

Patient Information leaflet

BONEFOS
® 400 MG CAPSULES
(disodium clodronate)
PATIENT INFORMATION LEAFLET
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. See section 4.
Your medicine is available using the above name but will referred to
as
Bonefos Capsules throughout the following leaflet.
WHAT IS IN THIS LEAFLET:
1.
What Bonefos Capsules are and what they are used for
2.
What you need to know before you take Bonefos Capsules
3.
How to take Bonefos Capsules
4.
Possible side effects
5.
How to store Bonefos Capsules
6.
Contents of the pack and other information
1. WHAT BONEFOS CAPSULES ARE AND WHAT THEY ARE USED FOR
Bonefos Capsules contain sodium clodronate which belongs to a group of
medicines called bisphosphonates.These medicines help prevent the loss
of
calcium from bones.
Bonefos Capsules are used to help manage bone diseases, particularly
those associated with cancer. Bonefos Capsules also help maintain
normal
levels of calcium in your blood.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE BONEFOS
CAPSULES
DO NOT TAKE BONEFOS CAPSULES IF:
-
you have VERY POOR KIDNEY FUNCTION
-
you are ALLERGIC to sodium clodronate, or to any of the other
ingredients
of this medicine (listed in section 6).
-
you are ALREADY TAKING ANOTHER SIMILAR MEDICINE.
➙ TELL YOUR DOCTOR if any of these apply to you and DO NOT TAKE
BONEFOS.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Bonefos capsules.
Your doctor will take special care if:
-
you have PROBLEMS WITH YOUR KIDNEYS
-
you have (or have had) PAIN, SWELLING OR NUMBNESS OF THE JAW or a
“heavy jaw feeling” or

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