Bonefos 800mg tablets

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:

800mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 06060200; GTIN: 5016703008842

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
BONEFOS® 800MG TABLETS
(sodium clodronate)
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.
The name of your medicine is Bonefos 800mg Tablets, but will
be referred to as Bonefos tablets throughout the remainder of the
leaflet
WHAT IS IN THIS LEAFLET
1. What Bonefos tablets are and what they are used for
2. What you need to know before you take Bonefos tablets
3. How to take Bonefos tablets
4. Possible side effects
5. How to store Bonefos tablets
6. Contents of the pack and other 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. WHAT YOU NEED TO KNOW BEFORE YOU TAKE BONEFOS TABLETS
DO NOT TAKE BONEFOS TABLETS 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.
Î
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 tablets.
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

Summary of Product characteristics

OBJECT 1
BONEFOS TABLETS
Summary of Product Characteristics Updated 11-Oct-2017 | Bayer plc
1. Name of the medicinal product
Bonefos 800 mg tablets
2. Qualitative and quantitative composition
Each tablet contains 1000 mg of disodium clodronate tetrahydrate,
equivalent to 800 mg of anhydrous
disodium clodronate.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Pale white, oval-shaped, film-coated tablets for oral use.
4. Clinical particulars
4.1 Therapeutic indications
Bonefos tablets are indicated in the management of osteolytic lesions,
hypercalcaemia and bone pain
associated with skeletal metastases in patients with carcinoma of the
breast or multiple myeloma.
Bonefos tablets 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. A Bonefos
800mg tablet may be divided
into two to ease swallowing, but the halves ha