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Name of the medicinal product
Qualitative and quantitative composition
Each tablet contains 1000 mg of disodium clodronate tetrahydrate, equivalent to 800 mg of anhydrous disodium ...
Pale white, oval-shaped, film-coated tablets for oral use.
Bonefos tablets are indicated in the management of osteolytic lesions, hypercalcaemia and bone pain associated ...
Posology and method of administration
Adequate fluid intake should be maintained during treatment. A Bonefos 800mg tablet may be divided into ...
Bonefos tablets are contraindicated in patients with severe renal failure (creatinine clearance below ...
Special warnings and precautions for use
Adequate fluid intake should be maintained during treatment. Patients with renal insufficiency Bonefos ...
Interaction with other medicinal products and other forms of interaction
Concomitant use with other bisphosphonates is contraindicated. Patients receiving NSAIDs in addition ...
Pregnancy and lactation
There are limited amount of data from the use of clodronate in pregnant women. Bonefos is not recommended ...
Effects on ability to drive and use machines
The most common reported drug reaction is diarrhoea which is usually mild and occurs more commonly with ...
Symptoms Increases in serum creatinine and renal dysfunction have been reported with high intravenous ...
Clodronate is a bisphosphonate, (formerly diphosphonates), a group of analogues of pyrophosphate, which ...
Absorption As with other bisphosphonates, the gastrointestinal absorption of clodronate is low, about ...
Preclinical safety data
Systemic tolerance Repeated dose oral and intravenous toxicity studies in rats and mini-pigs up to 6 ...
List of excipients
Croscarmellose sodium Magnesium stearate Silicified microcrystalline cellulose Stearic acid Coating: ...
The shelf life of Bonefos 800 mg tablets is three years.
Special precautions for storage
Bonefos tablets are stored below 25°C.
Nature and contents of container
Bonefos tablets are supplied in clear, colourless PVC/aluminium blister packs of 10 and 60 tablets. ...
Special precautions for disposal and other handling
Marketing authorization holder
Bayer plc Bayer House Strawberry Hill Newbury Berks RG14 1JA Trading as Bayer plc, Bayer Schering Pharma ...
Marketing authorization number(s)
Date of first authorization / renewal of the authorization
01 May 2008
Date of revision of the text
16 August 2011