Bonefos
(Disodium Clodronate)

What Bonefos is and what it is 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.

How to take Bonefos

You need to take plenty of fluids (such as water) before, during and after your treatment. Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The capsules should be swallowed whole with plain water. Never take them with milk because it reduces the amount of Bonefos capsules that your body can absorb. The daily dosage of Bonefos capsules varies. In most cases the dose is between 1600mg (4 capsules) and 3200mg (8 capsules) per day. If you have problems with your kidneys then the daily dosage may be reduced. If you have been prescribed a single daily dose of Bonefos capsules, it should be taken (preferably in the morning) on an empty stomach with a glass of plain water. After using Bonefos capsules, you should not eat, drink (other than plain water) or take any other medicines by mouth for 1 hour. If you have been prescribed a twice daily dose, the first dose should be taken as recommended above. The second dose should be taken between meals, more than 2 hours after and 1 hour before eating, drinking (other than plain water), or taking any other medicines by mouth. If you take more Bonefos capsules than you should  Get medical help immediately and drink plenty of water. If possible, take your capsules with you to show the doctor. Your doctor may want to check the amount of calcium in your blood and how well your kidneys and liver are working. If you forget to take the Bonefos capsules Do not take the missed dose, just take your next dose at the usual time.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects have been observed during treatment with Bonefos capsules. If you experience any of these serious side effects, seek immediate medical attention:
• difficulty breathing
• allergic skin reactions such as a rash, redness or itching
• numbness and tingling sensations around the mouth and/or in the fingers and toes, muscle cramps or spasms (in the back, hands and/or feet) or fits
• kidney problems which can be experienced as feeling generally unwell, a reduced appetite and you may observe foamy urine
• severe kidney damage which may include symptoms such as weakness or tiredness, change in frequency of urination and swelling of the face, arms, legs and abdomen. These problems are more common when taking some types of anti-inflammatory drug (most often diclofenac) at the same time as Bonefos capsules
• pain, swelling or numbness of the jaw, a “heavy jaw feeling” or loosening of a tooth, especially if you have been treated in the past with bisphosphonates such as zoledronate and pamidronate v015_0
• severe bone, joint and/or muscle pain that can start days to several months after starting treatment with Bonefos capsules
• talk to your doctor if you have ear pain, discharge from the ear, and/or an ear infection. These could be signs of bone damage in the ear (osteonecrosis of the external auditory canal) which could occur very rarely. Unusual fracture of the thigh bone particularly in patients on long-term treatment for osteoporosis may occur rarely. Contact your doctor if you experience pain, weakness or discomfort in your thigh, hip or groin as this may be an early indication of a possible fracture of the thigh bone.

The following side effects are presented by how often they may occur:

Common side effects (may affect up to 1 in 10 people)
• low calcium levels in the blood without any symptoms (asymptomatic hypocalcaemia) or small increases in the levels of liver enzymes, which can be detected by blood tests
• diarrhoea
• feeling sick or being sick

Rare side effects (may affect up to 1 in 1,000 people)
• low calcium levels in the blood with symptoms (symptomatic hypocalcaemia) which may include numbness and tingling sensations around the mouth and/or in the fingers and toes, muscle cramps or spasms (in the back, hands and/or feet) or, less frequently, fits
• increased blood levels of a hormone (parathyroid hormone) or certain enzymes (alkaline phosphatase) which can be detected by blood tests
• allergic skin reaction such as a rash, redness or itching
• breathing difficulties (bronchospasm) – if you have any difficulty breathing seek immediate medical attention.
• Unusual fracture of the thigh bone (particularly in patients on long-term treatment for osteoporosis) – contact your doctor if you experience pain, weakness or discomfort in your thigh, hip or groin Other Side effects (frequency unknown)
• breathing problems in patients with a condition called aspirin-sensitive asthma
• allergic reaction causing difficulty breathing – if you have any difficulty breathing seek immediate medical attention
• kidney problems which may include severe kidney damage and in rare cases fatal kidney failure have been reported. These problems are more common when taking some types of anti-inflammatory drug (most often diclofenac) at the same time as Bonefos capsules
• dead tissue in the jaw bone (osteonecrosis of the jaw) which is mainly seen in patients who have been treated in the past with bisphosphonates such as zoledronate and pamidronate. Symptoms include pain, swelling or numbness of the jaw, a “heavy jaw feeling” or loosening of a tooth
• severe bone, joint and/or muscle pain that can start days to several months after starting treatment with Bonefos capsules. However, these symptoms may also be linked to the reason you are taking Bonefos capsules.
• Swelling and irritation of the uvea (the middle layer of the eye) has been observed with Bonefos. Swelling or infection of the conjunctiva (the membrane lining of the eyelids) has been reported in one patient who received Bonefos and another biphosphonate at the same time. To date, swelling and irritation of the episclera (a thin layer of tissue v015_0 covering the sclera, the white outer wall of the eye) and the sclera, which has been reported with other biphosphonates, have not been reported with Bonefos.  Tell your doctor if any side effect gets serious, or if you get any effects not listed in this leaflet.

Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects, you can help provide more information on the safety of this medicine. United Kingdom Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard Malta ADR Reporting Website: www.medicinesauthority.gov.mt/adrportal

How to Store Bonefos

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