Package leaflet: Information for the user

Bonefos 800 mg tablets

sodium clodronate

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

3. How to take Bonefos tablets

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 tablets should be swallowed with plain water. Tablets may be divided into two halves to help with swallowing, but the two halves must be taken at the same time.

Do not crush or dissolve the tablets before you take them. Never take them with milk because it reduces the amount of drug that your body can absorb.

The daily dosage of Bonefos tablets varies. In most cases the dose is between 1600mg (2 tablets) and 3200mg (4 tablets) 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 tablets, it should be taken (preferably in the morning) on an empty stomach with a glass of plain water. After using Bonefos tablets, 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.

4. 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 tablets.

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 tablets
• pain, swelling or numbness of the jaw, a “heavy jaw feeling” or loosening of a tooth, especially if you who have been treated in the past with bisphosphonates such as zoledronate and pamidronate
• severe bone, joint and/or muscle pain that can start days to several months after starting treatment with Bonefos tablets
• 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 difficulties 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 tablets
• 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 tablets. However, these symptoms may also be linked to the reason you are taking Bonefos tablets.
• 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 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.

5. How to store Bonefos tablets

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on both the carton and on each blister strip of tablets after EXP. The expiry date refers to the last day of that month.

Do not store above 25°C.

Do not throw away any medicines via waste water or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information