Due to regulatory changes, the content of the following Patient Information Leaflet may vary from the one found in your medicine pack. Please compare the 'Leaflet prepared/revised date' towards the end of the leaflet to establish if there have been any changes.
If you have any doubts or queries about your medication, please contact your doctor or pharmacist.
Bonefos Capsules
sodium clodronate
Please read this leaflet carefully. It contains a summary of the information available on your medicine. The information in this leaflet applies to BONEFOS Capsules only. If after reading this you have any questions ask your doctor or pharmacist.
What You Should Know About Bonefos Capsules
The name of your medicine is BONEFOS Capsules. Each capsule contains 500 mg sodium clodronate tetrahydrate equivalent to 400 mg of sodium clodronate as the active ingredient.
The capsules also contain the following inactive ingredients: talc, calcium stearate, silica, lactose, gelatin, red iron oxide (E172), titanium dioxide (E171) and yellow iron oxide (E172).
BONEFOS Capsules are available in packs of 30 and 120 capsules.
BONEFOS Capsules belong to the group of medicines called bisphosphonates which help prevent the loss of calcium from bones.
The Product Licence for BONEFOS Capsules is held by:
and the capsules are manufactured by:
How BONEFOS Capsules Help You
BONEFOS Capsules help manage bone diseases, particularly those associated with cancer. BONEFOS also helps maintain normal levels of calcium in your blood.
Before Taking BONEFOS Capsules
Tell your doctor or pharmacist if:
- You are pregnant, likely to become pregnant, or if you are breast feeding
- You have had an allergic reaction (causing rash, itching, or more rarely shortness of breath) to BONEFOS Capsules or to similar medicines
- You have had an allergic reaction to any of the inactive ingredients, e.g. lactose, mentioned above
- You are already taking a similar kind of medicine
- You have any chronic kidney problems
- You are also taking non-steroidal anti-inflammatory drugs to relieve pain e.g. ibuprofen or diclofenac, or if you are taking antibiotics
- You are taking antacids or mineral supplements
- You have or have had pain, swelling or numbness of the jaw or a "heavy jaw feeling" or loosening of a tooth.
If you are having dental treatment or will undergo dental surgery, tell your dentist that you are being treated with a bisphosphonate, such as BONEFOS. Certain types of dental treatment are not recommended while taking bisphosphonates.
If in doubt ask your doctor or pharmacist.
Do not give BONEFOS Capsules to children
How to take BONEFOS Capsules
Follow your doctor's instructions about when and how to take your medicine and always read the label.
The usual recommended dose is 4 capsules a day taken as a single dose or in two divided doses (2 capsules per dose). However your doctor may prescribe up to 8 capsules a day.
Do not take more than the doctor has prescribed.
If you take an overdose tell your doctor immediately.
Swallow the tablets whole with a little liquid but NOT with milk. Take the capsules at least 1 hour before or 1 hour after food. If BONEFOS Capsules are taken with milk or with food, it is more difficult for them to enter your blood stream and so you will not get the full benefit of your medicine.
For the same reasons, DO NOT take BONEFOS Capsules with mineral supplements as these may also reduce the effectiveness of your medicine.
Make sure that you drink a lot of fluid e.g. water or diluted squash throughout your treatment with BONEFOS Capsules.
If your kidney function is abnormal your doctor will reduce your daily dose of BONEFOS Capsules.
DO NOT STOP TAKING THIS MEDICINE EXCEPT ON YOUR DOCTOR'S ADVICE.
If you forget to take your medicine, do not worry - just take the next dose at the usual time.
After Taking BONEFOS Capsules
All medicines sometimes cause side effects.
A few people experience upset stomachs, for example sickness and diarrhoea after taking BONEFOS Capsules. If you do experience any such symptoms they may improve if you follow the divided dose recommendations (i.e. take half the number of capsules in the morning and the remaining half in the evening). Skin reactions, such as rash, redness or itching have also been reported. These effects are usually mild.
Unwanted effects on the kidneys have been reported. This appears to be more common in patients receiving non-steroidal anti-inflammatory drugs such as ibuprofen or diclofenac, although no definite association has been established.
Occasionally increased levels of serum parathyroid hormone, certain enzymes and creatinine (a component of urine) have been reported. Rarely, blood calcium levels have fallen below normal. If any of these changes do occur, they are unlikely to cause any noticeable symptoms.
Your doctor will periodically carry out tests during treatment to ensure that your kidneys are working properly and to monitor the level of calcium in your blood.
Rarely, this type of drug has caused difficulty in breathing.
Isolated cases of osteonecrosis of the jaw (dead tissue in the jaw bone) have been reported, mainly 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.
If you experience any of these effects and they persist or become troublesome consult your doctor. You should also consult your doctor if you experience any other effects not mentioned above.
How To Store BONEFOS Capsules
Store BONEFOS Capsules below 25°C.
Keep this medicine out of the sight and reach of children.
Do not take this medicine after the expiry date which you will find printed on the packaging.
REMEMBER THIS MEDICINE IS FOR YOU (only a doctor can prescribe it for you). NEVER give it to others as it may harm them even if their symptoms are the same as yours.
This leaflet was revised in May 2008.
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