Patient Leaflet Updated 09-Oct-2017 | Bayer plc
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.
Package leaflet: Information for the user
Bonefos 800 mg tablets
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
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:
Warnings and precautions
Talk to your doctor or pharmacist before taking Bonefos tablets.
Your doctor will take special care if:
If you are having dental treatment or will undergo dental surgery, tell your dentist that you are being treated with a bisphosphonate. Certain types of dental treatment are not recommended while taking bisphosphonates.
Other medicines and Bonefos tablets
Tell your doctor if you are taking, have recently taken or might take any other medicines.
Tell your doctor if you are taking:
Do not take any other medicines by mouth for 2 hours before and 1 hour after each dose of Bonefos tablets.
Bonefos tablets with food and drink
It is important that you take your tablets on an empty stomach (otherwise your body will not absorb the drug properly).
Except for plain water, do not eat or drink for 2 hours before and 1 hour after each dose. It is particularly important to avoid drinking milk in this period.
You can drink water whenever you like.
Pregnancy and breastfeeding
Bonefos tablets are not normally given to people during pregnancy. If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Do not breastfeed while you are taking Bonefos tablets.
Driving and using machines
Bonefos tablets have no known effect on your ability to drive or use machines.
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.
If you take more Bonefos tablets than you should
If you forget to take Bonefos tablets
Do not take the missed dose, just take your next dose at the usual time.
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:
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)
Rare side effects (may affect up to 1 in 1,000 people)
Other side effects (frequency unknown)
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 via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard. By reporting side effects, you can help provide more information on the safety of this medicine.
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
What Bonefos tablets contain
The active substance is sodium clodronate.
Each tablet contains 800mg sodium clodronate.
The other ingredients are croscarmellose sodium, magnesium stearate, silicified microcrystalline cellulose and stearic acid. Opadry II white (containing Macrogol (PEG) 3350, Polyvinyl alcohol (partially hydrolysed), Purified water, Talc, and Titanium dioxide (E171)).
What Benefos tablets look like and contents of the pack
Pale white, oval-shaped, film-coated tablets
Bonefos Tablets are available in packs of 60 tablets
Marketing authorisation holder:
This leaflet was last revised in: August 2017
Product licence number: PL00010/0522