Bonefos 400mg Capsules
PACKAGE LEAFLET: INFORMATION FOR THE USER
Bonefos® 400mg Capsules
(sodium clodronate)
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section
4.
What is in this leaflet:
1. What Bonefos® 400mg Capsules are and what they are used for
2. What you need to know before you take Bonefos® 400mg Capsules
3. How to take Bonefos® 400mg Capsules
4. Possible side effects
5. How to store Bonefos® 400mg Capsules
6. Contents of the pack and other information
1. WHAT BONEFOS® 400MG CAPSULES ARE AND WHAT THEY ARE USED FOR
Bonefos® 400mg Capsules contain sodium clodronate which belongs to a group of medicines called bisphosphonates. These medicines help prevent the loss of calcium from bones.
Bonefos® 400mg Capsules are used to help manage bone diseases, particularly those associated with cancer. Bonefos® 400mg Capsules also help maintain normal levels of calcium in your blood.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE BONEFOS® 400MG CAPSULES
Do not take Bonefos® 400mg Capsules if:
• you have very poor kidney function
• you are allergic to sodium clodronate, or to any of the other ingredients of this medicine (listed in section 6).
• you are already taking another similar medicine.
^ Tell your doctor if any of these apply to you and do not take Bonefos® 400mg Capsules Warnings and precautions
Talk to your doctor or pharmacist before taking Bonefos® 400mg Capsules.
Your doctor will take special care if:
• you have problems with your kidneys
• you have (or have had) pain, swelling or numbness of the jaw or a
“heavy jaw feeling” or loosening of a tooth.
^ Tell your doctor before you take Bonefos® 400mg Capsules, if any of these apply to you.
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® 400mg Capsules
Tell your doctor if you are taking, have recently taken or might take any other medicines.
Tell your doctor if you are taking:
• non-steroidal anti-inflammatory drugs to relieve pain (e.g. ibuprofen or diclofenac)
• antibiotics
• antacids or mineral supplements
• a drug called estramustine which is used to treat cancer.
Do not take any other medicines by mouth for 2 hours before and 1 hour after each dose of Bonefos® 400mg Capsules.
Bonefos® 400mg Capsules with food and drink
It is important that you take your capsules 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® 400mg Capsules 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® 400mg Capsules. Driving and using machines
Bonefos® 400mg Capsules have no known effect on your ability to drive or use machines.
Bonefos® 400mg capsules contain lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. HOW TO TAKE BONEFOS® 400MG CAPSULES
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® 400mg Capsules that your body can absorb.
The daily dosage of Bonefos® 400mg 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® 400mg Capsules, it should be taken (preferably in the morning) on an empty stomach with a glass of plain water. After using Bonefos® 400mg 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 capsules
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® 400mg 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® 400mg 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
• severe bone, joint and/or muscle pain that can start days to several months after starting treatment with Bonefos® 400mg 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 longterm 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® 400mg 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® 400mg Capsules. However, these symptoms may also be linked to the reason you are taking Bonefos® 400mg Capsules.
• Swelling and irritation of the uvea (the middle layer of the eye) has been observed with Bonefos® 400mg Capsules. Swelling or infection of the conjunctiva (the membrane lining of the eyelids) has been reported in one patient who received Bonefos® 400mg Capsules 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® 400mg Capsules.
^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 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® 400MG CAPSULES
• Keep out of the sight and reach of children.
• Do not store above 25°C.
• Do not use after the expiry date (This is printed on both the carton label and blister).
• Do not dispose of medicines in waste water or household rubbish.
Any unused capsules should be returned to your pharmacist who will dispose of them properly. This helps protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION What Bonefos® 400mg Capsules contain
Each capsule contains 400mg of the active ingredient sodium clodronate (as the tetrahydrate)
Each capsule also contains colloidal anhydrous silica, lactose, talc, calcium stearate, gelatin, red iron oxide (E172), yellow iron oxide (E172), black printing ink, and titanium dioxide (El 71).
What Bonefos® 400mg Capsules look like and the contents of the pack
Each pale yellow capsule is marked ‘BONEFOS®' in black ink on the cap.
Bonefos® 400mg Capsules are available in bottles containing 60 or 120 capsules.
Who manufactured your medicine
Manufactured by Bayer Schering Pharma Oy., Pansiontie 47, 20210 Turku, Finland. Procured from within the EU and repackaged by Product Licence Holder: Beachcourse Limited, 20 Alliance Court, Alliance Road, London W3 0RB.
PL16378/0381 |POM|
Revision date: 27.06.2016 Leaflet reference: BON400 U/T
Bonefos® is a registered trademark
2