Bonefos 800mg Tablets
Leaflet Details
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Licence Number: |
PLPI 33723/0150 |
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Leaflet size: |
210mm x 250mm, Portrait double sided - 2 columns on each side |
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Column width: |
97.5mm |
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Text Free Border: |
5mm (around edge & between columns) |
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Font: |
Arial |
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Font Size: |
Title = 15pt Generic Name = 12pt Main Section Headings = 10pt Sub Headings = 8pt Main Text = Font 8pt / Leading 9pt Statement for Blind = 12pt |
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Colour: |
Black print on white paper |
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UK Leaflet: |
Bayer, August 2011 |
Lexon Revision date: 19/12/12
Ref:LTT150/191212/1/F & Ref:LTT150/191212/1/B = Bonefos 800mg Tablets (Front & Back)
Ref:LTT150/191212/2/F & Ref:LTT150/191212/2/B = Sodium Clodronate 800mg Tablets (Front & Back)
This is the final mock-up.
This leaflet is being bridged to 15184/0891, 0892, 0893
Bonefos 800mg Tablets
(sodium clodronate)
Patient Information Leaflet
Read all of this leaflet carefully before you start taking this medicine.
- Keep this leaflet. You may need to read it again.
- If you have more questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Your medicine is called Bonefos 800mg capsules but will be referred to as Bonefos throughout this Patient Information Leaflet.
In this leaflet:
[3 What Bonefos Tablets are and what they are used for [2 Before you take Bonefos Tablets [3 How you take Bonefos Tablets [4 Possible side effects ^ How to store Bonefos Tablets Further information
[3 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 Before you take Bonefos Tablets
Do not take Bonefos Tablets if:
* you have very poor kidney function
* you are allergic to the active ingredient (sodium clodronate), or to any of the other ingredients. The ingredients are 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.
The 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 Tablets, 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 Tablets
Tell your doctor about any other medicines that you are taking, or have recently taken. This includes any products you bought without a prescription.
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 Tablets.
Food and drink with Bonefos Tablets
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 Tablets are not normally given to people during pregnancy. If you think you might be pregnant or if you are planning a family, tell your doctor before taking Bonefos Tablets.
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.
[2 How you take Bonefos Tablets
You need to take plenty of fluids (such as water) before, during and after your treatment.
You should take Bonefos Tablets exactly as prescribed by your doctor.
The capsules should be swallowed whole with plain water. Never take them with milk because it reduces the amount of Bonefos Tablets that your body can absorb.
The daily dosage of Bonefos Tablets 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 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 too many capsules
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 are working.
If you forget to take the capsules
Do not take the missed dose, just take your next dose at the usual time.
Bonefos 800mg Tablets
(sodium clodronate)
Patient Information Leaflet (continued)
[4 Possible side effects
Like all medicines, Bonefos Tablets 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.
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
(These 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
(These 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 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.
Tell your doctor if any side effect gets serious, or if you get any effects not listed in this leaflet.
[4 How to store Bonefos Tablets
* KEEP THIS MEDICINE OUT OF THE REACH AND SIGHT OF CHILDREN.
* Do not store above 30°C.
* Do not take your tablets out of the blister until it is time to take your dose.
* Do not use this medicine after the expiry date shown on the carton label or container label. If your doctor tells you to stop taking this medicine, return any unused tablets to your pharmacist (chemist) for safe disposal. Only keep this medicine, if your doctor tells you to. If your tablets become discoloured or show any other signs of deterioration, consult your pharmacist (chemist) who will tell you what to do.
[p Further information
What this medicine contains:
Each tablet contains 1000mg sodium clodronate tetrahydrate equivalent to sodium clodronate 800mg as the active ingredient.
Your medicine also contains the following inactive ingredients: silicified microcrystalline cellulose, croscarmellose sodium, stearic acid, magnesium stearate.
Opadry II white (containing macrogol (PEG) 3350, polyvinyl alcohol (partially hydrolysed), purified water, talc, and titanium dioxide (E171).
What this medicine looks like and contents of the pack
White, oval shaped, film-coated tablets debossed with L on the left side of the score line and 134 on the right side of the score line on one side and plain on the other side. Each available blister pack contains 60 tablets.
Manufacturer and Licence Holder
The tablets are manufactured by Bayer Oy, Pansiontie 47, 20210 Turku, Finland and is procured from within the eU. Product Licence Holder LTT Pharma Limited, Unit 18, East Moons Moat, Redditch, Worcestershire,
B98 0RE and repackaged by Lexon (UK) Limited, B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or pharmacist. They will have additional information about this medicine and will be able to advise you.
|PQM PL 33723/0150 Bonefos is a registered trademark of Bayer Oy.
Revision date: 19/12/12
Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414 for help.
Sodium Clodronate 800mg Tablets
Patient Information Leaflet
Read all of this leaflet carefully before you start taking this medicine.
- Keep this leaflet. You may need to read it again.
- If you have more questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Your medicine is called Sodium Clodronate 800mg capsules but will be referred to as Sodium Clodronate Tablets throughout this Patient Information Leaflet.
In this leaflet:
[2 What Sodium Clodronate Tablets are and what they are used for
[2 Before you take Sodium Clodronate Tablets
^2 How you take Sodium Clodronate Tablets
^2 Possible side effects
[2 How to store Sodium Clodronate Tablets
[2 Further information
What Sodium Clodronate Tablets are and what they are used for
Sodium Clodronate Tablets contain sodium clodronate which belongs to a group of medicines called bisphosphonates. These medicines help prevent the loss of calcium from bones.
Sodium Clodronate Tablets are used to help manage bone diseases, particularly those associated with cancer. Sodium Clodronate Tablets also help maintain normal levels of calcium in your blood.
^2 Before you take Sodium Clodronate Tablets
Do not take Sodium Clodronate Tablets if:
* you have very poor kidney function
* you are allergic to the active ingredient (sodium clodronate), or to any of the other ingredients. The ingredients are 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.
The 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 Sodium Clodronate Tablets, 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 Sodium Clodronate Tablets
Tell your doctor about any other medicines that you are taking, or have recently taken. This includes any products you bought without a prescription.
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 Sodium Clodronate Tablets.
Food and drink with Sodium Clodronate Tablets
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
Sodium Clodronate Tablets are not normally given to people during pregnancy. If you think you might be pregnant or if you are planning a family, tell your doctor before taking Sodium Clodronate Tablets.
Do not breastfeed while you are taking Sodium Clodronate Tablets.
Driving and using machines
Sodium Clodronate Tablets have no known effect on your ability to drive or use machines.
How you take Sodium Clodronate Tablets
You need to take plenty of fluids (such as water) before, during and after your treatment.
You should take Sodium Clodronate Tablets exactly as prescribed by your doctor.
The capsules should be swallowed whole with plain water. Never take them with milk because it reduces the amount of Sodium Clodronate Tablets that your body can absorb.
The daily dosage of Sodium Clodronate Tablets 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 Sodium Clodronate Tablets, it should be taken (preferably in the morning) on an empty stomach with a glass of plain water. After using Sodium Clodronate 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 too many capsules
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 are working.
If you forget to take the capsules
Do not take the missed dose, just take your next dose at the usual time.
Sodium Clodronate 800mg Tablets
Patient Information Leaflet (continued)
^ Possible side effects
Like all medicines, Sodium Clodronate Tablets can cause side effects, although not everybody gets them. The following side effects have been observed during treatment with Sodium Clodronate 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 Sodium Clodronate 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 Sodium Clodronate Tablets.
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
(These 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
(These 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 Sodium Clodronate 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 Sodium Clodronate Tablets.
However, these symptoms may also be linked to the reason you are taking Bonefos Tablets.
Tell your doctor if any side effect gets serious, or if you get any effects not listed in this leaflet.
How to store Sodium Clodronate Tablets
* KEEP THIS MEDICINE OUT OF THE REACH AND SIGHT OF CHILDREN.
* Do not store above 30°C.
* Do not take your tablets out of the blister until it is time to take your dose.
* Do not use this medicine after the expiry date shown on the carton label or container label. If your doctor tells you to stop taking this medicine, return any unused tablets to your pharmacist (chemist) for safe disposal. Only keep this medicine, if your doctor tells you to. If your tablets become discoloured or show any other signs of deterioration, consult your pharmacist (chemist) who will tell you what to do.
^6 Further information
What this medicine contains:
Each tablet contains 1000mg sodium clodronate tetrahydrate equivalent to sodium clodronate 800mg as the active ingredient.
Your medicine also contains the following inactive ingredients: silicified microcrystalline cellulose, croscarmellose sodium, stearic acid, magnesium stearate.
Opadry II white (containing macrogol (PEG) 3350, polyvinyl alcohol (partially hydrolysed), purified water, talc, and titanium dioxide (E171).
What this medicine looks like and contents of the pack
White, oval shaped, film-coated tablets debossed with L on the left side of the score line and 134 on the right side of the score line on one side and plain on the other side. Each available blister pack contains 60 tablets.
Manufacturer and Licence Holder
The tablets are manufactured by Bayer Oy, Pansiontie 47, 20210 Turku, Finland and is procured from within the eU. Product Licence Holder LTT Pharma Limited, Unit 18, East Moons Moat, Redditch, Worcestershire,
B98 0RE and repackaged by Lexon (UK) Limited, B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or pharmacist. They will have additional information about this medicine and will be able to advise you.
POM PL 33723/0150
Revision date: 19/12/12