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SODIUM CLODRONATE 800MG TABLETS

Active substance(s): DISODIUM CLODRONATE / SODIUM CLODRONATE

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S1105 LEAFLET Bonefos 20150817

PACKAGE LEAFLET: INFORMATION FOR USER

BONEFOS 800mg TABLETS
(disodium clodronate)
Your medicine is known as Bonefos 800mg Tablets but will be
referred to as Bonefos Tablets throughout the following 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.

Food and drink with Bonefos Tablets
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 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.

In this leaflet:

3. HOW YOU TAKE BONEFOS TABLETS

1

What Bonefos Tablets are and what they are used for

2

Before you take Bonefos Tablets

You need to take plenty of fluids (such as water) before, during
and after your treatment.

3

How you take Bonefos Tablets

4

Possible side effects

5

How to store Bonefos Tablets

6

Further 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. 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.

You should take Bonefos Tablets exactly as prescribed by your
doctor.
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 too many tablets
 Get medical help immediately and drink plenty of water. If
possible, take your tablets 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 tablets
Do not take the missed dose, just take your next dose at the usual
time.
4. POSSIBLE SIDE EFFECTS

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

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.

Tell your doctor about any other medicines that you are taking, or
have recently taken. This includes any products you bought without
a prescription.

 difficulty breathing

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.

If you experience any of these serious side effects, seek
immediate medical attention:
 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 longterm 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.

Reporting of side effects
UK
If you get any side effects, talk to your doctor, pharmacist or nurse.
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

The following side effects are presented by how often they may
occur:



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

Common side effects



Do not store Bonefos Tablets above 25°C.

(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

Do not use after the expiry date printed on the carton or bottle
label.



If your doctor tells you to stop taking the Tablets, please take
them back to the pharmacist for safe disposal. Only keep the
Tablets if your doctor tells you to.

 feeling sick or being sick



If the Tablets become discoloured or show any other signs of
deterioration, you should seek the advice of your pharmacist
who will tell you what to do.

Rare side effects



Do not dispose of medicines in waste water or household
rubbish. Any unused tablets should be returned to a pharmacist
(chemist) who will dispose of them properly. This helps protect
the environment.

 diarrhoea

(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

6. FURTHER INFORMATION
What Bonefos Tablets contain


Each tablet contains 1000 mg disodium clodronate tetrahydrate
equivalent to disodium clodronate 800 mg as the active
ingredient.



Bonefos Tablets also contain the following: silicified
microcrystalline cellulose (microcrystalline cellulose, silica
colloidal anhydrous), croscarmellose sodium, stearic acid,
magnesium stearate, opadry II white (macrogol (PEG) 3350,
partially hydrolysed polyvinyl alcohol, purified water, talc, and
titanium dioxide (E171)).

 allergic skin reaction such as 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)

What Bonefos Tablets look like and contents of the pack

 breathing problems in patients with a condition called aspirinsensitive asthma
 allergic reaction causing difficulty breathing

if you have any difficulty breathing seek immediate
medical attention

Bonefos tablets are white, oval shaped, film-coated tablet marked
‘L’ and ‘134’ on either side of a scoreline on one side and plain on
the other.

 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 antiinflammatory drug (most often diclofenac) at the same time as
Bonefos Tablets

Product Licence holder

 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.

Bonefos Tablets are available as blister packs of 60 Tablets.

Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House,
Alperton Lane, Wembley, HA0 1DX.
Manufacturer
This product is manufactured by Bayer Oy, Pansiontie 47,
SF-20210 Turku, Finland.
POM

PL 19488/1105

Leaflet revision date: 17 August 2015
Bonefos is a registered trade mark of Schering Oy, Finland.
S1105 LEAFLET Bonefos 20150817

S1105 LEAFLET Sodium clodronate 20150817

PACKAGE LEAFLET: INFORMATION FOR USER

SODIUM CLODRONATE 800mg TABLETS
(disodium clodronate)
Your medicine is known as Sodium Clodronate 800mg Tablets but
will be referred to as Sodium Clodronate Tablets throughout the
following 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.

 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 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
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.

In this leaflet:

Driving and using machines

1

What Sodium Clodronate Tablets are and what they are
used for

Sodium Clodronate Tablets have no known effect on your ability to
drive or use machines.

2

Before you take Sodium Clodronate Tablets

3

How you take Sodium Clodronate Tablets

3. HOW YOU TAKE SODIUM CLODRONATE TABLETS

4

Possible side effects

5

How to store Sodium Clodronate Tablets

You need to take plenty of fluids (such as water) before, during
and after your treatment.

6

Further information

You should take Sodium Clodronate Tablets exactly as prescribed
by your doctor.

1. WHAT SODIUM CLODRONATE TABLETS ARE AND WHAT
THEY ARE USED FOR

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.

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.

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.

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.

The daily dosage of Sodium Clodronate 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 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.

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
Sodium Clodronate.

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 tablets

 you have problems with your kidneys

 Get medical help immediately and drink plenty of water. If
possible, take your tablets 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.

 you have (or have had) pain, swelling or numbness of the
jaw or a “heavy jaw feeling” or loosening of a tooth.

If you forget to take the tablets

 Tell your doctor before you take Sodium Clodronate Tablets, if
any of these apply to you.

Do not take the missed dose, just take your next dose at the usual
time.

The 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 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

4. 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

 Tell your doctor if any side effect gets serious, or if you get
any effects not listed in this leaflet.

 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

Reporting of side effects

 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

UK
If you get any side effects, talk to your doctor, pharmacist or nurse.
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.

 severe bone, joint and/or muscle pain that can start days to
several months after starting treatment with Sodium Clodronate
Tablets.

5. HOW TO STORE SODIUM CLODRONATE TABLETS


KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

Unusual fracture of the thigh bone particularly in patients on longterm 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.



Do not store Sodium Clodronate Tablets above 25°C.



Do not use after the expiry date printed on the carton or bottle
label.



If your doctor tells you to stop taking the Tablets, please take
them back to the pharmacist for safe disposal. Only keep the
Tablets if your doctor tells you to.



If the Tablets become discoloured or show any other signs of
deterioration, you should seek the advice of your pharmacist
who will tell you what to do.



Do not dispose of medicines in waste water or household
rubbish. Any unused tablets should be returned to a pharmacist
(chemist) who will dispose of them properly. This helps protect
the environment.

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

6. FURTHER INFORMATION
Rare side effects

What Sodium Clodronate Tablets contain

(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

Each tablet contains 1000 mg disodium clodronate tetrahydrate
equivalent to disodium clodronate 800 mg as the active
ingredient.



Sodium Clodronate Tablets also contain the following: silicified
microcrystalline cellulose (microcrystalline cellulose, silica
colloidal anhydrous), croscarmellose sodium, stearic acid,
magnesium stearate, opadry II white (macrogol (PEG) 3350,
partially hydrolysed polyvinyl alcohol, purified water, talc, and
titanium dioxide (E171)).

 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 rash, redness or itching
 breathing difficulties (bronchospasm) - if you have any difficulty
breathing seek immediate medical attention

What Sodium Clodronate Tablets look like and contents of the
pack

 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.

Sodium Clodronate tablets are white, oval shaped, film-coated
tablet marked ‘L’ and ‘134’ on either side of a scoreline on one side
and plain on the other.
Sodium Clodronate Tablets are available as blister packs of 60
Tablets.

Other side effects (frequency unknown)
 breathing problems in patients with a condition called aspirinsensitive 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 antiinflammatory 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 Sodium Clodronate Tablets.
 Swelling and irritation of the uvea (the middle layer of the eye)
has been observed with Sodium Clodronate. Swelling or
infection of the conjunctiva (the membrane lining of the eyelids)
has been reported in one patient who received Sodium
Clodronate 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 Sodium Clodronate.

Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House,
Alperton Lane, Wembley, HA0 1DX.
Manufacturer
This product is manufactured by Bayer Oy, Pansiontie 47,
SF-20210 Turku, Finland.
POM

PL 19488/1105

Leaflet revision date: 17 August 2015

S1105 LEAFLET Sodium clodronate 20150817

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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