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SODIUM CLODRONATE 800MG TABLETS

Active substance(s): DISODIUM CLODRONATE / SODIUM CLODRONATE

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Bonefos® 800mg tablets
(sodium clodronate)
Package leaflet: Information for the user
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.
The name of your medicine is Bonefos 800mg
tablets but will be referred to as Bonefos
throughout this leaflet.
What is in this leaflet
1 What Bonefos is and what it is used for
2 What you need to know before you take
Bonefos
3 How to take Bonefos
4 Possible side effects
5 How to store Bonefos
6 Contents of the pack and other information
1. What Bonefos is and what it is used for
Bonefos contain sodium clodronate which
belongs to a group of medicines called
bisphosphonates. These medicines help prevent
the loss of calcium from bones.
Bonefos are used to help manage bone diseases,
particularly those associated with cancer.
Bonefos also help maintain normal levels of
calcium in your blood.
2. What you need to know before you take
Bonefos
Do not take Bonefos 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.
Warnings and precautions
Talk to your doctor or pharmacist before taking
Bonefos.
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, 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
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.
Bonefos 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 breast-feeding
Bonefos 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 breast-feed while you are taking
Bonefos.
Driving and using machines
Bonefos have no known effect on your ability to
drive or use machines.
3. How to take Bonefos
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 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, it should be taken (preferably in the
morning) on an empty stomach with a glass of
plain water. After using Bonefos, 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 than you should
 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 Bonefos
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.

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
 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
 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 difficulties 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

 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. However, these
symptoms may also be linked to the reason
you are taking Bonefos.
 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.
Reporting of side effects
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
Keep out of the sight and reach of children.
Do not take the tablets after the expiry date which
is stated on the carton and blister label after
‘Exp’. The expiry date refers to the last day of that
month.
Do not store above 25ºC.
Store in the original package.
If the tablets become discoloured or show any
signs of deterioration, seek the advice of your
pharmacist.
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no
longer required. These measures will help to
protect the environment.
6. Contents of the pack and other information
What Bonefos tablet contain
The active ingredient in Bonefos is sodium
clodronate.
Each film-coated tablet contains 800mg sodium
clodronate (as the tetrahydrate).
The other ingredients are croscarmellose sodium,
stearic acid, microcrystalline cellulose,
magnesium stearate, Opadry II white - polyvinyl
alcohol, talc, titanium dioxide (E171), and
macrogol 3350.
What Bonefos looks like and contents of the
pack
Bonefos is white oval shaped tablet marked with
‘L 134’ on one side and blank on the other side.
It is available in packs of 60 tablets. Each
PVC/AL blister pack contains 10 tablets.
Manufactured by: Bayer Oy, Pansiontie 47,
20210 Turku, Finland.
Procured from within the EU and repackaged
by the Product Licence Holder:
B&S Healthcare, Unit 4, Bradfield Road, Ruislip,
Middlesex, HA4 0NU, UK.
Bonefos® 800mg tablets; PL 18799/2952
Leaflet date: 21.07.2016

POM

Sodium Clodronate 800mg tablets
Package leaflet: Information for the user
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.
The name of your medicine is Sodium Clodronate
800mg tablets but will be referred to as Sodium
Clodronate throughout this leaflet.
What is in this leaflet
1 What Sodium Clodronate is and what it is used
for
2 What you need to know before you take
Sodium Clodronate
3 How to take Sodium Clodronate
4 Possible side effects
5 How to store Sodium Clodronate
6 Contents of the pack and other information
1. What Sodium Clodronate is and what it is
used for
Sodium Clodronate contain sodium clodronate
which belongs to a group of medicines called
bisphosphonates. These medicines help prevent
the loss of calcium from bones.
Sodium Clodronate are used to help manage
bone diseases, particularly those associated with
cancer. Sodium Clodronate also help maintain
normal levels of calcium in your blood.
2. What you need to know before you take
Sodium Clodronate
Do not take Sodium Clodronate 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 Sodium Clodronate.
Warnings and precautions
Talk to your doctor or pharmacist before taking
Sodium Clodronate.
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 Sodium
Clodronate, 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
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
Sodium Clodronate.
Sodium Clodronate 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 breast-feeding
Sodium Clodronate 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 breast-feed while you are taking Sodium
Clodronate.
Driving and using machines
Sodium Clodronate have no known effect on your
ability to drive or use machines.
3. How to take Sodium Clodronate
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 Sodium Clodronate 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, it should be taken
(preferably in the morning) on an empty stomach
with a glass of plain water. After using Sodium
Clodronate, 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 Sodium Clodronate than you
should
 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 Sodium Clodronate
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 Sodium Clodronate.

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
 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
 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 difficulties 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

 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. However,
these symptoms may also be linked to the
reason you are taking Sodium Clodronate.
 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.
 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,
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 Sodium Clodronate
Keep out of the sight and reach of children.
Do not take the tablets after the expiry date which
is stated on the carton and blister label after
‘Exp’. The expiry date refers to the last day of that
month.
Do not store above 25ºC.
Store in the original package.
If the tablets become discoloured or show any
signs of deterioration, seek the advice of your
pharmacist.
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no
longer required. These measures will help to
protect the environment.
6. Contents of the pack and other information
What Sodium Clodronate tablet contain
The active ingredient in Sodium Clodronate is
sodium clodronate.
Each film-coated tablet contains 800mg sodium
clodronate (as the tetrahydrate).
The other ingredients are croscarmellose sodium,
stearic acid, microcrystalline cellulose,
magnesium stearate, Opadry II white - polyvinyl
alcohol, talc, titanium dioxide (E171), and
macrogol 3350.
What Sodium Clodronate looks like and
contents of the pack
Sodium Clodronate is white oval shaped tablet
marked with ‘L 134’ on one side and blank on the
other side.
It is available in packs of 60 tablets. Each
PVC/AL blister pack contains 10 tablets.
Manufactured by: Bayer Oy, Pansiontie 47,
20210 Turku, Finland.
Procured from within the EU and repackaged
by the Product Licence Holder:
B&S Healthcare, Unit 4, Bradfield Road, Ruislip,
Middlesex, HA4 0NU, UK.
Sodium Clodronate 800mg tablets;
PL 18799/2952
Leaflet date: 21.07.2016

POM

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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