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BONEFOS 800MG TABLETS

Active substance(s): SODIUM CLODRONATE / SODIUM CLODRONATE TETRAHYDRATE

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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 tablets
throughout this leaflet.
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:
 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 tablets.
Warnings and precautions
Talk to your doctor or pharmacist before taking
Bonefos tablets.
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.

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 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.

If you take more Bonefos tablets 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.

Other medicines and Bonefos tablets
Tell your doctor if you are taking, have recently
taken or might take any other medicines.

If you forget to take Bonefos tablets
Do not take the missed dose, just take your next
dose at the usual time.

 Tell your doctor before you take Bonefos
tablets, if any of these apply to you.

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.

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:
 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
 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 antiinflammatory 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.
 Swelling and irritation of the uvea (the middle
layer of the eye) has been observed with
Bonefos tablets. Swelling or infection of the
conjunctiva (the membrane lining of the eyelids)
has been reported in one patient who received
Bonefos tablets 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 tablets.
 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 any 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 take Bonefos tablets
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 30ºC.
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 tablets contain
The active substance is sodium clodronate.
Each film-coated tablet contains 800mg sodium
clodronate (as the tetrahydrate).
The tablets also contain croscarmellose sodium,
stearic acid, silicified microcrystalline cellulose,
magnesium stearate.
The tablet coating contains Opadry II white
(macrogol (PEG) 3350, polyvinyl alcohol (partially
hydrolysed), talc, titanium dioxide (E171), and
purified water).
What Benefos tablets look like and contents of
the pack
Bonefos tablets are available in packs of 60
tablets. Each 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
Leaflet date: 10.11.2016

PL 18799/2127
POM

Bonefos is registered trademark of Bayer group of
companies.

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