Bonefos® 800mg Tablets
(sodium clodronate)
Your medicine is known by the above name, but
will be referred to as
Bonefos Tablets throughout this leaflet.
Patient Information Leaflet
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 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.
►
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.
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.
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.
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.
2) What you need to know before you take
Bonefos Tablets
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.
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.
â 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.
â 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.
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 more Bonefos Tablets than you
should
â 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 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, 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
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.
► 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.
â 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 Tablets
Keep out of the sight and reach of children.
Do not use after the expiry date which is
stated on the carton and on
each blister strip of tablets. The expiry date
refers to the last day of that
month.
Do not store above 30°C.
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.
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.
6) Contents of the pack and other information
What Bonefos Tablets contains
The active substance is sodium clodronate.
Each tablet contains 800mg of sodium
clodronate (as the tetrahydrate).
The tablets also contain croscarmellose
sodium, magnesium stearate,
silicified microcrystalline cellulose and
stearic acid.
The tablet coating is made from Opadry
Y-1-7000, which contains
hypromellose, titanium dioxide E171 and
macrogol 400.
What Bonefos Tablets looks like and contents
of the pack
Pale white, oval-shaped, film-coated tablets
printed with ‘L’ breakline ‘134’
on one side and plain on the other side.
Bonefos Tablets are available in blister
strips of 60 in a carton.
PL 10383/1871
Bonefos 800mg Tablets
POM
Who makes and repackages your medicine?
Your medicine is manufactured Bayer Schering
Pharma Oy Pansiontie 47
20210 Turku, Finland. Procured from within the
EU and repackaged by
Product Licence Holder: Primecrown Ltd, 4/5
Northolt Trading Estate,
Belvue Road, Northolt, Middlesex, UB5 5QS.
Leaflet date: 13.09.2016
Bonefos is a registered trademark of Bayer Oy,
Finland.
