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BONEFOS 800 MG TABLETS

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

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T06645

BONEFOS® 800 mg Tablets
(sodium clodronate)

Patient Information Leaflet
Your medicine is called Bonefos 800 mg Tablets
but will be referred to as Bonefos Tablets
throughout this 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.
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.
� Tell your doctor before you take Bonefos

Tablets, if any of these apply to you.

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
BonefosTablets.
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 1600 mg
(2 tablets) and 3200 mg (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
� 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 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.

Like all medicines, this medicine can cause side
effects, although not everybody gets them.

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

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

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.
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.

The following side effects have been observed
during treatment with Bonefos Tablets.

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• 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:

5. How to store Bonefos Tablets
• Keep out of the sight and reach of children.
• Do not use after the expiry date which is
marked on the carton and each blister strip
of capsules.
• Do not store above 25 °C.
• If the tablets become discoloured or show
signs of any deterioration, you should seek
the advice of your pharmacist.
• Do not dispose of medicines in waste water
or household rubbish. Any unused capsules
should be returned to a pharmacist
(chemist) who will dispose of them properly.
This helps protect the environment.

6. Contents of
information

the

pack

and

other

What Bonefos Tablets contain

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

The active substance is sodium clodronate.
Each tablet contains 800mg sodium clodronate.
The tablets also contain croscarmellose
sodium,
magnesium
stearate,
silicified
microcrystalline cellulose and stearic acid.
The tablet coating is made from Opadry® II
white, which contains macrogol (PEG) 3350,
partially hydrolyzed polyvinyl alcohol, purified
water, talc and titanium dioxide (E171).

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.

What’s in the pack
Bonefos Tablets are available in packs of 60
tablets.

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. 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.

Bonefos Tablets are pale white, oval shape and
debossed ‘L 134’ with a score line on one side
and plain on the reverse.
Manufacturer and Product Licence Holder:
Bonefos Tablets are manufactured by Bayer
OY, Pansiontie 47, 20210 Turku, Finland. It is
procured from within the EU by the Product
Licence Holder: Swinghope Limited, Brandon
House, Marlowe way, Croydon CR0 4XS, UK
and repackaged by Interport Limited, Brandon
House, Marlowe way, Croydon CR0 4XS, UK.
POM
PL No: 10380/1424
Leaflet revision date: 11/10/2016
Bonefos® is a registered trademark for Bayer
Schering Pharma OY.

� 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 or
pharmacist. 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.

T06645

Expand Transcript

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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