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BONEFOS 800MG TABLETS

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

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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.
 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.
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
 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.
 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.

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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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