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BONEFOS 400MG CAPSULES

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

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Bonefos® 400mg Capsules
(sodium clodronate)
Your medicine is known by the above name, but will be referred to as
Bonefos Capsules 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 Capsules are and what they are used for
2) What you need to know before you take Bonefos Capsules
3) How to take Bonefos Capsules
4) Possible side effects
5) How to store Bonefos Capsules
6) Contents of the pack and other information

1) What Bonefos Capsules are and what they are used for
Bonefos Capsules contain sodium clodronate which belongs to a group of
medicines called bisphosphonates. These medicines help prevent the loss
of calcium from bones.
Bonefos Capsules are used to help manage bone diseases, particularly
those associated with cancer. Bonefos Capsules also help maintain normal
levels of calcium in your blood.

2) What you need to know before you take Bonefos Capsules
Do not take Bonefos Capsules 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 capsules.
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 Capsules, 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 Capsules
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 Capsules.
Bonefos Capsules with food and drink
It is important that you take your capsules 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 Capsules 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 Capsules.
Driving and using machines
Bonefos Capsules have no known effect on your ability to drive or use
machines.
Bonefos Capsules contain lactose
If you have been told by your doctor that you have an intolerance to some
sugars, contact your doctor before taking this medicine.

3) How to take Bonefos Capsules
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 capsules should be swallowed whole with plain water. Never take
them with milk because it reduces the amount of Bonefos Capsules that
your body can absorb.
The daily dosage of Bonefos Capsules varies. In most cases the dose is
between 1600mg (4 capsules) and 3200mg (8 capsules) 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 Capsules, it
should be taken (preferably in the morning) on an empty stomach with a
glass of plain water. After using Bonefos Capsules, 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 Capsules than you should
 Get medical help immediately and drink plenty of water. If
possible, take your capsules 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 the Bonefos Capsules
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 Capsules.
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 Capsules
► pain, swelling or numbness of the jaw, a “heavy jaw feeling” or
loosening of a tooth, especially if you 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 Capsules.
► 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 difficulty
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 Capsules
► 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 Capsules. However, these
symptoms may also be linked to the reason you are taking Bonefos
Capsules.
► 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 Capsules
• Keep out of the sight and reach of children.
• Do not use after the expiry date which is stated on the carton and
container. The expiry date refers to the last day of that month.
• Do not store above 25°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 Capsules contains
The active substance is sodium clodronate.
Each capsule contains 400mg of sodium clodronate.
The capsules also contain calcium stearate, colloidal silica, lactose and talc.
The capsule shell contains gelatin, titanium dioxide (E171), yellow iron
oxide (E172) and red iron oxide (E172).
What Bonefos Capsules looks like and contents of the pack
Pale yellow, hard gelatin capsules, printed ‘BONEFOS’ in black on the cap.
Bonefos Capsules are available in plastic bottles containing 100 capsules.
PL 10383/1869

Bonefos 400mg Capsules

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: 03.08.2016
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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