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BONEFOS CAPSULES 400MG

Active substance(s): SODIUM CLODRONATE TETRAHYDRATE

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84827215

400 mg capsules
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.
R

Keep this leaflet. You may need to read it
again.
R If you have any further questions, ask your
doctor or pharmacist.
R 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.
R 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:
R you have very poor kidney function
R you are allergic to sodium clodronate, or to
any of the other ingredients of this medicine
(listed in section 6).
R you are already taking another similar
medicine.
B 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:
R you have problems with your kidneys
R you have (or have had) pain, swelling or
numbness of the jaw or a “heavy jaw feeling”
or loosening of a tooth.
B 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:
R non-steroidal anti-inflammatory drugs to
relieve pain (e.g. ibuprofen or diclofenac)
R antibiotics
R antacids or mineral supplements
R 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
B 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.
Please turn over B

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If you experience any of these serious side effects,
seek immediate medical attention:
R difficulty breathing
R

allergic skin reactions such as a rash, redness
or itching

R

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

R

kidney problems which can be experienced as
feeling generally unwell, a reduced appetite
and you may observe foamy urine

R

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

R

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

R

severe bone, joint and/or muscle pain that can
start days to several months after starting
treatment with Bonefos capsules.

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)
R 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
R diarrhoea
R

feeling sick or being sick

Rare side effects (may affect up to 1 in 1,000
people)
R 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
R

increased blood levels of a hormone
(parathyroid hormone) or certain enzymes
(alkaline phosphatase) which can be detected
by blood tests

R

allergic skin reaction such as a rash, redness or
itching

R

breathing difficulties (bronchospasm) – if you
have any difficulty breathing seek immediate
medical attention.

R

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

R
R

allergic reaction causing difficulty breathing
– if you have any difficulty breathing seek
immediate medical attention

R

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 capsules

R

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

R

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.

R

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.

B 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 (see details below). By
reporting side effects, you can help provide more
information on the safety of this medicine.
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
Malta
ADR Reporting
Website: www.medicinesauthority.gov.mt/
adrportal
5. How to store Bonefos capsules
Keep this medicine out of the sight and reach of
children.
Do not use this medicine after the expiry date
which is stated on the carton and each blister strip
of capsules after EXP. The expiry date refers to the
last day of that month.
Do not store above 25°C
Do not throw away any medicines via waste water
or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These
measures will help protect the environment.
6. Contents of the pack and other information
What Bonefos capsules contain
The active substance is sodium clodronate.
Each capsule contains 400mg sodium clodronate.
The other ingredients are calcium stearate,
colloidal silica, lactose and talc gelatine, titanium
dioxide (E171), yellow iron oxide (E172) and red
iron oxide (E172).
What Bonefos capsules look like and contents
of the pack
Pale yellow, hard gelatine capsules printed
’BONEFOS’ in black
Bonefos Capsules are available in packs of 120
Marketing authorisation holder:
Bayer plc
Bayer House
Strawberry Hill
Newbury
Berkshire RG14 1JA
Manufacturer:
Bayer Oy
Pansiontie 47
20210 Turku
Finland
This leaflet was last revised in:
August 2015
Product licence number:
PL00010/0521

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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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