BONEFOS CAPSULES 400MG

Active substance: SODIUM CLODRONATE TETRAHYDRATE

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80809476

Do not take Bonefos Capsules if:
R you have very poor kidney function
R you are allergic to the active ingredient
(sodium clodronate), or to any of the other
ingredients. The ingredients are 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.
The 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 about any other medicines that
you are taking, or have recently taken. This
includes any products you bought without a
prescription.
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.
Food and drink with Bonefos Capsules
It is important that you take your capsules on
an empty stomach (otherwise your body will not
absorb the drug properly).

3. How you take Bonefos Capsules
You need to take plenty of fluids (such as water)
before, during and after your treatment.
You should take Bonefos Capsules exactly as
prescribed by your doctor.
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 too many capsules
R 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 are working.
If you forget to take the capsules
Do not take the missed dose, just take your next
dose at the usual time.
4. Possible side effects
Like all medicines, Bonefos Capsules 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:
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

Please turn over B

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2. Before you take Bonefos Capsules

Driving and using machines
Bonefos Capsules have no known effect on your
ability to drive or use machines.

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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.

Do not breastfeed while you are taking Bonefos
Capsules.

3/1
Pms 186, 355, Black

Bonefos Capsules contain sodium clodronate
which belongs to a group of medicines called
bisphosphonates. These medicines help prevent
the loss of calcium from bones.

Pregnancy and breastfeeding
Bonefos Capsules are not normally given to people
during pregnancy. If you think you might be
pregnant or if you are planning a family, tell your
doctor before taking Bonefos Capsules.

Marianne Murto



1. What Bonefos Capsules are and what they
are used for

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.

148 x 297

Package leaflet – information for the user
Read all of this leaflet carefully before you
start taking this medicine.
R Keep this leaflet. You may need to read it
again.
R If you have more questions, ask your doctor or
pharmacist.
R This medicine has been prescribed for you. Do
not pass it on to others. It may harm them,
even if their symptoms are the same as yours.
R If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet:
1 What Bonefos Capsules are and what they
are used for
2 Before you take Bonefos Capsules
3 How you take Bonefos Capsules
4 Possible side effects
5 How to store Bonefos Capsules
6 Further information

80809476

Bayer Oy

sodium clodronate

23.4.2013

Capsules

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 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
(These 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
(These 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.

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.
5. How to store Bonefos Capsules
Keep out of the reach and sight of children.
Do not use after the expiry date which is marked
on the carton and each blister strip of capsules.
Store below 25 °C.
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. Further Information
What Bonefos Capsules contain
The active substance is sodium clodronate.
Each capsule contains 400mg sodium clodronate.
The capsules also contain calcium stearate,
colloidal silica, lactose and talc.
The capsule shell contains gelatine, titanium
dioxide (E171), yellow iron oxide (E172) and red
iron oxide (E172).
What’s in the pack
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 last revised: August 2012
Product licence number: PL 00010/0521

Other Side effects (frequency unknown)
R breathing problems in patients with a
condition called aspirin-sensitive asthma
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.

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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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