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BONEFOS 400MG CAPSULES

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

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THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

000-0000D

BONEFOS® 400mg CAPSULES
(sodium clodronate)
Patient Information Leaflet
27mm

This product is known by the above name but will be referred to as Bonefos Capsules in this leaflet.

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. Before you take Bonefos Capsules
Do not take Bonefos Capsules if:
• you have very poor kidney function
• you are allergic to the active ingredient (sodium clodronate), or to any of the other ingredients. The
ingredients are 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.

WARNING!

The 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.

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.

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.
Do not breastfeed while you are taking Bonefos Capsules.

UK PIL DATED JUNE 2014
REPORTING OF SIDE EFFECTS

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

6464/2286D

21/10/14
DATE OF PROOF:

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.

CODE:

DATE:

DT
ARTWORKER:
PRODUCT:

Bonefos 400mg caps

Q.A.
APPROVED:
CUSTOMER: Waymade

PRE-PRESS NO.:

05-0269

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
• 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 capsules
Do not take the missed dose, just take your next dose at the usual time.

Colour
Swatch

Black

WARNING!

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.
DATE:

CUSTOMER
APPROVED:

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.

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD
FONT SIZE 8
BRIDGED TO
CRESTOR 6464/2069 2070

Notes:

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

PROOF HISTORY:
v.1 - waymade -21/10/14

Leaflet Flat Size = 148 x 400

Read all of this leaflet carefully before you start taking this medicine.
Keep this leaflet. You may need to read it again.
• If you have more questions, ask your doctor or pharmacist.
• 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.
• 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.

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

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.

The following side effects are presented by how often they may occur:
Common side effects
(These 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

WARNING!

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.

UK PIL DATED JUNE 2014
REPORTING OF SIDE EFFECTS

6464/2286D








5. How to store Bonefos Capsules
Do not use after the expiry date printed on the carton or bottle label.
Bonefos 400mg capsules should not be stored above 25°C.
Keep all medicines out of the sight and reach of children.
If your doctor tells you to stop taking the capsules, please take them back to the pharmacist for safe
disposal. Only keep the capsules if your doctor tells you to. If the capsules become discoloured or
show any other signs of deterioration, you should consult your pharmacist who will advise you what
to do.
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
Your medicine is called Bonefos 400mg capsules. Each pale yellow capsule contains 500mg of sodium
clodronate tetrahydrate, equivalent to 400mg of sodium clodronate as the active ingredient, and is marked
‘BONEFOS’ on the cap in black printing ink and is plain on the body.
Bonefos 400mg capsules contain the following ingredients:
talc, lactose, calcium stearate, colloidal silica, gelatin, black printing ink, titanium dioxide (E171), red iron oxide
(E172) and yellow iron oxide (E172).
Bonefos 400mg capsules are available as a plastic bottle, with a plastic cap and tamper-evident ring,
containing 100 capsules.
POM

PL No: 6464/2286

This product is manufactured by Bayer Oy, Pansiontie 47, 20210 Turku, Finland and is procured from within
the EU and repackaged by the Product Licence holder:
Waymade plc Miles Gray Road, Basildon, Essex SS14 3FR

Colour
Swatch

Black

Leaflet revision and issue date (Ref.) 21.10.2014
Bonefos is a registered trademark of Schering Oy

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WARNING!

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
Capsules. Swelling or infection of the conjunctiva (the membrane lining of the eyelids) has been
reported in one patient who received Bonefos Capsules 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 Capsules.
• Tell your doctor if any side effect gets serious, or if you get any effects not listed in this leaflet.

CODE:

DATE:
21/10/14

DATE:

DT

DATE OF PROOF:

PRODUCT:

Bonefos 400mg caps

ARTWORKER:

CUSTOMER
APPROVED:
CUSTOMER: Waymade

PRE-PRESS NO.:

05-0269

Q.A.
APPROVED:

Rare side effects
(These 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.

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD
FONT SIZE 8
BRIDGED TO
CRESTOR 6464/2069 2070

Notes:

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.

PROOF HISTORY:
v.1 - waymade -21/10/14

Leaflet Flat Size = 148 x 400

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.

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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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