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BONEFOS 800MG TABLETS

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

BONEFOS® 800mg TABLETS
(disodium clodronate)
Patient Information Leaflet
27mm

This product is known by the above name but will usually be referred to as Bonefos Tablets throughout this
leaflet.

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

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.
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.
2. Before you take Bonefos Tablets
Do not take Bonefos Tablets 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 Tablets, if any of these apply to you.

Other medicines and Bonefos Tablets
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:
• 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.

DATE:
17/02/15

DT
ARTWORKER:

Food and drink with Bonefos Tablets
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 think you might be pregnant or if
you are planning a family, tell your doctor before taking Bonefos Tablets.

DATE OF PROOF:

Q.A.
APPROVED:
PRE-PRESS NO.:

05-0269

Do not take any other medicines by mouth for 2 hours before and 1 hour after each dose of Bonefos
Tablets.

Do not breastfeed while you are taking Bonefos Tablets.

6464/2287D
CODE:

TO UK PIL DATED JUNE 2014
REPORTING OF SIDE EFFECTS

Bonefos 800mg tabs
PRODUCT:

CUSTOMER: Waymade

Driving and using machines
Bonefos Tablets have no known effect on your ability to drive or use machines.
3. How you take Bonefos Tablets
You need to take plenty of fluids (such as water) before, during and after your treatment.
You should take Bonefos Tablets exactly as prescribed by your doctor.
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.
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.
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 too many tablets
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.
If you forget to take the tablets
Do not take the missed dose, just take your next dose at the usual time.

Colour
Swatch

Black

WARNING!

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.

Notes:

In this leaflet:
1. What Bonefos Tablets are and what they are used for
2. Before you take Bonefos Tablets
3. How you take Bonefos Tablets
4. Possible side effects
5. How to store Bonefos Tablets
6. Further information

PROOF HISTORY:
v.2 - waymade - 17/02/15

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 Tablets can cause side effects, although not everybody gets them. The following
side effects have been observed during treatment with Bonefos Tablets.

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!

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.

TO UK PIL DATED JUNE 2014
REPORTING OF SIDE EFFECTS

6464/2287D








5. How to store Bonefos Tablets
Do not use after the expiry date printed on the carton or blister label.
Bonefos 800mg Tablets should not be stored above 25°C.
Keep all medicines out the sight and reach of children.
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.
If the tablets 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 tablets should be
returned to a pharmacist (chemist) who will dispose of them properly. This helps to protect the
environment.

6. Further information
Your medicine is called Bonefos 800mg Tablets.
Each white oblong tablet contains 800mg of the active ingredient, disodium clodronate (as the tetrahydrate)
and is marked ‘L’ breakline ‘134’ on one side and is plain on the reverse.
Bonefos 800mg Tablets contain the following ingredients:
microcrystalline cellulose, croscarmellose sodium, magnesium stearate, stearic acid, and colloidal anhydrous
silica.
Coating contains: Opadry II white (macrogol (PEG) 3350, partially hydrolyzed polyvinyl alcohol, purified
water, talc and titanium dioxide (E171)).
Bonefos 800mg Tablets are available as blister packs of 60 tablets.
POM

PL No: 6464/2287

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
Leaflet revision and issue date (Ref.) 17.02.2015
Bonefos is a registered trademark of BAYER Oy

Colour
Swatch

Black

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 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.

CODE:

DATE:
17/02/15

DATE:

DT

DATE OF PROOF:

PRODUCT:

Bonefos 800mg tabs

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 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.2 - waymade - 17/02/15

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 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.

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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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