CLASTEON 400MG CAPSULES

Active substance: CLODRONATE DISODIUM TETRAHYDRATE

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Patient Information Leaflet:

CLASTEON 400MG CAPSULES

(Sodium clodronate)
Please read this leaflet carefully before taking
Clasteon Capsules. Keep the leaflet in case you
need to refer to it again. If you want to know more
about Clasteon Capsules or have any questions, you
should ask your doctor or pharmacist.
1. WHAT CLASTEON CAPSULES ARE AND WHAT THEY ARE
USED FOR

Clasteon Capsules contain sodium clodronate, which
is one of a group of medicines known as
bisphosphonates.
Clasteon Capsules are used to manage bone
diseases, particularly those associated with cancer.
They also help to maintain normal levels of calcium
in your blood.
2. WHAT YOU NEED TO KNOW BEFORE TAKING CLASTEON
CAPSULES
You must NOT take Clasteon Capsules and
should talk to your doctor if:
• you are allergic to sodium clodronate, similar
medicines or any of the ingredients (listed in
section 6)
• you have very poor kidney function
• you are already taking a similar medicine
(containing bisphosphonates)
Tell your doctor if:
• you have kidney problems
• you have ever had pain or swelling of your jaw
• you are having or planning to have dental
treatment or surgery. If you are having dental
treatment tell your dentist that you are being
treated with a bisphosphonate (Clasteon).
Other medicines and Clasteon
Tell your doctor or pharmacist if you are taking or
have recently taken any other medicine including
those obtained without a prescription. This is
particularly important if you are taking any of the
following:
• antibiotics
• non-steroidal anti-inflammatory medicines such as
ibuprofen or diclofenac
• antacid indigestion tablets
• mineral supplements
• estamustine, used to treat prostate cancer.

Pregnancy and breastfeeding
Clasteon 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 this medicine.
Do not breastfeed while you are taking Clasteon
Capsules.
3. HOW TO TAKE CLASTEON CAPSULES
Always take the capsules as your doctor tells you to.
Clasteon is for use in adults only.
The usual dose is 4 capsules daily taken as a single
dose or, if more than 4 capsules, divided into two
doses. Your doctor may tell you to take fewer than 4
capsules, but no more than 8 capsules daily.
• Swallow the capsules whole, with water (NOT milk
- see below)
• Single daily dose: Take in the morning on an
empty stomach, with a glass of water. Do not eat,
drink (except water) or take any medicines for 1
hour after.
• Twice daily dose: Take the first dose as above.
Take the second dose between meals, more than
2 hours after and 1 hour before eating, drinking
(except water) or taking any other medicines.
• Make sure you drink a lot of fluid (water or diluted
squash) during treatment with Clasteon.
Clasteon should not be taken with food or with drinks
containing milk as it is harder for the medicine to be
absorbed into the blood and so it does not work as
well.
If you forget a dose take it as soon as possible.
However, if it is nearly time for your next dose, skip
the missed dose and carry on as before. Do not take
a double dose.
If you take too many Clasteon Capsules or
someone else accidentally takes your medicine,
contact your doctor, pharmacist or nearest hospital
immediately.
Symptoms of an overdose may be a feeling of
sickness, or being sick (nausea or vomiting).
Continued overleaf…….

Your doctor has prescribed this medicine for you.
Never give it to others as it may harm them, even if
their symptoms are the same as yours.
4. POSSIBLE SIDE EFFECTS
As with all medicines Clasteon Capsules may cause
side effects in some patients.
Stop taking the capsules and contact your doctor
if any of the following occur:
• wheezing or difficulty in breathing
• swelling of face, tongue or throat
• itching, rash.
These may be symptoms of an allergic
(hypersensitivity) reaction.
Common side effects (occur in less than 1 in 10
patients):
• being sick, feeling sick (nausea) or diarrhoea. If
this happens it may help if you take half the
number of capsules in the morning and the rest in
the evening
Rare side effects (occur in less than 1 in 1,000
patients)
• skin reactions
• difficulty breathing
• 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.
• low calcium levels in the blood or increased levels
of some hormones or enzymes. These are unlikely
to cause noticeable symptoms.
Other side effects (frequency unknown):
• kidney problems. This can happen if Clasteon is
taken together with a non-steroidal antiinflammatory drug (e.g. diclofenac). In these
cases, your doctor may wish to check your kidneys
from time to time.
• isolated cases of severe disease of the jaw bone
(osteonecrosis - damage and death of the bone),
mainly in patients treated with other
bisphosphonates e.g. zoledronate and
pamidronate. Symptoms may include pain,
swelling or numbness of the jaw
• severe bone, joint or muscle pain
• inflammation of part of the eye, conjunctivitis.
Your doctor may test your blood from time to time, to

check that Clasteon is working correctly.
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 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 THIS MEDICINE
Keep this medicine out of the sight and reach of
children.
Do not use this medicine after the expiry date printed
on the pack.
If your doctor decides to stop the treatment, return
any leftover capsules to the pharmacist. Only keep
them if your doctor tells you to.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What is in this medicine:
Each capsule contains 400mg of the active
ingredient sodium clodronate (as the tetrahydrate).
The other ingredients are talc, maize starch,
magnesium stearate and sodium starch glycolate.
The capsule shell is made of gelatin and contains
titanium dioxide (E171), indigotin (E132) and printing
ink.
What this medicine looks like and contents of the
pack:
Clasteon capsules are white and blue oblong shaped
capsules, marked CLASTEON, available in packs of
30, 60 or 120 capsules.
Marketing authorisation holder: Beacon
Pharmaceuticals Ltd. Tunbridge Wells, Kent TN1
1YG.
Manufacturer: Abiogen Pharma S.p.A., via Meucci
36, Ospedaletto - Pisa - Italy.
Date of last revision: 04/2014

Beacon Pharmaceuticals Ltd,
85 High Street, Tunbridge Wells.TN1 1YG. UK

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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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