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 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. 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).
Taking/using other medicines
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.

If you have side effects which do not improve, or
any other effects which concern you please tell your
doctor or pharmacist.
Your doctor may test your blood from time to time,
to check that Clasteon is working correctly.
5. STORING CLASTEON CAPSULES
Keep this medicine out of the reach and sight 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. FURTHER 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: 11/2012

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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