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CLASTEON 400MG CAPSULES

Active substance(s): 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

Customer: Beacon PL 18157/0028
Change: PRAC Update
Colour: 273 CV
Size: 148 x 200mm Proof: 1
Date: 26 Jan 16

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.
Very rare side effects (occur in less than 1 in
10,000 patients):
● Talk to your doctor if you have ear pain, discharge
from the ear, and/or an ear infection. These could
be signs of bone damage in the ear.
Other side effects (frequency unknown):
● kidney problems. This can happen if Clasteon is taken
together with a non-steroidal anti-inflammatory 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: 11/2015

Beacon Pharmaceuticals Ltd,
85 High Street, Tunbridge Wells.TN1 1YG. UK
ABXP028BNA
161185-08 C.Deca 148 Tacca V. 26/31 mm Corpo 9

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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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