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CLASTEON 800MG FILM-COATED TABLETS

Active substance(s): SODIUM CLODRONATE

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Package leaflet: Information for the patient/user

CLASTEON 800MG FILM-COATED TABLETS
(Sodium clodronate)
Please read this leaflet carefully before taking Clasteon
tablets.
Keep the leaflet in case you need to refer to it again. If you
want to know more about Clasteon tablets or have any
questions, you should ask your doctor or pharmacist.
What is in this leaflet
1.What Clasteon tablets are used for
2.What you need to know before taking Clasteon tablets
3.How to take Clasteon tablets
4.Possible side effects
5.How to store this medicine
6.Contents of the pack and other information

1. WHAT CLASTEON TABLETS ARE USED FOR
Clasteon tablets contain sodium clodronate, which is one of a
group of medicines known as bisphosphonates. These
medicines help prevent loss of calcium from bones.
Clasteon tablets 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 TABLETS

Customer: Beacon PL 18157/0225
Change: PRAC Update
Colour: 273 CV
Size: 148 x 200mm Proof: 1
Date: 26 Jan 16

You must NOT take Clasteon tablets 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 pregnant or breast feeding
● you are already taking a similar medicine (containing
bisphosphonates).
Tell your doctor if:
● you have ever had/have pain, numbness or swelling of your
jaw or a heavy jaw feeling or loosening of a tooth
● you are having dental treatment or will undergo dental
surgery, tell your dentist that you are being treated with a
bisphosphonate (Sodium clodronate). Certain types of
dental treatment are not recommended while taking
bisphosphonates
● you have problems with your kidneys.
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.
Do not take any other medicines by mouth for 2 hours before
and 1 hour after each dose of Clasteon Tablets.

Food and drink with Clasteon 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
Clasteon 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 Clasteon
Tablets.
Do not breastfeed while you are taking Clasteon Tablets.
Driving and using machines
Clasteon Tablets have no known effect on your ability to drive
or use machines.
Important information about some of the ingredients of
this medicine
This medicinal product contains 128.24 mg sodium per tablet.
To be taken into consideration by patients on a controlled
sodium diet.

3. HOW TO TAKE CLASTEON TABLETS
Always take the tablets exactly as your doctor tells you to.
Clasteon tablets are for use in adults only.
You need to take plenty of fluids (such as water) before, during
and after your treatment.
The daily dosage varies. In most cases the dose is between
1600 mg (2 tablets) and 3200 mg (4 tablets) per day. If you
have problems with your kidneys then the dose may be
reduced.
● Swallow the tablets with plain water. The 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 and never take them
with milk because this reduces the amount of drug that your
body can absorb.
● Take the tablets at least 2 hours before or 1 hour after food
(and avoid milk during this period).
● Take the tablets even if you are not eating at present.
If you have been prescribed a single daily dose of Clasteon
Tablets, it should be taken (preferably in the morning) on an
empty stomach with a glass of plain water. After using
Clasteon 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 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 tablets or someone else
accidentally takes your medicine, 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 are working.
Symptoms of an overdose may be a feeling of sickness, or
being sick (nausea or vomiting).

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 tablets may cause side effects
in some patients.
Stop taking the tablets 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.
If you experience any of the following serious side effects,
seek immediate medical attention:
● 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 Clasteon Tablets
● 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 Clasteon
Tablets
Common side effects (occur in less than 1 in 10 patients):
● 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
● being sick, feeling sick (nausea) or diarrhoea. If this
happens it may help if you take half the number of tablets 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 with symptoms
(symptomatic hypocalcaemia) or small increases in levels
of liver enzymes or some hormones
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)
● Breathing problems – aspirin sensitive asthma or allergic
reactions

● Kidney problems which may include severe kidney damage
and has been fatal, this is more common in patients also
taking diclofenac
● Dead tissue in the jaw bone (osteonecrosis) seen mainly in
patients treated in the past with zoledronate or pamidronate
● Severe bone, joint and/or muscle pain
● Inflammation of part of the eye, conjunctivitis.
Your doctor may test your blood from time to time, to check
that Clasteon tablets are 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 (see details below). By
reporting side effects you can help provide more information
on the safety of this medicine.
UK: Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
Malta: The Medicines Authority, Post-Licensing Directorate,
203 level 3 Rue D'Argens, GŻR-1368 Gżira
Website: www.medicinesauthority.gov.mt
e-mail: postlicensing.medicinesauthority@gov.mt

5. HOW TO STORE THIS MEDICINE
Keep this medicine out of the sight and reach of children.
Do not use Clasteon after the expiry date which is stated on
the carton and blister after EXP. The expiry date refers to the
last day of that month.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to
protect the environment.
6.CONTENTS OF THE PACK AND OTHER INFORMATION
What is in this medicine:
Each tablet contains 800mg of the active ingredient sodium
clodronate (as the tetrahydrate).
The other ingredients are starch pregelatinised,
microcrystalline cellulose, colloidal silicon dioxide, sodium
starch glycolate (type A) and magnesium stearate. The tablet
coating contains: hypromellose, titanium dioxide (E171) and
macrogol 400.
What this medicine looks like and contents of the pack:
Clasteon tablets are white oval convex film-coated tablets with
a breakline, the breakline is only to facilitate breaking for ease
of swallowing and not to divide into equal doses. Available in
packs of 10, 30 or 60 tablets. Not all pack sizes may be
marketed.
The product is called Clasteon 800mg film-coated Tablets in
the UK, Ireland and Malta.
Marketing authorisation holder: Beacon Pharmaceuticals
Ltd. Tunbridge Wells, Kent TN1 1YG, UK.
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
ABXP225BNA
161175-02 C.Deca 132 Tacca V. 26/31 mm Corpo 7,4

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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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