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LORON 520MG FILM-COATED TABLETS

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

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Package leaflet: Information for the patient

28040958

Loron 520

520 mg film-coated tablets
Clodronate disodium

Read all of this leaflet carefully
before you start taking this
medicine because it contains
important information for you.
• Keep this leaflet. You may need to
read it again.
• If you have any further questions,
ask your doctor or pharmacist.
• This medicine has been prescribed
for you only. Do not pass it on to
others. It may harm them even if
their signs of illness are the same
as yours.
• If you get any side effects, talk to
your doctor or pharmacist. This
includes any possible side effects
not listed in this leaflet. See
section 4.
What is in this leaflet
1. What Loron is and what it is used
for
2. What you need to know before
you take Loron
3. How to take Loron
4. Possible side effects
5. How to store Loron
6. Contents of the pack and other
information

1. What Loron is and
what it is used for
Loron contains a medicine called
clodronate disodium. This medicine
is a non-amino-bisphosphonate.
Loron is used to treat bone problems
in people with certain types of cancer.
These problems include:
• Loss of calcium (a mineral) from
the bones and bone pain.
• High levels of calcium in the blood
caused by loss of calcium from the
bones.
Loron works by binding to the bones.
This helps to stop the bones from
losing calcium which helps to keep
the bones strong.

2. What you need to
know before you take
Loron
Do not take Loron:
• if you are allergic (hypersensitive)
to clodronate disodium or any of
the other ingredients of Loron
(listed in section 6).
• if you have pain or discomfort in
your stomach or bowel that is
severe.
• if you are pregnant, might become
pregnant, or are breast-feeding
(see the section on 'Pregnancy and
breast-feeding').
• if you have problems with your
kidneys (renal failure with creatinine
clearance below 10 ml/min).
• if you are taking any other bisphosphonate medicines. These include
amongst others alendronate sodium,
ibandronic acid and risedronate
sodium. For details see the section
on 'Other medicines and Loron'.
Warnings and precautions
Talk to your doctor or pharmacist
before taking Loron.
• Loron tablets should be taken with
care if you have kidney problems
(see section 3).
During treatment with Loron you
must drink large amounts of liquid
(water). This is particulary important if you have too much calcium
in the blood (hypercalcaemia) or if
your kidneys do not work adequately (renal insufficiency).
Before and during therapy with
Loron, regular checks should be
made on kidney function with
serum creatinine, serum calcium
and phosphate levels.
• Monitoring of liver enzymes is
recommended.
• Osteonecrosis (death of bone tissue)
of the jaw, generally associated with
pulling teeth and/or local infection
(including inflammation of the bone
or bone marrow (osteomyelitis), has
been reported when bisphosphonates were used intravenously
or orally for the treatment of cancer.
Many of these patients were also
receiving chemotherapy and
corticosteroids. Osteonecrosis of
the jaw has also been reported in
patients with osteoporosis receiving
oral bisphosphonates.
If you are planning to have dental
treatment or dental surgery, talk to
your doctor before you start taking
Loron. Your doctor may want you
to have the dental treatment before
you start taking this medicine.
If you need to have dental treatment
or dental surgery while you are
taking Loron, talk to your doctor
and tell your dentist that you are
taking this medicine.
• Orally administered, mainly
nitrogen-containing,
bisphosphonates may cause local
irritation of the upper gastrointestinal mucosa. Thus, talk to
your doctor if you have known
gastrointestinal problems (e.g.
Barrett's oesophagus, swallowing
disorder, other oesophageal

diseases, gastritis, duodenitis or
ulcers. Stop taking Loron and tell
your doctor if you start to have
difficulty or pain when swallowing,
or you begin to get indigestion or
heartburn, or your indigestion or
heartburn gets worse.
• If you experience pain, weakness
or discomfort in your thigh, hip or
groin, consult your doctor, as this
might be an early sign of a possible
thighbone fracture.
Children
No data are available.
Other medicines and Loron
Tell your doctor or pharmacist if you
are taking, have recently taken or
might take any other medicines. This
includes medicines that you buy
without a prescription and herbal
medicines. This is because Loron
can affect the way some medicines
work. Also some other medicines
can affect the way Loron works:
• Other bisphosphonate medicines
such as alendronate sodium,
ibandronic acid or risedronate
sodium. These are used to treat
bone diseases including osteoporosis.
• Antibiotics called 'aminoglycosides'.
These include e.g. streptomycin and
gentamicin. If you have taken one
of these antibiotics in the last
month, you must tell your doctor
or pharmacist. Aminoglycosides
can enhance the calcium-lowering
effect of clodronate, even if you
have stopped taking them some
weeks before. As a result, the
amount of calcium and magnesium
in your blood may be reduced.
• Medicines called 'non-steroidal
anti-inflammatory drugs' (NSAIDs),
most often diclofenac. There have
been reports that clodronate may be
associated with the onset of kidney
disorder during concomitant taking
of drugs against pain and
inflammation.
• Antacids (used to treat indigestion)
and mineral supplements. Uptake
of the active substance within the
gastrointestinal tract (absorption)
and hence the effect of clodronate
can be reduced by medicines with
high levels of calcium, iron or
magnesium. You should therefore
allow a sufficient interval (about
2 hours) between taking such
medicines and clodronate.
• Estramustine. An increase in the
serum concentration of estramustine
phosphate by up to 80% has been
reported when estramustine
phosphate and clodronate were
used at the same time.
Loron with food and drink
Tell your doctor or pharmacist if you
are taking any food supplements that
contain calcium. You may need to
stop taking these while you are
taking Loron. Also calcium rich
foods may impair absorption.
Pregnancy, breast-feeding and
fertility
Do not take Loron if you are pregnant,
might become pregnant or are breastfeeding. This is because it may affect
your baby. You should use effective
contraception during treatment with
Loron.
Driving and using machines
Loron is not likely to affect you
being able to drive or use any tools
or machines.
Loron contains lactose and sodium
Loron contains lactose, which is a
type of sugar. If you have been told by
your doctor that you cannot tolerate
or digest some sugars (have an intolerance to some sugars), talk to your
doctor before taking this medicine.
Each Loron film-coated tablet
contains 3.6 mmol (or 83.4 mg) of
sodium. You should take this into
consideration if you are on a
controlled sodium diet.

3. How to take Loron
Always take Loron exactly as your
doctor has told you. Check with your
doctor or pharmacist if you are not
sure.
After taking Loron you should not
lay down, but remain in an upright
position to prevent upper abdominal
pain.
Adults and elderly people
• The usual dose is 2 film-coated
tablets once a day. (This is known
as a 'single daily dose'.)
• Your doctor may change this to
1 film-coated tablet twice a day
(i.e. 'twice daily dose'), if certain
side effects happen.
• If your doctor thinks it is necessary,
your dose may be increased to a
maximum of 4 film-coated tablets
a day.

People with kidney problems
• If you have problems with your
kidneys (renal failure with
creatinine clearance between 10
and 30 ml/min), your doctor may
want you to take a daily dose that
is half of the recommended adult
dose.
If you have been prescribed a
'single daily dose'
The single daily dose (2 film-coated
tablets) should be taken in the
morning on an empty stomach one
hour before eating, drinking or taking
any other oral drugs.
If you have been prescribed a 'twice
daily dose'
The first dose (i.e. the 1st film-coated
tablet) should be taken in the
morning on an empty stomach one
hour before eating, drinking or taking
any other oral drug. The second dose
(i.e. the 2nd film-coated tablet)
should be taken between meals, more
than two hours after and one hour
before eating, drinking or taking any
other oral drugs.
Swallow the film-coated tablets with
a glass of water (not milk).
Use in children
No data are available.
If you take more Loron than you
should
Contact a doctor immediately or go
to a hospital straight away. Take the
medicine pack with you. Drink plenty
of water.
The following effects may happen:
feeling or being sick, 'pins and
needles' in your hands or feet, or
cramps in your muscles which may
be signs of hypocalcaemia (decrease
in calcium in the blood). Nausea and
vomiting may occur.
Increases in serum creatinine and renal
dysfunction have been reported with
high intravenous doses of clodronate.
One case of total kidney failure and
liver damage has been reported after
accidental ingestion of 20,000 mg
(50x400 mg) of clodronate.
If you forget to take Loron
• If you forget to take a dose, take it
as soon as you remember. However,
if it is nearly time for the next dose,
skip the missed dose.
• Do not take a double dose to make
up for a forgotten dose.
If someone else takes your Loron
film-coated tablets by mistake, they
should talk to a doctor or go to a
hospital straight away.
If you have any further questions on
the use of this medicine, ask your
doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine can
cause side effects, although not
everyone gets them.
The most common reported drug
reaction is diarrhoea which is usually
mild and occurs more commonly at
higher doses.
The following is a list of side effects
that have been associated with the
use of Loron.
Common (may affect up to 1 in 10
people):
- nausea, vomiting and diarrhoea,
usually mild and at higher dosages
- hypocalcaemia (asymptomatic)
- increase of liver enzymes
(transaminases) in blood, usually
within normal range
Rare (may affect up to 1 in 1,000
people):
- allergic reaction
- hypersensitivity reactions manifesting as skin reaction
- hypocalcaemia (symptomatic)
- increased serum parathyroid
hormone associated with serum
calcium decreased
- increased serum alkaline phosphatase
- transaminases increased (exceeding
twice the normal range without
associated other hepatic function
abnormality)
- unusual (atypical) fractures of the
thighbone
- worsening kidney function

- eye disorders including uveitis
(inflammation of the uvea, the
vascular skin of the eye), conjunctivitis (pink eye), episcleritis (inflammation of the episclera, a thin
layer of tissue covering the white
part of the eye) and scleritis (inflammation of the white of the eye)
- airway-constricting reactions in
patients with aspirin-sensitive
asthma
- hypersensitivity reactions manifesting as respiratory disorder
- impairment of renal function
(elevation of serum creatinine and
proteinuria), severe renal damage
especially after rapid intravenous
infusion of high doses
- individual cases of renal failure, in
rare cases with fatal outcome, have
been reported especially when
clodronate and certain pain and
anti-inflammatory drugs (mainly
diclofenac) were used at the same
time
- severe bone, joint, and/or muscle
pain. The onset of symptoms
varied from days to several months
after starting treatment.
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.

5. How to store Loron
• Loron 520 mg film-coated tablets
do not need special storage
conditions.
• Keep this medicine out of the sight
and reach of children.
• Do not use this medicine after the
expiry date which is stated after
(EXP). The expiry date refers to
the last day of that month.
• Do not throw away any medicines
via wastewater. Ask your pharmacist how to throw away medicines
you no longer use. These measures
will help protect the environment.

6. Contents of the pack
and other information
What Loron contains
The active substance is clodronate
disodium. Each film-coated tablet
contains 520 mg clodronate disodium.
The other ingredients are talc, maize
starch, cellulose microcrystalline,
magnesium stearate, sodium starch
glycolate, hypromellose, polyacrylate
dispersion 30%, macrogol 10000,
lactose monohydrate, titanium dioxide
(E171), polysorbate 80 and sodium
citrate.
What Loron looks like and contents
of the pack
Loron film-coated tablets are oblong
white film-coated tablets with “E9”
marked on one side. They are scored
with a break line on both sides, so
that they can easily be broken into
equal halves.
Loron film-coated tablets are
supplied in blister packs containing
10 or 60 film-coated tablets. Not all
pack sizes may be marketed.
Marketing Authorisation Holder
and Manufacturer
Marketing Authorisation Holder
RIEMSER Pharma GmbH
An der Wiek 7
17493 Greifswald-Insel Riems
Germany
Manufacturer
CENEXI
52 Rue Marcel et Jacques Gaucher
94120 Fontenay sous Bois
France
UK distributor
Intrapharm Laboratories Ltd
The Courtyard Barns, Choke Lane,
Maidenhead, Berks, SL6 6PT
United Kingdom
This leaflet was last revised in
July 2016.

Very rare (may affect up to 1 in
10,000 people):
- decreased serum phosphate level
- increased serum lactate dehydrogenase (LDH)
- breathing problems, including
shortness of breath and tightness
in the chest
- 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.
Not known (cannot be estimated
from the available data):
- pain in the mouth and/or jaw, mouth
swelling or ulcers, numbness or
heavy feeling in the jaw, or loose
teeth or molars. This may indicate
jawbone damage (osteonecrosis),
which is generally accompanied
by infection and delayed recovery,
often after extraction of a tooth or
molar.

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28040958

Expand Transcript

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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