LORON 520MG TABLETS

Active substance: CLODRONATE DISODIUM TETRAHYDRATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Loron® 520mg Tablets /
Disodium Clodronate 520mg Tablets
(disodium clodronate)

Your tablets are available using the above names, but will be
referred to as Loron 520mg Tablets throughout this leaflet.

Please read all of this leaflet carefully before
you start taking this medicine.

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. Do not pass it on
to others. It may harm them even if their symptoms are the
same as yours.
If any of the side effects become serious or troublesome, or
if you notice any side effects not listed in this leaflet, please
tell your doctor or pharmacist.

In this leaflet:
1.
2.
3.
4.
5.
6.

What Loron 520mg Tablets are and what they are used for
Before you take Loron 520mg Tablets
How to take Loron 520mg Tablets
Possible side effects
How to store Loron 520mg Tablets
Further information

1. What Loron 520mg Tablets are and what
they are used for
Loron 520mg Tablets contain a medicine called disodium
clodronate. This belongs to a group of medicines called
‘bisphosphonates’.
Loron 520mg Tablets are 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 520mg Tablets work by binding to the bones. This helps to
stop the bones from losing calcium which helps to keep the bones
strong.

2. Before you take Loron 520mg Tablets
Do not take Loron 520mg Tablets if:

You are allergic (hypersensitive) to disodium clodronate or
any of the other ingredients of Loron 520mg Tablets (listed
in Section 6: Further information).
You are taking any other bisphosphonate medicines. These
include alendronate sodium, ibandronic acid and risedronate
sodium. See the section on “Taking other medicines”.
You have pain or discomfort in your stomach or bowel that is
severe or has been going on for a long time.
You have problems with your kidneys (renal failure).
You are pregnant, might become pregnant, or are
breast-feeding (see the section on ‘Pregnancy and
breast-feeding’).

Do not take Loron 520mg Tablets if any of the above apply to you.
If you are not sure, talk to your doctor or pharmacist before
taking Loron 520mg Tablets.

Take special care with Loron 520mg Tablets

Check with your doctor or pharmacist before taking Loron 520mg
Tablets if:
You have heartburn, stomach pain or discomfort, or have an
ulcer. Stop taking Loron 520mg Tablets 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.
You have ever had pain or swelling of your jaw.

Dental treatment

If you are planning to have dental treatment or dental
surgery, talk to your doctor before you start taking Loron
520mg Tablets. 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 520mg Tablets, talk to your doctor and
tell your dentist that you are taking this medicine.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines. This includes medicines that
you buy without a prescription and herbal medicines. This is
because Loron 520mg Tablets can affect the way some medicines
work. Also some other medicines can affect the way Loron 520mg
Tablets work.
Do not take Loron 520mg Tablets, and tell your doctor or
pharmacist, if you are taking any of the following medicines:
Other bisphosphonate medicines such as alendronate
sodium, ibandronic acid or risedronate sodium. These are
used to treat bone diseases including osteoporosis.

Tell your doctor or pharmacist if you are taking any of the
following medicines:

Medicines called ‘non-steroidal anti-inflammatory drugs’
(NSAIDs). These include aspirin, indometacin and ibuprofen.
Antibiotics called ‘aminoglycosides’. These include
streptomycin and gentamicin. If you have taken one of these
antibiotics in the last month, you must tell your doctor or
pharmacist.
Antacids containing calcium (used to treat indigestion).

Taking Loron 520mg Tablets with food and food
supplements

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 520mg Tablets.

Pregnancy and breast-feeding

Do not take Loron 520mg Tablets if you are pregnant, might
become pregnant or are breast-feeding. This is because it may
affect your baby. You should use effective contraception during
treatment with Loron 520mg Tablets.

Driving and using machines

Loron 520mg Tablets are not likely to affect you being able to
drive or use any tools or machines.

Important information about some of the
ingredients of Loron 520mg Tablets

Loron 520mg Tablets contain 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 520mg Tablet contains 3.6mmol (or 83.4mg) of
sodium. You should take this into consideration if you are on a
controlled sodium diet.

3. How to take Loron 520mg Tablets
Always take Loron 520mg Tablets exactly as your doctor has told
you. You should check with your doctor or pharmacist if you are
not sure.
Take Loron 520mg Tablets one hour before or one hour
after food.
Swallow each tablet with a drink (not milk).

Adults and elderly people

The usual dose is 2 tablets once a day.
Your doctor may change this to 1 tablet twice a day, if
certain side effects happen.
If your doctor thinks it is necessary, your dose may be
increased to a maximum of 4 tablets a day.

People with kidney problems

If you have problems with your kidneys, your doctor may
want you to take 1 tablet a day.

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If you take more Loron 520mg Tablets than you
should

If you take more Loron 520mg Tablets than you should, talk to a
doctor or go to a hospital straight away. Take the medicine pack
with you. The following effects may happen: feeling or being sick,
‘pins and needles’ in your hands or feet, or cramps in your
muscles.

If you forget to take Loron 520mg Tablets

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 (two doses at the same time) to
make up for a forgotten dose.

If someone else takes your Loron 520mg 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, Loron 520mg Tablets can cause side effects,
although not everyone will get them.

The following side effects may happen with this medicine:

Feeling sick or having mild diarrhoea. Tell your doctor if this
happens to you. You may be given some advice to help you
with these problems.
Changes to your blood. Your doctor may want you to have
blood tests to check for this.
Problems with your kidneys.
Allergic skin rashes and itching.
Breathing problems, including shortness of breath and
tightness in the chest.
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.
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.

If any of the side effects become serious or troublesome, or if you
notice any side effects not listed in this leaflet, please tell your
doctor or pharmacist.

5. How to store Loron 520mg Tablets
Keep out of the sight and reach of children
Do not use this medicine after the expiry date shown on the
label.
If your doctor decides to stop the treatment, return any
leftover tablets to the pharmacist. Only keep them if your
doctor tells you to.
If the tablets appear discoloured or show any other signs of
deterioration, take them to your pharmacist who will advise
you.
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. Further information
What Loron 520mg Tablets contain

Each film-coated tablet contains 520mg of disodium clodronate
(as the tetrahydrate).
Loron 520mg Tablets also contain talc, maize starch,
microcrystalline cellulose, magnesium stearate and sodium starch
glycollate.
The film coat contains lactose, methylhydroxypropylcellulose,
poly (meth) acrylic acid esters, macrogol 10,000, talc, titanium
dioxide (E171), polysorbate 80 and sodium citrate.

What Loron 520mg Tablets look like and contents of
the pack
Loron 520mg Tablets are oblong, white, film-coated tablets,
imprinted with 'E9' on one side and with a break line on both
sides.

Loron 520mg Tablets are supplied in packs of 30 or 60 tablets.

Manufacturer

Your medicine is manufactured by: Roche Nederland B.V.,
Beneluxlaan 2a, 3446 GR Woerden, The Netherlands.
Procured from within the EU and repackaged by: Doncaster
Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.
Product Licence holder: BR Lewis Pharmaceuticals Ltd.,
Kirk Sandall, Doncaster, DN3 1QR.
PL No: 08929/0218

POM

Leaflet issue and revision date (Ref): 30.10.12
Loron® is a registered trademark of Riemser Arzneimittel AG.

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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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