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LORON 520MG FILM-COATED TABLETS

Active substance: CLODRONATE DISODIUM TETRAHYDRATE

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Interim Version

Description:
Country / Lang.:
Date / Time:
Material No.:
MAH No.:
Manufact. No.:
Dimensions / TD:
Color:
Cutting die:
LAETUS Code:
Font Type / Size:

Loron 520 mg, var type II, Variante 1
Großbritannien
14.11.2014 14:20
XXXXXXX/XX
28040958
125 x 315 mm
schwarz
magenta

Times New Roman 9,5 Pkt.
SKU / DU: 8108664

28040958

Patient Information Leaflet

Loron® 520 mg Film-coated Tablets
Clodronate disodium

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. What Loron is and what it is
used for
2. Before you take Loron
3. How to take Loron
4. Possible side effects
5. How to store Loron
6. Further 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. 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: 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 if any of the
above apply to you. If you are
not sure, talk to your doctor or
pharmacist before taking Loron.
Take special care with Loron
Check with your doctor or
pharmacist before taking Loron if:

• You have heartburn, stomach pain
or discomfort, or have an ulcer. 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.
• 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. 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.
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
can affect the way some medicines
work. Also some other medicines
can affect the way Loron works.
Do not take Loron, 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 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.
Pregnancy and breast-feeding
Do not take Loron 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.
Driving and using machines
Loron is not likely to affect you

being able to drive or use any tools
or machines.
Important information about some
of the ingredients of Loron
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 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.
You should check with your doctor
or pharmacist if you are not sure.
• Take Loron 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.
If you take more Loron than you
should
If you take more Loron 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
• 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
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 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 longterm 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
• Loron 520 mg Film-coated Tablets
do not need special storage
conditions.
• Keep out of the reach and sight of
children.
• Do not use Loron after the expiry
date printed on the pack.
• Do not throw away any left over
tablets. Instead return them to your
pharmacist so that they can be
disposed of carefully. Only keep
them if your doctor tells you to.

6. Further information
What Loron contains
The active substance in Loron 520
mg Film-coated Tablets is clodronate
disodium. Each 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 tablets are oblong white
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 tablets are supplied in blister
packs containing 10 or 60 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
RIEMSER Pharma GmbH
An der Wiek 7
17493 Greifswald-Insel Riems
Germany
UK distributor
Intrapharm Laboratories Ltd
The Courtyard Barns, Choke Lane,
Maidenhead, Berks, SL6 6PT
United Kingdom
This leaflet was last revised
in November 2014.
XXXXXXX/XX
28040958

Interim Version

Description:
Country / Lang.:
Date / Time:
Material No.:
MAH No.:
Manufact. No.:
Dimensions / TD:
Color:
Cutting die:
LAETUS Code:
Font Type / Size:

Loron 520 mg, var type II, Variante 2
Großbritannien
14.11.2014 14:30
XXXXXXX/XX
28040958
125 x 315 mm
schwarz
magenta

Times New Roman 9,5 Pkt.
SKU / DU: 8108664

28040958

Patient Information Leaflet

Loron® 520 mg Film-coated Tablets
Clodronate disodium

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. What Loron is and what it is
used for
2. Before you take Loron
3. How to take Loron
4. Possible side effects
5. How to store Loron
6. Further 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. 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: 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 if any of the
above apply to you. If you are
not sure, talk to your doctor or
pharmacist before taking Loron.
Take special care with Loron
Check with your doctor or
pharmacist before taking Loron if:

• You have heartburn, stomach pain
or discomfort, or have an ulcer. 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.
• 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. 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.
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
can affect the way some medicines
work. Also some other medicines
can affect the way Loron works.
Do not take Loron, 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 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.
Pregnancy and breast-feeding
Do not take Loron 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.
Driving and using machines
Loron is not likely to affect you

being able to drive or use any tools
or machines.
Important information about some
of the ingredients of Loron
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 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.
You should check with your doctor
or pharmacist if you are not sure.
• Take Loron 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.
If you take more Loron than you
should
If you take more Loron 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
• 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
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 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 longterm 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
• Loron 520 mg Film-coated Tablets
do not need special storage
conditions.
• Keep out of the reach and sight of
children.
• Do not use Loron after the expiry
date printed on the pack.
• Do not throw away any left over
tablets. Instead return them to your
pharmacist so that they can be
disposed of carefully. Only keep
them if your doctor tells you to.

6. Further information
What Loron contains
The active substance in Loron 520
mg Film-coated Tablets is clodronate
disodium. Each 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 tablets are oblong white
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 tablets are supplied in blister
packs containing 10 or 60 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 November 2014.
XXXXXXX/XX
28040958

Expand view ⇕

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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