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CARBIMAZOLE 5 MG TABLETS

Active substance(s): CARBIMAZOLE

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Packaging Leaflet: Information for the patient

NeoMercazole® 5 mg Tablets
(carbimazole)

Your medicine is known by the above name but will be referred to as NeoMercazole
throughout this leaflet. NeoMercazole Tablets is also available in strength 20 mg and
reference to this strength may also be included within this leaflet.
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. Do not pass it on to others. It may
harm them, even if their symptoms 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.
In this leaflet:
1. What NeoMercazole is and what it is
used for
2. What you need to know before you take
NeoMercazole
3. How to take NeoMercazole
4. Possible side effects
5. How to store NeoMercazole
6. Contents of the pack and other
information.
1. WHAT NEOMERCAZOLE IS AND
WHAT IT IS USED FOR
NeoMercazole contains the active
substance carbimazole. NeoMercazole
belongs to a group of medicines called
anti-thyroid agents. NeoMercazole is used
to reduce the formation of thyroid
hormones in adults and children with an
overactive thyroid gland. The condition is
called hyperthyroidism. NeoMercazole is
also used in more serious cases, for
example, to restore the normal function of
the thyroid before its partial removal by
surgery. It may also be used together with
other treatments for hyperthyroidism.
2. WHAT YOU NEED TO KNOW BEFORE
YOU TAKE NEOMERCAZOLE
• If you are allergic (hypersensitive) to
carbimazole or any of the ingredients of
NeoMercazole.
• If you are allergic (hypersensitive) to
other anti-thyroid medicines such as
thiamazole, methimazole or
propylthiouracil.
• If you are breast-feeding.
• If you have a serious blood disorder.
• If you have a severe liver disorder.
Warnings and precautions
Take special care with NeoMercazole
• If you have a swelling in your neck called
an 'intrathoracic goitre'.
• If you have bone marrow depression.
• If you are receiving radio-iodine (for
thyroid problems).
• If you are of child-bearing potential.
• If you are allergic to thiamazole,
methimazole or propylthiouracil (other
thyroid medications).
• If you are lactose intolerant or have any
other lactose deficiency.
• If you are sucrose intolerant or have any
other sucrose deficiency.
• If you are unable to comply with the
instructions for use or cannot be
monitored regularly.

Talk to your doctor or pharmacist before
taking NeoMercazole
• If you are pregnant, think you may be
pregnant or are trying to become
pregnant.
• If you have mild or moderate liver
problems.
If you are not sure if the above applies to
you, talk to your doctor or pharmacist
before taking NeoMercazole.
Children
Do not give this medicine to children under
the age of two years because it may not be
safe or effective.
Other medicines and NeoMercazole
Please tell your doctor or pharmacist if you
are taking or have recently taken any other
medicines. This includes medicines
obtained without a prescription, including
herbal medicines. This is because
NeoMercazole can affect the way some
medicines work. Also, some medicines can
affect the way NeoMercazole works.
In particular tell your doctor or pharmacist if
you are taking any of the following:
• Theophylline used to treat asthma or
breathing problems.
• Medicines called anticoagulants, which
are used to thin the blood e.g. warfarin.
• Steroids such as prednisolone.
• An antibiotic called erythromycin.
• A medicine for heart failure called digitalis.
• Medicines for high blood pressure called
beta-blockers.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think
you may be pregnant or are planning to
have a baby, ask your doctor or pharmacist
for advice before taking this medicine.
You NeoMercazole treatment is important
for you and may need to be continued
during pregnancy but very rarely it can
cause harm to a developing foetus.
However, to reduce the possibility of any
effects on your baby:
• Your doctor should prescribe the lowest
dose possible.
• Your treatment may be discontinued
three to four weeks before you are due
to give birth.
• You should not breast-feed if you are
using NeoMercazole. This is because
small amounts may pass into the
mother’s milk.
Ask your doctor or pharmacist for advice
before taking any medicine.
Driving and using machines
You can drive when taking NeoMercazole,
but do not drive until you know how it
affects you.
NeoMercazole contain lactose and
sucrose
If your doctor has told you that you have an
intolerance to some sugars, contact your
doctor before taking this medicine.
3. HOW TO TAKE NEOMERCAZOLE
Always take NeoMercazole exactly as your
doctor has told you. You should check with
your doctor or pharmacist if you are not sure.
• The tablets should be taken by mouth.
• You can take the tablets before, after or
during meals.

• Each day’s tablets may be divided into
two (morning and evening) or three daily
doses (morning, noon and night).
Adults and the elderly: The
recommended starting dose is one to three
20 mg tablets, or four to twelve 5 mg
tablets daily. Once control is achieved your
doctor will gradually reduce your dose to
one to three 5 mg tablets each day.
Use in children: The recommended
starting dose is three 5 mg tablets daily.
The dosage will be decided by your doctor
according to your individual needs, and
may be changed at intervals during
treatment.
Do not change the dosage without
consulting your doctor first.
Your doctor may decide to add an
additional tablet (I-thyroxine), to help
control your condition.
Some improvement is usually felt within
one to three weeks. However, full beneficial
effects usually take four to eight weeks.
In order to maintain control of the thyroid
gland, you may need to continue to take
NeoMercazole tablets for several months.
Your doctor will decide when treatment can
be stopped. They may ask you to have
occasional blood tests to help them to
determine how you are responding to
treatment.
Radio-iodine is another treatment for
hyperthyroidism. If you need radioiodine
treatment, your doctor will tell you to stop
taking NeoMercazole temporarily.
If you take more NeoMercazole than you
should
If you take more NeoMercazole than you
should, contact your doctor or nearest
hospital emergency department
immediately. Take the container and any
remaining tablets with you.
If you forget to take NeoMercazole
If you forget to take NeoMercazole take the
next dose as soon as you remember. If
your next dose is due, take both doses
together.
If you have any further questions of the use
of this medicine ask your doctor or
pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, NeoMercazole can
cause side effects, although not everybody
gets them.
Allergic reactions
If you have an allergic reaction, stop taking
NeoMercazole and see a doctor straight
away. The signs may include: sudden rash,
swelling or difficulty breathing.
Stop taking NeoMercazole and see a
doctor straight away if you notice any of the
following side effects:
• Sore throat.
• Mouth ulcers.
• High temperature or fever.
• Significant tiredness.
• Increased bruising or bleeding tendency.
• You are feeling generally unwell or think
that you may have an infection.
In addition, if you experience any of these
symptoms while taking NeoMercazole you
should also contact your doctor
immediately:
• Muscle pain or weakness.
• Nerve pain.
• Swelling of lymph nodes.
• Swelling of glands in your mouth.
• Feeling faint (low blood sugar).
• Yellowing of your skin or whites of your
eyes.

These could be signs of muscle problems,
jaundice or inflammation of the liver and
under medical supervision your doctor may
want you to stop taking the medicine and
carry out some blood tests on you.
Do not stop taking NeoMercazole until
you have consulted your doctor.
NeoMercazole can sometimes cause bone
marrow depression which causes a
reduction in the number of blood cells and
reduces the ability to fight infection. If it is
not treated as soon as it is detected the
condition can become life-threatening. Your
doctor should carry out tests to check for
bone marrow depression before restarting
your treatment.
Other side effects include:
• Feeling sick.
• Headache.
• Skin rashes, including urticarial (nettle
rash).
• Itching.
• Stomach upset.
• Painful joints.
The following side effects have also been
reported:
• Hair loss.
• Loss of taste.
• Angioedema, a serious allergic reaction
with symptoms that may include swollen
tongue, lips, face or throat.
• Lung problems, with symptoms that
include shortness of breath or a cough.
• Kidney problems, with symptoms that
include a reduction in the amount of
urine passed, fluidretention and blood in
the urine.
If at any time you are concerned about
these or any other unwanted effects, talk to
your doctor as soon as possible.
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 NEOMERCAZOLE
Keep out of the sight and reach of
children.
Do not use after the expiry date printed on
the carton, and bottle label after EXP. The
expiry date refers to the last day of that
month.
Do not store above 25°C. Store in the
original container.
If the tablets become discoloured or show
any other signs of deterioration, you should
seek the advice of your pharmacist who
will tell you what to do.
Do not throw away any medicines via
wastewater or household waste. 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 NeoMercazole contains:
• The active substance is carbimazole.
Each tablet contains 5 mg carbimazole.
• The other ingredients are lactose
monohydrate, sucrose, maize starch,
gelatine, magnesium stearate, acacia,
talc and red iron oxide (E172).
What NeoMercazole looks like and
content of the pack
NeoMercazole 5 mg Tablets are pink
circular tablets with 'Neo 5' printed on one
side and plain on the reverse.
NeoMercazole 5 mg is available in plastic
bottles of 100 tablets.
Manufactured by:
Amdipharm Plc, Regency House, Miles
Gray Road, Basildon, Essex, SS14 3AF,
UK. Or,
Wasdell Packaging Ltd, Gloucestershire,
GL10 2BJ, UK. Or,
Cenexi SAS, 52 rue Marcel et Jacques
Gaucher, 94120 Fontenay-sous-Bois,
France.
Procured from within the EU by the
Product Licence Holder:
Expono Ltd, Smethwick, Birmingham, B66
2JT, UK.
Repackaged by:
N.G. Ltd, Birmingham, B66 2JT, UK.
PL 22961/0152 - NeoMerazole® 5 mg
Tablets
POM
Revision Date: 14.03.2016
Ref: 805
NeoMercazole® is a registered trademark
of Amdipharm Mercury International
Limited.

Packaging Leaflet: Information for the patient

Carbimazole 5 mg Tablets
Your medicine is known by the above name but will be referred to as Carbimazole
throughout this leaflet. Carbimazole Tablets is also available in strength 20 mg and
reference to this strength may also be included within this leaflet.
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. Do not pass it on to others. It may
harm them, even if their symptoms 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.
In this leaflet:
1. What Carbimazole is and what it is used
for
2. What you need to know before you take
Carbimazole
3. How to take Carbimazole
4. Possible side effects
5. How to store Carbimazole
6. Contents of the pack and other
information.
1. WHAT CARBIMAZOLE IS AND WHAT
IT IS USED FOR
Carbimazole contains the active substance
carbimazole. Carbimazole belongs to a
group of medicines called anti-thyroid
agents. Carbimazole is used to reduce the
formation of thyroid hormones in adults and
children with an overactive thyroid gland.
The condition is called hyperthyroidism.
Carbimazole is also used in more serious
cases, for example, to restore the normal
function of the thyroid before its partial
removal by surgery. It may also be used
together with other treatments for
hyperthyroidism.
2. WHAT YOU NEED TO KNOW BEFORE
YOU TAKE CARBIMAZOLE
• If you are allergic (hypersensitive) to
carbimazole or any of the ingredients of
Carbimazole.
• If you are allergic (hypersensitive) to
other anti-thyroid medicines such as
thiamazole, methimazole or
propylthiouracil.
• If you are breast-feeding.
• If you have a serious blood disorder.
• If you have a severe liver disorder.
Warnings and precautions
Take special care with Carbimazole
• If you have a swelling in your neck called
an 'intrathoracic goitre'.
• If you have bone marrow depression.
• If you are receiving radio-iodine (for
thyroid problems).
• If you are of child-bearing potential.
• If you are allergic to thiamazole,
methimazole or propylthiouracil (other
thyroid medications).
• If you are lactose intolerant or have any
other lactose deficiency.
• If you are sucrose intolerant or have any
other sucrose deficiency.
• If you are unable to comply with the
instructions for use or cannot be
monitored regularly.

Talk to your doctor or pharmacist before
taking Carbimazole
• If you are pregnant, think you may be
pregnant or are trying to become
pregnant.
• If you have mild or moderate liver
problems.
If you are not sure if the above applies to
you, talk to your doctor or pharmacist
before taking Carbimazole.
Children
Do not give this medicine to children under
the age of two years because it may not be
safe or effective.
Other medicines and Carbimazole
Please tell your doctor or pharmacist if you
are taking or have recently taken any other
medicines. This includes medicines
obtained without a prescription, including
herbal medicines. This is because
Carbimazole can affect the way some
medicines work. Also, some medicines can
affect the way Carbimazole works.
In particular tell your doctor or pharmacist if
you are taking any of the following:
• Theophylline used to treat asthma or
breathing problems.
• Medicines called anticoagulants, which
are used to thin the blood e.g. warfarin.
• Steroids such as prednisolone.
• An antibiotic called erythromycin.
• A medicine for heart failure called digitalis.
• Medicines for high blood pressure called
beta-blockers.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think
you may be pregnant or are planning to
have a baby, ask your doctor or pharmacist
for advice before taking this medicine.
You Carbimazole treatment is important for
you and may need to be continued during
pregnancy but very rarely it can cause
harm to a developing foetus. However, to
reduce the possibility of any effects on your
baby:
• Your doctor should prescribe the lowest
dose possible.
• Your treatment may be discontinued
three to four weeks before you are due
to give birth.
• You should not breast-feed if you are
using Carbimazole. This is because
small amounts may pass into the
mother’s milk.
Ask your doctor or pharmacist for advice
before taking any medicine.
Driving and using machines
You can drive when taking Carbimazole,
but do not drive until you know how it
affects you.
Carbimazole contain lactose and
sucrose
If your doctor has told you that you have an
intolerance to some sugars, contact your
doctor before taking this medicine.
3. HOW TO TAKE CARBIMAZOLE
Always take Carbimazole exactly as your
doctor has told you. You should check with
your doctor or pharmacist if you are not sure.
• The tablets should be taken by mouth.
• You can take the tablets before, after or
during meals.

• Each day’s tablets may be divided into
two (morning and evening) or three daily
doses (morning, noon and night).
Adults and the elderly: The
recommended starting dose is one to three
20 mg tablets, or four to twelve 5 mg
tablets daily. Once control is achieved your
doctor will gradually reduce your dose to
one to three 5 mg tablets each day.
Use in children: The recommended
starting dose is three 5 mg tablets daily.
The dosage will be decided by your doctor
according to your individual needs, and
may be changed at intervals during
treatment.
Do not change the dosage without
consulting your doctor first.
Your doctor may decide to add an
additional tablet (I-thyroxine), to help
control your condition.
Some improvement is usually felt within
one to three weeks. However, full beneficial
effects usually take four to eight weeks.
In order to maintain control of the thyroid
gland, you may need to continue to take
Carbimazole tablets for several months.
Your doctor will decide when treatment can
be stopped. They may ask you to have
occasional blood tests to help them to
determine how you are responding to
treatment.
Radio-iodine is another treatment for
hyperthyroidism. If you need radioiodine
treatment, your doctor will tell you to stop
taking Carbimazole temporarily.
If you take more Carbimazole than you
should
If you take more Carbimazole than you
should, contact your doctor or nearest
hospital emergency department
immediately. Take the container and any
remaining tablets with you.
If you forget to take Carbimazole
If you forget to take Carbimazole take the
next dose as soon as you remember. If
your next dose is due, take both doses
together.
If you have any further questions of the use
of this medicine ask your doctor or
pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Carbimazole can cause
side effects, although not everybody gets
them.
Allergic reactions
If you have an allergic reaction, stop taking
Carbimazole and see a doctor straight
away. The signs may include: sudden rash,
swelling or difficulty breathing.
Stop taking Carbimazole and see a doctor
straight away if you notice any of the
following side effects:
• Sore throat.
• Mouth ulcers.
• High temperature or fever.
• Significant tiredness.
• Increased bruising or bleeding tendency.
• You are feeling generally unwell or think
that you may have an infection.
In addition, if you experience any of these
symptoms while taking Carbimazole you
should also contact your doctor
immediately:
• Muscle pain or weakness.
• Nerve pain.
• Swelling of lymph nodes.
• Swelling of glands in your mouth.
• Feeling faint (low blood sugar).
• Yellowing of your skin or whites of your
eyes.

These could be signs of muscle problems,
jaundice or inflammation of the liver and
under medical supervision your doctor may
want you to stop taking the medicine and
carry out some blood tests on you.
Do not stop taking Carbimazole until
you have consulted your doctor.
Carbimazole can sometimes cause bone
marrow depression which causes a
reduction in the number of blood cells and
reduces the ability to fight infection. If it is
not treated as soon as it is detected the
condition can become life-threatening. Your
doctor should carry out tests to check for
bone marrow depression before restarting
your treatment.
Other side effects include:
• Feeling sick.
• Headache.
• Skin rashes, including urticarial (nettle
rash).
• Itching.
• Stomach upset.
• Painful joints.
The following side effects have also been
reported:
• Hair loss.
• Loss of taste.
• Angioedema, a serious allergic reaction
with symptoms that may include swollen
tongue, lips, face or throat.
• Lung problems, with symptoms that
include shortness of breath or a cough.
• Kidney problems, with symptoms that
include a reduction in the amount of
urine passed, fluidretention and blood in
the urine.
If at any time you are concerned about
these or any other unwanted effects, talk to
your doctor as soon as possible.
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 CARBIMAZOLE
Keep out of the sight and reach of
children.
Do not use after the expiry date printed on
the carton, and bottle label after EXP. The
expiry date refers to the last day of that
month.
Do not store above 25°C. Store in the
original container.
If the tablets become discoloured or show
any other signs of deterioration, you should
seek the advice of your pharmacist who
will tell you what to do.
Do not throw away any medicines via
wastewater or household waste. 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 Carbimazole contains:
• The active substance is carbimazole.
Each tablet contains 5 mg carbimazole.
• The other ingredients are lactose
monohydrate, sucrose, maize starch,
gelatine, magnesium stearate, acacia,
talc and red iron oxide (E172).
What Carbimazole looks like and
content of the pack
Carbimazole 5 mg Tablets are pink circular
tablets with 'Neo 5' printed on one side and
plain on the reverse.
Carbimazole 5 mg is available in plastic
bottles of 100 tablets.
Manufactured by:
Amdipharm Plc, Regency House, Miles
Gray Road, Basildon, Essex, SS14 3AF,
UK. Or,
Wasdell Packaging Ltd, Gloucestershire,
GL10 2BJ, UK. Or,
Cenexi SAS, 52 rue Marcel et Jacques
Gaucher, 94120 Fontenay-sous-Bois,
France.
Procured from within the EU by the
Product Licence Holder:
Expono Ltd, Smethwick, Birmingham, B66
2JT, UK.
Repackaged by:
N.G. Ltd, Birmingham, B66 2JT, UK.
PL 22961/0152 - Carbimazole 5 mg Tablets
Revision Date: 14.03.2016
Ref: 804

POM

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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