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NEOMERCAZOLE 20MG TABLETS

Active substance(s): CARBIMAZOLE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

NeoMercazole® 20mg Tablets/
Carbimazole 20mg Tablets
(carbimazole)

Your medicine is available using one of the above names but will
be referred to as NeoMercazole throughout 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
onto 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.
2.
3.
4.
5.
6.

What NeoMercazole is and what it is used for
What you need to know before you take NeoMercazole
How to take NeoMercazole
Possible side effects
How to store NeoMercazole
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
Do not take NeoMercazole







If you are allergic (hypersensitive) to carbimazole or any of
the ingredients of NeoMercazole.
If you are allergic (hypersensitive) to other antithyroid medications 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

Driving and using machines






NeoMercazole contains lactose and sucrose.







If you have a swelling in your neck called an ‘intrathoracic
goitre’.
If you have bone marrow depression.
If you are receiving radioiodine (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.

You can drive when taking NeoMercazole, but do not drive until
you know how it affects you.
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 20mg tablets, or four to twelve 5mg tablets daily. Once
control is achieved your doctor will gradually reduce your dose to
one to three 5mg tablets each day.

Children

Use in children: The recommended starting dose is three 5mg
tablets daily.

Other medicines and NeoMercazole

The dosage will be decided by your doctor according to your
individual needs, and may be changed at intervals during
treatment.

Do not give this medicine to children under the age of two years
because it may not be safe or effective.
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.
Your 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.

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Do not change the dosage without consulting your doctor first.
Your doctor may decide to add an additional tablet (l-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.
Radioiodine 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 urticaria (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, fluid retention 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 this medicine out of the sight and reach of children.
This medicine must not be used after the date (EXP) printed
on the pack. The expiry date refers to the last day of the
month. Return any left over medicine to your pharmacist.
Only keep it if your doctor tells you to.
Do not store above 25ºC. Store in the original container.
If your tablets appear discoloured, or show any other signs
of deterioration, take them to your pharmacist who will
advise you.

6. Contents of the pack and other
information.
What NeoMercazole contains

The active substance is carbimazole. Each tablet contains 20mg
carbimazole.
The tablets also contain sucrose, lactose, maize starch, gelatin,
magnesium stearate, acacia, talc, red iron oxide (E172) and
cellulose microcrystalline.

What NeoMercazole looks like and contents of the
pack

Each 20mg tablet is a pink circular tablet with Neo on one side and
20
plain on the reverse.
The tablets come in plastic container of 100 with a tamper evident
ring.

Manufacturer

Manufactured by: Amdipharm Plc, Regency House, Miles Gray
Road, Basildon, Essex, SS14 3AF.
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: 08929/0525

POM

Leaflet Revision and Issue date (Ref): 24.03.15
NeoMercazole® is a registered trademark of Amdipharm 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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