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NEOMERCAZOLE 5MG TABLETS

Active substance: CARBIMAZOLE

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NeoMercazole® 5mg Tablets / Carbimazole 5mg Tablets
(carbimazole)
Your medicine is known by one of the above names, but will be referred to as
NeoMercazole throughout this:
Patient Information Leaflet
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 severe, or if you notice any side
effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1) What NeoMercazole is and what it is used for
2) Before you take NeoMercazole
3) How to take NeoMercazole
4) Possible side effects
5) How to store NeoMercazole
6) Further information

1) What NeoMercazole is and what it is used for
NeoMercazole belongs to a group of medicines called anti-thyroid agents.
NeoMercazole is used to reduce the formation of thyroid hormones in people
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) Before you take NeoMercazole

Pregnancy and breast-feeding
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.
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.
Important information about some of the ingredients of NeoMercazole
NeoMercazole contains 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.
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 usual 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.

Do not take NeoMercazole
• If you are allergic (hypersensitive) to carbimazole or any of the
ingredients of NeoMercazole.
• If you are breast-feeding.
• If you have a serious blood disorder.
• If you have a severe liver disorder.

Children: the usual starting dose is three 5mg tablets daily.

Take special care with NeoMercazole
• If you are pregnant, think you may be pregnant or are trying to become
pregnant.
• If you have mild or moderate liver problems.

Do not stop taking NeoMercazole until you have consulted your doctor.

Tell your doctor if any of the above applies to you.

Some improvement is usually felt within one to three weeks. However, full
beneficial effects usually take four to eight weeks.

Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken
any other medicines, including medicines obtained without a prescription, or
the following:
• Theophylline used to treat asthma or breathing problems
• Medicines called anticoagulants, which are used to thin the blood e.g.
warfarin

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.

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. He may ask you to have occasional blood tests to
help him 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.

5) How to store NeoMercazole
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.

• Keep all medicines 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.
• 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 NeoMercazole contains:
The active substance is carbimazole. Each tablet contains 5mg carbimazole.

If you experience any of these symptoms whilst taking NeoMercazole please
contact your doctor immediately:
• 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

The other ingredients are sucrose, lactose monohydrate, acacia, talc, maize
starch, magnesium stearate, gelatin and red iron oxide (E172).

In addition, if you experience any of these symptoms while taking
NeoMercazole you should also contact your doctor immediately:
• muscle aches or pains
• 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.

PL 10383/2065

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.

What NeoMercazole looks like and content of the pack
NeoMercazole 5mg tablets are pink, round, biconvex, uncoated tablets with
Neo 5 stamped on one side and plain on the other.
NeoMercazole 5mg is available in plastic bottles of 100 tablets.
NeoMercazole 5mg Tablets /
Carbimazole 5mg Tablets

POM

Who makes and repackages your medicine
Your medicine is manufactured by Amdipharma Plc., Regency House, Miles
Gray Road, Basildon, Essex, SS14 3AF, UK or Cenexi SAS, 52 rue Marcel et
Jacques Gaucher, 94120 Fontenay-sous-Bois, France. Procured from within
the EU and repackaged by Product Licence Holder: Primecrown Ltd, 4/5
Northolt Trading Estate, Belvue Road, Northolt, Middlesex, UB5 5QS.
Leaflet date: 08.05.2013
NeoMercazole
Switzerland.

®

is a registered trademark of Amdipharm AG, Basle,

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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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