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CARBIMAZOLE 5 MG TABLETS

Active substance: CARBIMAZOLE

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Package leaflet: Information for the user

Carbimazole 5 mg and 20 mg tablets
Your medicine is known by one of the above names, but
will be referred to as Carbimazole throughout this leaflet.

If you are not sure if the above applies to you, talk to your
doctor or pharmacist before taking Carbimazole.

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.

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

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
The name of your medicine is Carbimazole 5 mg tablets or
Carbimazole 20 mg tablets (this will be referred to as
Carbimazole throughout this leaflet). Carbimazole belongs
to a group of medicines called anti-thyroid agents.
Carbimazole is used to reduce the formulation of thyroid
hormones in adults and children with an over-active 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
Do not take Carbimazole:
 If you are allergic (hypersensitive) to carbimazole or any
of the other 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

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.
Your Carbimazole treatment is important for you and may
need to be continued during pregnancy but very rarely it
can cause harm to 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 tablets 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.

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.

3.

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.

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

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.

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
(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 Carbimazole tablets for several
months. Your doctor will decide when treatment can be
stopped. They may ask you to have occasional blood test
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 tablets 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, fluid retention
and blood in the urine.
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, website:
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 this medicine out of the sight and reach of
children
Do not use Carbimazole after the expiry date which is
stated on the label. The expiry date refers to the last day of
that month.
Do not store above 25°C
Store Carbimazole in the original container
Medicines should not be disposed of via waste water or
household waste. Ask your pharmacist how to dispose of
medicines you no longer require or medicines that have
expired. These measures will help to protect the
environment.
6. CONTENTS OF THE PACK AND OTHER
INFORMATION
What Carbimazole contains
 The active ingredient is carbimazole. Each tablet
contains 5mg or 20 mg of Carbimazole.
 The other ingredients are sucrose, lactose
monohydrate, acacia, talc, maize starch, magnesium
stearate, gelatin and the colourant red iron oxide
(E172). Carbimazole 20mg tablet also contains
microcrystalline cellulose.
What Carbimazole 5mg and 20mg tablets look like and
contents of the pack
The Carbimazole 5 mg tablets are pink circular tablets,
marked with ‘Neo 5’ on one side and plain on the reverse.
The Carbimazole 20 mg tablets are pink circular tablets,
marked with ‘Neo 20’ on one side and plain on the reverse.
Carbimazole are available in plastic containers of 100
tablets with a tamper evident ring.
Manufacturer
Amdipharm Plc, Regency House, Miles Gray Road,
Basildon, Essex, SS14 3AF, United Kingdom.
OR
Cenexi SAS, 52 rue Marcel et Jacques Gaucher, 94120
Fontenay-sous-Bois, France.
PL 33948/0031
PL 33948/0032

Carbimazole 5 mg Tablets
Carbimazole 20 mg Tablets

POM

Procured from within the EU and repackaged by the
Product Licence Holder: Summer Healthcare Ltd., 4 Petre
Road, Clayton-Le-Moors, Accrington BB5 5JB, UK.
Leaflet date: 18th June 2015

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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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