CARBIMAZOLE 5MG TABLETS

PACKAGE LEAFLET: INFORMATION FOR THE USER

CARBIMAZOLE 5MG TABLETS
Carbimazole Tablets are available in two
strengths: 5mg and 20mg.
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.
What is 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
(called Carbimazole in this leaflet). This
belongs to a group of medicines called
'anti-thyroid' medicines. Carbimazole is
used for adults and children with an overactive thyroid gland (called
'hyper-thyroidism').
 It works by reducing the amount of
thyroid hormones made in your thyroid
gland
 It can be used on its own, or with other
treatments for an over-active thyroid
gland
 It can also be used before part of the
thyroid gland has been removed by
surgery. It helps the thyroid gland work
properly before the surgery.

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 tablets
(listed in Section 6)
 You are allergic (hypersensitive) to
other anti-thyroid medicines such
as thiamazole, methimazole or
propylthiouracil
 You are breast-feeding
 You have a severe liver disorder
 You have a serious blood disorder.
Do not take Carbimazole tablets if any of the
above apply to you. If you are not sure,
talk to your doctor or pharmacist before
taking Carbimazole.
Warnings and precautions
Take special care with Carbimazole
Check with your doctor or pharmacist
before taking your medicine if:
 You have a swelling in your neck called
an 'intrathoracic goitre'
 You are pregnant, think you may
become pregnant or are trying to
become pregnant
 You have bone marrow depression
 You have mild or moderate liver
problems
 You are receiving radio-iodine (for
thyroid problems)
 You are of child bearing potential
 You are allergic to thiamazole,
methimazole or
propylthiouracil (other thyroid
medications)
 You are lactose intolerant or

have any other lactose
deficiency
 You are unable to comply with
the instructions for use or
cannot be monitored regularly.
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:
 Medicines to thin your blood or to stop
clotting
 A medicine to help your breathing called
'theophylline'
 Steroids such as prednisolone
 An antibiotic called erythromycin
 A medicine for heart failure called digitalis
 Medicines for high blood pressure called
beta-blockers. If any of the above apply to
you (or you are not sure), talk to your doctor
or pharmacist before taking Carbimazole.
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. This is
because there is a very small chance that
your baby may be affected.
In some cases, your doctor may prescribe
Carbimazole while you are pregnant. He or
she will talk to you about this. If they do, they
will lower the possibility of any effects on your
baby by:
 Using the lowest possible dose
 Stopping treatment three to four weeks
before you are due to give birth.
Do not breast-feed if you are taking
Carbimazole. This is because small
amounts may pass into the mother's milk.
Driving and using machines
You can drive when taking Carbimazole, but
do not drive until you know how it affects
you.
Carbimazole tablets contain lactose
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.
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.
Taking this medicine
 Take this medicine by mouth
 Swallow the tablets whole with a drink of
water
 You can take the tablets before, during or
after meals
 The tablets you take each day may
be split into two (morning and
evening) or three (morning,
afternoon and night). Ask your
pharmacist if you are not sure.
How much to take at the start
The doctor will decide on a starting dose,
and then see how well it works.
 If needed, he or she will then change the
dose



This is to find a dose that suits you best.

Adults
The recommended starting dose for the 5
mg tablets is between 4 and 12 tablets
each day.
The recommended starting dose for the 20
mg tablets is between 1 and 3 tablets each
day.
Use in children
The recommended starting dose is three
5 mg tablets each day.
How much to take after the starting dose
Your illness will usually start to improve within
one to three weeks. However, it usually takes
four to eight weeks to have full benefit from
your treatment.
 When your illness is controlled,
your doctor will gradually lower
your dose to one to three 5 mg
tablets each day
 Do not change your dose without
talking to your doctor first.
You may need to keep taking Carbimazole
for several months to keep control of your
thyroid gland. Your doctor will decide when
treatment can be stopped. Your doctor may
ask you to have occasional blood tests to
see how well your treatment is working.
Your doctor may decide to add an additional
tablet (l-thyroxine), to help control your
condition.
Radio-iodine
Another treatment for an over-active thyroid
is called "radio-iodine". If you need radioiodine treatment your doctor will tell you to
stop taking Carbimazole tablets for a while.
If you take more Carbimazole than you
should
If you take more Carbimazole than you
should, talk to a doctor or go to a hospital
straight away. Take the medicine pack or this
leaflet and any remaining tablets with you.
If you forget to take Carbimazole
If you forget a dose, take it as soon as you
remember. If it is time for your next dose, take
both doses together.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Carbimazole can cause
side effects, although not everybody gets
them. The side effects usually happen in the
first eight weeks of your treatment.
Do not be alarmed by this list of possible side
effects. You may not get any of 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:
 Any infection such as a sore throat or
mouth ulcers
 Fever
 Unusual bruising or bleeding
 Feeling unusually tired
 You are feeling generally unwell or think
that you may have an infection.
Your doctor may need to do some tests to
check for something called 'bone marrow
depression' before you start your
treatment again.
Tell your doctor if you get any of the
following side effects:
 Liver problems such as yellowing
of the skin or eyes (jaundice)
 Muscle pain or weakness
 Nerve pain
 Swelling of lymph nodes
 Swelling of glands in your mouth
 Feeling faint (low blood sugar).
Other side effects include:
If you get any of the following side effects,
they normally go away while you keep
taking your medicine.

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Feeling sick (nausea)
Headache or feeling dizzy
Skin rashes
Itching
Stomach upset
Painful joints
Hair thinning
Changes to your taste.

The following side effects have also been
reported:
 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 or pharmacist. 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 out of the sight and reach
of children.
 Do not use Carbimazole 20mg
Tablets after the expiry date which
is stated on the carton and bottle
after Exp. The expiry date refers to
the last day of that month.
 Do not store above 25ºC. Store in
the original container.
 If your doctor decides to stop your
treatment, take any tablets you
have left back to the pharmacy.
 If your tablets appear discoloured,
or show any other signs of
deterioration, take them to your
pharmacist who will advise you.
 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. CONTENTS OF THE PACK AND OTHER
INFORMATION
What Carbimazole 5mg Tablets
contain
The active substance is carbimazole. Each
tablet contains 5mg carbimazole. The
tablets also contain sucrose, lactose
monohydrate, acacia, talc, maize starch,
magnesium stearate, gelatin and red iron
oxide (E172).
What Carbimazole 5mg Tablets look
like and contents of the pack
Carbimazole 5mg are pink, circular tablets
with 'Neo 5' on one side and plain on the
reverse.
Carbimazole 5mg Tablets come in packs of
100 tablets.
Manufacturer
Manufactured by: Amdipharm Plc, Regency
House, Miles Gray Road, Basildon, Essex,
SS14 3AF
or
Cenexi SAS, 52 rue Marcel et Jacques
Gaucher, 94120 Fontenay-sous-Bois,
France.
Procured from within the EU and
repackaged for theProduct Licence holder:
Millsdale Pharmaceuticals,Warrington,
Cheshire, WA2 7UB. UK.
PL No: 08811/0038

POM

This leaflet was prepared 26th August
2015.