Carbimazole 10mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Carbimazole

Available from:

Macleods Pharma UK Ltd

ATC code:

H03BB01

INN (International Name):

Carbimazole

Dosage:

10mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 06020200; GTIN: 8901463124758

Patient Information leaflet

The name of your medicine is Carbimazole 5 mg tablets or
Carbimazole 10 mg tablets or Carbimazole 15 mg tablets or
Carbimazole 20 mg tablets (it will be referred to as Carbimazole
throughout the leaflet). 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
-
This medicine has been prescribed for you only. Do not pass it on
to others. It may harm them, even if their signs of illness are the
same as yours.
CARBIMAZOLE 5MG, 10MG, 15MG AND 20 MG
TABLETS
-
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.
PACKAGE LEAFLET: INFORMATION FOR THE USER
-
If you have any further questions, ask your doctor or pharmacist.
-
Keep this leaflet. You may need to read it again.
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
WHAT IS IN THIS LEAFLET:
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU
:
Ÿ
if you had inflammation of the pancreas (acute pancreatitis) after
administration of carbimazole or thiamazole in the past.
Ÿ
if you have a severe liver disorder.
Ÿ
if you have a serious blood disorder.
Ÿ
if you have had a serious allergy to other anti-thyroid medications
such as thiamazole, methimazole or propylthiouracil.
Ÿ
if you are aller

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Carbimazole 10mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10mg of carbimazole.
Excipient(s) with known effect
Lactose monohydrate (97.175mg per tablet)
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Pink, mottled, round, biconvex uncoated tablets, debossed with "10" on
one
side and plain on other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Carbimazole is an anti-thyroid agent. It is indicated in adults and
children in
all conditions where reduction of thyroid function is required.
Such conditions are:
1. Hyperthyroidism.
2. Preparation for thyroidectomy in hyperthyroidism.
3. Therapy prior to and post radio-iodine treatment.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Carbimazole
should
only
be
administered
if
hyperthyroidism
has
been
confirmed by laboratory tests.
_Adults _
The initial dose is in the range 20 - 60 mg, taken as two to three
divided doses.
The dose should be titrated
against thyroid function until the patient is
euthyroid
in
order
to
reduce
the
risk
of
over-treatment
and
resultant
hypothyroidism. Subsequent therapy may then be administered in one of
two
ways.
_Maintenance regimen:_ Final dosage is usually in the range 5 - 15 mg
per day,
which may be taken as a single daily dose. Therapy should be continued
for at
least six, and up to eighteen months.
Serial thyroid function is recommended, together with appropriate
dosage
modification in order to maintain a euthyroid state.
_Blocking-replacement regimen:_ Dosage is maintained at the initial
level, i.e.
20 - 60 mg per day, and supplemental l-thyroxine, 50 - 150 mcg per
day, is
administered concomitantly, in order to prevent hypothyroidism.
Therapy
should be continued for at least six months and up to eighteen months.
Where a single dosage of less than 20 mg is recommended, it is
intended that
Carbimazole 5 mg tablets should be taken.
Elderly
No special dosage regimen is required, but care should be taken to