Carbimazole 20mg tablets

Krajina: Spojené kráľovstvo

Jazyk: angličtina

Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktívna zložka:

Carbimazole

Dostupné z:

Mawdsley-Brooks & Company Ltd

ATC kód:

H03BB01

INN (Medzinárodný Name):

Carbimazole

Dávkovanie:

20mg

Forma lieku:

Oral tablet

Spôsob podávania:

Oral

Trieda:

No Controlled Drug Status

Typ predpisu:

Valid as a prescribable product

Prehľad produktov:

BNF: 06020200

Príbalový leták


Do not change the dosage without consulting your
doctor first

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. Your doctor may ask you
to have occasional blood tests to help determine
how you are responding to treatment

Radio-iodine is another treatment for hyperthyroidism. If you
need radio-iodine treatment, your doctor will tell you to stop
taking Carbimazole temporarily.
RECOMMENDED DOSE
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.
USE IN CHILDREN: the recommended starting dose is three 5 mg
tablets daily.
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 a dose, take it as soon as you remember. If it is time
for
your next dose, take both doses together.
If you have any further questions of the use of this medicine ask
your doctor or pharmacist.
Like all medicines, Carbimazole can cause side effects, although not
everybody gets them.
SERIOUS SIDE EFFECTS:
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

itching

increased bruising or bleeding tendency

significant tiredness

you are feeling generally unwell or think that you may have an
infecti

Súhrn charakteristických

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Carbimazole 20mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Carbimazole 20mg tablet contains 20mg of carbimazole.
Excipients with known effect: lactose anhydrous 295.750mg.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet.
White coloured, round-shaped, uncoated tablets debossed “CARB” on
one side and
“20” on the other side having diameter 9.60mm.
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 monitoring 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 r