Carbimazole 20mg tablets

Ülke: Birleşik Krallık

Dil: İngilizce

Kaynak: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktif bileşen:

Carbimazole

Mevcut itibaren:

Alliance Healthcare (Distribution) Ltd

ATC kodu:

H03BB01

INN (International Adı):

Carbimazole

Doz:

20mg

Farmasötik formu:

Oral tablet

Uygulama yolu:

Oral

Sınıf:

No Controlled Drug Status

Reçete türü:

Valid as a prescribable product

Ürün özeti:

BNF: 06020200

Bilgilendirme broşürü

– 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 or might take 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
Carbimazole can cause harm to an unborn baby.
If you could get pregnant, use reliable contraception from the
time you start treatment and during treatment.
If you are pregnant, think you may be pregnant or are planning
to have a baby, tell your doctor straight away. Your treatment
with Carbimazole may need to be continued during pregnancy if
the potential benefit outweighs the potential risk to you and your

Ürün özellikleri

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