Carbimazole 5mg tablets

Nchi: Uingereza

Lugha: Kiingereza

Chanzo: MHRA (Medicines & Healthcare Products Regulatory Agency)

Viambatanisho vya kazi:

Carbimazole

Inapatikana kutoka:

Flamingo Pharma (UK) Ltd

ATC kanuni:

H03BB01

INN (Jina la Kimataifa):

Carbimazole

Kipimo:

5mg

Dawa fomu:

Oral tablet

Njia ya uendeshaji:

Oral

Darasa:

No Controlled Drug Status

Dawa ya aina:

Valid as a prescribable product

Bidhaa muhtasari:

BNF: 06020200; GTIN: 5060464501043

Tabia za bidhaa

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Carbimazole 5 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg of Carbimazole.
Excipient(s) with known effect:
Each tablet contains 21.870 mg lactose monohydrate.
Each tablet contains 9.00 mg sucrose.
For full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Tablet
Pink coloured, speckled, round, biconvex, uncoated tablets plain on
both sides
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
Carbimazole
Tablets
should
only
be
administered
if
hyperthyroidism
has
been
confirmed by laboratory tests.
Posology
_Older people _
No special dosage regimen is required, but care should be taken to
observe the
contraindications and warnings as it has been reported that the risk
of a fatal outcome
to neutrophil dyscrasia may be greater in the elderly (aged 65 or
over).
_Paediatric population _
Use in children and adolescents (3 to 17 years of age)
The usual initial daily dose is 15 mg per day adjusted according to
response.
Use in children (2 years of age and under)
Safety and efficacy of carbimazole in children below 2 years of age
have not been
evaluated systematically. Use of carbimazole in children below 2 years
of age is
therefore not recommended.
_Adults _
The initial dose is in the range 20 mg to 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 mg to 15
mg per day,
which may be taken as a single daily dose. Thera