Carbimazole 5mg tablets

Negara: Inggris

Bahasa: Inggris

Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)

Bahan aktif:

Carbimazole

Tersedia dari:

CST Pharma Ltd

Kode ATC:

H03BB01

INN (Nama Internasional):

Carbimazole

Dosis:

5mg

Bentuk farmasi:

Oral tablet

Rute administrasi :

Oral

Kelas:

No Controlled Drug Status

Jenis Resep:

Valid as a prescribable product

Ringkasan produk:

BNF: 06020200; GTIN: 5055946807348

Selebaran informasi

– 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

Karakteristik produk

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.
Excipients with known effect:
Lactose Anhydrous
(140.485 mg per tablet)
For a full list of excipients see section 6.1.
3
PHARMACEUTICAL FORM
Pale pink, uncoated, round, biconvex tablets marked with LINK C5 on
one side and a
scoreline on the reverse.
The score line is only to facilitate breaking for ease of swallowing
and not to divide into
equal doses.
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 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