Carbimazole 5mg tablets

Negara: Inggris

Bahasa: Inggris

Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)

Bahan aktif:

Carbimazole

Tersedia dari:

Ria Generics 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: 5060325270828

Selebaran informasi

390.00 mm
160.00 mm
25.00 mm
folded size
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CARBIMAZOLE 5MG TABLETS
CARBIMAZOLE 20MG TABLETS
Carbimazole
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START
TAKING THIS MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your
doctor or pharmacist.
-
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.
-
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.
WHAT IS IN THIS LEAFLET
1.
What carbimazole tablet is and what it is used for
2.
What you need to know before you take
carbimazole tablet
3.
How to take carbimazole tablet
4.
Possible side effects
5.
How to store carbimazole tablet
6.
Contents of the pack and other information
1. WHAT CARBIMAZOLE TABLET IS AND WHAT IT IS USED
FOR
The name of your medicine is carbimazole 5mg
Tablets or carbimazole 20 mg Tablets (called
carbimazole tablet in this leaflet). Carbimazole tablet
contains the active substance carbimazole.
Carbimazole tablet belongs to a group of medicines
called anti-thyroid agents. Carbimazole tablet is used
to reduce the formation of thyroid hormones in adults
and children with an overactive thyroid gland. The
condition is called hyperthyroidism.
Carbimazole tablet 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 TABLETS
DO NOT TAKE CARBIMAZOLE TABLET
•
If you are allergic (hypersensitive} to carbimazole
or any of the ingredients of carbimazole tablet
(listed in section 6)
•
If you have had a serious allergy to other anti-
thyroid medications such as thiamazole,
methimazole or propylthiouracil
•
If you ar

Karakteristik produk

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Carbimazole 5mg tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Carbimazole 5mg tablets contains carbimazole 5mg carbimazole
Excipient(s) with known effect
Each 5mg tablet contains lactose anhydrous 70mg
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Carbimazole 5mg tablets
White coloured, 6.30mm round shaped, uncoated tablets, debossed
“5” on one side
and break line on other side.
Carbimazole 5 mg Tablets
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 adminis