Carbimazole 20 mg Tablets

国家: 爱尔兰

语言: 英文

来源: HPRA (Health Products Regulatory Authority)

有效成分:

Carbimazole

可用日期:

Essential-Healthcare Ltd.

ATC代码:

H03BB; H03BB01

INN（国际名称）:

Carbimazole

剂量:

20 milligram(s)

药物剂型:

Tablet

处方类型:

Product subject to prescription which may be renewed (B)

治疗领域:

Sulfur-containing imidazole derivatives; carbimazole

授权状态:

Not marketed

授权日期:

2018-06-14

资料单张

1
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. 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.
IN THIS LEAFLET:
1.
What Carbimazole is and what it is used for
2.
What you need to know before you take Carbimazole
3.
How to take Carbimazole
4.
Possible side effects
5.
How to store Carbimazole
6.
Contents of the pack and other information
1.
WHAT CARBIMAZOLE IS AND WHAT IT IS USED FOR
The name of your medicine is Carbimazole 5 mg Tablets or Carbimazole
20 mg Tablets (this will be
referred to Carbimazole throughout the leaflet). Carbimazole contains
the active ingredient
carbimazole. Carbimazole belongs to a group of medicines called
anti-thyroid agents. Carbimazole is
used to reduce the formation of thyroid hormones in adults and
children with an overactive thyroid
gland. The condition is called hyperthyroidism. Carbimazole 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
DO NOT TAKE CARBIMAZOLE

If you are allergic (hypersensitive) to carbimazole or any of the
other ingredients of Carbimazole.

If you are allergic (hypersensitive) to other anti-thyroid medicines
such as thiamazole, methimazole
or propylthiouracil
.

If you are breast-feeding.

If you have a severe liver disorder.

If you have a serious blood disorder.

If you had inflammation of

产品特点

Health Products Regulatory Authority
12 January 2021
CRN00C3SF
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Carbimazole 20 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each uncoated tablet contains 20 mg carbimazole.
_Excipient with known effect: _
Each tablet contains 280 mg of lactose.
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Tablet. White coloured, 9.60mm round shaped standard concave, uncoated
tablet plain on one side and scoreline on other side.
The scoreline 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 the