Carbimazole 20mg tablets

Страна: Великобритания

Язык: английский

Источник: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активный ингредиент:

Carbimazole

Доступна с:

CST Pharma Ltd

код АТС:

H03BB01

ИНН (Международная Имя):

Carbimazole

дозировка:

20mg

Фармацевтическая форма:

Oral tablet

Администрация маршрут:

Oral

класс:

No Controlled Drug Status

Тип рецепта:

Valid as a prescribable product

Обзор продуктов:

BNF: 06020200; GTIN: 5055946803869

тонкая брошюра

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
REDUZOL 5MG, 10MG AND 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 Reduzol Tablets are and what they are used for
2.
What you need to know before you take Reduzol Tablets
3.
How to take Reduzol Tablets
4.
Possible side effects
5.
How to store Reduzol Tablets
6.
Contents of the pack and other information
1.
WHAT REDUZOL TABLETS ARE AND WHAT THEY ARE USED FOR
The name of your medicine is Reduzol 5mg Tablets, Reduzol 10mg Tablets
or Reduzol 20mg
Tablets (called Reduzol Tablets in this leaflet). Reduzol Tablets
contains the active substance
carbimazole. This belongs to a group of medicines called anti-thyroid
agents. Reduzol Tablets
are used to reduce the formation of thyroid hormones in for adults and
children with an over-
active thyroid gland. This 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 REDUZOL TABLETS
_ _
DO NOT TAKE REDUZOL TABLETS:
•
If you are allergic to carbimazole or any of the other ingredients of
this medicine (listed
in section 6).
•
If you are allergic to other anti-thyroid medicines such as
thiamazole, methimazole or
propylthiouracil.
•
If you are breast-feeding.
•
If you have a serious blood disorder.
•
If you have a severe liver disorder.

Характеристики продукта

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