Carbimazole 5 mg Tablets

Valsts: Īrija

Valoda: angļu

Klimata pārmaiņas: HPRA (Health Products Regulatory Authority)

Aktīvā sastāvdaļa:

Carbimazole

Pieejams no:

Renata Pharmaceuticals (Ireland) Limited

ATĶ kods:

H03BB01

SNN (starptautisko nepatentēto nosaukumu):

Carbimazole

Zāļu forma:

Tablet

Ārstniecības joma:

carbimazole

Autorizācija statuss:

Marketed

Autorizācija datums:

2022-11-18

Lietošanas instrukcija

1
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE USER
CARBIMAZOLE 5 MG TABLETS
CARBIMAZOLE 20 MG 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 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 or 20 mg Tablets (this
will be referred to as
Carbimazole throughout this leaflet). Carbimazole contains the active
substance 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 to carbimazole or any of the ingredients of this
medicine (listed in section
6).
•
If you are allergic to other anti-thyroid medications such as
thiamazole, methimazole or
propylthiouracil.
•
If you have a serious blood disorder.
•
If you have a severe liver disorder.
•
If you had inflammation of the pancreas (acute pancreatitis) afte

Produkta apraksts

Health Products Regulatory Authority
30 May 2023
CRN00DJ4T
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Carbimazole 5 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Carbimazole 5 mg Tablet contains carbimazole 5 mg.
Excipients with known effect:
Lactose, anhydrous (52.9 mg/tablet)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
5.2 mm, white, circular-shaped, flat-faced, bevelled edge uncoated
tablets debossed with "5" on one side and "C" on other side.
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 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.
Therapy should be continued for at least six months 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 mg to 60 mg per day, and supplemental
L-thyroxine, 50 mcg to 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 recom