NeoMercazole 5 mg Tablets

Nazione: Irlanda

Lingua: inglese

Fonte: HPRA (Health Products Regulatory Authority)

Principio attivo:

Carbimazole

Commercializzato da:

Amdipharm Limited

Codice ATC:

H03BB; H03BB01

INN (Nome Internazionale):

Carbimazole

Dosaggio:

5 milligram(s)

Forma farmaceutica:

Tablet

Tipo di ricetta:

Product subject to prescription which may be renewed (B)

Area terapeutica:

Sulfur-containing imidazole derivatives; carbimazole

Stato dell'autorizzazione:

Marketed

Data dell'autorizzazione:

1995-03-13

Foglio illustrativo

Page 1 of 6
PACKAGE LEAFLET: INFORMATION FOR THE USER
NEOMERCAZOLE
®
5 MG TABLETS
NEOMERCAZOLE
®
20 MG TABLETS
carbimazole
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING YOUR
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 onto
others.
It may harm them, even if their signs of illness are the same as
yours.
-
If any of the 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 NeoMercazole is and what it is used for
2.
What you need to know before you take NeoMercazole
3.
How to take NeoMercazole
4.
Possible side effects
5.
How to store NeoMercazole
6.
Content of the pack and other information
1. WHAT NEOMERCAZOLE IS AND WHAT IT IS USED FOR
The name of your medicine is NeoMercazole 5mg Tablets or Neomercazole
20mg Tablets (called NeoMercazole in this leaflet). NeoMercazole
contains
the active substance carbimazole. NeoMercazole belongs to a group of
medicines called anti-thyroid agents. NeoMercazole is used to reduce
the
formation of thyroid hormones in adults and children with an
overactive
thyroid gland. The condition is called hyperthyroidism.
NeoMercazole 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 NOW BEFORE YOU TAKE NEOMERCAZOLE
DO NOT TAKE NEOMERCAZOLE

If you are allergic to carbimazole or any of the ingredients of this
medicine (listed in section 6)

If you have had a serious allergy 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 p

Scheda tecnica

Health Products Regulatory Authority
09 April 2021
CRN00C3ZC
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
NeoMercazole 5 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each NeoMercazole 5 mg tablet contains carbimazole 5 mg.
Excipients with known effect:
Lactose monohydrate (30.0 mg/tablet)
Sucrose (139.39 mg/tablet)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
Pink, circular biconvex tablet, imprinted with "Neo 5" on the obverse
and plain on the reverse.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
NeoMercazole 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
NeoMercazole 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 is recommended, together with appropriate
dosage modification in order to maintain aeuthyroid 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 NeoMer