Carbimazole 5 Tablets

Country: Malta

Tungumál: enska

Heimild: Medicines Authority

Virkt innihaldsefni:

CARBIMAZOLE

Fáanlegur frá:

Remedica Limited Limassol Industrial Estate, Aharnon Street, 3056 Limassol, Cyprus

ATC númer:

H03BB01

INN (Alþjóðlegt nafn):

CARBIMAZOLE 5 mg

Lyfjaform:

FILM-COATED TABLET

Samsetning:

CARBIMAZOLE 5 mg

Gerð lyfseðils:

POM

Lækningarsvæði:

THYROID THERAPY

Leyfisstaða:

Authorised

Leyfisdagur:

2006-12-15

Upplýsingar fylgiseðill

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CARBIMAZOLE 5 MG FILM-COATED 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 tablets (this will be
referred to
Carbimazole
throughout
the
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 other ingredients of
this
medicine (listed in section 6).

if you are allergic (hypersensitive) to other anti-thyroid medications
such as
thiamazole, methimazole or propylthiouracil.

if you are breast feeding.

if you have a serious blood disorder.

if you have severe liver disorder.

if you had inflam

Vara einkenni

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SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Carbimazole 5 mg film-coated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains carbimazole 5 mg.
Excipient(s) with known effect
This product contains 90.0 mg lactose and 0.004 mg Ponceau 4R E124.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablet.
Light-pink, round, scored, film-coated tablets, with Remedica’s logo
on one side.
The tablet can be divided into equal doses.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Carbimazole is an anti-thyroid agent. It is indicated 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.
_Older people _
No special dosage regimen is required, but care should be taken to
observe the contra-
indications 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 _
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Use in children and adolescents (3 to 17 years of age)
The usual initial daily dose is 15mg 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 – 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