Carbimazole 5mg tablets

Χώρα: Ηνωμένο Βασίλειο

Γλώσσα: Αγγλικά

Πηγή: MHRA (Medicines & Healthcare Products Regulatory Agency)

Δραστική ουσία:

Carbimazole

Διαθέσιμο από:

Tillomed Laboratories Ltd

Φαρμακολογική κατηγορία (ATC):

H03BB01

INN (Διεθνής Όνομα):

Carbimazole

Δοσολογία:

5mg

Φαρμακοτεχνική μορφή:

Oral tablet

Οδός χορήγησης:

Oral

Kατηγορία:

No Controlled Drug Status

Τρόπος διάθεσης:

Valid as a prescribable product

Περίληψη προϊόντος:

BNF: 06020200; GTIN: 5024655005611

Φύλλο οδηγιών χρήσης

297 mm
210 mm
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 or Carbimazole
20 mg tablets (it will be referred to as Carbimazole throughout the
leaflet).
Carbimazole
tablets
contains
the
active
substance
carbimazole.
Carbimazole belongs to a group of medicine called antithyroid agents.
Carbimazole is used to reduce the formation of thyroid hormones in
adults and children with an overactive thyroid gland. The conditions
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
ingredients of carbimazole
●
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 a severe liver disorder.
●
if you had inflammation of the pancreas (acute pancreatitis) after
administration of carbimazole or thiamazole in the

Αρχείο Π.Χ.Π.

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Carbimazole 5 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg of carbimazole.
Excipient(s) with known effect:
Each tablet contains 70.00 mg of lactose anhydrous.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet.
White colour
6.30mm
, round shaped, uncoated tablets,
debossed “5”
on one side and
breakline on other side.
The score line is only to facilitate breaking for ease of swallowing
and not to divide
into equal doses.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Carbimazole 5 mg tablets 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 5 mg tablets 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 then be administered in one of two