Carbimazole Macleods Tablets 10mg

Land: Malta

Språk: engelsk

Kilde: Medicines Authority

Aktiv ingrediens:

CARBIMAZOLE

Tilgjengelig fra:

Macleods Pharma UK Ltd Wynyard Park House, Wynyard Avenue, Wynyard, Billingham TS22 5TB , United Kingdom

ATC-kode:

H03BB01

INN (International Name):

CARBIMAZOLE 10 mg

Legemiddelform:

TABLET

Sammensetning:

CARBIMAZOLE 10 mg

Resept typen:

POM

Terapeutisk område:

THYROID THERAPY

Autorisasjon status:

Withdrawn

Autorisasjon dato:

2018-02-14

Informasjon til brukeren

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PACKAGE LEAFLET: INFORMATION FOR THE USER
CARBIMAZOLE MACLEODS 5MG, 10MG, 15MG AND 20 MG TABLETS
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. Do not pass it on to
others. It may harm them, even if their
symptoms 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 Macleods is and what it is used for
2. What you need to know before you take Carbimazole Macleods
3. How to take Carbimazole Macleods
4. Possible side effects
5. How to store Carbimazole Macleods
6. Contents of the pack and other information
1.
WHAT CARBIMAZOLE MACLEODS IS AND WHAT IT IS USED FOR
The name of your medicine is Carbimazole Macleods 5 mg tablets or
Carbimazole Macleods 10 mg
tablets or Carbimazole Macleods 15 mg tablets or Carbimazole Macleods
20 mg tablets (it will be
referred
to
as
Carbimazole
throughout
the
leaflet).
Carbimazole
contains
the
active
substance
carbimazole. Carbimazole belongs to a group of medicine called
anti-thyroid 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 a

Preparatomtale

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Carbimazole
Macleods
10mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10mg of carbimazole.
Excipient(s) with known effect
Lactose monohydrate (97.175mg per tablet)
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Pink, mottled, round, biconvex uncoated tablets, debossed with "10" on
one
side and plain on other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Carbimazole
Macleods
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
Macleods
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 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. The