Carbimazole Macleods Tablets 15mg

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 15 mg

Legemiddelform:

TABLET

Sammensetning:

CARBIMAZOLE 15 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Withdrawn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

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SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Carbimazole Macleods 15mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 15mg of carbimazole.
Excipient(s) with known effect
Lactose monohydrate (145.764mg per tablet)
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Pink, mottled, round, biconvex uncoated tablets, debossed with "15" 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).
_ _
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_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