Carbimazole 5mg tablets

Ország: Egyesült Királyság

Nyelv: angol

Forrás: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktív összetevők:

Carbimazole

Beszerezhető a:

Accord-UK Ltd

ATC-kód:

H03BB01

INN (nemzetközi neve):

Carbimazole

Adagolás:

5mg

Gyógyszerészeti forma:

Oral tablet

Az alkalmazás módja:

Oral

Osztály:

No Controlled Drug Status

Recept típusa:

Valid as a prescribable product

Termék összefoglaló:

BNF: 06020200; GTIN: 5060333020149

Betegtájékoztató

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CARBIMAZOLE 5MG & 20MG TABLETS PIL - UK
Black
BBBB2307
RH
20-08-21
25-08-21
RH
160 x 270
9pt
Tiofarma BV
20-08-21
24-08-21
02
Version 7
12.02.2020
German GTIN 14
(incorporating PZN):
Cartons and label leaflets only
(labels only when specified)
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 Tablets are and what they are used for
2. What you need to know before you take Carbimazole
Tablets
3. How to take Carbimazole Tablets
4. Possible side effects
5. How to store Carbimazole Tablets
6. Contents of the pack and other information
1. WHAT CARBIMAZOLE TABLETS ARE AND WHAT THEY
ARE USED FOR
Carbimazole belongs to a group of medicines called anti-
thyroid agents. It is used in adults and children for the
following:
• Hyperthyroidism, which is a condition where in the
thyroid gland is hyperactive. Carbimazole is used to
reduce the formation of thyroid hormones.
• Treatment in more serious cases, for example, to
restore the normal function of the thyroid before its
partial removal by surgery.
• It is also u

Termékjellemzők

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Carbimazole 5mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Carbimazole Ph. Eur. 5mg
Excipients with known effect:
Each tablet also contains lactose monohydrate. For full list of
excipients, see section
6.1
3
PHARMACEUTICAL FORM
Tablet
White, round, biconvex, uncoated tablets with a score line on one side
and
embossed ‘F1’ on the other
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Carbimazole is an anti-thyroid agent. It is indicated in adults and
children in
all conditions where reduction of thyroid function is required.
1. Hyperthyroidism.
2. Preparation for thyroidectomy in hyperthyroidism.
3. Preparation for, and as concomitant therapy with, radio-iodine
treatment.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Carbimazole should only be administered if hyperthyroidism has been
confirmed by
laboratory tests.
Posology
ELDERLY
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 to 60mg, 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 to 15mg
per day, which
may be taken as a single daily dose. Therapy should be continued for
at lea