Tegretol Prolonged Release 400mg tablets

국가: 영국

언어: 영어

출처: MHRA (Medicines & Healthcare Products Regulatory Agency)

유효 성분:

Carbamazepine

제공처:

Sigma Pharmaceuticals Plc

ATC 코드:

N03AF01

INN (국제 이름):

Carbamazepine

복용량:

400mg

약제 형태:

Modified-release tablet

관리 경로:

Oral

수업:

No Controlled Drug Status

처방전 유형:

Caution - AMP level prescribing advised

제품 요약:

BNF: 04080100

환자 정보 전단

_S271 LEAFLET Tegretol 20190430 _
PACKAGE LEAFLET: INFORMATION FOR THE USER
TEGRETOL
® PROLONGED RELEASE 400MG TABLETS
(carbamazepine)
Your medicine is known as TEGRETOL PROLONGED RELEASE
400mg TABLETS but will be referred to as Tegretol Prolonged
Release Tablets throughout the following leaflet.
Information for other strength of Tegretol Prolonged Release
Tablets also may be present in this leaflet.
WHAT YOU NEED TO KNOW ABOUT TEGRETOL PROLONGED RELEASE
TABLETS
Your doctor has decided that you need this medicine to help treat
your condition.
PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU START TO TAKE YOUR
MEDICINE. IT CONTAINS IMPORTANT INFORMATION. KEEP THE LEAFLET IN
A SAFE PLACE BECAUSE YOU MAY WANT TO READ IT AGAIN.
If you have any other questions, or if there is something you don’t
understand, please ask your doctor or pharmacist.
This medicine has been prescribed for you. Never give it to
someone else. It may not be the right medicine for them even if
their symptoms seem to be the same as yours.
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.
IN THIS LEAFLET:
1.
What Tegretol Prolonged Release Tablets are and what they
are used for
2.
Things to consider before you start to take Tegretol Prolonged
Release Tablets
3.
How to take Tegretol Prolonged Release Tablets
4.
Possible side effects
5.
How to store Tegretol Prolonged Release Tablets
6.
Further information
1.
WHAT TEGRETOL PROLONGED RELEASE TABLETS ARE
AND WHAT THEY ARE USED FOR
Tegretol Prolonged Release Tablets are specially formulated to
release the active ingredient gradually. Carbamazepine, the active
ingredient, can affect the body in several different ways. It is an
anti-convulsant medicine (prevents fits), it can also modify some
types of pain and can control mood disorders.
Tegretol Prolonged Release Tablets are used

To treat some forms of epilepsy

To treat a painful condition of the face called trigeminal
neuralgia

To help control seriou

제품 특성 요약

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Tegretol
®
Prolonged Release 400mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
The active ingredient is 5H-dibenzo[b,f]azepine-5-carboxamide.
Each coated tablet contains 400 mg carbamazepine Ph.Eur.
3
PHARMACEUTICAL FORM
Prolonged Release Tablet.
Tablets which are brownish-orange, oval, slightly biconvex, coated
tablets with a score on
each side. One side bears the imprint “ENE/ENE”, the other
“CG/CG”.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Epilepsy - generalised tonic-clonic and partial seizures.
Note: Tegretol is not usually effective in absences (petit mal) and
myoclonic seizures.
Moreover, anecdotal evidence suggests that seizure exacerbation may
occur in patients with
atypical absences.
The paroxysmal pain of trigeminal neuralgia.
For the prophylaxis of manic-depressive psychosis in patients
unresponsive to lithium
therapy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Tegretol
Prolonged
Release
is
given
orally,
generally
in
the
same
total
daily
dose
as
conventional Tegretol dosage forms but usually in two divided doses.
In a few patients when
changing from other oral dosage forms of Tegretol to Tegretol
Prolonged Release the total
daily dose may need to be increased, particularly when it is used in
polytherapy. When
starting treatment with Tegretol Prolonged Release in monotherapy,
100-200mg once or twice
daily is recommended. This may be followed by a slow increase in
dosage until the best
response is obtained, often 800-1200mg daily. In some instances,
1600mg or even 2000mg
daily may be necessary.
Tegretol Prolonged Release (either the whole or half divisible tablet
as prescribed), should not
be chewed but should be swallowed with a little liquid, before, during
or between meals. The
divisible tablet presentation enables flexibility of dosing to be
achieved.
Before deciding to
initiate treatment, patients of Han Chinese and Thai origin should
whenever possible be screened for HLA-B*1502 as this allele strongly
predi