Tegretol Prolonged Release 400mg tablets

Land: Storbritannia

Språk: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv ingrediens:

Carbamazepine

Tilgjengelig fra:

Novartis Pharmaceuticals UK Ltd

ATC-kode:

N03AF01

INN (International Name):

Carbamazepine

Dosering :

400mg

Legemiddelform:

Modified-release tablet

Administreringsrute:

Oral

Klasse:

No Controlled Drug Status

Resept typen:

Caution - AMP level prescribing advised

Produkt oppsummering:

BNF: 04080100; GTIN: 5010678545906

Informasjon til brukeren

TEGRETOL
® PROLONGED RELEASE 200MG TABLETS/
TEGRETOL
® PROLONGED RELEASE 400MG TABLETS
(carbamazepine)
Your medicine is known by one of the above names, but will be referred
to
as Tegretol Prolonged Release Tablets throughout this:
PATIENT INFORMATION LEAFLET
IN THIS LEAFLET:
1) What Tegretol Prolonged Release Tablets are and what they are used
for
2) What you need to know before you 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) Contents of the pack and other 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 serious mood disorders when some other medicines
don’t
work.
2) WHAT YOU NEED TO KNOW BEFORE YOU TAKE TEGRETOL PROLONGED
RELEASE TABLETS
SOME PEOPLE MUST NOT TAKE TEGRETOL PROLONGED RELEASE TABLETS.
TALK TO YOUR DOCTOR IF:
•
you think you may be hypersensitive (allergic) to carbamazepine or
similar drugs such as oxcarbazepine (Trileptal), or to any of a
related
group of drugs known as tricyclic antidepressants (such as
amitriptyline
or imipramine). If you are allergic to carbamazepine there is a one in
four
(25%)
chance
that
you
could
also
have
an
allergic
reaction
to
oxcarbazepine.
•
you think you may be allergic to any of the other ingredients of
Tegretol
Prolonged Release Tablets (these are listed at the end of the
leaflet).
Signs of a hypersensitivity reaction include swelling of the face or
mouth
(angioedema), breathing problems, runny nose, skin rash, blistering or

Preparatomtale

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