Tegretol 400mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Carbamazepine

Available from:

Mawdsley-Brooks & Company Ltd

ATC code:

N03AF01

INN (International Name):

Carbamazepine

Dosage:

400mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Caution - AMP level prescribing advised

Product summary:

BNF: 04080100

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
TEGRETOL
® RETARD 200 MG TABLETS
TEGRETOL
® RETARD 400 MG TABLETS
(CARBAMAZEPINE)
The name of your medicine is Tegretol Retard 200 mg Tablets or
Tegretol Retard 400 mg Tablets, and will be referred to as Tegretol
Retard Tablets throughout this leaflet.
WHAT YOU NEED TO KNOW ABOUT TEGRETOL RETARD 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 Retard Tablets are and what they are used for
2) Things to consider before you start to take Tegretol Retard Tablets
3) How to take Tegretol Retard Tablets
4) Possible side effects
5) How to store Tegretol Retard Tablets
6) Further information
1) WHAT TEGRETOL RETARD TABLETS ARE AND WHAT THEY ARE USED FOR
Tegretol Retard 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 Retard 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) THINGS TO CONSIDER BEFORE YOU START TO TAKE TEGRETOL RETARD
TABLETS
SOME PEOPLE MUST NOT TAKE TEGRETOL RETARD TABLETS. TALK TO YOUR
DOCT

Summary of Product characteristics

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