Tegretol 200mg tablets

Land: Vereinigtes Königreich

Sprache: Englisch

Quelle: MHRA (Medicines & Healthcare Products Regulatory Agency)

Wirkstoff:

Carbamazepine

Verfügbar ab:

Novartis Pharmaceuticals UK Ltd

ATC-Code:

N03AF01

INN (Internationale Bezeichnung):

Carbamazepine

Dosierung:

200mg

Darreichungsform:

Oral tablet

Verabreichungsweg:

Oral

Klasse:

No Controlled Drug Status

Verschreibungstyp:

Caution - AMP level prescribing advised

Produktbesonderheiten:

BNF: 04080100; GTIN: 5010678545708

Gebrauchsinformation

B-612 Graphic Studio
ul. Wólczańska 143
90-525 Łódź, Poland
[phone]
email: [e-mail]
Artwork creator:
Creation date:
Proof No.:
Andrzej Szymański
21-Apr-2022
2
Artwork Order No.:
AW identifier No. New:
AW identifier No. Old:
300021137
300021137-GB
300003816-GB
Artwork Order description:
LFT_TEGRETOL_TAB_ALL DOSAGES_GB
Packaging site:
PS, IT, TORRE ANNUNZIATA, NTO
Dimension:
630 X 148 MM
Printing colours:
Technical colours:
PANTONE 2144 C
Cutting
Tech. Drawing No.:
5666-O
Live text:
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No
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Condensed font:
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No
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Font type:
News Gothic
Print enhancements:
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Minimum font size body text:
9 pt
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PACKAGE LEAFLET: INFORMATION FOR THE USER
TEGRETOL
® 100, 200 AND
400 MG TABLETS
(CARBAMAZEPINE)
WHAT YOU NEED TO KNOW ABOUT TEGRETOL 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 Tablets are and what they are used for
2. What you need to know before you take Tegretol
Tablets
3. How to take Tegretol Tablets
4. Possible side effects
5. How to store Tegretol Tablets
6. Contents of the pack and other information
1. WHAT TEGRETOL TAB

Fachinformation

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Tegretol® 200 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
The active ingredient is 5H-dibenzo[b,f]azepine-5-carboxamide.
Each tablet contains 200 mg carbamazepine Ph.Eur.
3
PHARMACEUTICAL FORM
The tablets are white, round, flat, uncoated tablets with bevelled
edges, having
one side impressed “CG”, the other “G/K” and a score.
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 is given orally, usually in two or three divided doses.
Tegretol may be taken
during, after or between meals, with a little liquid e.g. a glass of
water.
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
predicts the
risk of severe carbamazepine-associated Stevens-Johnson syndrome (See
information
on genetic testings and cutaneous reactions in section 4.4).
_ _
_Epilepsy_:
The dose of carbamazepine should be adjusted to the needs of the
individual patient
to achieve adequate control of seizures. Determination of plasma
levels may help in
establishing
the
optimum
dosage.
In
the
treatment
of
epilepsy,
the
dose
of
carbamazepine usually requires total plasma-carbamazepine
concentrations of about 4
to 12 micrograms/mL (17 to 50 micromoles/litre) (see warnings and
precautions).
_ Adults:_ It is advised that with all formulations of Tegretol, a
gradually increasing
dosage scheme is used and this should be adjusted to suit the needs of
the individual
patient.
Tegretol should be taken in a number of divided doses although
in