Tegretol 100mg tablets

Riik: Suurbritannia

keel: inglise

Allikas: MHRA (Medicines & Healthcare Products Regulatory Agency)

Toimeaine:

Carbamazepine

Saadav alates:

Novartis Pharmaceuticals UK Ltd

ATC kood:

N03AF01

INN (Rahvusvaheline Nimetus):

Carbamazepine

Annus:

100mg

Ravimvorm:

Oral tablet

Manustamisviis:

Oral

Klass:

No Controlled Drug Status

Retsepti tüüp:

Caution - AMP level prescribing advised

Toote kokkuvõte:

BNF: 04080100; GTIN: 5010678545609

Infovoldik

Artwork creator:
Rizwana Shaik
Creation date:
22-Jul-2022
Proof No.:
2
Artwork Order No.:
300029568
AW identifier No. New:
934030-GB
AW identifier No. Old:
933725
Artwork Order description:
LEAFLET_TEGRETOL_TAB_GB
Packaging site:
CM, IT, MILANO, MIPHARM (IM)
Dimension:
160 X 710 MM
Tech. Drawing No.:
LFT_160x710_pp30
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934030-GB
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 TABLETS ARE AND WHAT THEY ARE
USED FOR
Carbamazepine, the active ingredient in Tegretol
Tablets, 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 is used
•
To

Toote omadused

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Tegretol® 100 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
The active ingredient is 5H-dibenzo[b,f]azepine-5-carboxamide.
Each tablet contains 100 mg carbamazepine Ph.Eur.
3
PHARMACEUTICAL FORM
The tablets are white, round, flat, uncoated tablets with bevelled
edges, having
one side impressed “GEIGY”, the other “B/W” 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