Tegretol 200mg Chewtabs

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Carbamazepine

Available from:

Novartis Pharmaceuticals UK Ltd

ATC code:

N03AF01

INN (International Name):

Carbamazepine

Dosage:

200mg

Pharmaceutical form:

Chewable tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04080100; GTIN: 5010678544008

Patient Information leaflet

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Teg100-200mgChew-PL-UK-3a
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TEGRETOL
®
CHEWTABS 100 AND 200 MG
(carbamazepine)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TO TAKE THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them even if
their signs of illness are the same as yours.
-
If you get any side effects talk to your doctor or pharmacist. This
includes any possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Tegretol Chewtabs is and what it is used for
2.
What you need to know before you take Tegretol Chewtabs
3.
How to take Tegretol Chewtabs
4.
Possible side effects
5.
How to store Tegretol Chewtabs
6.
Contents of the pack and other information
1.
WHAT TEGRETOL CHEWTABS IS AND WHAT IT IS USED FOR
Tegretol Chewtabs should be chewed before swallowing, so it is
particularly useful for people who have
difficulty in swallowing. 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 Chewtabs is 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 CHEWTABS
Your doctor may want you to have a number of blood tests before you
start taking Tegretol Chewtabs and
from time to time during your treatment. This is quite usual and
nothing to worry about.
DO NOT TAKE TEGRETOL CHEWTABS
-
If you are 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

Summary of Product characteristics

TEGRETOL TABLETS 100MG, 200MG, 400MG
Summary of Product Characteristics Updated 14-Nov-2017 | Novartis
Pharmaceuticals UK Ltd
1. Name of the medicinal product
Tegretol
®
100mg, 200mg and 400mg Tablets
2. Qualitative and quantitative composition
The active ingredient is 5H-dibenzo[b,f]azepine-5-carboxamide.
Each tablet contains 100mg / 200mg / 400mg carbamazepine Ph.Eur.
3. Pharmaceutical form
100mg Tablets :
The tablets are white, round, flat, uncoated tablets with bevelled
edges, having one
side impressed “GEIGY”, the other “B/W” and a score.
200mg Tablets :
The tablets are white, round, flat, uncoated tablets with bevelled
edges, having one
side impressed “CG”, the other “G/K” and a score.
400mg Tablets :
The tablets are white, flat, rod-shaped tablets with bevelled edges.
One side bears the
imprint "CG/CG", the other "LR/LR" and both sides are scored.
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 opt