Tegretol 400mg Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Carbamazepine

Available from:

Novartis Ireland Limited

ATC code:

N03AF; N03AF01

INN (International Name):

Carbamazepine

Dosage:

400 milligram(s)

Pharmaceutical form:

Tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Carboxamide derivatives; carbamazepine

Authorization status:

Marketed

Authorization date:

1979-04-01

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TEGRETOL® 100 MG TABLETS
TEGRETOL® 200 MG TABLETS
TEGRETOL® 400 MG TABLETS
carbamazepine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 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
Tegretol Tablets contain a medicine called carbamazepine.
Carbamazepine can affect the body in
several different ways.
Tegretol Tablets help to control messages passed from the brain to
muscles along the nerve pathways
in the body. It is an anti-epileptic medicine (prevents fits). It can
also modify some types of pain and
can control mood disorders.
Tegretol Tablets are used in adults to treat the following:
• some forms of epilepsy
• a painful condition of the face called “trigeminal neuralgia”
and some other nerve pains
• serious mood disorders when other medicines have not worked
• alcohol withdrawal problems.
Tegretol Tablets are also used in children to treat some forms of
epilepsy.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TEGRETOL TABLETS
DO NOT TAKE TEGRETOL TABLETS IF:
• you are allergic to carbamazepine or similar medicines such as
oxcarbazepine (Trileptal), or to any of
a related group of medicines called tricyclic antidepressants (such as
amitriptyline or imipramine).
• you are allergic to any

Summary of Product characteristics

Health Products Regulatory Authority
25 July 2023
CRN00DQT7
Page 1 of 18
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Tegretol 400mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 400 mg carbamazepine.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
White, flat, rod-shaped tablets with bevelled edges imprinted CG/CG on
one side and LR/LR on the other, with a score-line on
both sides.
The score-line is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
1.
As an anticonvulsant in the management of epilepsy (generalised
tonic-clonic and partial seizure types).
2.
The paroxysmal pain of trigeminal neuralgia - Tegretol may also be
used to relieve the lancinating component of
other forms of deafferentation pain, for example glossopharyngeal
neuralgia, peripheral diabetic neuropathy,
tabetic lightning pain, superior laryngeal neuralgia, stump pain,
phantom limb pain and post herpetic neuralgia.
3.
Management of alcohol withdrawal symptoms.
4.
Treatment of mania and prophylaxis of manic-depressive illness
especially in patients unresponsive to lithium.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Tegretol Tablets are given orally, usually in two to four divided
doses.
Tegretol may be taken during, after or between meals. The tablets
should be taken with a little liquid, e.g. a glass of water.
The final dose adjustment should always depend on the clinical
response in the individual patient.
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 SJS (See information on genetic
testings and cutaneous reactions in section 4.4)
1. EPILEPSY
Treatment should be initiated with a low daily dosage, to be slowly
increased until an optimal effect is obtained. The dose of
carbamazepine should be adjusted to the needs of the