TEGRETOL SR 400 Milligram Tablet Prolonged Release

Pays: Irlande

Langue: anglais

Source: HPRA (Health Products Regulatory Authority)

Ingrédients actifs:

CARBAMAZEPINE

Disponible depuis:

Novartis Pharmaceuticals UK Ltd

Code ATC:

N03AF01

DCI (Dénomination commune internationale):

CARBAMAZEPINE

Dosage:

400 Milligram

forme pharmaceutique:

Tablet Prolonged Release

Type d'ordonnance:

Product subject to prescription which may be renewed (B)

Domaine thérapeutique:

Antiepileptics

Statut de autorisation:

Authorised

Date de l'autorisation:

1993-05-31

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Both Production Site:
Torre
WO:
1516620
CTM:
Flagiello, Angela
Comp. Description:
LEAFLET_TEGRETOL SR_FCT_ALL 
DOSAGES_IE
Printing Colours:
Black
Comp. No. New:
1516620_IE
Comp. No. Old:
N/A
Format/Dimension:
148 x 630 mm
Tech. Drawing No.:
5666/O
Technical Colours:
Cutting
Min. Font Size Text:
9 pt
Font Type:
News Gothic
Version No.: 1
Date: 22 Jun 2016
J.N.: 284016
Braille: 
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1516620_IE
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TEGRETOL SR 200MG AND 400MG 
PROLONGED RELEASE 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 SR Prolonged Release Tablets areand what they are 
used for
2. What you need to know before you take Tegretol SR Prolonged
Release 
Tablets
3. How to take Tegretol SR Prolonged Release Tablets
4. Possible side effects 
5. How to store Tegretol SR Prolonged Release Tablets
6. Contents of the pack and other information
1. WHAT TEGRETOL SR PROLONGED RELEASE TABLETS IS AND WHAT IT IS 
USED FOR
Tegretol SR Prolonged Release Tablets contains a medicine called 
carbamazepine. Carbamazepine can affect the body in several 
different ways. Tegretol SR Prolonged Release Tablets helps to 
control messages passed from the brain to muscles along the nerve 
pathways in the body. It is an anti-epileptic medicine (prevents
fit

Résumé des caractéristiques du produit

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Tegretol SR 400mg prolonged release tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Tegretol SR 400mg prolonged release tablet contains 400 mg
carbamazepine
Excipients: Polyethoxylated castor oil 0.44 mg per tablet
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged release tablet.
Brownish-orange, oval, slightly biconvex , film-coated, prolonged
release tablets with a score on each side, imprinted
with ‘ENE/ENE’ on one side and ‘CG/CG’ on the other.
The tablet can be divided into equal halves.
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 SR Prolonged Release tablets are given orally, usually in two
to four divided doses.
Tegretol SR Prolonged Release tablets are generally given in the same
total does as conventional Tegretol dosage
forms but in a few patients when changing from other oral dosage forms
of Tegretol to Tegretol SR Prolonged Release
tablets, the total daily dose may need to be increased.
The final dose adjustment should always depend on the clinical
response in the individual patient.
Tegretol may be taken during, after or between meals.
The SR Prolonged Release tablets should not be chewed but
should be taken with a little liquid, e.g. a glass of water.
As a result of slow, controlled release of the active substance from
the SR Prolonge