Tegretol SR 400mg prolonged release tablets

Šalis: Airija

kalba: anglų

Šaltinis: HPRA (Health Products Regulatory Authority)

Veiklioji medžiaga:

Carbamazepine

Prieinama:

Novartis Ireland Limited

ATC kodas:

N03AF; N03AF01

INN (Tarptautinis Pavadinimas):

Carbamazepine

Dozė:

400 milligram(s)

Vaisto forma:

Prolonged-release tablet

Recepto tipas:

Product subject to prescription which may be renewed (B)

Gydymo sritis:

Carboxamide derivatives; carbamazepine

Autorizacija statusas:

Marketed

Leidimo data:

1993-05-31

Pakuotės lapelis

1
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 are and 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 ARE AND WHAT THEY ARE 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 fits). It can also modify some types of pain and
can control mood disorders.
Tegretol SR Prolonged Release 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 SR Prolonged Release Tablets are also used in children to
treat some forms of epilepsy.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE TEGRETOL SR PROLONGED RELEASE
TABLETS
DO NOT TAKE TEGRETOL SR PROLONGED RELEASE TABLETS IF:
• you are allergic to

Prekės savybės

Health Products Regulatory Authority
25 July 2023
CRN00DQT7
Page 1 of 19
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
Excipient(s) with known effect: polyethoxylated castor oil 0.44 mg per
tablet.
For the 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 glas