Carbamazepine 400 mg Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Carbamazepine

Available from:

Azure Pharmaceuticals Ltd

ATC code:

N03AF01

INN (International Name):

Carbamazepine

Dosage:

400 milligram(s)

Pharmaceutical form:

Tablet

Therapeutic area:

carbamazepine

Authorization status:

Not marketed

Authorization date:

2020-10-30

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CARBAMAZEPINE 100 MG TABLETS
CARBAMAZEPINE 200 MG TABLETS
CARBAMAZEPINE 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 Carbamazepine Tablets are and what they are used for
2.
What you need to know before you take Carbamazepine Tablets
3.
How to take Carbamazepine Tablets
4.
Possible side effects
5.
How to store Carbamazepine Tablets
6.
Contents of the pack and other information
1.
WHAT CARBAMAZEPINE TABLETS ARE AND WHAT THEY ARE USED FOR
Carbamazepine Tablets contain a medicine called carbamazepine.
Carbamazepine can affect the body
in several different ways.
Carbamazepine 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.
Carbamazepine is 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.
Carbamazepine Tablets are also used in children to treat some forms of
epilepsy.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CARBAMAZEPINE TABLETS
DO NOT TAKE CARBAMAZEPINE 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

Summary of Product characteristics

Health Products Regulatory Authority
19 September 2022
CRN00CXVD
Page 1 of 18
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Carbamazepine 400 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each uncoated tablet contains 400 mg of Carbamazepine.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet: White to off white, flat, rod shaped, uncoated tablets with
bevelled edges, having 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. Carbamazepine 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
Carbamazepine is given orally, usually in two or four divided doses.
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
individual
patient
to
achieve
adequate
control
of
seizures.
Determination of plasma levels may help in establishing the optimum
d