Carbamazepine Essential Pharma 125 mg Suppositories

Land: Ierland

Taal: Engels

Bron: HPRA (Health Products Regulatory Authority)

Werkstoffen:

Carbamazepine

Beschikbaar vanaf:

Essential Pharma (M) Limited

ATC-code:

N03AF01

INN (Algemene Internationale Benaming):

Carbamazepine

Dosering:

125 milligram(s)

farmaceutische vorm:

Suppository

Therapeutisch gebied:

carbamazepine

Autorisatie-status:

Not marketed

Autorisatie datum:

2016-05-13

Bijsluiter

Car125-250mgSupp/PL/IE/8a
1/9
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CARBAMAZEPINE ESSENTIAL PHARMA 125 AND 250 MG SUPPOSITORIES
Carbamazepine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 Essential Pharma Suppositories are and what they
are used for
2.
What you need to know before you use Carbamazepine Essential Pharma
Suppositories
3.
How to use Carbamazepine Essential Pharma Suppositories
4.
Possible side effects
5.
How to store Carbamazepine Essential Pharma Suppositories
6.
Contents of the pack and other information
1.
WHAT CARBAMAZEPINE ESSENTIAL PHARMA SUPPOSITORIES ARE AND WHAT THEY
ARE USED FOR
Carbamazepine Essential Pharma Suppositories contain a medicine called
carbamazepine. Carbamazepine
can affect the body in several different ways. Carbamazepine Essential
Pharma Suppositories 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).
Carbamazepine Essential Pharma Suppositories are used to treat some
forms of epilepsy in adults and
children, for up to 7 days, when treatment by mouth is not possible.
This might be if you are having an
operation, for example.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE CARBAMAZEPINE ESSENTIAL PHARMA
SUPPOSITORIES
DO NOT USE CARBAMAZEPINE ESSENTIAL PHARMA SUPPOSITORIES
-
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 a

Productkenmerken

Health Products Regulatory Authority
02 June 2023
CRN00DJ3J
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SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Carbamazepine Essential Pharma 125 mg Suppositories
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each suppository contains 125 mg carbamazepine
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Suppository
White to off-white, torpedo shaped suppositories with a fatty odour.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
As an anticonvulsant in the management of epilepsy (generalised
tonic-clonic and partial seizures).
Carbamazepine Essential Pharma suppositories are for short-term use as
replacement therapy in patients where oral treatment
is temporarily not possible.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Carbamazepine Essential Pharma is available in suppositories, for
short term use. They are intended as replacement therapy
(maximum period recommended: 7 days) in patients for whom oral
treatment is temporarily not possible, for example in
post-operative patients.
When switching from oral formulations of carbamazepine to
suppositories the dosage should be increased by approximately
25% (the 125 mg and 250 mg suppositories correspond to the 100 mg and
200 mg tablets respectively).
The final dose adjustment should always depend on the clinical
response in the individual patient. Carbamazepine Essential
Pharma suppositories, in appropriate doses, have been shown to provide
plasma levels which are well within the therapeutic
range.
The pharmacokinetic properties of the suppositories are such that the
maximum daily dose is limited to 1000 mg (250 mg four
times daily at 6 hourly intervals).
Use in the elderly
Due to the potential for drug interactions, the dosage of
Carbamazepine Essential Pharma should be selected with caution in
elderly patients.
Paediatric population
Carbamazepine Essential Pharma suppositories are not recommended for
very young children.
Special populations
Health Products Regulatory Authority
02 June 2023
CRN00DJ3J
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