CARBAMAZEPINE ESSENTIAL PHARMA

Maa: Irlanti

Kieli: englanti

Lähde: HPRA (Health Products Regulatory Authority)

Aktiivinen ainesosa:

CARBAMAZEPINE

Saatavilla:

Essential Pharma Ltd

ATC-koodi:

N03AF01

INN (Kansainvälinen yleisnimi):

CARBAMAZEPINE

Annos:

250 Milligram

Lääkemuoto:

Suppositories

Prescription tyyppi:

Product subject to prescription which may be renewed (B)

Terapeuttinen alue:

carbamazepine

Valtuutuksen tilan:

Not Marketed

Valtuutus päivämäärä:

1994-04-19

Pakkausseloste

Car125-250mgSupp/PL/IE/4
1
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

Valmisteyhteenveto

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Carbamazepine Essential Pharma 250 mg Suppositories
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each suppository contains 250 mg carbamazepine
For a 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
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 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.
_Use in paediatric patients_
Carbamazepine Essential Pharma suppositories are not recommended for
very young children.
SPECIAL POPULATIONS
RENAL IMPAIRMENT / HEPATIC IMPAIRMENT
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