Carbamazepine 125mg suppositories

Country: United Kingdom

Bahasa: Inggeris

Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)

Bahan aktif:

Carbamazepine

Boleh didapati daripada:

Essential Pharma Ltd

Kod ATC:

N03AF01

INN (Nama Antarabangsa):

Carbamazepine

Dos:

125mg

Borang farmaseutikal:

Suppository

Laluan pentadbiran:

Rectal

Kelas:

No Controlled Drug Status

Jenis preskripsi:

Valid as a prescribable product

Ringkasan produk:

BNF: 04080100; GTIN: 5060334120213

Risalah maklumat

PACKAGE LEAFLET: INFORMATION FOR THE USER
CARBAMAZEPINE ESSENTIAL PHARMA
125 AND 250 MG SUPPOSITORIES
(CARBAMAZEPINE)
WHAT YOU NEED TO KNOW ABOUT CARBAMAZEPINE ESSENTIAL
PHARMA SUPPOSITORIES
Your doctor has decided that you need this medicine to help
treat your condition.
PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU START TO USE THE
SUPPOSITORIES. IT CONTAINS IMPORTANT INFORMATION.
Keep the
leaflet in a safe place because you may want to read it again.
If you have any other questions, or if there is something you
don’t understand, please ask your doctor or pharmacist.
This medicine has been prescribed for you. Never give it to
someone else. It may not be the right medicine for them even if
their symptoms seem to be the same as yours.
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.
IN THIS LEAFLET:
1. What Carbamazepine Essential Pharma Suppositories are
and what they are used for
2. Things to consider before you are treated with
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. Further information
1. WHAT CARBAMAZEPINE ESSENTIAL PHARMA
SUPPOSITORIES ARE AND WHAT THEY ARE USED FOR
Carbamazepine, the active ingredient in Carbamazepine
Essential Pharma Suppositories, is an anti-convulsant medicine
(prevents fits).
Carbamazepine Essential Pharma Suppositories are used to
treat some forms of epilepsy. They are useful in the short term,
(maximum 7 days), for patients who cannot take medicines by
mouth, e.g. after surgery or if unconscious.
2. THINGS TO CONSIDER BEFORE YOU ARE TREATED WITH
CARBAMAZEPINE ESSENTIAL PHARMA SUPPOSITORIES
SOME PEOPLE MUST NOT HAVE CARBAMAZEPINE ESSENTIAL
PHARMA SUPPOSITORIES. MAKE SURE YOUR DOCTOR KNOWS IF;
•
you think you may be hypersensitive (allergic) to
carbamazepine or similar drugs such as oxcarbazepine
(Trileptal), or to any of a related group of

Ciri produk

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Carbamazepine Essential Pharma 125mg Suppositories
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
The active ingredient is 5H-dibenzo[b,f]azepine-5-carboxamide
(carbamazepine).
Each suppository contains 125 mg carbamazepine Ph.Eur.
3
PHARMACEUTICAL FORM
White to practically white, torpedo shaped suppositories
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Epilepsy - generalised tonic-clonic and partial seizures.
Note: Carbamazepine Essential Pharma is not usually effective in
absences (petit mal)
and myoclonic seizures. Moreover, anecdotal evidence suggests that
seizure
exacerbation may occur in patients with atypical absences.
No clinical data are available on the use of Carbamazepine Essential
Pharma
Suppositories in indications other than epilepsy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
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 Stevens-Johnson syndrome (See
information
on genetic testings and cutaneous reactions in section 4.4).
_Epilepsy: _
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 dosage. In the treatment of epilepsy, the
dose of
carbamazepine usually requires total plasma-carbamazepine
concentrations of about 4
to 12 micrograms/mL (17 to 50 micromoles/litre) (see warnings and
precautions).
_Adults, Elderly, Children and Adolescents:_ 125mg and 250mg
suppositories are
available for short-term use as replacement therapy (maximum period
recommended:
7 days) in patients for whom oral treatment is temporarily not
possible, for example
in post-operative or unconscious subjects.
When switching from oral formulations to suppositories the dosage
should be
increased by approximately 25% (the 125 and 250mg suppositories
correspond to 100