Carbamazepine 400mg tablets

Krajina: Spojené kráľovstvo

Jazyk: angličtina

Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktívna zložka:

Carbamazepine

Dostupné z:

Sigma Pharmaceuticals Plc

ATC kód:

N03AF01

INN (Medzinárodný Name):

Carbamazepine

Dávkovanie:

400mg

Forma lieku:

Oral tablet

Spôsob podávania:

Oral

Trieda:

No Controlled Drug Status

Typ predpisu:

Caution - AMP level prescribing advised

Prehľad produktov:

BNF: 04080100

Príbalový leták

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, the active ingredient in Carbamazepine Tablets,
can affect the body in several different ways. It is an
anti-convulsant medicine (prevents fits), it can also modify some
types of pain and can control mood disorders.
Carbamazepine is used:
•
To treat some forms of epilepsy
•
To treat a painful condition of the face called trigeminal neuralgia
•
To help control serious mood disorders when some other
medicines don’t work.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CARBAMAZEPINE TABLETS
DO NOT TAKE CARBAMAZEPINE TABLETS:
•
If you are allergic to carbamazepine or any of the other
ingredients of this medicine (listed in section 6). Signs of an
allergic reaction include swelling of the face or mouth
(angioedema), breathing problems, runny nose, skin rash,
blistering or peeling.
•
If you are allergic to similar kind of drugs as carbamazepine
such as oxcarbazepine (Trileptal), or to any of a related group
of drugs known as tricyclic antidepressants (such as
amitriptyline
or
imipramine).
If
you
are
allergic
to
carbamazepine there is a one in four (25%) chance that you
could also have an allergic reaction to o

Súhrn charakteristických

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Carbamazepine Noumed 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
Tablets: White to off white, flat, rod shaped, uncoated tablets with
beveled-edges,
having score line on both sides
The score line is only to facilitate breaking for ease of swallowing
and not divide
tablet into equal doses.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Epilepsy - generalised tonic-clonic and partial seizures.
Note: Carbamazepine 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.
The paroxysmal pain of trigeminal neuralgia.
For the prophylaxis of manic-depressive psychosis in patients
unresponsive to lithium
therapy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
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 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 section
4.4).
_Adults: _
It is advised that with all formulations of carbamazepine, a gradually
increasing
dosage scheme is used and this should be adjusted to suit the needs of
the
individual patient.
Carbamazepine should be taken in a number of divided doses although
initially
100-200mg once or twice daily is recommended. This may be followed by
a slow
increase until the best response is obtained, of