Epanutin Infatabs 50mg chewable tablets

Land: Verenigd Koninkrijk

Taal: Engels

Bron: MHRA (Medicines & Healthcare Products Regulatory Agency)

Werkstoffen:

Phenytoin

Beschikbaar vanaf:

Viatris UK Healthcare Ltd

ATC-code:

N03AB02

INN (Algemene Internationale Benaming):

Phenytoin

Dosering:

50mg

farmaceutische vorm:

Chewable tablet

Toedieningsweg:

Oral

klasse:

No Controlled Drug Status

Prescription-type:

Valid as a prescribable product

Product samenvatting:

BNF: 04080100; GTIN: 5013457011340 5013457011852

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
EPANUTIN
® INFATABS 50 MG CHEWABLE TABLETS
PHENYTOIN
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 Epanutin Infatabs are and what they are
used for
2.
What
you
need
to
know
before
you
take
Epanutin
3.
How to take Epanutin
4.
Possible side effects
5.
How to store Epanutin
6.
Contents of the pack and other information
1.
WHAT EPANUTIN INFATABS ARE AND WHAT THEY
ARE USED FOR
This medicine contains phenytoin, which is one of a
group of medicines called anti-epileptic drugs; these
medicines are usually used to treat epilepsy and
prevent or treat seizures.
Epanutin can be used to control a variety of
epileptic conditions, to control or prevent seizures
during or after brain surgery or severe head injury.
Epanutin can also be used to treat a condition
called trigeminal neuralgia (which causes facial
nerve pain).
You should consult your doctor if you are unsure
why you have been given Epanutin Infatabs, if you
do not feel better or if you feel worse.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
EPANUTIN
DO NOT TAKE EPANUTIN
•
if
you
are
allergic
(hypersensitive)
to
phenytoin, or any of the other ingredients of
this medicine (listed in section 6)
•
if you are allergic to other medicines for
epilepsy
•
if you are also taking delavirdine (used for
HIV therapy).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before you take
Epanutin if you suffer from or have suffered in the
past from any of the following conditions:
•
Liver disease
•

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Epanutin Infatabs 50mg Chewable Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains phenytoin 50 mg.
Excipients with known effect:
Each tablet also contains 474.80 mg confectioner’s sugar (sucrose
ground together
with maize starch to a fine powder), 0.0031 mg of the colouring agent
E110 (Sunset
yellow FCF) and 0.13 mg of sodium.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Chewable tablet
A yellow triangular chewable tablet with flat sides, a bevelled edge
and a breaking
line on one side with P-D 007 imprinted on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Control of tonic-clonic seizures (grand mal epilepsy), partial
seizures (focal including
temporal lobe) or a combination of these, and for the prevention and
treatment of
seizures occurring during or following neurosurgery and/or severe head
injury.
Epanutin has also been employed in the treatment of trigeminal
neuralgia but it
should only be used as second line therapy if carbamazepine is
ineffective or patients
are intolerant to carbamazepine.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Dosage: _
Dosage should be individualised as there may be wide interpatient
variability in
phenytoin serum levels with equivalent dosage. Epanutin should be
introduced in
small dosages with gradual increments until control is achieved or
until toxic effects
appear. In some cases serum level determinations may be necessary for
optimal
dosage adjustments - the clinically effective level is usually 10
mcg/mL- 20 mcg/mL
(40-80 micromoles/l) although some cases of tonic-clonic seizures may
be controlled
with lower serum levels of phenytoin. With recommended dosage a period
of 7 to 10
days may be required to achieve steady state serum levels with
Epanutin and changes
in dosage should not be carried out at intervals shorter than 7 to 10
days. Maintenance
of treatment should be the lowest dose of anticonvulsant consistent
with control of
seizures.
_