Phenytoin sodium 100mg capsules

País: Reino Unido

Idioma: inglés

Fuente: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredientes activos:

Phenytoin sodium

Disponible desde:

Ennogen Healthcare Ltd

Código ATC:

N03AB02

Designación común internacional (DCI):

Phenytoin sodium

Dosis:

100mg

formulario farmacéutico:

Oral capsule

Vía de administración:

Oral

clase:

No Controlled Drug Status

tipo de receta:

Caution - AMP level prescribing advised

Resumen del producto:

BNF: 04080100

Información para el usuario

PACKAGE LEAFLET: INFORMATION FOR THE USER
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 CAPSULES ARE AND WHAT THEY ARE
USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
EPANUTIN CAPSULES
3. HOW TO TAKE EPANUTIN CAPSULES
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE EPANUTIN CAPSULES
6. CONTENTS OF THE PACK AND OTHER INFORMATION
EPANUTIN™
100mg Hard Capsules
(phenytoin sodium)
Your medicine is known by the above name, but will be
referred to as Epanutin Capsules throughout this leaflet.
YOU WILL FIND MORE ABOUT EPANUTIN™
CAPSULES ON THE BACK OF THIS LEAFLET
1. WHAT EPANUTIN CAPSULES ARE AND
WHAT THEY ARE USED FOR
Epanutin Capsules are one of a group of medicines
called anti-epileptic drugs; these medicines are used to
treat epilepsy.
Epanutin Capsules 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 Capsules can also be used
to treat trigeminal neuralgia (facial nerve pain).
You should ask your doctor if you are unsure why you have been
given Epanutin Capsules.
2. WHAT YOU NEED TO KNOW BEFORE
YOU TAKE EPANUTIN CAPSULES
DO NOT TAKE EPANUTIN CAPSULES
•
if you are allergic to Phenytoin, or any of the other ingredients
of this medicine (listed in section 6).
•
if you are allergic to other medicines with a similar chemical
structure to Phenytoin (e.g. hydantoins).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Epanutin Capsules.
Medicines are not always

Ficha técnica

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Phenytoin Sodium NRIM 100mg Capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 100mg of phenytoin sodium.
Each capsule also contains 85.50 mg of lactose.
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Capsule, Hard (capsules)
Size “3” Hard gelatin capsule with orange transparent coloured cap
printed with
“146” and white coloured body, containing white granular powder.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Phenytoin Sodium NRIM 100mg Capsules are indicated for the following:
-
Control of tonic-clonic seizures (grand mal epilepsy), partial
seizures (focal
including temporal lobe) or a combination of these
-
The
prevention
and
treatment
of
seizures
occurring
during
or
following
neurosurgery and/or severe head injury.
Phenytoin Sodium NRIM 100mg Capsules have also been employed in the
treatment
of
trigeminal
neuralgia
but
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
Phenytoin Sodium NRIM Capsules contain phenytoin sodium. Although
100mg of
phenytoin sodium is equivalent to 92mg of phenytoin on a molecular
weight basis,
these molecular equivalents are not necessarily biologically
equivalent. Physicians
should therefore exercise care in those situations where it is
necessary to change the
dosage form and serum level monitoring is advised.
Posology
Dosage should be individualised as there may be wide interpatient
variability in
phenytoin serum levels with equivalent dosage. Phenytoin 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
10-20mg/l (40-80
micromoles/l) although some cases of tonic-clonic seizures may be
controlled with
lower serum levels of phenytoin. With rec