Epanutin 25 mg Hard Capsules

Nazione: Irlanda

Lingua: inglese

Fonte: HPRA (Health Products Regulatory Authority)

Principio attivo:

PHENYTOIN SODIUM

Commercializzato da:

Upjohn EESV

Codice ATC:

N03AB; N03AB02

INN (Nome Internazionale):

PHENYTOIN SODIUM

Dosaggio:

25 milligram(s)

Forma farmaceutica:

Capsule, hard

Area terapeutica:

Hydantoin derivatives; phenytoin

Stato dell'autorizzazione:

Marketed

Data dell'autorizzazione:

1976-10-29

Foglio illustrativo

Page 1 of 7
2021-0070143
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
EPANUTIN
® 25 MG HARD CAPSULES
(PHENYTOIN SODIUM)
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 Hard Capsules 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 HARD CAPSULES 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 used to treat epilepsy.
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 trigeminal neuralgia (facial
nerve pain).
You should ask your doctor if you are unsure why you have been given
Epanutin Capsules, 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 taking medicines for HIV infection, such as delavirdine.
_ _
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

Kidney disease

Porphyria

Scheda tecnica

Health Products Regulatory Authority
29 March 2023
CRN00CXSD
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Epanutin 25 mg Hard Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 25 mg phenytoin sodium.
Excipient with known effect
Each capsule contains 66.857 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, hard.
A white powder in a No. 4 hard gelatin capsule with a white opaque
body and purple cap, radially imprinted “EPANUTIN 25”.
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
For oral administration only.
_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 10–20 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.
_Epanutin Capsules, Suspension and Infatabs:_
Epanutin Capsules contain ph