Epanutin 100 mg Hard Capsules

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

PHENYTOIN SODIUM

Available from:

Pfizer Healthcare Ireland

ATC code:

N03AB; N03AB02

INN (International Name):

PHENYTOIN SODIUM

Dosage:

100 milligram(s)

Pharmaceutical form:

Capsule, hard

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Hydantoin derivatives; phenytoin

Authorization status:

Marketed

Authorization date:

1979-04-01

Patient Information leaflet

Page 1 of 8
2020-0062933
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
EPANUTIN
® 100 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

Porphyri

Summary of Product characteristics

Health Products Regulatory Authority
27 January 2021
CRN00C4Q5
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Epanutin 100 mg Hard Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains phenytoin sodium 100 mg
Excipient with known effect
Each capsule contains 96.15 mg lactose monohydrate
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Capsules, hard.
A white powder in a No. 3 hard gelatin capsule with a white opaque
body and orange cap, radially imprinted ‘EPANUTIN 100’.
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 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 seven
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 ten days.
Maintenance of treatment should be the lowest dose of anticonvulsant
consistent with control of seizures.
_Epanutin Capsules, Suspension and Infatabs:_
Epanutin Capsule