Epanutin 100 mg Hard Capsules

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

PHENYTOIN SODIUM

Available from:

PCO Manufacturing Ltd.

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:

Authorised

Authorization date:

2011-04-08

Patient Information leaflet

_ _
_ _
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

Porphyria (an inherited diseas

Summary of Product characteristics

Health Products Regulatory Authority
15 July 2022
CRN00D0NT
Page 1 of 3
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Epanutin 100 mg Hard Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 100 mg phenytoin sodium.
Excipient(s) with known effect
Lactose Monohydrate
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Hard Capsule
_Product imported from Spain and Greece:_
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
As per PA23055/003/003
5 PHARMACOLOGICAL PROPERTIES
As per PA23055/003/003
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Core:
Lactose monohydrate
Magnesium stearate
Shell:
Gelatin (E441)
Erythrosine (E127)
Quinolone yellow (E104)
Titanium dioxide (E171)
Sodium laurilsulfate
Printing inks:
UK product:
Shellac
Black iron oxide (E172)
Propylene glycol
It may also contain potassium hydroxide.
Spanish product:
Colour code 10A1
Shellac in ethanol
Black iron oxide (E172)
N-Butyl alcohol
Dehydrated alcohol
Health Products Regulatory Authority
15 July 2022
CRN00D0NT
Page 2 of 3
Isopropyl alcohol
Propylene glycol
Ammonium hydroxide 28%
Purified water
OR
Colour code 1014
Shellac
Dehydrated alcohol
Isopropyl alcohol
Butylated alcohol
Propylene glycol
Concentrated ammonium solution
Black iron oxide (E172)
Potassium hydroxide
Purified water
Greek Product:
Shellac Glaze ~ 45% in ethanol
Black iron oxide
N-butyl alcohol
Purified water,
Propylene glycol
Anhydrous ethanol
Isopropyl alcohol
Ammonium hydroxide (28%)
6.2 INCOMPATIBILITIES
Not applicable
6.3 SHELF LIFE
The shelf life expiry date for this product shall be the date on the
container of the product in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25 ºC.
Store in the original package in order to protect from light.
6.5 NATURE AND CONTENTS OF CONTAINER
White container with white cap containing 84 or 100 capsules and a
desiccant, packaged in an outer carton.
Not al