Epanutin 100mg Hard Capsules

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

PHENYTOIN SODIUM

Available from:

Imbat Limited

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:

2011-12-21

Patient Information leaflet

Page 1 of 2
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
EPANUTIN

100MG HARD CAPSULES
(phenytoin sodium)
Your medicine is available using the above name but will be
referred to as Epanutin throughout this leaflet.
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 is and what it is 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 IS AND WHAT IT IS 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, 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:
�

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Epanutin 100mg Hard Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains Phenytoin Sodium 100mg
Excipients: lactose monohydrate
For full list of excipients, see Section 6.1.
3 PHARMACEUTICAL FORM
Capsule, hard
_Product imported from Spain:_
Hard gelatine capsule with a white opaque body and orange cap, marked
‘Epanutin 100’ on cap and body
4 CLINICAL PARTICULARS
As per PA0822/011/003
5 PHARMACOLOGICAL PROPERTIES
As per PA0822/011/003
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Core:
Lactose Monohydrate
Magnesium Stearate
Shell:
Gelatin (E441)
Titanium Dioxide (E171)
Erythrosine (E127)
Sodium Lauryl sulfate
Quinolone Yellow (E104)
Printing ink:
Shellac
Black iron oxide (E172)
N-Butyl alcohol
Propylene glycol
dehydrated alcohol
Isopropyl alcohol
Ammonium hydroxide
Water
H
E
A
L
T
H
P
R
O
D
U
C
T
S
R
E
G
U
L
A
T
O
R
Y
A
U
T
H
O
R
I
T
Y
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
_D_
_a_
_t_
_e_
_ _
_P_
_r_
_i_
_n_
_t_
_e_
_d_
_ _
_0_
_7_
_/_
_0_
_6_
_/_
_2_
_0_
_1_
_7_
_C_
_R_
_N_
_ _
_2_
_1_
_9_
_2_
_2_
_6_
_1_
_p_
_a_
_g_
_e_
_ _
_n_
_u_
_m_
_b_
_e_
_r_
_:_
_ _
_1_
Or
Shellac
Dehydrated alcohol
Isopropyl alcohol
Butyl alcohol
Propylene glycol
Concentrated ammonium solution
Black iron oxide (E172)
Potassium hydroxide
Water
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf-life expiry date of this product is the date shown on the
bottle and outer carton of the product as marketed in
the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25ºC. Store in the origin