Epanutin Infatabs 50mg Chewable Tablets

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

Aktivna sestavina:

Phenytoin

Dostopno od:

Pfizer Healthcare Ireland

Koda artikla:

N03AB; N03AB02

INN (mednarodno ime):

Phenytoin

Odmerek:

50 milligram(s)

Farmacevtska oblika:

Chewable tablet

Tip zastaranja:

Product subject to prescription which may be renewed (B)

Terapevtsko območje:

Hydantoin derivatives; phenytoin

Status dovoljenje:

Marketed

Datum dovoljenje:

1975-05-09

Navodilo za uporabo

Page 1 of 8
2017-0028856, 2019-0056973
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
EPANUTIN
® INFATABS 50 MG CHEWABLE TABLETS
(PHENYTOIN)
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 Infatabs 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 INFATABS 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 usually used to treat epilepsy and prevent
or treat seizures.
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 a condition
called trigeminal neuralgia (which causes facial nerve pain).
You should consult your doctor if you are unsure why you have been
given Epanutin Infatabs, 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 also taking delavirdine (used for HIV therapy).
_ _
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 th

Lastnosti izdelka

Health Products Regulatory Authority
22 October 2020
CRN008LHW
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Epanutin Infatabs 50mg Chewable Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains phenytoin 50 mg.
Excipients with known effect:
Each tablet also contains 474.80 mg confectioner's sugar (sucrose
ground together with maize starch to a fine powder),
0.0031 mg of the colouring agent E110 (Sunset yellow FCF) and 0.13 mg
of sodium.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Chewable tablet.
A yellow, triangular chewable tablet with flat sides, a bevelled edge
and a breaking line on one side with P-D 007 imprinted on
the other side.
The scoreline is only to facilitate breaking for ease of swallowing
and not to divide into equal doses as this is a chewable tablet.
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
_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 to 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 lev