Epanutin 30 mg/5ml Oral Suspension

Nazione: Irlanda

Lingua: inglese

Fonte: HPRA (Health Products Regulatory Authority)

Principio attivo:

Phenytoin

Commercializzato da:

Pfizer Healthcare Ireland

Codice ATC:

N03AB; N03AB02

INN (Nome Internazionale):

Phenytoin

Dosaggio:

30 mg/5ml

Forma farmaceutica:

Oral suspension

Tipo di ricetta:

Product subject to prescription which may be renewed (B)

Area terapeutica:

Hydantoin derivatives; phenytoin

Stato dell'autorizzazione:

Marketed

Data dell'autorizzazione:

1979-04-01

Foglio illustrativo

Page 1 of 8
2020-0062082, 2020-0062083, 2020-0062084
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
EPANUTIN
® 30 MG/5 ML ORAL SUSPENSION
(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 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 epilepsy and 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 consult your doctor if you are unsure why you have been
given Epanutin 30 mg/5 ml
Oral Suspension 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 the following conditions:

Liver disease

Kidney disease

Porphyria (an inherited dise

Scheda tecnica

Health Products Regulatory Authority
19 January 2021
CRN009ZKT
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Epanutin 30 mg/5ml Oral Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml of suspension contains 30 mg phenytoin.
Excipients with known effect
Each 5 ml also contains:
25 mg sodium benzoate (E211) equivalent to 5 mg/ml
1.044 g sucrose equivalent to 208.8 mg/ml
19.875 mg ethanol equivalent to 3.975 mg/ml
0.316 mg carmoisine (E122) equivalent to 0.063 mg/ml
0.100 mg Sunset yellow FCF (E110) equivalent to 0.020 mg/ml.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral suspension.
Viscous, cherry red coloured oral suspension.
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 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 levels with Epanutin, and changes in dosage should not be
carried out at intervals shorter than 7 to 10 days.
Maintenance