Epanutin 30mg/5ml oral suspension

Nazione: Regno Unito

Lingua: inglese

Fonte: MHRA (Medicines & Healthcare Products Regulatory Agency)

Principio attivo:

Phenytoin

Commercializzato da:

Viatris UK Healthcare Ltd

Codice ATC:

N03AB02

INN (Nome Internazionale):

Phenytoin

Dosaggio:

6mg/1ml

Forma farmaceutica:

Oral suspension

Via di somministrazione:

Oral

Classe:

No Controlled Drug Status

Tipo di ricetta:

Valid as a prescribable product

Dettagli prodotto:

BNF: 04080100; GTIN: 5013457011401

Foglio illustrativo

Page 1 of 7
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
EPANUTIN® 30 MG/ 5ML 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, 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 30mg/5ml
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 disease that affects haemoglobin biosynthesis)

Al

Scheda tecnica

OBJECT 1
EPANUTIN 30MG/5ML ORAL SUSPENSION
Summary of Product Characteristics Updated 06-Feb-2018 | Pfizer
Limited
1. Name of the medicinal product
EPANUTIN 30 MG/5 ML 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 1.044 g Sucrose, 24.66 microlitres Ethanol,
0.316 mg Carmoisine (E122), 0.1 mg
Sunset Yellow FCF (E110).
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 - 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 of treatment should
be the lowest dose of anticonvulsant
consistent with control of seizures.
_Epanutin Capsules, Oral Suspension and Infatabs:_