EPANUTIN 50 mg Hard Capsules

מדינה: מלטה

שפה: אנגלית

מקור: Malta Medicines Authority

מרכיב פעיל:

PHENYTOIN SODIUM

זמין מ:

Viatris Hellas Ltd 253-255, Mesogion Avenue, 154 51 Neo Psychiko, Athens,, Greece

קוד ATC:

N03AB02

INN (שם בינלאומי):

PHENYTOIN SODIUM 50 mg

טופס פרצבטיות:

HARD CAPSULE

הרכב:

PHENYTOIN SODIUM 50 mg

סוג מרשם:

POM

איזור תרפויטי:

ANTIEPILEPTICS

מצב אישור:

Authorised

תאריך אישור:

2006-11-29

עלון מידע

Page 1 of 8
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
EPANUTIN
® 50 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 inherite

מאפייני מוצר

Page
1
of
18
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
EPANUTIN 50 mg Hard Capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains phenytoin sodium 50 mg
Excipient with known effect
Each capsule contains 90.71 mg lactose monohydrate.
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Capsules, hard.
A white powder in a No 4 hard gelatin capsule with a white opaque body
and a flesh coloured
opaque cap, radially imprinted 'EPANUTIN 50'.
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 10–20 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, Suspension and Infatabs:_
Epanutin Capsules contain phenytoin sodium whereas Epanutin Suspension
and E