EPANUTIN 100 MG

Land: Israel

Språk: engelsk

Kilde: Ministry of Health

Aktiv ingrediens:

PHENYTOIN SODIUM

Tilgjengelig fra:

PFIZER PFE PHARMACEUTICALS ISRAEL LTD

ATC-kode:

N03AB02

Legemiddelform:

CAPSULES

Sammensetning:

PHENYTOIN SODIUM 100 MG

Administreringsrute:

PER OS

Resept typen:

Required

Produsert av:

PFIZER INC, USA

Terapeutisk gruppe:

PHENYTOIN

Terapeutisk område:

PHENYTOIN

Indikasjoner:

Treatment of epilepsy.

Autorisasjon dato:

2022-01-31

Informasjon til brukeren

Epanutin 100 mg, Capsules, PIL, CC TC 270622
2022-0079455
1
PATIENT LEAFLET IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986
The medicine is dispensed with a doctor’s prescription only
EPANUTIN
TM 100 MG
CAPSULES
EACH CAPSULE CONTAINS: 100 MG PHENYTOIN SODIUM
Inactive ingredients and allergens: See section 2 under ‘Important
information
about some of this medicine’s ingredients’ and section 6
“Further information”.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE. This
leaflet
contains concise information about this medicine. If you have any
further
questions, consult your doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may
harm them, even if it seems to you that their medical condition is
similar to
yours.
1. WHAT IS THIS MEDICINE INTENDED FOR?
For the treatment of epilepsy.
THERAPEUTIC GROUP: anticonvulsant.
2. BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE IF:
•
you are sensitive (allergic) to the active ingredient or to any of the
other
ingredients contained in the medicine (see section 6) or to medicines
of the
hydantoin group, including hypersensitivity reaction such as
angioedema.
•
you have suffered in the past from liver problems due to taking
phenytoin.
•
you are taking delavirdine
.
SPECIAL WARNINGS
REGARDING USE OF THE
MEDICINE
BEFORE TREATMENT WITH EPANUTIN, TELL YOUR DOCTOR IF:
•
You are suffering or have suffered from depression, mood swings,
suicidal
thoughts or behavior.
•
You have experienced in the past an allergic reaction to medicines
similar to
Epanutin, such as carboxamides, barbiturates, succinimides and
oxazolidinediones.
•
You are suffering or have suffered from liver or kidney problems.
Epanutin 100 mg, Capsules, PIL, CC TC 270622
2022-0079455
2
•
You are suffering or have suffered from porphyria.
•
You are suffering or have suffered from high blood sugar levels
(hyperglycemia).
•
You consume alcohol.
•
You are pregnant or planning to become pregnant. Epanutin may caus

Preparatomtale

Epanutin 100mg, Capsules LPD CC 27 April 2022
2021-0068321, 2021-0068319, 2021-0068320
1
EPANUTIN
™ 100 MG
NAME OF THE MEDICINAL PRODUCT
EPANUTIN
™
100 MG
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 100 mg of phenytoin sodium
Excipients with known effect:
For the full list of excipients, see section Description (11) in this
leaflet.
PHARMACEUTICAL FORM
Capsules
1 THERAPEUTIC INDICATIONS
Phenytoin is indicated for the treatment of epilepsy.
2 DOSAGE AND ADMINISTRATION
GENERAL
Phenytoin capsules, are formulated with the sodium salt of phenytoin.
The free acid form of phenytoin is used in
the phenytoin suspensions (125 mg/5 mL). Because there is
approximately an 8% increase in drug content with the
free acid form over that of the sodium salt, dosage adjustments and
serum level monitoring may be necessary when
switching from a product formulated with the free acid to a product
formulated with the sodium salt and vice versa.
For all oral formulations, dosage should be individualized to provide
maximum benefit. In some cases serum
drug level determinations may be necessary for optimal dosage
adjustments. Optimum control without clinical
signs of toxicity occurs more often with serum levels between 10-20
mcg/mL, although some mild cases of tonic-
clonic (grand mal) epilepsy may be controlled with lower serum levels
of phenytoin.
With recommended dosage a period of seven to ten days may be required
to achieve steady state drug levels with
phenytoin, and changes in dosage (increase or decrease) should not be
carried out at intervals shorter than seven to
ten days.
ADULT DOSAGE
Divided daily dosage:
For oral capsules, patients who have received no previous treatment
may be started on 300 mg daily, to be taken in
three equally divided doses, and the dosage then adjusted to suit
individual requirements. For most adults, the
satisfactory maintenance dosage will be 300 mg to 400 mg daily, to be
taken in three to four equally divided doses
respectively. An increase up to 600mg daily may be made if necessa