GEODON 40 Milligram Capsules Hard

מדינה: אירלנד

שפה: אנגלית

מקור: HPRA (Health Products Regulatory Authority)

מרכיב פעיל:

ZIPRASIDONE HYDROCHLORIDE MONOHYDRATE

זמין מ:

Pfizer Limited

קוד ATC:

N05AE04

INN (שם בינלאומי):

ZIPRASIDONE HYDROCHLORIDE MONOHYDRATE

כמות:

40 Milligram

טופס פרצבטיות:

Capsules Hard

סוג מרשם:

Product subject to prescription which may not be renewed (A)

איזור תרפויטי:

Antipsychotics

מצב אישור:

Authorised

תאריך אישור:

2002-03-08

עלון מידע

Page 1 of 8
2015-0009549
IE GE 142
PACKAGE LEAFLET: INFORMATION FOR THE USER
GEODON™
20 MG, 40 MG, 60 MG, 80 MG CAPSULES, HARD
ZIPRASIDONE
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 Geodon capsules are and what they are used for
2.
What you need to know before you use Geodon capsules
3.
How to take Geodon capsules
4.
Possible side effects
5.
How to store Geodon capsules
6.
Contents of the pack and other information
1.
WHAT GEODON CAPSULES ARE AND WHAT THEY ARE USED FOR
Geodon capsules belong to a group of medicines called antipsychotics.
Geodon capsules
are
used
for
the
treatment
of
schizophrenia
in
adults
-
a
mental
disorder
characterised by the following symptoms: to hear, see and feel things
that do not exist, to believe in
something not true, to feel unusual suspicions, to be absent and have
difficulty in establishing social
relationships, nervousness, depression or anxiety.
Geodon capsules are also used for the treatment of manic or mixed
episodes of moderate severity in
bipolar disorder in adults and children and adolescents aged 10-17
years - a mental disorder
characterised by alternate stages of euphoric (mania) or depressed
mood states. During mania
episodes, the most characteristic symptoms are: elated behaviour,
exaggerated self-esteem, increase in
energy, decreased need for sleeping, lack of concentration or
hyperactivity and repeated high risk-
taking behaviour.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE GEODON CAPSULES
DO NOT TAKE GEODON CAPSULES
-
if you are allergic to ziprasi

מאפייני מוצר

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Geodon 40mg capsules, hard.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains ziprasidone hydrochloride monohydrate
equivalent to 40 mg, of ziprasidone
Excipient(s) with known effects:
Each 40 mg capsule contains 87.83 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, hard
40 mg – No 4, blue capsules, marked “Pfizer” and ZDX 40
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Ziprasidone is indicated for the treatment of schizophrenia in adults.
Ziprasidone is indicated for the treatment of manic or mixed episodes
of moderate severity in bipolar disorder in adults,
children and adolescents aged 10-17 years (prevention of episodes of
bipolar disorder has not been established - see
section 5.1).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults_
The recommended dose, in acute treatment of schizophrenia and bipolar
mania, is 40 mg twice daily taken with food.
Daily dosage may subsequently be adjusted on the basis of individual
clinical status up to a maximum of 80 mg twice
daily. If indicated, the maximum recommended dose may be reached as
early as day 3 of treatment.
_It is of particular importance not to exceed the maximum dose as the
safety profile above 160 mg/day has not been_
_confirmed and ziprasidone is associated with dose-related
prolongation of the QT interval (see sections 4.3 and 4.4)._
In maintenance treatment of schizophrenia patients, ziprasidone should
be administered at the lowest effective dose; in
many cases, a dose of 20 mg twice daily may be sufficient.
_Elderly_
A lower starting dose is not routinely indicated but should be
considered for those 65 and over when clinical factors
warrant.
_Patients with renal impairment_
No dose adjustment is required in patients with impaired renal
function (see section 5.2).
_Patients with hepatic impairment_
In patients with hepatic insufficiency, lower doses should be
considered (see sections 4.4 and 5