GEODON 40 MG CAPSULES

Država: Izrael

Jezik: angleščina

Source: Ministry of Health

Aktivna sestavina:

ZIPRASIDONE AS HYDROCHLORIDE MONOHYDRATE

Dostopno od:

PFIZER PFE PHARMACEUTICALS ISRAEL LTD

Koda artikla:

N05AE04

Farmacevtska oblika:

CAPSULES

Sestava:

ZIPRASIDONE AS HYDROCHLORIDE MONOHYDRATE 40 MG

Pot uporabe:

PER OS

Tip zastaranja:

Required

Izdeluje:

PFIZER INC, USA

Terapevtska skupina:

ZIPRASIDONE

Terapevtsko območje:

ZIPRASIDONE

Terapevtske indikacije:

•Schizophrenia.Treatment of schizophrenia and for maintenance of clinical improvement during continuationTherapy in adults.•Bipolar mania.Ziprasidone is indicated as monotherapy in the treatment of adults with manic or mixed episodes associatedwith bipolar disorder with or without psychotic features.•Bipolar disorder.Maintenance treatment of bipolar disorder, as an adjunct to lithium or valproate in adults.

Datum dovoljenje:

2022-02-28

Navodilo za uporabo

Geodon Capsules PIL CC 090522
2020-0065988 2020-0065987, 2022-0078298
1
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
This medicine is dispensed with a doctor’s prescription only
GEODON
®
20 MG CAPSULES
GEODON
®
40 MG CAPSULES
GEODON
®
60 MG CAPSULES
GEODON
®
80 MG CAPSULES
EACH CAPSULE CONTAINS:
ZIPRASIDONE (AS HYDROCHLORIDE MONOHYDRATE) 20 MG, 40 MG, 60 MG, 80 MG
Inactive ingredients and allergens in this medicine: 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 THIS 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.
This medicine is not intended for treatment of children and
adolescents under 18 years of age.
Important information that you should know:
GEODON IS NOT INTENDED FOR THE TREATMENT OF PATIENTS WITH
DEMENTIA-RELATED PSYCHOSIS.
ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS, WHO ARE BEING
TREATED WITH
ANTIPSYCHOTICS, ARE AT HIGH RISK OF DEATH.
1.
WHAT IS THIS MEDICINE INTENDED FOR?
An antipsychotic medicine for treatment of schizophrenia in adults,
for treatment of manic
episodes that are part of bipolar disorder (bipolar mania) in adults,
as well as for maintenance
treatment of bipolar disorder, in combination with lithium or
valproate in adults.
THERAPEUTIC GROUP:
Atypical antipsychotics – antagonists for D
2
dopamine and 5HT
2A
serotonin receptors in the
brain.
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).
• You are suffering or have recently suffered from severe dysfunction
of the heart, such
as QT interval prolongation syn

Lastnosti izdelka

Geodon IM & Capsules CC LPD 090522
2020-0065988 2020-0065987, 2022-0078298
1
FULL PRESCRIBING INFORMATION
_ _
NAME OF THE MEDICINAL PRODUCT
Geodon
®
IM 20 mg
Geodon
®
20 mg Capsules
Geodon
®
40 mg Capsules
Geodon
®
60 mg Capsules
Geodon
®
80 mg Capsules
QUALITATIVE AND QUANTITATIVE COMPOSITION
GEODON
® INTRAMUSCULAR
Geodon
®
IM 20 mg contains 40.93 mg of ziprasidone mesylate trihydrate.
GEODON
® ORAL CAPSULES
Each capsule contains 20, 40, 60 or 80 mg of ziprasidone (as
hydrochloride monohydrate)
Excipients with known effect:
Each capsule contains lactose
For the full list of excipients, _see section_ _Description (10)_ in
this leaflet.
PHARMACEUTICAL FORM
Capsules
OR
Powder for solution for injection
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED
PSYCHOSIS
ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS TREATED WITH
ANTIPSYCHOTIC DRUGS ARE AT AN INCREASED RISK OF DEATH. GEODON
® IS
NOT APPROVED FOR THE TREATMENT OF PATIENTS WITH DEMENTIA-RELATED
PSYCHOSIS _[SEE WARNINGS AND PRECAUTIONS (4.1)]. _
1
INDICATIONS AND USAGE
GEODON
® INTRAMUSCULAR
Ziprasidone powder and solvent for solution for injection is indicated
for the rapid control of agitation in adult patients with
schizophrenia, when oral therapy is not
appropriate, for a maximum of 3 consecutive days.
Treatment with ziprasidone powder and solvent for solution for
injection should be discontinued, and the use of oral ziprasidone
should be initiated, as soon as
clinically appropriate.
GEODON
® ORAL CAPSULES
Ziprasidone hydrochloride monohydrate oral capsules are indicated for:
Schizophrenia.
Treatment of schizophrenia and for maintenance of clinical improvement
during continuation therapy in adults.
Bipolar mania.
Ziprasidone is indicated as monotherapy in the treatment of adults
with manic or mixed episodes associated with bipolar disorder with or
without psychotic features.
Bipolar Disorder
Maintenance treatment of bipolar disorder, as an adjunct to lithium or
valproate in adults.
When deciding among the alternative treatm