GEODON 60 MG CAPSULES

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

ZIPRASIDONE AS HYDROCHLORIDE MONOHYDRATE

Available from:

PFIZER PFE PHARMACEUTICALS ISRAEL LTD

ATC code:

N05AE04

Pharmaceutical form:

CAPSULES

Composition:

ZIPRASIDONE AS HYDROCHLORIDE MONOHYDRATE 60 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

R - PHARM GERMANY GMBH

Therapeutic area:

ZIPRASIDONE

Therapeutic indications:

• Schizophrenia. Treatment of schizophrenia and for maintenance of clinical improvement during continuation therapy. • Bipolar mania. Ziprasidone is indicated as monotherapy in the treatment of 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.

Authorization date:

2014-09-09

Patient Information leaflet

Geodon Capsules PIL CC 310121
2017-0030120, 2017-0030124, 2020-0063467
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, and for
treatment of manic episodes that are part
of bipolar disorder (bipolar mania), as well as for maintenance
treatment of bipolar disorder, in combination
with lithium or valproate.
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 syndrome, a recent heart

Summary of Product characteristics

Geodon IM & Capsules CC LPD 310121
2017-0030120, 2017-0030124, 2020-0063467
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 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.
Bipolar mania.
Ziprasidone is indicated as monotherapy in the treatment of 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.
When deciding among the alternative treatments available for the
condition need