Ziprasidone Aurobindo 80mg capsules, hard

מדינה: מלטה

שפה: אנגלית

מקור: Medicines Authority

מרכיב פעיל:

ZIPRASIDONE

זמין מ:

Aurobindo Pharma (Malta) Limited Vault 14, Level 2, Valletta Waterfront, Floriana FRN 1913, Malta

קוד ATC:

N05AE04

INN (שם בינלאומי):

ZIPRASIDONE 80 mg

טופס פרצבטיות:

HARD CAPSULE

הרכב:

ZIPRASIDONE 80 mg

סוג מרשם:

POM

איזור תרפויטי:

PSYCHOLEPTICS

מצב אישור:

Authorised

תאריך אישור:

2013-06-13

עלון מידע

Page 1 of 8
PACKAGE LEAFLET: INFORMATION FOR THE USER
ZIPRASIDONE AUROBINDO 20 MG CAPSULES, HARD
ZIPRASIDONE AUROBINDO 40 MG CAPSULES, HARD
ZIPRASIDONE AUROBINDO 60 MG CAPSULES, HARD
ZIPRASIDONE AUROBINDO 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 Ziprasidone Aurobindo is and what it is used for
2.
What you need to know before you take Ziprasidone Aurobindo
3.
How to take Ziprasidone Aurobindo
4.
Possible side effects
5.
How to store Ziprasidone Aurobindo
6.
Contents of the pack and other information
1.
WHAT ZIPRASIDONE AUROBINDO IS AND WHAT IT IS USED FOR
Ziprasidone Aurobindo belong to a group of medicines called
antipsychotics.
Ziprasidone Aurobindo is 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.
Ziprasidone Aurobindo is 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

מאפייני מוצר

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Ziprasidone Aurobindo 20 mg capsules, hard
Ziprasidone Aurobindo 40 mg capsules, hard
Ziprasidone Aurobindo 60 mg capsules, hard
Ziprasidone Aurobindo 80 mg capsules, hard
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains ziprasidone hydrochloride monohydrate
equivalent to 20 mg of
ziprasidone.
Each hard capsule contains ziprasidone hydrochloride monohydrate
equivalent to 40 mg of
ziprasidone.
Each hard capsule contains ziprasidone hydrochloride monohydrate
equivalent to 60 mg of
ziprasidone.
Each hard capsule contains ziprasidone hydrochloride monohydrate
equivalent to 80 mg of
ziprasidone.
Excipient(s) with known effect: lactose monohydrate
Each 20 mg capsule contains 56.363 mg lactose monohydrate.
Each 40 mg capsule contains 112.726 mg lactose monohydrate.
Each 60 mg capsule contains 169.088 mg lactose monohydrate.
Each 80 mg capsule contains 225.451 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsule, hard
Ziprasidone 20mg Capsules:
Blue opaque cap/Off-white opaque body, size '5' hard gelatin capsules
imprinted in black ink with
‘F’ on cap and '26' on body, filled with creamy to pale pinkish
granular powder.
Ziprasidone 40mg Capsules:
Blue opaque cap/ Blue opaque body, size '3' hard gelatin capsules
imprinted in black ink with ‘F’ on
cap and '38' on body, filled with creamy to pale pinkish granular
powder.
Ziprasidone 60mg Capsules:
Off-white opaque cap/ Off-white opaque body, size '2' hard gelatin
capsules imprinted in black ink
with ‘F’ on cap and '39' on body, filled with creamy to pale
pinkish granular powder.
Ziprasidone 80mg Capsules:
Blue opaque cap/Off-white opaque body, size '1' hard gelatin capsules
imprinted in black ink with
‘X’ on cap and '66' on body, filled with creamy to pale pinkish
granular powder.
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4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ziprasidone is indicated for the treatment of schizophrenia in