Zipwell 60 mg capsules, hard

País: Malta

Língua: inglês

Origem: Medicines Authority

Ingredientes ativos:

ZIPRASIDONE

Disponível em:

Actavis Group PTC ehf Revkjavikurvegi 76-78, 220 Hafnarfjordur, Iceland

Código ATC:

N05AE04

DCI (Denominação Comum Internacional):

ZIPRASIDONE 60 mg

Forma farmacêutica:

HARD CAPSULE

Composição:

ZIPRASIDONE 60 mg

Tipo de prescrição:

POM

Área terapêutica:

PSYCHOLEPTICS

Status de autorização:

Withdrawn

Data de autorização:

2009-10-20

Folheto informativo - Bula

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PACKAGE LEAFLET: INFORMATION FOR THE USER
ZIPWELL 20 MG CAPSULES, HARD
ZIPWELL 40 MG CAPSULES, HARD
ZIPWELL 60 MG CAPSULES, HARD
ZIPWELL 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 Zipwell is and what it is used for
2.
What you need to know before you take Zipwell
3.
How to take Zipwell
4.
Possible side effects
5.
How to store Zipwell
6.
Contents of the pack and other information
1.
WHAT ZIPWELL IS AND WHAT IT IS USED FOR
Zipwell contains ziprasidone and belongs to a group of medicines
called antipsychotics.
Zipwell 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.
Zipwell 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 TAKE ZIPWELL
DO NOT TAKE ZIPWELL
-
if you are allergic to ziprasi

Características técnicas

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Zipwell 20 mg capsules, hard
Zipwell 40 mg capsules, hard
Zipwell 60 mg capsules, hard
Zipwell 80 mg capsules, hard
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule, hard contains ziprasidone hydrochloride equivalent to 20
mg, 40 mg, 60 mg or 80 mg of
ziprasidone.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsule, hard.
20 mg capsule: Hard gelatin capsule size 4 with white body and blue
cap.
40 mg capsule: Hard gelatin capsule size 4 with blue body and blue
cap.
60 mg capsule: Hard gelatin capsule size 3 with white body and white
cap.
80 mg capsule: Hard gelatin capsule size 2 with white body and blue
cap.
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 and 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
disorder, is 40 mg ziprasidone 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.
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_Elderly _
A lower starting dose is not routinely indicated but should be
considered for those 65 and ove