Zeldox 40 mg Kapsel, hård

Land: Sverige

Språk: svenska

Källa: Läkemedelsverket (Medical Products Agency)

Aktiva substanser:

ziprasidonhydrokloridmonohydrat

Tillgänglig från:

Medartuum AB

ATC-kod:

N05AE04

INN (International namn):

ziprasidone hydrochloride monohydrate

Dos:

40 mg

Läkemedelsform:

Kapsel, hård

Sammansättning:

ziprasidonhydrokloridmonohydrat Aktiv substans; natriumlaurilsulfat Hjälpämne; laktosmonohydrat Hjälpämne; propylenglykol Hjälpämne

Klass:

Apotek

Receptbelagda typ:

Receptbelagt

Terapiområde:

Ziprasidon

Bemyndigande status:

Avregistrerad

Tillstånd datum:

2004-03-10

Bipacksedel

1
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE USER
ZELDOX
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 Zeldox capsules are and what they are used for
2.
What you need to know before you use Zeldox capsules
3.
How to take Zeldox capsules
4.
Possible side effects
5.
How to store Zeldox capsules
6.
Contents of the pack and other information
1.
WHAT ZELDOX CAPSULES ARE AND WHAT ARE THEY USED FOR
Zeldox capsules belong to a group of medicines called antipsychotics.
Zeldox 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.
Zeldox 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 ZELDOX CAPSULES
DO NOT TAKE ZELDOX CAPSULES
-
if you are allergic to ziprasidone or any of the

Produktens egenskaper

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Zeldox 20 mg capsules, hard
Zeldox 40 mg capsules, hard
Zeldox 60 mg capsules, hard
Zeldox 80 mg capsules, hard
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains ziprasidone hydrochloride monohydrate
equivalent to 20 mg,
40 mg, 60 mg or 80 mg of ziprasidone
Excipient(s) with known effects:
Each 20 mg capsule contains 66.1 mg lactose monohydrate.
Each 40 mg capsule contains 87.83 mg lactose monohydrate.
Each 60 mg capsule contains 131.74 mg lactose monohydrate.
Each 80 mg capsule contains 175.65 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsule, hard
20 mg – No 4, blue/white capsules, marked “Pfizer” and ZDX 20
40 mg – No 4, blue capsules, marked “Pfizer” and ZDX 40
60 mg – No 3, white capsules, marked “Pfizer” and ZDX 60
80 mg – No 2, blue/white capsules, marked “Pfizer” and ZDX 80
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
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 admini