Latuda
Maa: Euroopan unioni
Kieli: englanti
Lähde: EMA (European Medicines Agency)
Pakkausseloste
(PIL)
10-01-2024
Valmisteyhteenveto
(SPC)
10-01-2024
Julkisesta arviointikertomuksesta
(PAR)
14-09-2020
Aktiivinen ainesosa:
lurasidone
Saatavilla:
Aziende Chimiche Riunite Angelini Francesco S.p.A.
ATC-koodi:
N05AE05
INN (Kansainvälinen yleisnimi):
lurasidone
Terapeuttinen ryhmä:
Psycholeptics
Terapeuttinen alue:
Schizophrenia
Käyttöaiheet:
Treatment of schizophrenia in adults aged 18 years and over.
Tuoteyhteenveto:
Revision: 25
Valtuutuksen tilan:
Authorised
Valtuutus päivämäärä:
2014-03-21
Pakkausseloste
37
B. PACKAGE LEAFLET
38
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LATUDA 18.5 MG FILM-COATED TABLETS
LATUDA 37 MG FILM-COATED TABLETS
LATUDA 74 MG FILM-COATED TABLETS
lurasidone
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 Latuda is and what it is used for
2.
What you need to know before you take Latuda
3.
How to take Latuda
4.
Possible side effects
5.
How to store Latuda
6.
Contents of the pack and other information
1.
WHAT LATUDA IS AND WHAT IT IS USED FOR
Latuda contains the active substance lurasidone and belongs to a group
of medicines called
antipsychotics. It is used to treat symptoms of schizophrenia in
adults (aged 18 years and over) and
adolescents aged 13-17 years. Lurasidone works by blocking receptors
in the brain to which the
substances dopamine and serotonin attach. Dopamine and serotonin are
neurotransmitters (substances
that allow nerve cells to communicate with each other) that are
involved in the symptoms of
schizophrenia. By blocking their receptors, lurasidone helps to
normalise the activity of the brain,
reducing the symptoms of schizophrenia.
Schizophrenia is a disorder with symptoms such as hearing things,
seeing or sensing things that are not
there, mistaken beliefs, unusual suspiciousness, becoming withdrawn,
incoherent speech and
behaviour and emotional flatness. People with this disorder may also
feel depressed, anxious, guilty,
or tense. This medicine is used to improve your symptoms of
schizophrenia.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE LATUDA
DO NOT TAKE
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Valmisteyhteenveto
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Latuda 18.5 mg film-coated tablets
Latuda 37 mg film-coated tablets
Latuda 74 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Latuda 18.5 mg film-coated tablets
Each film-coated tablet contains lurasidone hydrochloride equivalent
to18.6 mg lurasidone.
Latuda 37 mg film-coated tablets
Each film-coated tablet contains lurasidone hydrochloride equivalent
to 37.2 mg lurasidone.
Latuda 74 mg film-coated tablets
Each film-coated tablet contains lurasidone hydrochloride equivalent
to 74.5 mg lurasidone.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Latuda 18.5 mg film-coated tablets
White to off-white, film-coated round tablets of 6 mm debossed with
‘LA’
Latuda 37 mg film-coated tablets
White to off-white, film-coated round tablets of 8 mm debossed with
‘LB’
Latuda 74 mg film-coated tablets
Pale green, film-coated oval tablets of 12 mm x 7 mm debossed with
‘LD’
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Latuda is indicated for the treatment of schizophrenia in adults and
adolescent aged 13 years and over.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adult population_
The recommended starting dose is 37 mg of lurasidone once daily. No
initial dose titration is required.
It is effective in a dose range of 37 to 148 mg once daily. Dose
increase should be based on physician
judgement and observed clinical response. The maximum daily dose
should not exceed 148 mg.
Patients on doses higher than 111 mg once daily who discontinue their
treatment for longer than
3 days should be restarted on 111 mg once daily and up-titrated to
their optimal dose. For all other
doses patients can be restarted on their previous dose without need
for up-titration.
_Paediatric population_
The recommended starting dose is 37 mg of lurasidone once daily. No
initial dose titration is required.
It is effective in a dose range of 37 to 74 mg once daily. Dose
increase should
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