Reagila
Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
Indlægsseddel
(PIL)
07-06-2022
Produktets egenskaber
(SPC)
07-06-2022
Offentlige vurderingsrapport
(PAR)
18-09-2017
Aktiv bestanddel:
cariprazine hydrochloride
Tilgængelig fra:
Gedeon Richter
ATC-kode:
N05AX15
INN (International Name):
cariprazine
Terapeutisk gruppe:
Psycholeptics
Terapeutisk område:
Schizophrenia
Terapeutiske indikationer:
Reagila is indicated for the treatment of schizophrenia in adult patients.
Produkt oversigt:
Revision: 7
Autorisation status:
Authorised
Autorisation dato:
2017-07-13
Indlægsseddel
40
B. PACKAGE LEAFLET
41
PACKAGE LEAFLET: INFORMATION FOR THE USER
REAGILA 1.5 MG HARD CAPSULES
REAGILA 3 MG HARD CAPSULES
REAGILA 4.5 MG HARD CAPSULES
REAGILA 6 MG HARD CAPSULES
cariprazine
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. This includes any
possible side effects not listed
in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Reagila is and what it is used for
2.
What you need to know before you take Reagila
3.
How to take Reagila
4.
Possible side effects
5.
How to store Reagila
6.
Contents of the pack and other information
1.
WHAT REAGILA IS AND WHAT IT IS USED FOR
Reagila contains the active substance cariprazine and belongs to a
group of medicines called
antipsychotics. It is used to treat adults with schizophrenia.
Schizophrenia is a disease characterised by symptoms such as hearing,
seeing or sensing things which
are not there (hallucination), suspiciousness, mistaken beliefs,
incoherent speech and behaviour and
emotional flatness. People with this condition may also feel
depressed, guilty, anxious, tense, or not
being able to start or keep up planned activities, unwillingness to
speak, lack of emotional response to
a situation that would normally stimulate feelings in others.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE REAGILA
DO NOT TAKE REAGILA
-
if you are allergic to cariprazine or any of the other ingredients of
this medicine (listed in
section 6).
-
if you are taking medicines used to treat:
-
hepatitis caused by the hepatitis C virus (medicines containing
boceprevir and telaprevir)
-
bacterial infections (medicines containing clarithromycin,
telithromycin, erythromycin
and nafcillin)
-
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Produktets egenskaber
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Reagila 1.5 mg hard capsules
Reagila 3 mg hard capsules
Reagila 4.5 mg hard capsules
Reagila 6 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Reagila 1.5 mg hard capsules
Each hard capsule contains cariprazine hydrochloride corresponding to
1.5 mg cariprazine.
Reagila 3 mg hard capsules
Each hard capsule contains cariprazine hydrochloride corresponding to
3 mg cariprazine.
Excipient with known effect
Each hard capsule contains 0.0003 mg Allura red AC (E 129).
Reagila 4.5 mg hard capsules
Each hard capsule contains cariprazine hydrochloride corresponding to
4.5 mg cariprazine.
Excipient with known effect
Each hard capsule contains 0.0008 mg Allura red AC (E 129).
Reagila 6 mg hard capsules
Each hard capsule contains cariprazine hydrochloride corresponding to
6 mg cariprazine.
Excipient with known effect
Each hard capsule contains 0.0096 mg Allura red AC (E 129).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule
Reagila 1.5 mg hard capsules
‘Size 4’ (approximately 14.3 mm in length) hard gelatin capsule
with white opaque cap and white
opaque body imprinted with “GR 1.5” on the capsule body with black
ink. The capsules are filled with
white to yellowish white powder mixture.
Reagila 3 mg hard capsules
‘Size 4’ (approximately 14.3 mm in length) hard gelatin capsule
with green opaque cap and white
opaque body imprinted with “GR 3” on the capsule body with black
ink. The capsules are filled with
white to yellowish white powder mixture.
3
Reagila 4.5 mg hard capsules
‘Size 4’ (approximately 14.3 mm in length) hard gelatin capsule
with green opaque cap and green
opaque body imprinted with “GR 4.5” on the capsule body with white
ink. The capsules are filled with
white to yellowish white powder mixture.
Reagila 6 mg hard capsules
‘Size 3’ (approximately 15.9 mm in length) hard gelatin capsule
with purple opaque cap and white
opaque body imprinted with “GR 6” on th
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