Reagila

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

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Active ingredient:

cariprazine hydrochloride

Available from:

Gedeon Richter

ATC code:

N05AX15

INN (International Name):

cariprazine

Therapeutic group:

Psycholeptics

Therapeutic area:

Schizophrenia

Therapeutic indications:

Reagila is indicated for the treatment of schizophrenia in adult patients.

Product summary:

Revision: 7

Authorization status:

Authorised

Authorization date:

2017-07-13

Patient Information leaflet

                                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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Summary of Product characteristics

                                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
                                
                                Read the complete document
                                
                            

Documents in other languages

Patient Information leaflet Patient Information leaflet Bulgarian 07-06-2022
Summary of Product characteristics Summary of Product characteristics Bulgarian 07-06-2022
Public Assessment Report Public Assessment Report Bulgarian 18-09-2017
Patient Information leaflet Patient Information leaflet Spanish 07-06-2022
Public Assessment Report Public Assessment Report Spanish 18-09-2017
Patient Information leaflet Patient Information leaflet Czech 07-06-2022
Public Assessment Report Public Assessment Report Czech 18-09-2017
Patient Information leaflet Patient Information leaflet Danish 07-06-2022
Public Assessment Report Public Assessment Report Danish 18-09-2017
Patient Information leaflet Patient Information leaflet German 07-06-2022
Public Assessment Report Public Assessment Report German 18-09-2017
Patient Information leaflet Patient Information leaflet Estonian 07-06-2022
Public Assessment Report Public Assessment Report Estonian 18-09-2017
Patient Information leaflet Patient Information leaflet Greek 07-06-2022
Public Assessment Report Public Assessment Report Greek 18-09-2017
Patient Information leaflet Patient Information leaflet French 07-06-2022
Public Assessment Report Public Assessment Report French 18-09-2017
Patient Information leaflet Patient Information leaflet Italian 07-06-2022
Public Assessment Report Public Assessment Report Italian 18-09-2017
Patient Information leaflet Patient Information leaflet Latvian 07-06-2022
Public Assessment Report Public Assessment Report Latvian 18-09-2017
Patient Information leaflet Patient Information leaflet Lithuanian 07-06-2022
Summary of Product characteristics Summary of Product characteristics Lithuanian 07-06-2022
Public Assessment Report Public Assessment Report Lithuanian 18-09-2017
Patient Information leaflet Patient Information leaflet Hungarian 07-06-2022
Summary of Product characteristics Summary of Product characteristics Hungarian 07-06-2022
Public Assessment Report Public Assessment Report Hungarian 18-09-2017
Patient Information leaflet Patient Information leaflet Maltese 07-06-2022
Public Assessment Report Public Assessment Report Maltese 18-09-2017
Patient Information leaflet Patient Information leaflet Dutch 07-06-2022
Public Assessment Report Public Assessment Report Dutch 18-09-2017
Patient Information leaflet Patient Information leaflet Polish 07-06-2022
Public Assessment Report Public Assessment Report Polish 18-09-2017
Patient Information leaflet Patient Information leaflet Portuguese 07-06-2022
Summary of Product characteristics Summary of Product characteristics Portuguese 07-06-2022
Public Assessment Report Public Assessment Report Portuguese 18-09-2017
Patient Information leaflet Patient Information leaflet Romanian 07-06-2022
Public Assessment Report Public Assessment Report Romanian 18-09-2017
Patient Information leaflet Patient Information leaflet Slovak 07-06-2022
Public Assessment Report Public Assessment Report Slovak 18-09-2017
Patient Information leaflet Patient Information leaflet Slovenian 07-06-2022
Summary of Product characteristics Summary of Product characteristics Slovenian 07-06-2022
Public Assessment Report Public Assessment Report Slovenian 18-09-2017
Patient Information leaflet Patient Information leaflet Finnish 07-06-2022
Public Assessment Report Public Assessment Report Finnish 18-09-2017
Patient Information leaflet Patient Information leaflet Swedish 07-06-2022
Public Assessment Report Public Assessment Report Swedish 18-09-2017
Patient Information leaflet Patient Information leaflet Norwegian 07-06-2022
Summary of Product characteristics Summary of Product characteristics Norwegian 07-06-2022
Patient Information leaflet Patient Information leaflet Icelandic 07-06-2022
Summary of Product characteristics Summary of Product characteristics Icelandic 07-06-2022
Patient Information leaflet Patient Information leaflet Croatian 07-06-2022
Public Assessment Report Public Assessment Report Croatian 18-09-2017

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