REAGILA 6

Land: Israel

Sprog: engelsk

Kilde: Ministry of Health

Aktiv bestanddel:

CARIPRAZINE AS HYDROCHLORIDE

Tilgængelig fra:

DEXCEL LTD, ISRAEL

ATC-kode:

N05AX15

Lægemiddelform:

HARD CAPSULE

Sammensætning:

CARIPRAZINE AS HYDROCHLORIDE 6 MG

Indgivelsesvej:

PER OS

Recept type:

Required

Fremstillet af:

GEDEON RICHTER PLC, HUNGARY

Terapeutisk område:

CARIPRAZINE

Terapeutiske indikationer:

- For the treatment of schizophrenia in adult patients- Acute treatment of manic or mixed episodes associated with bipolar I disorder in adult- Treatment of depressive episodes associated with bipolar I disorder (bipolar depression) in adults

Autorisation dato:

2020-01-27

Indlægsseddel

Reagila
®
1.5, 3, 4.5, 6 Capsules
PATIENT PACKAGE INSERT ACCORDING TO PHARMACISTS’ REGULATIONS
)PREPARATIONS( - 1986
This medicine can be sold with a physician’s prescription only
Each capsule contains cariprazine as hydrochloride salt at a dose of
1.5, 3, 4.5 or 6
mg respectively.
Inactive ingredients and allergens in the medicine- see section 6
”Additional information”
and in section 2 ”Important information about some of the
ingredients of this medicine”.
READ THIS ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE. This
leaflet contains
concise information about this medicine. If you have any further
questions, ask the
doctor or the pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm
them, even if you think that their medical condition is similar to
yours.
1. WHAT IS THE MEDICINE INTENDED FOR?
Treatment of schizophrenia in adults.
Acute treatment of manic or mixed episodes associated with bipolar I
disorder in
adults.
Treatment of depressive episodes associated with bipolar I disorder in
adults.
REAGILA contains the active ingredient cariprazine and belongs to a
group of medicines
called antipsychotics.
Schizophrenia is a disease characterized by symptoms such as hearing,
seeing or
sensing things which are not there )hallucinations(, suspiciousness,
mistaken beliefs,
incoherent speech and behavior 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.
Bipolar disorder is a mental disorder that causes extreme mood
changes. Extreme
insane behavior is on one side of the disorder and severe depression
is on the other.
THERAPEUTIC GROUP: antipsychotic medicine.
2. BEFORE USING THE MEDICINE
DO NOT USE THE MEDICINE IF YOU:
are hypersensitive )allergic( to the active ingredient )cariprazine(
or to any of the
other ingredients this medicine conta

Produktets egenskaber

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Reagila 1.5
Reagila 3
Reagila 4.5
Reagila 6
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Reagila 1.5
Each hard capsule contains cariprazine hydrochloride corresponding to
1.5 mg cariprazine.
Reagila 3
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
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
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
White capsule imprinted with “GR 1.5” in black ink.
Reagila 3
Green and white capsule imprinted with “GR 3” in black ink.
Reagila 4.5
Green capsule imprinted with “GR 4.5” in white ink.
Reagila 6
Purple and white capsule imprinted with “GR 6” in black ink.
2
4.
CLINICAL
PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Reagila is indicated for the:
•
Treatment of schizophrenia in adult patients.
•
Acute treatment of manic or mixed episodes associated with bipolar I
disorder in adult.
•
Treatment of depressive episodes associated with bipolar I disorder
(bipolar depression) in
adults.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Schizophrenia _
The recommended starting dose of cariprazine is 1.5 mg once daily.
Thereafter the dose can be
increased slowly in 1.5 mg increments to a maximum dose of 6 mg/day,
if needed. The lowest
effective dose should be maintained according to the clinical
judgement of the treating physician.
Because of the long half-life of cariprazine and its active
metabolites, changes in dose will not be fully
reflected in plasma for several weeks. Patients should be monitored