INVEGA 6 MG

Country: Ísrael

Tungumál: enska

Heimild: Ministry of Health

Virkt innihaldsefni:

PALIPERIDONE

Fáanlegur frá:

J-C HEALTH CARE LTD

ATC númer:

N05AX13

Lyfjaform:

TABLETS EXTENDED RELEASE

Samsetning:

PALIPERIDONE 6 MG

Stjórnsýsluleið:

PER OS

Gerð lyfseðils:

Required

Framleitt af:

JANSSEN CILAG S.P.A., ITALY

Meðferðarhópur:

PALIPERIDONE

Lækningarsvæði:

PALIPERIDONE

Ábendingar:

Invega is indicated for :-treatment of schizophrenia in adults and adolescents (12-17 years).-treatment of schizoaffective disorder in adults.

Leyfisdagur:

2023-07-31

Upplýsingar fylgiseðill

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986
The medicine is dispensed with a doctor’s prescription only
INVEGA
® 3 MG,
INVEGA
® 6 MG,
INVEGA
® 9 MG
EXTENDED-RELEASE TABLETS
,ג״מ 3
TM
הגווניא
,ג״מ 6
TM
הגווניא
ג״מ 9
TM
הגווניא
ךשוממ רורחשב תוילבט
غلم 9 ،غلم 6 ،غلم 3 ﺎﭽﻴﭭﻨﻳإ
دتمم رﻳرحت تاذ صارقأ
INVEGA 3 MG CONTAINS PALIPERIDONE 3 MG
INVEGA 6 MG CONTAINS PALIPERIDONE 6 MG
INVEGA 9 MG CONTAINS PALIPERIDONE 9 MG
Inactive and allergenic ingredients in the preparation – see chapter
2
section “Important information about some of the ingredients of the
medicine” and chapter 6 – “Further information”.
READ THE LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE.
This leaflet contains concise information about the medicine. If you
have further questions, refer to the doctor or pharmacist.
This medicine has been prescribed for the treatment of your ailment.
Do not pass it on to others. It may harm them even if it seems to you
that their ailment is similar.
1. WHAT IS THE MEDICINE INTENDED FOR?
The medicine is used to treat schizophrenia in adults and adolescents
aged 12 years and above, and schizoaffective disorder in adults.
THERAPEUTIC GROUP: Antipsychotic medicines
Schizophrenia is a disorder with symptoms characterized by hearing,
seeing or sensing things that are not there, false beliefs, unusual
suspiciousness, becoming withdrawn, incoherent speech, behavioral
and emotional flatness (lack of emotional expression). Patients with
schizophrenia may also feel depressed, anxious, guilty, or tense.
Schizoaffective disorder is a mental condition in which patients
experience a mix of schizophrenia symptoms (as listed above) in
addition to mood disorder symptoms (very elated mood, sadness,
feeling nervous, distracted, sleeplessness, talkativeness, loss of
interest in everyday activities, sleeping too much or too little,
eating
too much or too little, and recurren

Vara einkenni

1.
NAME OF THE MEDICINAL PRODUCT
INVEGA 3 mg
INVEGA 6 mg
INVEGA 9 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each extended-release tablet contains 3 mg of paliperidone.
Each extended-release tablet contains 6 mg of paliperidone.
Each extended-release tablet contains 9 mg of paliperidone.
For the 3mg tablets:
Excipient with known effect:
Each 3 mg tablet contains 13.2 mg lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Extended-release tablet
Trilayer capsule-shaped white tablets of 11 mm in length and 5 mm in
diameter printed with “PAL 3”
Trilayer capsule-shaped beige tablets of 11 mm in length and 5 mm in
diameter printed with “PAL 6”
Trilayer capsule-shaped pink tablets of 11 mm in length and 5 mm in
diameter printed with “PAL 9”
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
INVEGA is indicated for the treatment of schizophrenia in adults and
in adolescents (12-17 years).
INVEGA is indicated for the treatment of schizoaffective disorder in
adults.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Schizophrenia (adults)_
The recommended dose of INVEGA for the treatment of schizophrenia in
adults is 6 mg once daily,
administered in the morning. Initial dose titration is not required.
Some patients may benefit from lower
or higher doses within the recommended range of 3 mg to 12 mg once
daily. Dosage adjustment, if
indicated, should occur only after clinical reassessment. When dose
increases are indicated, increments
of 3 mg/day are recommended and generally should occur at intervals of
more than 5 days.
_Schizoaffective disorder (adults)_
The recommended dose of INVEGA for the treatment of schizoaffective
disorder in adults is 6 mg once
daily, administered in the morning. Initial dose titration is not
required. Some patients may benefit from
higher doses within the recommended range of 6 mg to 12 mg once daily.
Dosage adjustment, if
indicated, should occur only after clinical reassessment. When dose
increases are indicated, increments
of 3 mg/day are recomm