Invega

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

paliperidone

Available from:

Janssen-Cilag International NV

ATC code:

N05AX13

INN (International Name):

paliperidone

Therapeutic group:

Psycholeptics

Therapeutic area:

Schizophrenia; Psychotic Disorders

Therapeutic indications:

Invega is indicated for the treatment of schizophrenia in adults and in adolescents 15 years and older.Invega is indicated for the treatment of schizoaffective disorder in adults.

Product summary:

Revision: 18

Authorization status:

Authorised

Authorization date:

2007-06-24

Patient Information leaflet

43
B.
PACKAGE LEAFLET
44
PACKAGE LEAFLET: INFORMATION FOR THE USER
INVEGA 3 MG PROLONGED-RELEASE TABLETS
INVEGA 6 MG PROLONGED-RELEASE TABLETS
INVEGA 9 MG PROLONGED-RELEASE TABLETS
INVEGA 12 MG PROLONGED-RELEASE TABLETS
Paliperidone
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, pharmacist or
nurse.
-
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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What INVEGA is and what it is used for
2.
What you need to know before you take INVEGA
3.
How to take INVEGA
4.
Possible side effects
5.
How to store INVEGA
6.
Contents of the pack and other information
1.
WHAT INVEGA IS AND WHAT IT IS USED FOR
INVEGA contains the active substance paliperidone which belongs to the
class of antipsychotic
medicines.
INVEGA is used to treat schizophrenia in adults and in adolescents
aged 15 years and older.
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there, mistaken beliefs, unusual suspiciousness, becoming withdrawn,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.
INVEGA is also used to treat schizoaffective disorder in adults.
Schizoaffective disorder is a mental condition in which a person
experiences a combination of
schizophrenia symptoms (as listed above) in addition to mood disorder
symptoms (feeling very high,
feeling sad, feeling agitated, distracted, sleeplessness,
talkativeness, losing interest in everyday
activities, sleeping too much or too little, eating too much or too
little, and recurrent thoughts of
suicide).
INVEGA c

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
INVEGA 3 mg prolonged-release tablets
INVEGA 6 mg prolonged-release tablets
INVEGA 9 mg prolonged-release tablets
INVEGA 12 mg prolonged-release tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged-release tablet contains 3 mg of paliperidone.
Each prolonged-release tablet contains 6 mg of paliperidone.
Each prolonged-release tablet contains 9 mg of paliperidone.
Each prolonged-release tablet contains 12 mg of paliperidone.
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
Prolonged-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”
Trilayer capsule-shaped yellow tablets of 11 mm in length and 5 mm in
diameter printed with
“PAL 12”
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
INVEGA is indicated for the treatment of schizophrenia in adults and
in adolescents 15 years and
older.
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, a