Invega 6mg modified-release tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Paliperidone

Available from:

Janssen-Cilag Ltd

ATC code:

N05AX13

INN (International Name):

Paliperidone

Dosage:

6mg

Pharmaceutical form:

Modified-release tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04020100; GTIN: 5012674901472

Patient Information leaflet

1
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there, mistaken beliefs, unusual suspiciousness, becoming withdrawn,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 can help alleviate the

Summary of Product characteristics

OBJECT 1
INVEGA 3 MG PROLONGED-RELEASE TABLETS
Summary of Product Characteristics Updated 05-Sep-2017 | Janssen-Cilag
Ltd
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 f