Invega

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Paliperidone 6mg (Drug Layer 1 = 1.8 mg, Drug layer 2 = 4.2 mg.)

Available from:

Janssen-Cilag (New Zealand) Ltd

INN (International Name):

Paliperidone 6 mg (Drug Layer 1 = 1.8 mg, Drug layer 2 = 4.2 mg.)

Dosage:

6 mg

Pharmaceutical form:

Modified release tablet

Composition:

Active: Paliperidone 6mg (Drug Layer 1 = 1.8 mg, Drug layer 2 = 4.2 mg.) Excipient: Butylated hydroxytoluene Carnauba wax Cellulose acetate Hyetellose Hypromellose Iron oxide red Iron oxide yellow Macrogol 3350 Macrogol 400 Opacode black NS-78-17821 Polyethylene oxide Povidone Sodium chloride Stearic acid Titanium dioxide

Units in package:

Blister pack, PVC-PCTFE/Paper-Al, 28 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Janssen Pharmaceutical Sciences Unlimited Company (JPSUC)

Therapeutic indications:

INVEGA is indicated for the treatment of acute exacerbations of schizoaffective disorder as monotherapy and in combination with antidepressants and/ or mood stabilisers (lithium and valproate).

Product summary:

Package - Contents - Shelf Life: Blister pack, OPA-Al-PVC/Al-paper (Child resistant) - 28 tablets - 24 months from date of manufacture stored at or below 25°C - Blister pack, OPA-Al-PVC/Al-paper (Child resistant) - 56 tablets - 24 months from date of manufacture stored at or below 25°C

Authorization date:

2006-08-17

Patient Information leaflet

INVEGA SUSTENNA
®
1
INVEGA SUSTENNA
®
_MODIFIED RELEASE SUSPENSION FOR INJECTION _
_Paliperidone palmitate _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
common questions about INVEGA
SUSTENNA. It does not contain all
of the available information. It does
not take the place of talking to your
doctor or pharmacist.
IF YOU HAVE ANY CONCERNS ABOUT
USING INVEGA SUSTENNA, ASK
YOUR DOCTOR OR PHARMACIST.
Your doctor and pharmacist have
more information.
KEEP THIS INFORMATION HANDY.
You can refer to it later if you have
any questions.
WHAT INVEGA
SUSTENNA IS USED
FOR
INVEGA SUSTENNA belongs to a
group of medicines called
antipsychotic agents which improve
the symptoms of certain types of
mental illness.
It is used to treat symptoms of
schizophrenia, a mental illness with
disturbances in thinking, feelings and
behaviour. INVEGA SUSTENNA
helps to correct a chemical imbalance
in the brain associated with this
condition. It can also be used to
lessen the chance of your
schizophrenia symptoms from
coming back.
Some of the most common
symptoms of schizophrenia may
include:
•
Seeing, hearing, or sensing things
that are not there (hallucinations)
•
Believing that what other people
say is not true (delusions)
•
Not trusting others and feeling
very suspicious (paranoia)
•
Avoiding family and friends and
wanting to be alone
It may take some time before your
symptoms of schizophrenia start to
improve. Remember that INVEGA
SUSTENNA is one part of your
overall treatment plan. It is important
to keep all your appointments, so you
can get your treatments on time and
your doctor can check your progress.
Your doctor, however, may prescribe
this medicine for another use.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY IT HAS BEEN
PRESCRIBED TO YOU.
BEFORE YOU TAKE IT
_WHEN YOU MUST NOT USE IT _
DO NOT USE INVEGA SUSTENNA
IF YOU KNOW YOU ARE ALLERGIC TO ANY
OF ITS INGREDIENTS LISTED AT THE END
OF THIS LEAFLET OR MEDICINES
CONTAINING PALIPERIDONE (E.G.
INVEGA) OR RISPERIDONE (E.G.

Summary of Product characteristics

CCDS180507
Page 1 of 26
INVEGA TABS(180723)ADS
INVEGA
®
PALIPERIDONE
NEW ZEALAND DATASHEET
1. PRODUCT NAME
INVEGA 3 mg modified release tablets
INVEGA 6 mg modified release tablets
INVEGA 9 mg modified release tablets
INVEGA 12 mg modified release tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Paliperidone
INVEGA (paliperidone) is a novel antipsychotic agent belonging to the
benzisoxazole-derivatives
class.
Excipient(s) with known effect
The 3 mg tablet contains 13.2 mg lactose
For a full list of excipients, see SECTION 6.1.
3. PHARMACEUTICAL FORM
Modified release tablet
3 mg
White, capsule shaped tablets imprinted with “PAL 3”.
6 mg
Beige, capsule shaped tablets imprinted with “PAL 6”.
9 mg
Pink, capsule shaped tablets imprinted with “PAL 9”.
12 mg Dark yellow, capsule shaped tablets imprinted with “PAL 12”.
INVEGA utilises osmotic drug-release technology, whereby osmotic
pressure delivers paliperidone
from the dosage form at a controlled rate. The system, which resembles
a capsule-shaped tablet in
appearance,
comprises
an
osmotically
active
trilayer
core
surrounded
by
a
subcoat
and
semipermeable membrane. The trilayer core is composed of two drug
layers containing the drug and
excipients, and a push layer containing osmotically active components.
There are two precision
laser-drilled orifices on the drug-layer dome of the tablet. Each
strength is identified by a unique
colour overcoat and print markings. In an aqueous environment, such as
the gastrointestinal tract,
the
water-dispersible
colour
overcoat
erodes
quickly.
Water
is
then
imbibed
through
the
semipermeable, rate-controlling membrane. The membrane controls the
rate at which water enters
the tablet core, which, in turn, controls drug delivery. The
hydrophilic polymers of the core hydrate
and swell, creating a gel containing paliperidone that is then pushed
out through the tablet orifices.
The biologically inert components of the tablet remain intact during
gastrointestinal transit and are
eliminated in the stool as a tablet shell,