INVEGA paliperidone 9mg modified release tablet blister pack

Land: Ástralía

Tungumál: enska

Heimild: Department of Health (Therapeutic Goods Administration)

Virkt innihaldsefni:

paliperidone, Quantity: 9 mg

Fáanlegur frá:

Janssen-Cilag Pty Ltd

INN (Alþjóðlegt nafn):

Paliperidone

Lyfjaform:

Tablet, modified release

Samsetning:

Excipient Ingredients: sodium chloride; iron oxide red; purified water; hyetellose; macrogol 3350; Carnauba Wax; butylated hydroxytoluene; polyethylene oxide; povidone; stearic acid; isopropyl alcohol; propylene glycol; iron oxide black; hypromellose; titanium dioxide; macrogol 400; cellulose acetate

Stjórnsýsluleið:

Oral

Einingar í pakka:

28 tablets, 7 tablets, 56 tablets

Gerð lyfseðils:

(S4) Prescription Only Medicine

Ábendingar:

INVEGA is indicated for the treatment of schizophrenia, including acute treatment and recurrence prevention. INVEGA is indicated for the treatment of acute exacerbations of schizoaffective disorder as monotherapy and in combination with antidepressants and/or mood stabilizers (lithium and valproate).

Vörulýsing:

Visual Identification: Pink, capsule shaped tablets imprinted with "PAL 9".; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Leyfisstaða:

Registered

Leyfisdagur:

2007-09-17

Upplýsingar fylgiseðill

INVEGA
®
1
INVEGA
®
_PROLONGED RELEASE TABLETS _
_Paliperidone _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
common questions about Invega. 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, ASK YOUR DOCTOR OR
PHARMACIST.
Your doctor and pharmacist have
more information.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT INVEGA IS USED
FOR
Invega 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. It is also used to treat
other types of related psychoses.
Invega helps to correct a chemical
imbalance in the brain associated
with these conditions.
Invega tablets are formulated with a
special shell that controls the release
of the active ingredient gradually
throughout the day. The tablet shell
does not dissolve completely after all
the drug has been released and
sometimes the tablet shell may be
seen in your stool. This is normal.
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.
Invega is not addictive.
BEFORE YOU TAKE IT
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE INVEGA IF YOU KNOW
YOU ARE ALLERGIC TO ANY OF ITS
INGREDIENTS LISTED AT THE END OF THIS
LEAFLET OR MEDICINES CONTAINING
RISPERIDONE (E.G. RISPERDAL).
Signs of allergy may include skin
rash, itching, shortness of breath,
and/or swollen face or tongue.
DO NOT TAKE IT AFTER THE EXPIRY DATE
PRINTED ON THE PACK.
If you take it after the expiry date has
passed, it may not work as well.
DO NOT TAKE IT IF THE PACKAGING IS
TORN OR SHOWS SIGNS OF BEING
TAMPERED WITH.
DO NOT TAKE IT IF THE TABLETS
APPEARANCE HAS CHANGED.
DO NOT TAKE IT TO TREAT ANY OTHER
COMPLAINTS UNLESS YOUR DOCTOR SAYS
IT IS S

Vara einkenni

CCDS200407ver17
Page 1 of 29
INVEGA(200729)API
INVEGA

PALIPERIDONE
AUSTRALIAN PRODUCT INFORMATION
1.
NAME OF THE MEDICINE
Paliperidone
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
INVEGA (paliperidone) is a novel antipsychotic agent belonging to the
benzisoxazole-derivatives class.
INVEGA is available as a modified release tablet containing 3, 6, 9
and 12 mg of paliperidone.
Excipient(s) with known effect:
Lactose monohydrate - 3 mg tablet only.
For a full list of excipients, see section 6.1 List of Excipients.
3.
PHARMACEUTICAL FORM
Modified Release Tablets.
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
tri-layer
core
surrounded
by
a
sub-coat
and
semipermeable membrane. The tri-layer 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, along wit