SANDOZ VENLAFAXINE XR venlafaxine (as hydrochloride) 75 mg modified release capsule blister pack

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv ingrediens:

venlafaxine hydrochloride, Quantity: 84.9 mg (Equivalent: venlafaxine, Qty 75 mg)

Tilgjengelig fra:

Alembic Pharmaceuticals Australia Pty Ltd

INN (International Name):

Venlafaxine hydrochloride

Legemiddelform:

Capsule, modified release

Sammensetning:

Excipient Ingredients: iron oxide black; colloidal anhydrous silica; ethylcellulose; iron oxide red; magnesium stearate; microcrystalline cellulose; povidone; purified talc; titanium dioxide; Gelatin; copovidone; propylene glycol; butan-1-ol; isopropyl alcohol; purified water; Shellac; ethanol absolute; ammonia

Administreringsrute:

Oral

Enheter i pakken:

28 capsules

Resept typen:

(S4) Prescription Only Medicine

Indikasjoner:

SANDOZ VENLAFAXINE XR is indicated for the treatment of: - Major depression, including prevention of relapse and recurrence where appropriate; - Generalised anxiety disorder; - Social anxiety disorder; Panic disorder, including prevention of relapse.

Produkt oppsummering:

Visual Identification: Peach opaque cap/ peach opaque body, size '1' hard capsule with thick and thin radial circular bands on both the cap and body in red ink.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Autorisasjon status:

Licence status A

Autorisasjon dato:

2017-05-17

Informasjon til brukeren

SANDOZ
®
VENLAFAXINE XR
1
SANDOZ
® VENLAFAXINE
XR
_venlafaxine hydrochloride modified release capsules _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Sandoz Venlafaxine
XR modified release capsules. It does
not contain all the available
information.
It does not take the place of talking to
your doctor or pharmacist. All
medicines have risks and benefits.
Your doctor has weighed the risks of
you taking Sandoz Venlafaxine XR
against the expected benefits it will
have for you.
IF YOU HAVE ANY QUESTIONS ABOUT
SANDOZ VENLAFAXINE XR, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR SANDOZ
VENLAFAXINE XR MODIFIED RELEASE
CAPSULES.
You may need to read it again.
WHAT SANDOZ
VENLAFAXINE XR IS
USED FOR
_WHAT IT DOES _
Sandoz Venlafaxine XR modified
release capsules are used in the
treatment and prevention of relapse
of depression and panic attacks and
in the treatment of anxiety, including
avoidance or fear of social situations.
Depression can affect your whole
body and may cause emotional and
physical symptoms such as feeling
low in spirit, being unable to enjoy
life, poor appetite or overeating,
disturbed sleep, loss of sex drive,
lack of energy and feeling guilty over
nothing.
Excessive anxiety is a condition in
which you feel constantly and
uncontrollably worried and
distressed. It may also make you feel
irritable, and cause difficulty in
thinking and sleeping. Other
common symptoms associated with
anxiety may include a dry mouth, a
lump in the throat, cold clammy
hands, diarrhoea and nausea.
Depression and anxiety are treatable
illnesses. Anxiety or tension
associated with the normal stress of
everyday life usually does not require
treatment with medicines.
_HOW IT WORKS _
Sandoz Venlafaxine XR contains the
active ingredient called venlafaxine
hydrochloride. It belongs to a class of
medications for depression and
anxiety, called Serotonin-
Noradrenaline Reuptake Inhibitors
(SNRIs).
Serotonin and noradrenaline are
chemical messengers that allow
certa

Preparatomtale

Venlafaxine Sandoz-pi
Page 1 of 32
AUSTRALIAN PRODUCT INFORMATION
SANDOZ VENLAFAXINE XR (VENLAFAXINE {AS HYDROCHLORIDE})
MODIFIED RELEASE CAPSULES
1.
NAME OF THE MEDICINE
Venlafaxine (as hydrochloride)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Sandoz
Venlafaxine
XR
venlafaxine
(as
hydrochloride)
modified
release
capsules
are
available containing 75 mg or 150 mg of venlafaxine (as
hydrochloride).
List of Excipient with known effect: Phenylalanine, sulfites.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Modified release capsules.
Sandoz Venlafaxine XR capsules are a modified release formulation,
which release the active
constituent, venlafaxine hydrochloride, from mini-tablets within the
capsule. Drug release is
controlled by diffusion through the coating on the mini-tablets and is
not pH dependent.
Sandoz
Venlafaxine
XR
venlafaxine
(as
hydrochloride)
modified
release
capsules
are
available as:
•
75 mg, peach opaque cap/peach opaque body size “1” hard capsule
with thick and
thin radial circular bands on both the cap and body in red ink.
•
150 mg, dark orange opaque cap/dark orange opaque body size “0”
hard capsule with
thick and thin radial circular bands on both the cap and body in white
ink.
4.
CLINICAL PARTICULARS
4.1.
T
HERAPEUTIC INDICATIONS
Sandoz Venlafaxine XR is indicated for the treatment of:
•
Major Depression, including prevention of relapse and recurrence where
appropriate;
•
Generalised Anxiety disorder;
•
Social Anxiety Disorder;
•
Panic Disorder, including prevention of relapse.
4.2.
D
OSE AND METHOD OF ADMINISTRATION
DOSAGE
_MAJOR DEPRESSION, GENERALISED ANXIETY DISORDER AND SOCIAL ANXIETY
DISORDER _
The usual recommended dose for the treatment of major depression,
generalised anxiety
disorder or social anxiety disorder is 75 mg per day given once daily.
After two weeks, the
dose may be increased to 150 mg per day given once daily if further
clinical improvement is
required. If needed, this can be increased up to 225 mg given once