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

Maa: Australia

Kieli: englanti

Lähde: Department of Health (Therapeutic Goods Administration)

Aktiivinen ainesosa:

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

Saatavilla:

Arrotex Pharmaceuticals Pty Ltd

INN (Kansainvälinen yleisnimi):

Venlafaxine hydrochloride

Lääkemuoto:

Capsule, modified release

Koostumus:

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

Antoreitti:

Oral

Kpl paketissa:

28 capsules

Prescription tyyppi:

(S4) Prescription Only Medicine

Käyttöaiheet:

APO-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.

Tuoteyhteenveto:

Visual Identification: Peach opaque / peach opaque size 1 hard capsule with thick and thin radial circular band on the body and cap in red ink. The capsule is filled with white to off white, round, biconvex, film coated mini tablets.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Valtuutuksen tilan:

Licence status A

Valtuutus päivämäärä:

2017-06-23

Pakkausseloste

APO- VENLAFAXINE XR CAPSULES
1
APO- VENLAFAXINE XR
CAPSULES
_Venlafaxine hydrochloride _
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055 _
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about venlafaxine. 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 using this medicine
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may want to read it again.
WHAT THIS MEDICINE IS
USED FOR
Venlafaxine is used to treat major
depression, and to prevent it coming
back. It is also used to treat panic
attacks and anxiety.
Venlafaxine belongs to a group of
medicines called serotonin-
noradrenaline reuptake inhibitors
(SNRIs).
Venlafaxine increases the level of
serotonin and noradrenaline in the
brain, helping to restore your feeling
of wellness.
Depression may cause emotional and
physical symptoms such as feeling
low, poor appetite or lack of energy.
Excessive anxiety may cause you to
feel constantly and uncontrollably
worried and distressed. It may also
make you feel irritable, and cause
difficulty in thinking and sleeping.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed
Venlafaxine XR for another reason.
This medicine is available only with
a doctor's prescription.
This medicine is not addictive.
There is not enough information to
recommend the use of this medicine
for children under the age of 18
years.
BEFORE YOU TAKE THIS
MEDICINE
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE THIS MEDICINE IF YOU
HAVE AN ALLERGY TO:
•
venlafaxine
•
any of the ingredients listed at the
end of this leaflet
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling

Valmisteyhteenveto

1
AUSTRALIAN PRODUCT INFORMATION
APO-VENLAFAXINE XR (VENLAFAXINE HYDROCHLORIDE)
CAPSULES
1
NAME OF THE MEDICINE
Venlafaxine hydrochloride.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each modified release capsule contains venlafaxine 75 mg (as 84.90 mg
venlafaxine
hydrochloride) or venlafaxine 150 mg (as 169.80 mg venlafaxine
hydrochloride) as the active
ingredient.
EXCIPIENTS WITH KNOWN EFFECT
Gelatin (also contains sulfites and phenylalanine).
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
VENLAFAXINE XR 75 MG MODIFIED RELEASE CAPSULES
Peach opaque / peach opaque size 1 hard capsule with thick and thin
radial circular band on
the body and cap in red ink. The capsule is filled with white to off
white, round, biconvex, film
coated mini tablets.
VENLAFAXINE XR 150 MG MODIFIED RELEASE CAPSULES
Dark orange / dark orange size 0 hard capsule with thick and thin
radial circular band on the
body and cap in white ink. The capsule is filled with white to off
white, round, biconvex, film
coated mini tablets.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
•
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
DOSE AND METHOD OF ADMINISTRATION
APO-Venlafaxine XR 75 mg and 150 mg Modified Release Capsules are
intended for oral
administration.
2
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/day given once daily.
After two weeks the dose
may be increased to 150 mg/day given once daily if further clinical
improvement is required. If
needed, this can be increased up to 225 mg given once daily. Dose
increments should be
made at intervals of approximately two weeks or more, but not less
than four days.
The recommended dose is based on results of clinical trial