APO-DULOXETINE duloxetine (as hydrochloride) 60 mg enteric capsule blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

duloxetine hydrochloride, Quantity: 67.3 mg

Available from:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

Duloxetine hydrochloride

Pharmaceutical form:

Capsule, enteric

Composition:

Excipient Ingredients: Gelatin; triethyl citrate; titanium dioxide; sucrose; brilliant blue FCF; hypromellose phthalate; purified talc; hypromellose; iron oxide yellow; maize starch; propylene glycol; butan-1-ol; isopropyl alcohol; purified water; Shellac; ethanol absolute; ammonia; potassium hydroxide

Administration route:

Oral

Units in package:

28 capsules

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Duloxetine capsules are indicated for the treatment of major depressive disorder (MDD). Treatment of Generalised Anxiety Disorder (GAD).

Product summary:

Visual Identification: Opaque blue/opaque green hard gelatin capsule '158' on body and 'A' on cap with white ink; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 30 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2014-02-20

Patient Information leaflet

APO- DULOXETINE
1
APO- DULOXETINE
_Contains the active ingredient duloxetine (as duloxetine
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 this medicine. 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 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 need to read it again.
WHAT THIS MEDICINE IS
USED FOR
Duloxetine is used to treat:
•
major depressive disorder (MDD)
•
generalised anxiety disorder
(GAD) - excessive worry
Duloxetine belongs to a group of
medicines called serotonin and
noradrenaline reuptake inhibitors
(SNRIs). SNRIs are believed to work
by their action on serotonin and
noradrenaline in the brain. Serotonin
and noradrenaline are the chemical
messengers responsible for
controlling the psychological and
painful symptoms of depression.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed this
medicine for another reason.
This medicine is available only with
a doctor's prescription.
This medicine should not be used in
children and adolescents 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:
•
any medicine containing
duloxetine
•
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 of the face, lips, tongue
or other parts of the body
•
rash, itching or hives on the skin
DO NOT TAKE THIS MEDICINE IF YOU
HAVE OR HAVE HAD LIVER DISEASE.
DO NOT TAKE THIS MEDICINE IF YOU
ARE TA

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
APO- DULOXETINE (DULOXETINE HYDROCHLORIDE)
ENTERIC CAPSULES
1
NAME OF THE MEDICINE
Duloxetine hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 30 mg or 60 mg duloxetine (as hydrochloride) as
the active ingredient.
EXCIPIENTS WITH KNOWN EFFECT
Sucrose.
APO- Duloxetine capsules
also contain traces of sulphites and phenylalanine.
For
the full list of excipients see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Each capsule contains enteric-coated pellets of duloxetine
hydrochloride that are designed to
prevent degradation of the drug in the acidic environment of the
stomach.
30 MG CAPSULES – Hard gelatin capsules with a white opaque body and
blue opaque cap.
Imprinted “157” on the body and “A” on the cap in green ink.
Filled with white to off-white
granules.
60 MG CAPSULES – Hard gelatin capsules with a green opaque body and
blue opaque cap.
Imprinted “158” on the body and “A” on the cap in white ink.
Filled with white to off-white
granules.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
•
Treatment of major depressive disorder (MDD).
•
Treatment of generalised anxiety disorder (GAD).
4.2
DOSE AND METHOD OF ADMINISTRATION
APO- Duloxetine capsules are intended for oral administration.
DOSAGE
MAJOR DEPRESSIVE DISORDER
Duloxetine should be administered for the treatment of major
depressive disorder at a dose of
60 mg once daily, with or without food. There is no adequate evidence
suggesting that patients
not responding to 60 mg once daily will benefit from having their dose
increased.
GENERALISED ANXIETY DISORDER
The recommended starting dose of duloxetine in patients with
generalized anxiety disorder is
30 mg once daily with or without food. The daily dose should be
increased in 30 mg increments
until the minimum effective dose is achieved. The maximum dose is 120
mg per day, given as
120 mg once daily. Doses above 120 mg have not been systematically
evaluated.
2
INITIAL TOLERABILITY
For patients in whom initial tolerabi