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

מדינה: אוסטרליה

שפה: אנגלית

מקור: Department of Health (Therapeutic Goods Administration)

מרכיב פעיל:

duloxetine hydrochloride, Quantity: 67.3 mg

זמין מ:

Alembic Pharmaceuticals Australia Pty Ltd

INN (שם בינלאומי):

Duloxetine hydrochloride

טופס פרצבטיות:

Capsule, enteric

הרכב:

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

מסלול נתינה (של תרופות):

Oral

יחידות באריזה:

28 capsules

סוג מרשם:

(S4) Prescription Only Medicine

סממני תרפויטית:

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

leaflet_short:

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: PVC/PCTFE (Aclar)/Al; Container Life Time: 30 Months; Container Temperature: Store below 25 degrees Celsius

מצב אישור:

Licence status A

תאריך אישור:

2013-06-14

עלון מידע

Duloxetine Sandoz
®
1
_ _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about DULOXETINE
SANDOZ.
It does not contain all of the
available information. It does not
take the place of talking to your
doctor or pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you taking DULOXETINE
SANDOZ 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 your
medicine. You may need to read it
again.
WHAT DULOXETINE SANDOZ IS
USED FOR
DULOXETINE SANDOZ 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 physical symptoms of
depression.
DULOXETINE SANDOZ is used to
treat:

major depressive disorder
(depression)

generalized Anxiety Disorder
(excessive worry)
ASK YOUR DOCTOR IF YOU HAVE
ANY QUESTIONS ABOUT WHY
DULOXETINE SANDOZ HAS
BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed
DULOXETINE SANDOZ for
another reason.
DULOXETINE SANDOZ is
available only with a doctor's
prescription.
DULOXETINE SANDOZ is not
recommended for use in children
and adolescents under the age of 18
years.
BEFORE YOU TAKE
DULOXETINE
SANDOZ
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE DULOXETINE
SANDOZ IF YOU ARE ALLERGIC TO
ANY MEDICINES CONTAINING
DULOXETINE HYDROCHLORIDE OR 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 DULOXETINE
SANDOZ IF YOU HAVE LIVER
DISEASE.
This could increase the chance of
you having liver problems during
treatment with DULOXETINE
SANDOZ.
DO NOT TAKE THIS M

מאפייני מוצר

210721 Duloxetine Sandoz-pi
Page 1 of 26
AUSTRALIAN PRODUCT INFORMATION
DULOXETINE SANDOZ
®
ENTERIC
CAPSULES (DULOXETINE
HYDROCHLORIDE)
1.
NAME OF THE MEDICINE
Duloxetine (present as the hydrochloride).
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
DULOXETINE SANDOZ enteric capsules come in two strengths and contain
enteric-coated
pellets of duloxetine hydrochloride equivalent to 30 mg or 60 mg of
duloxetine.
Excipient with known effect: sucrose
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
DULOXETINE SANDOZ 30 mg enteric capsule - Opaque blue/white hard
gelatin capsule
‘157’ on body and ‘A’ on cap with green ink.
DULOXETINE SANDOZ 60 mg
_ _
enteric capsule - Opaque blue/opaque green hard gelatin
capsule ‘158’ on body and ‘A’ on cap with white ink.
4.
CLINICAL PARTICULARS
4.1.
T
HERAPEUTIC INDICATIONS
DULOXETINE SANDOZ is indicated for the treatment of:
•
major depressive disorder (MDD)
•
generalised anxiety disorder (GAD)
4.2.
D
OSE AND METHOD OF ADMINISTRATION _MAJOR DEPRESSIVE DISORDER _
DULOXETINE SANDOZ 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.
210721 Duloxetine Sandoz-pi
Page 2 of 26
_INITIAL TOLERABILITY _
For patients in whom initial tolerability may be a concern, such as
treatment-naïve patients or
those with a history of adverse events with other medications, use of
a lower starting dose
such as 30 mg once daily for one week before increasing t