TIXOL 30 duloxetine (as hydrochloride) 30 mg enteric capsule blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

duloxetine hydrochloride, Quantity: 33.65 mg

Available from:

Alphapharm Pty Ltd

INN (International Name):

Duloxetine hydrochloride

Pharmaceutical form:

Capsule, enteric

Composition:

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

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 Diabetic Peripheral Neuropathic Pain (DPNP). Treatment of Generalised Anxiety Disorder (GAD).

Product summary:

Visual Identification: Opaque blue/white hard gelatin capsule '157' on body and 'A' on cap with green ink; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 30 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2013-06-14

Patient Information leaflet

TIXOL
_duloxetine hydrochloride_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Tixol.
It does not contain all 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 Tixol against the
benefits expected for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT TIXOL IS USED FOR
Tixol belongs to a group of
medicines known as 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.
Tixol is used to treat:
•
Major depressive disorder
(depression)
•
Diabetic peripheral neuropathic
pain (nerve pain caused by
diabetes)
•
Generalised anxiety disorder
(excessive worry)
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
Tixol is available only with a doctor's
prescription.
Tixol is not recommended for use in
children and adolescents under the
age of 18 years.
BEFORE YOU TAKE TIXOL
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE TIXOL IF YOU HAVE AN
ALLERGY TO:
•
any medicine containing
duloxetine hydrochloride
•
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 TIXOL IF YOU HAVE LIVER
DISEASE.
This could increase the change of
you having liver problems during
treatment with Tixol.
DO NOT TAKE THIS MEDICINE IF YOU
ARE TAKING ANOTHER MEDICINE FOR
DEPRESSION CALLED A M

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
TIXOL
_Duloxetine (as hydrochloride) _
1
NAME OF THE MEDICINE
Duloxetine hydrochloride.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Duloxetine is available as capsules for oral administration.
Each capsule contains enteric-coated pellets of duloxetine
hydrochloride equivalent to 30 mg or 60 mg of
duloxetine that are designed to prevent degradation of the drug in the
acidic environment of the stomach.
Excipients with known effect: sugars, phenylalanine and sulfites.
The inactive ingredients also include Sugar Spheres (ARTG 2535),
hypromellose, purified talc, purified water,
sucrose, hypromellose phthalate, triethyl citrate, gelatin, titanium
dioxide, and indigo carmine.
The 30 mg capsules also contain Tekprint SB-4020 Green Ink (ARTG
2652). The 60 mg capsules also contain
iron oxide yellow, and TekPrint SW-0012 White Ink (ARTG 13175). The
enteric capsules are gluten free.
3
PHARMACEUTICAL FORM
The 30 mg enteric capsule has an opaque blue/white hard gelatin
capsule ‘157’ on body and ‘A’ on cap with
green ink.
The 60 mg enteric capsule has an opaque blue/opaque green hard gelatin
capsule ‘158’ on body and ‘A’ on cap
with white ink.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
TIXOL is indicated for the treatment of:
•
major depressive disorder (MDD)
•
diabetic peripheral neuropathic pain (DPNP)
•
generalised anxiety disorder (GAD).
4.2
DOSE AND METHOD OF ADMINISTRATION
MAJOR DEPRESSIVE DISORDER
TIXOL 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.
DIABETIC PERIPHERAL NEUROPATHIC PAIN
The starting and maintenance dose of duloxetine in diabetic peripheral
neuropathic pain is 60 mg once daily. As
the progression of diabetic neuropathy is highly variable and
management of pain is empirical, effectiveness of
duloxetine should be assessed on an individual b