ZACTIN fluoxetine 20mg (as hydrochloride) capsule blister pack

מדינה: אוסטרליה

שפה: אנגלית

מקור: Department of Health (Therapeutic Goods Administration)

מרכיב פעיל:

fluoxetine hydrochloride, Quantity: 22.36 mg (Equivalent: fluoxetine, Qty 20 mg)

זמין מ:

Alphapharm Pty Ltd

טופס פרצבטיות:

Capsule, hard

הרכב:

Excipient Ingredients: maize starch; purified talc; sodium lauryl sulfate; lactose monohydrate; Gelatin; colloidal anhydrous silica; magnesium stearate; brilliant blue FCF; titanium dioxide; erythrosine; quinoline yellow; indigo carmine; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; Shellac; strong ammonia solution; iron oxide black; potassium hydroxide

מסלול נתינה (של תרופות):

Oral

יחידות באריזה:

28 capsules

סוג מרשם:

(S4) Prescription Only Medicine

סממני תרפויטית:

Indicated for the treatment of major depression. Obsessive Compulsive Disorder (OCD).

leaflet_short:

Visual Identification: Size 3 capsule with light green opaque body and purple opaque cap, printed "FL20" on the body and the greek alpha symbol on the cap in black ink.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

מצב אישור:

Licence status A

תאריך אישור:

1995-11-13

עלון מידע

ZACTIN
_fluoxetine hydrochloride_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about ZACTIN.
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 ZACTIN 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 ZACTIN IS USED
FOR
ZACTIN is used to treat
•
depression
•
obsessive compulsive disorder
(OCD)
ZACTIN belongs to a group of
medicines called selective serotonin
reuptake inhibitors (SSRIs). SSRIs
are thought to work by their action
on brain chemicals called amines
which are involved in controlling
mood.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY ZACTIN HAS
BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed
ZACTIN for another reason.
ZACTIN is available only with a
doctor's prescription.
ZACTIN is not recommended for use
in children and adolescents under 18
years of age.
BEFORE YOU TAKE
ZACTIN
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE ZACTIN IF YOU ARE
ALLERGIC TO:
•
any other medicines containing
fluoxetine (such as Prozac and
Lovan)
•
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 ZACTIN IF YOU ARE
TAKING, OR HAVE TAKEN WITHIN THE
LAST 14 DAYS, ANOTHER MEDICINE FOR
DEPRESSION CALLED A MONOAMINE
OXIDASE INHIBITOR (MAOI). CHECK
WITH YOUR DOCTOR OR PHARMACIST IF
YOU ARE UNSURE AS TO WHETHER OR
NOT YOU ARE TAKING A MAOI.
IF YOU DO TAKE ZACTIN WHILE YOU
ARE TAKING A MAOI, YOU MAY
EXPERIENCE SHAKING (TREMOR),
SHIVERING, MUSCLE STIFFNESS, FEVER,
RAPID PULSE, RAPID BREATHING OR
CONFUSION. DO NOT TAKE ZACTIN IF
YOU ARE TAKIN

מאפייני מוצר

AUSTRALIAN PRODUCT INFORMATION
ZACTIN
_Fluoxetine hydrochloride _
1
NAME OF THE MEDICINE
Fluoxetine (as hydrochloride)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Zactin capsule contains fluoxetine hydrochloride equivalent to
fluoxetine 20 mg (64.7 micromol).
Excipients with known effect: sulfites and sugars as lactose.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Zactin
:
Fluoxetine 20 mg capsule: light green body printed with "FL20" in
black and
purple cap printed with "α" in black
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of:
•
Major depression
•
Obsessive Compulsive Disorder (OCD).
4.2
DOSE AND METHOD OF ADMINISTRATION
DEPRESSION
The usual recommended initial dose of fluoxetine in the treatment of
depression is 20 mg/day, taken in the
morning.
A dose increase may be considered after several weeks if no clinical
improvement is observed. Doses more
than 20 mg/day should be administered twice daily (morning and noon)
and should not exceed a maximum
daily
dose
of
80
mg
(see
Section
5.2
PHARMACOKINETIC
PROPERTIES
-
CLINICAL
ISSUES
RELATED TO ACCUMULATION AND SLOW ELIMINATION).
As with other antidepressant agents, the full antidepressant effect
may be delayed until 4 or more weeks of
therapy (see Section 5.2 PHARMACOKINETIC PROPERTIES - CLINICAL ISSUES
RELATED TO
ACCUMULATION AND SLOW ELIMINATION).
As with many other medications, patients with renal and/or hepatic
impairment should be given a lower or
less frequent dosage. A lower or less frequent dosage should also be
considered for patients, such as the
elderly, with concurrent disease or on multiple medications.
OBSESSIVE COMPULSIVE DISORDER
_Initial treatment -_
A dose of 20 mg/day, administered in the morning, is recommended as
the initial dose. If
insufficient clinical improvement is observed, a dose increase may be
considered after several weeks. The
full therapeutic effect may be delayed until 5 weeks of treatment or
longer.
Doses above 20 mg/day may be administered on a once a day (i