EDRONAX reboxetine 4mg (as mesilate) tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

reboxetine mesilate, Quantity: 5.224 mg (Equivalent: reboxetine, Qty 4 mg)

Available from:

Pfizer Australia Pty Ltd

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: calcium hydrogen phosphate dihydrate; microcrystalline cellulose; crospovidone; magnesium stearate; silicon dioxide

Administration route:

Oral

Units in package:

60, 30, 56, 28, 10, 14, 20

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

INDICATIONS: Edronax is indicated for the treatment of major depression and is effective in preventing the relapse of depressive symptoms.

Product summary:

Visual Identification: White, convex, round shape, 8mm diameter with a breakline on one side and engraved 'P' on the left of the breakline and 'U' on the right side of the breakline, and '7671' on the opposite side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2001-08-24

Patient Information leaflet

EDRONAX
®
_(ED-ROW-NACKS)_
_Reboxetine mesilate_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Edronax.
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 risks and
benefits. Your doctor has weighed
the risks of you taking Edronax
against the benefits it is expected to
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 EDRONAX IS
USED FOR
_WHAT IT DOES_
Edronax is used to treat depression.
_HOW IT WORKS_
Depression is longer lasting and/or
more severe than the 'low moods'
everyone has from time to time due
to the stress of everyday life. It is
thought to be caused by a chemical
imbalance in parts of the brain.
Edronax may correct this chemical
imbalance and help to relieve the
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 it
for another reason.
There is no evidence that Edronax is
addictive.
This medicine is available only with
a doctor's prescription.
_USE IN CHILDREN_
There is not enough information to
recommend the use of this medicine
in children or adolescents younger
than 18 years.
BEFORE YOU TAKE
EDRONAX
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE EDRONAX IF YOU HAVE
AN ALLERGY TO:
•
any medicine containing
reboxetine
•
any of the ingredients listed at the
end of this leaflet.
Some of the symptoms of an allergic
reaction to Edronax 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 EDRONAX IF YOU ARE
TAKING OTHER MEDICINES USED TO
TREAT DEPRESSION SUCH AS
MONOAMINE OXIDASE INHIBITORS
(MAOIS).
DO NOT TAKE EDRONAX IF YOU HAVE
GLAUCOMA (HIGH PRESSURE IN THE
EYE).
DO NOT GIVE THIS MEDICINE TO
CHILDREN OR A

Summary of Product characteristics

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Page 1 of 21
AUSTRALIAN
PRODUCT
INFORMATION
–
EDRONAX
® (REBOXETINE MESILATE)
1.
NAME OF THE MEDICINE
Reboxetine mesilate
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Edronax tablets contain 5.2 mg reboxetine mesilate corresponding to 4
mg reboxetine free
base.
3.
PHARMACEUTICAL FORM
4 mg EDRONAX tablets (containing 5.2 mg reboxetine mesilate) are
white, convex, round
tablets with a breakline on one side and engraved 'P' on the left of
the breakline and 'U' on the
right side of the breakline, and '7671' on the opposite side.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
EDRONAX is indicated for the treatment of major depression and is
effective in preventing
the relapse of depressive symptoms.
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSAGE
The onset of clinical effect is usually seen after 14 days of
treatment.
USE IN ADULTS
The recommended therapeutic dose is 4 mg twice daily (8 mg/day)
administered orally. After
3 weeks the dose can be increased up to 10 mg/day in case of
incomplete clinical response.
USE IN CHILDREN AND ADOLESCENTS (< 18 YEARS)
There are no data available on the use of reboxetine in children or
adolescents under 18 years
of age.
DOSAGE ADJUSTMENT
USE IN THE ELDERLY (> 65 YEARS)
The recommended therapeutic dose is 2 mg twice daily (4 mg/day)
administered orally. After
3 weeks the dose can be increased up to 6 mg/day in case of incomplete
clinical response.
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Page 2 of 21
USE IN RENAL OR HEPATIC IMPAIRMENT
The starting dose in patients with renal or moderate to severe hepatic
insufficiency should be
2 mg twice daily, increased according to patient tolerance.
4.3 CONTRAINDICATIONS
Hypersensitivity to reboxetine or any of the excipients.
Concomitant use in patients taking monoamine oxidase inhibitors
(MAOIs) is contraindicated.
Since reboxetine has a weak mydriatic effect, its use is not
recommended in patients with
narrow angle glaucoma.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
SEIZURES
Since