Edronax

Nchi: Nyuzilandi

Lugha: Kiingereza

Chanzo: Medsafe (Medicines Safety Authority)

Viambatanisho vya kazi:

Reboxetine mesilate 5.224mg equivalent to 4 mg reboxetine free base

Inapatikana kutoka:

Pfizer New Zealand Limited

INN (Jina la Kimataifa):

Reboxetine mesilate 5.224 mg (equivalent to 4 mg reboxetine free base)

Kipimo:

4 mg

Dawa fomu:

Tablet

Tungo:

Active: Reboxetine mesilate 5.224mg equivalent to 4 mg reboxetine free base Excipient: Calcium hydrogen phosphate dihydrate Crospovidone Hydrated silica Magnesium stearate Powdered cellulose

Vitengo katika mfuko:

Blister pack, PVC/PVDC & alim, 60 tablets

Darasa:

Prescription

Dawa ya aina:

Prescription

Viwandani na:

Sterling Pharma Solutions Limited

Bidhaa muhtasari:

Package - Contents - Shelf Life: Blister pack, PVC/PVDC & alim - 60 tablets - 24 months from date of manufacture stored at or below 25°C

Idhini ya tarehe:

1997-11-03

Taarifa za kipeperushi

EDRONAX
®
1
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 MEDICI

Tabia za bidhaa

Version: pfdedrot10322
Supersedes: pfdedrot10219
Page 1 of 21
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME_ _
EDRONAX

2 mg, 4 mg Tablet
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
EDRONAX tablets contain 2.6 mg or 5.2 mg reboxetine mesilate
corresponding to 2 mg or 4 mg
reboxetine free base respectively.
Chemical name: (2RS,
α
RS)-2-[
α
-(2-ethoxyphenoxy) benzyl] morpholine methanesulfonate.
Reboxetine mesilate has the empirical formula C
19
H
23
NO
3
-CH
4
O
3
S, and a molecular weight of
409.50. Reboxetine mesilate is freely soluble in water (>20% w/v).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablets
2 mg EDRONAX tablets: white, flat, capsule-shaped, 4mm x 8mm tablet
with a breakline on
both sides.
4 mg EDRONAX tablets: white, round, convex 8mm diameter tablet with a
breakline on one
side. A “P” is marked on the left side of the breakline. A “U”
is marked on the right side of
the breakline. The side opposite the breakline is marked with
“7671”.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Reboxetine is indicated for the treatment of depressive illness and
for maintaining the clinical
improvement in patients initially responding to treatment.
The remission of the acute phase of the depressive illness is
associated with an improvement
in the patient’s quality of life in terms of social adaptation.
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSE
EDRONAX tablets are for oral administration.
The onset of the clinical effect is generally seen after 14 days from
treatment start.
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Supersedes: pfdedrot10219
Page 2 of 21
USE IN ADULTS
The recommended therapeutic dose is 4mg twice daily (8mg/day)
administered orally. The
full therapeutic dose can be given upon starting treatment. After 3-4
weeks, this dose can be
increased to 10mg/day in case of incomplete clinical response.
USE IN THE ELDERLY (> 65 YEARS)
As with other antidepressants, in elderly subjects and in elderly
depressed patients, particularly
in the presence of concomitant systemic illnesses