Restore Clinical Super Calcium Complex

Krajina: Austrália

Jazyk: angličtina

Zdroj: Department of Health (Therapeutic Goods Administration)

Aktívna zložka:

Borax,Calcium citrate,Cholecalciferol,Hydroxyapatite,Magnesium oxide - heavy,Manganese amino acid chelate,Phytomenadione,Zinc gluconate

Dostupné z:

Canvale Holdings Pty Ltd

Trieda:

Medicine Listed

Príbalový leták

AURORIX
®
A
U
R
O
R
I
X
®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING AURORIX?
AURORIX contains the active ingredient moclobemide. AURORIX belongs to
a group of medicines called antidepressants.
Antidepressants are used to treat depression and work on the central
nervous system.
For more information, see Section 1. Why am I using AURORIX? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE AURORIX?
Do not use if you have ever had an allergic reaction to AURORIX or any
of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
AURORIX? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with AURORIX and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE AURORIX?
•
The usual dose is between 300 mg and 600 mg per day.
More instructions can be found in Section 4. How do I use AURORIX? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING AURORIX?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
AURORIX.
•
If you are being treated for depression, tell your doctor immediately
if you feel your condition has
worsened or if you are experiencing suicidal thoughts.
THINGS YOU
SHOULD NOT DO
•
Do not take any other medicines whether they require a prescription or
not without first telling your doctor.
•
Do not stop taking AURORIX or lower the dose without first checking
with your doctor.
DRIVING
OR USING
MACHINES
•
Be careful before you drive or use any machines or tools until you
know how AURORIX affects you.
•
AURORIX causes dizziness in some people at first.
DRINKING
ALCOHOL
•
Although drinking al

Súhrn charakteristických

AUSTRALIAN PRODUCT INFORMATION
AURORIX
®
_moclobemide tablets _
Page 1 of 18
1
NAME OF THE MEDICINE
_ _
Moclobemide
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each AURORIX 150 mg tablet contains 150 mg of moclobemide as the
active ingredient.
Each AURORIX 300 mg tablet contains 300 mg of moclobemide as the
active ingredient.
Excipients with known effect:
AURORIX 150 mg: Contains sugars as lactose.
AURORIX 300 mg: Contains lactose.
For the full list of excipients, see Section 6.1
LIST OF EXCIPIENTS
.
3 PHARMACEUTICAL FORM
150 mg tablets: oval, cylindrical, biconvex, pale yellow tablets
marked "150" on one side with a
break bar on the other side.
300 mg tablets: oval, cylindrical, biconvex, white to yellow-white
tablets marked "300" on one
side with a break bar on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of major depression.
4.2
DOSE AND METHOD OF ADMINISTRATION
ADULTS
AURORIX therapy should be initiated in two divided daily doses. The
recommended initial
daily dose is 300 or 450 mg. The recommended dose range is 300 – 600
mg/day. The dose
should not be raised until after the first week, as bioavailability
increases during this period.
Treatment should continue for at least 4-6 weeks in order to assess
the efficacy of the drug.
AURORIX should be taken after meals.
DOSAGE IN THE ELDERLY
No dosage adjustments are necessary in elderly patients.
DOSAGE IN PATIENTS WITH IMPAIRED RENAL FUNCTION
Single dose pharmacokinetic data suggest that no dosage adjustment may
be required in
patients with reduced renal function. However, multiple dose studies
with moclobemide
have not been performed in patients with renal dysfunction; therefore,
AURORIX should
AURORIX
®
– PRODUCT INFORMATION
Page 2 of 18
be used with caution in this patient population. In normal volunteers,
the absolute
bioavailability almost doubles following multiple dosing as compared
to a single dose.
DOSAGE IN PATIENTS WITH IMPAIRED HEPATIC FUNCTION
In patients with severely impaired hepatic metabolism, the daily dose
of