AMIRA 300 moclobemide 300 mg film-coated tablet blister pack

Χώρα: Αυστραλία

Γλώσσα: Αγγλικά

Πηγή: Department of Health (Therapeutic Goods Administration)

Δραστική ουσία:

moclobemide, Quantity: 300 mg

Διαθέσιμο από:

Viatris Pty Ltd

INN (Διεθνής Όνομα):

Moclobemide

Φαρμακοτεχνική μορφή:

Tablet, film coated

Σύνθεση:

Excipient Ingredients: maize starch; magnesium stearate; macrogol 6000; titanium dioxide; lactose monohydrate; sodium starch glycollate; hypromellose; povidone; purified talc; purified water; ethylcellulose; cetyl alcohol; hydrogen peroxide; sodium lauryl sulfate; octamethylcyclotetrasiloxane; silica dimethicone silylate; dimeticone 5000; cyclomethicone

Οδός χορήγησης:

Oral

Μονάδες σε πακέτο:

60 tablets

Τρόπος διάθεσης:

(S4) Prescription Only Medicine

Θεραπευτικές ενδείξεις:

Treatment of major depression.

Περίληψη προϊόντος:

Visual Identification: Oval, cylindrical, biconvex, white to yellow-white film coated tablet marked "300" on one side with a break bar on the other side.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 5 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Καθεστώς αδειοδότησης:

Licence status A

Ημερομηνία της άδειας:

2017-09-29

Φύλλο οδηγιών χρήσης

AMIRA
® 150 AND AMIRA
® 300
A
M
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A
®
1
5
0
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d
A
M
I
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A
®
3
0
0
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 AMIRA 150 OR AMIRA 300?
AMIRA 150 and AMIRA 300 contains the active ingredient moclobemide.
AMIRA 150 and AMIRA 300 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 AMIRA 150 or AMIRA
300? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE AMIRA 150 OR AMIRA 300?
Do not use if you have ever had an allergic reaction to AMIRA 150 or
AMIRA 300 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
AMIRA 150 or AMIRA 300? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with AMIRA 150 or AMIRA 300 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 AMIRA 150 OR AMIRA 300?
•
The usual dose is between 300 mg and 600 mg per day. The tablets are
taken twice daily after meals.
More instructions can be found in Section 4. How do I use AMIRA 150 or
AMIRA 300? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING AMIRA 150 OR AMIRA 300?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
AMIRA 150 or AMIRA 300.
•
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 AMIRA 150 or A

Αρχείο Π.Χ.Π.

AUSTRALIAN PRODUCT INFORMATION
AMIRA
®
150 AND AMIRA
®
300
_moclobemide tablets_
_ _
_ _
_ _
_ _
_ _
_ _
_ _
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Page 1 of 16
1
NAME OF THE MEDICINE
Moclobemide
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each AMIRA 150 tablet contains 150 mg of moclobemide as the active
ingredient.
Each AMIRA 300 tablet contains 300 mg of moclobemide as the active
ingredient.
Excipients with known effect:
AMIRA 150: Contains sugars as lactose.
AMIRA 300: Contain 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
Moclobemide 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. AMIRA 150 and AMIRA 300 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
AMIRA 150 and
AMIRA 300 should 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.
AMIRA® 150 and AMIRA® 300 –
PRODUCT INFORMATION
Page 2 of 16
DOSAGE IN PATIENTS WITH IMPAIRED HEPATIC