APO-MOCLOBEMIDE moclobemide 300mg tablet blister pack

Kraj: Australia

Język: angielski

Źródło: Department of Health (Therapeutic Goods Administration)

Składnik aktywny:

moclobemide, Quantity: 300 mg

Dostępny od:

Arrotex Pharmaceuticals Pty Ltd

Forma farmaceutyczna:

Tablet, film coated

Skład:

Excipient Ingredients: methylcellulose; croscarmellose sodium; microcrystalline cellulose; magnesium stearate; colloidal anhydrous silica; hypromellose; hyprolose; macrogol 8000; titanium dioxide

Droga podania:

Oral

Sztuk w opakowaniu:

60 tablets

Typ recepty:

(S4) Prescription Only Medicine

Wskazania:

Treatment of major depression.

Podsumowanie produktu:

Visual Identification: White, oval, biconvex, film-coated tablets, scored on one side and engraved "APO" over "300" on the other side.; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Status autoryzacji:

Registered

Data autoryzacji:

2000-08-17

Ulotka dla pacjenta

APO-MOCLOBEMIDE
1
APO-MOCLOBEMIDE
_Moclobemide _
CONSUMER MEDICINE INFORMATION
FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about moclobemide. It
does not contain all 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 using this medicine
against the benefits they expect it
will 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 want to read it again.
WHAT THIS MEDICINE IS
USED FOR
Moclobemide is used to treat
depression. It belongs to a group of
antidepressant medicines called
reversible inhibitors of monoamine
oxidase A (RIMA).
_HOW IT WORKS _
Antidepressants are used to treat
depression and work on the central
nervous system. They are thought to
work by their action on brain
chemicals called amines, which are
involved in controlling mood.
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. This
imbalance affects your whole body
and can cause emotional and physical
symptoms such as feeling low in
spirit, loss of interest in activities,
being unable to enjoy life, poor
appetite or overeating, disturbed
sleep, often waking up early, loss of
sex drive, lack of energy and feeling
guilty over nothing.
Moclobemide helps to correct this
chemical imbalance and may help
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
moclobemide for another reason.
This medicine is available only with
a doctor's prescription.
This medicine is not addictive.
There is not enough information to
recommend the use of this medicine
in children under 18 years of age.
BEFORE YOU TAKE THIS
ME

Charakterystyka produktu

1
AUSTRALIAN PRODUCT INFORMATION
APO-MOCLOBEMIDE (MOCLOBEMIDE) TABLETS
1
NAME OF THE MEDICINE
Moclobemide.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 150 mg or 300 mg moclobemide, as the active
ingredient.
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
150 MG TABLETS:
Pale yellow, oval, biconvex, film-coated tablets, scored on one side
and engraved “APO” over
“150” on the other.
300 MG TABLETS
White, oval, biconvex, film-coated tablets, scored on one side and
engraved “APO” over “300”
on the other.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of major depression.
4.2
DOSE AND METHOD OF ADMINISTRATION
APO-Moclobemide Tablets are intended for oral administration
DOSAGE
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.
Moclobemide should be taken after meals.
DOSAGE IN THE ELDERLY
No dosage adjustments are necessary in elderly patients.
RENAL IMPAIRMENT
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
moclobemide 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.
2
HEPATIC IMPAIRMENT
In patients with severely impaired hepatic metabolism, the daily dose
of moclobemide should
be reduced to ½ or ⅓ of the dose to reach the usual plasma level.
4.3
CONTRAINDICATIONS
•
Known hypersensitivity to the active ingredient or excipients in this
medicine (see
section 6.1 LIST OF EXCIPIENTS).
•
A