AKM POSACONAZOLE posaconazole 100 mg modified release tablet bottle pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

posaconazole, Quantity: 100 mg

Available from:

Pharmacor Pty Ltd

Pharmaceutical form:

Tablet, enteric coated

Composition:

Excipient Ingredients: hyprolose; magnesium stearate; croscarmellose sodium; colloidal anhydrous silica; microcrystalline cellulose; hypromellose acetate succinate; titanium dioxide; purified talc; iron oxide yellow; polyvinyl alcohol; macrogol 3350

Administration route:

Oral

Units in package:

60, 24, 96, 1000 (bulk pack - for dispensing only)

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Posaconazole is indicated for use in the treatment of the following invasive fungal infections in patients 13 years of age or older: Invasive aspergillosis in patients intolerant of, or with disease that is refractory to, alternative therapy. Fusariosis, zygomycosis, coccidioidomycosis, chromoblastomycosis, and mycetoma in patients intolerant of, or with disease that is refractory to, alternative therapy.,Posaconazole is also indicated for the: Prophylaxis of invasive fungal infections among patients 13 years of age and older, who are at high risk of developing these infections, such as patients with prolonged neutropenia or haematopoietic stem cell transplant (HSCT) recipients.

Product summary:

Visual Identification: Yellow, coated, oblong tablets, debossed with 100 on one side; Container Type: Bottle; Container Material: HDPE; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Registered

Authorization date:

2020-11-12

Patient Information leaflet

_PHARMACOR POSACONAZOLE Ver: 02 _
1
AKM POSACONAZOLE MODIFIED RELEASE TABLETS
_ _
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 AKM POSACONAZOLE?
AKM POSACONAZOLE contains the active ingredient Posaconazole.
Posaconazole is used to kill or stop the
growth of fungi that can cause infections. For more information, see
Section 1.Why am I using AKM
POSACONAZOLE? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE AKM POSACONAZOLE?
Do not use if you have ever had an allergic reaction to Posaconazole
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 AKM POSACONAZOLE? in the full CMI
.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with AKM POSACONAZOLE 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 AKM POSACONAZOLE?
Do not switch between taking AKM POSACONAZOLE Modified Release tablets
without talking to your doctor.
Follow all directions given to you by your doctor and pharmacist
carefully.
More instructions can be found in Section 4. How do I use AKM
POSACONAZOLE
? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING AKM POSACONAZOLE?
THINGS YOU SHOULD
DO
•
Remind
any
doctor,
dentist
or
pharmacist
you
visit
that
you
are
using
AKM
POSACONAZOLE.
•
If you are about to be started on any new medicine, remind your doctor
and pharmacist
that you are taking POSACONAZOLE
•
If
you
need
to
have
any
blood
tests,
tell
your
doctor
you
are
taking
AKM
POSACONAZOLE.
AKM
POSACONAZOLE
may
affect
the
results
of
some
laboratory tests.
THINGS YOU SHOULD
NOT DO
•
Do not give this medicine to anyone else, even if their condition
seems similar to yours.
•

Summary of Product characteristics

AKM POSACONAZOLE Ver: 02 1
AUSTRALIAN PRODUCT INFORMATION
AKM POSACONAZOLE
(POSACONAZOLE)
MODIFIED RELEASE TABLETS
1.
NAME OF THE MEDICINE
Posaconazole
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
AKM POSACONAZOLE modified release tablets contains 100 mg of
posaconazole.
Posaconazole is a white to off-white crystalline powder. It has a
melting range of 164
o
C 165
o
C
and is insoluble in water.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
AKM POSACONAZOLE modified release tablets is yellow, coated,
capsule-shaped tablet
containing 100 mg of posaconazole.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
AKM POSACONAZOLE (posaconazole) is indicated for use in the treatment
of the following
invasive fungal infections in patients 13 years of age or older:

Invasive aspergillosis in patients intolerant of, or with disease that
is refractory to, alternative
therapy.

Fusariosis,
zygomycosis,
coccidioidomycosis,
chromoblastomycosis,
and
mycetoma
in
patients intolerant of, or with disease that is refractory to,
alternative therapy.
AKM POSACONAZOLE is also indicated for the:
Prophylaxis of invasive fungal infections among patients 13 years of
age and older, who are at
high
risk
of
developing
these
infections,
such
as
patients
with
prolonged
neutropenia
or
haematopoietic stem cell transplant (HSCT) recipients.
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSAGE
AKM POSACONAZOLE modified release tablets should be swallowed whole,
and not be
divided, crushed, or chewed. AKM POSACONAZOLE modified release tablets
may be taken
without regard to food intake.
AKM POSACONAZOLE Ver: 02 2
Coadministration of drugs that can decrease the plasma concentrations
of posaconazole should
generally be avoided unless the benefit outweighs the risk. If such
drugs are necessary, patients
should be monitored closely for breakthrough fungal infections (see
SECTION 4.5 INTERACTIONS WITH
OTHER MEDICINES AND OTHER FORMS OF INTERACTION).
NON-INTERCHANGEABILITY BETWEEN AKM POSACONAZOLE MODIFIED RELEASE