POSACONAZOLE JUNO posaconazole 100 mg modified release tablets blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

posaconazole, Quantity: 100 mg

Available from:

Juno Pharmaceuticals Pty Ltd

Pharmaceutical form:

Tablet, modified release

Composition:

Excipient Ingredients: colloidal anhydrous silica; triethyl citrate; microcrystalline cellulose; croscarmellose sodium; propyl gallate; methacrylic acid - ethyl acrylate copolymer (1:1); xylitol; sodium stearylfumarate; hyprolose; titanium dioxide; purified talc; iron oxide yellow; polyvinyl alcohol; macrogol 3350

Administration route:

Oral

Units in package:

96, 24

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Posaconazole JUNO 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 JUNO 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, capsule shaped tablets, debossed with 100P on one side and plain on the other side.; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2020-08-07

Patient Information leaflet

Posaconazole Juno Modified Release Tablets
1
POSACONAZOLE JUNO
MODIFIED RELEASE TABLETS
The full CMI
on the next page has more details. If you are worried about using this
medicine, speak to your doctor or pharmacist.
Posaconazole Juno 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 Posaconazole Juno?
in the full CMI.
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 Posaconazole Juno? in the
full CMI.
Some medicines may interfere with 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.
Do not switch between taking Posaconazole Juno modified release
tablets and posaconazole oral suspension 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 Posaconazole
Juno?
in the full CMI.
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
posaconazole.
•
If you are about to start any other new medicine, tell your doctor
that you are taking posaconazole.
•
If you need to have any blood tests, tell your doctor you are taking
posaconazole. Posaconazole may affect
the results of some laboratory tests.
THINGS YOU
SHOULD NOT DO
•
Do not give posaconazole to anyone else, even if they have the same
condition as you.
•
Do not use posaconazole to treat any other medical complaints unless
your doctor tells you to.
DRIVING
OR USING
MACHINES
•
Posaconazole may cause dizziness, sleepiness, or blurred vision in
some people.
•
There have been side effects reported with po

Summary of Product characteristics

Australian Product Information
Posaconazole JUNO PI v2.0
Page | 1
AUSTRALIAN PRODUCT INFORMATION
_POSACONAZOLE JUNO_ _(POSACONAZOLE)_
1 NAME OF THE MEDICINE
Posaconazole.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Posaconazole is a white to off-white crystalline powder.
Posaconazole JUNO Modified Release Tablets contain 100 mg of
posaconazole per tablet.
For the full list of excipients, see Section 6.1 List of excipients.
3. PHARMACEUTICAL FORM
Posaconazole JUNO Modified Release Tablets are yellow, coated,
capsule-shaped tablets,
debossed with “100P” on one side and plain on the other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Posaconazole JUNO 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 JUNO 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
Posaconazole JUNO Modified Release Tablets should be swallowed whole,
and not be
divided, crushed, or chewed. Posaconazole JUNO Modified Release
Tablets may be taken
without regard to food intake.
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 Interactions).
NON-INTERCHANGEABILITY
BETWEEN
POSACONAZOLE
JUNO
MODIFIED
RELEASE TABLETS
AND
POSACONAZOLE ORAL SUSPENSION (AVAILABL