POSACONAZOLE SANDOZ posaconazole 100 mg modified release tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

posaconazole, Quantity: 100 mg

Available from:

Sandoz Pty Ltd

Pharmaceutical form:

Tablet, modified release

Composition:

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

Administration route:

Oral

Units in package:

24

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Posaconazole Sandoz (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 Sandoz 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, oval, bioconvex film-coated tablet debossed with "PS" on one side and "100" on other side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Registered

Authorization date:

2020-03-03

Patient Information leaflet

Posaconazole Sandoz
®
1
POSACONAZOLE SANDOZ
®
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 POSACONAZOLE SANDOZ?
Posaconazole Sandoz 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 Sandoz?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE POSACONAZOLE SANDOZ?
Do not use Posaconazole Sandoz 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 Sandoz?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Posaconazole Sandoz 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 POSACONAZOLE SANDOZ?
Follow all directions given to you by your doctor and pharmacist
carefully. The dose may vary from one patient to another.
•
Swallow the tablet whole with some water.
•
Do not crush, chew, break or dissolve Posaconazole Sandoz tablet.
•
Posaconazole Sandoz maybe taken with or without food.
More instructions can be found in Section 4. How do I use Posaconazole
Sandoz?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING POSACONAZOLE SANDOZ?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Posaconazole Sandoz.
•
If you are about to start any other new medicine, tell your doctor
that you are taking Posaconazole
Sandoz.
•
If you need to have any blood tests, tell your doctor you are taking
Posaconazole Sandoz.
Posaconazole Sandoz may affect the results of some laboratory te

Summary of Product characteristics

20220202-posaconazole sandoz-pi
Page 1 of 37
AUSTRALIAN PRODUCT INFORMATION
POSACONAZOLE SANDOZ
® (POSACONAZOLE)
1.
NAME OF THE MEDICINE
Posaconazole
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Posaconazole Sandoz modified release tablet contains 100 mg of
posaconazole.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Posaconazole Sandoz is a yellow, oval, biconvex, film coated tablet
debossed with “PS" on
one side and “100" on the other side.
4.
CLINICAL PARTICULARS
4.1.
T
HERAPEUTIC INDICATIONS
Posaconazole Sandoz (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 Sandoz 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.
D
OSE AND METHOD OF ADMINISTRATION
Posaconazole Sandoz should be swallowed whole, and not be divided,
crushed, or chewed.
Posaconazole Sandoz 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
Interactions with other medicines).
ADMINISTRATION INSTRUCTIONS FOR POSACONAZOLE SANDOZ
_Refractory Invasive Fungal Infections (IFI) / Intolerant Patients
with IFI:_
Loading dose of
300 mg (three 100 mg modified release tablets) twice a day on the
first day, then 300 mg
(three 100 mg modified release tablets) once a day th