VORICONAZOLE SANDOZ voriconazole 200mg film-coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

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Patient Information leaflet (PIL)

13-09-2022

Summary of Product characteristics (SPC)

09-09-2022

Public Assessment Report (PAR)

27-11-2017

Active ingredient:

voriconazole, Quantity: 200 mg

Available from:

Sandoz Pty Ltd

INN (International Name):

Voriconazole

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: pregelatinised maize starch; lactose monohydrate; povidone; croscarmellose sodium; magnesium stearate; titanium dioxide; hypromellose; triacetin

Administration route:

Oral

Units in package:

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Voriconazole Sandoz is indicated for treatment of the following fungal infections:,- Invasive aspergillosis.,- Serious Candida infections (including C. krusei), including oesophageal and systemic Candida infections (hepatosplenic candidiasis, disseminated candidiasis, candidaemia).,- Serious fungal infections caused by Scedosporium spp and Fusarium spp.,- Other serious fungal infections, in patients intolerant of, or refractory to, other therapy,- Prophylaxis in patients who are at high risk of developing invasive fungal infections. The indication is based on studies including patients undergoing haematopoietic stem cell transplantation.,- This brand is only available as tablets and therefore only indicated for adults and children 12 years or older who can tolerate tablets. For dosing requirements for populations who require intravenous or oral suspension treatment see DOSAGE and ADMINISTRATION.

Product summary:

Visual Identification: White to off-white, biconvex, capsule shaped film coated tablets with '200' debossed on one side and plain on other side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2015-03-17

Patient Information leaflet

Voriconazole Sandoz®
1
VORICONAZOLE 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 VORICONAZOLE SANDOZ?
Voriconazole Sandoz contains the active ingredient voriconazole.
Voriconazole Sandoz is used to treat fungal and yeast
infections.
For more information, see Section 1. Why am I using Voriconazole
Sandoz?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE VORICONAZOLE SANDOZ?
Do not use if you have ever had an allergic reaction to voriconazole
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. VORICONAZOLE SANDOZ SHOULD NOT BE USED
DURING PREGNANCY OR BREASTFEEDING, UNLESS
INDICATED BY YOUR DOCTOR. EFFECTIVE CONTRACEPTION SHOULD BE USED IN
WOMEN OF CHILDBEARING POTENTIAL.
For more information, see Section 2. What should I know before I use
Voriconazole Sandoz?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Voriconazole 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 VORICONAZOLE SANDOZ?
•
Your doctor will prescribe the amount required of Voriconazole Sandoz
based on your weight.
More instructions can be found in Section 4. How do I use Voriconazole
Sandoz?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING VORICONAZOLE SANDOZ?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Voriconazole Sandoz.
•
Avoid going out in the sun for long periods of time while you are
taking Voriconazole Sandoz.
Voriconazole Sandoz can cause sensitivity to sunlight.
•
Make sure you follow your doctor’s instructions and keep all
appointments, including blood tests.
•
If you are about to have any blood tests, tell your doctor that you

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Summary of Product characteristics

220906-voriconazole-sandoz-pi
Page 1 of 36
AUSTRALIAN PRODUCT INFORMATION
VORICONAZOLE SANDOZ
® (VORICONAZOLE) FILM-COATED TABLETS
1.
NAME OF THE MEDICINE
Voriconazole
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Voriconazole Sandoz 50 mg film-coated tablet contains 50 mg of
voriconazole.
Each Voriconazole Sandoz 200 mg film-coated tablet contains 200 mg of
voriconazole.
_Not all strengths may be marketed. _
_Excipient with known effect:_
Each tablet contains sugars as lactose.
_ _
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Voriconazole Sandoz 50 mg tablets - White to off-white, round,
biconvex, film coated tablets
with ‘50’ debossed on one side and plain on other side.
Voriconazole Sandoz 200 mg tablets - White to off-white, biconvex,
capsule shaped film
coated tablets with ‘200’ debossed on one side and plain on other
side
4.
CLINICAL PARTICULARS
4.1.
T
HERAPEUTIC INDICATIONS
Voriconazole Sandoz is indicated for treatment of the following fungal
infections:
•
Invasive aspergillosis
•
Serious
_Candida _
infections (including
_C. krusei), _
including oesophageal and systemic
_Candida _
infections (hepatosplenic candidiasis, disseminated candidiasis,
candidaemia)
•
Serious fungal infections caused by
_Scedosporium _
spp and
_Fusarium _
spp
•
Other serious fungal infections, in patients intolerant of, or
refractory to, other therapy
•
Prophylaxis in patients who are at high risk of developing invasive
fungal infections.
The indication is based on studies including patients undergoing
haematopoietic stem
cell transplantation.
This brand is only available as tablets and therefore only indicated
for adults and children 12
years or older who can tolerate tablets. For dosing requirements for
populations who require
intravenous or oral suspension treatment. See Section 4.2 Dose and
method of administration.
4.2.
D
OSE AND METHOD OF ADMINISTRATION
DOSAGE
This brand is only available as tablets and therefore only indicated
for adults and children 12
ye

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