VZOLE voriconazole 200 mg film-coated tablets blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

voriconazole, Quantity: 200 mg

Available from:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

Voriconazole

Pharmaceutical form:

Tablet, film coated

Composition:

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

Administration route:

Oral

Units in package:

2, 10, 14, 20, 28, 30, 50, 56, 100

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Voriconazole 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.

Product summary:

Visual Identification: White, caplet shaped film coated 15.6 mm tablet with V200 debossed on one side and plain on other side.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Licence status A

Authorization date:

2016-07-22

Patient Information leaflet

VZOLE
1
VZOLE
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 VZOLE?
VZOLE contains the active ingredient voriconazole. VZOLE is used to
treat fungal and yeast infections.
For more information, see Section 1. Why am I using VZOLE?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE VZOLE?
Do not use if you have ever had an allergic reaction to voriconazole,
any similar medicines, 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. VZOLE 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
VZOLE?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with VZOLE 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 VZOLE?
•
Your doctor will prescribe the amount required of VZOLE based on your
weight. The dose will be based on the form being
prescribed.
•
More instructions can be found in Section 4. How do I use VZOLE? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING VZOLE?
THINGS YOU
SHOULD DO
•
Remind any doctor or dentist you visit that you are using VZOLE.
•
Avoid going out in the sun for long periods of time while you are
taking VZOLE. VZOLE 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
are taking this medicine.
THINGS YOU
SHOULD NOT DO
•
Do not stop taking your medicine or lower the dosage without checking
with your doctor.
•
If you do not complete the

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION – VZOLE (VORICONAZOLE)
TABLETS
1
NAME OF THE MEDICINE
Voriconazole
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
VZOLE 50 mg film-coated tablets contain 50mg of voriconazole.
VZOLE 200 mg film-coated tablets contain 200mg of voriconazole.
Voriconazole, a broad-spectrum, triazole antifungal agent, is
available as film-coated tablets for oral
administration.
EXCIPIENTS WITH KNOWN EFFECTS
VZOLE tablets contain sugars as lactose.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
VZOLE 50 mg film-coated tablets are white, round, biconvex film coated
7 mm tablet with ‘V50’
debossed on one side and plain on other side.
VZOLE 200 mg film-coated tablets are white, caplet shaped film coated
15.6 mm tablet with ‘V200’
debossed on one side and plain on other side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Voriconazole 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.
2
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.
4.2
D
OSE AND METHOD OF ADMINISTRATION
VZOLE tablets are to be taken at least one hour before, or one hour
following, a meal.
VORICONAZOLE POWDER FOR ORAL SUSPENSION IS UNAVAILABLE IN THIS BRAND,
HOWEVER IS AVAILABLE IN OTHER
BRANDS. WHERE CORRECT DOSING REQUIRES ORAL SUSPENSION IN PAEDIATRIC OR
ADULT PATIENTS, THE ORAL
SUSPENSION AVAILABLE FROM OTHER SUPPLIERS SHOULD BE USED. FOR
INTRAVENOUS SPECIFIC DOSING
REQUIREMENTS, PLEASE REFER TO THE VORICONAZOLE IV POWDER FOR INJECTION
PRODUCT INFORMATION.
DOSAG