VORICONAZOLE ROWEX 50 Milligram Film Coated Tablet

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

VORICONAZOLE

Available from:

Rowex Ltd

ATC code:

J02AC03

INN (International Name):

VORICONAZOLE

Dosage:

50 Milligram

Pharmaceutical form:

Film Coated Tablet

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Triazole derivatives

Authorization status:

Authorised

Authorization date:

2013-07-04

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
VORICONAZOLE ROWEX 50 MG FILM-COATED TABLETS
VORICONAZOLE ROWEX 200 MG FILM-COATED TABLETS
Voriconazole
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist or
nurse.

This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist or
nurse. This includes any possible
side effects not listed in this leaflet (see section 4).
WHAT IS IN THIS LEAFLET
1.
What Voriconazole Rowex is and what it is used for
2.
What you need to know before you take Voriconazole Rowex
3.
How to take Voriconazole Rowex
4.
Possible side effects
5.
How to store Voriconazole Rowex
6.
Contents of the pack and other information
1. WHAT VORICONAZOLE ROWEX IS AND WHAT IT IS USED FOR
Voriconazole Rowex contains the active substance voriconazole.
Voriconazole Rowex is an
antifungal medicine. It works by killing or stopping the growth of the
fungi that cause infections.
It is used for the treatment of patients (adults and children over the
age of 2) with:

invasive aspergillosis (a type of fungal infection due to
_Aspergillus_ sp)

candidaemia (another type of fungal infection due to _Candida_ sp) in
non-neutropenic patients
(patients without abnormally low white blood cells count)

serious invasive _Candida_ sp. infections when the fungus is resistant
to fluconazole (another
antifungal medicine)

serious fungal infections caused by _Scedosporium_ sp. or _Fusarium_
sp. (two different species of
fungi).
Voriconazole Rowex is intended for patients with worsening, possibly
life-threatening, fungal
infections.
Prevention of fungal infections in high risk bone marrow transplant
recipients.
This product should only be taken under the supervision of a doctor

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Voriconazole Rowex 50mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50 mg Voriconazole.
Excipient with known effect
Each tablet contains 64.262 mg Lactose Monohydrate
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
White to off-white, round, biconvex, film coated tablets with ‘50’
debossed on one side and plain on other side.
Length: 7.1 ± 0.3 mm
Thickness 3.50 mm ± 0.30 mm
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Voriconazole, is a broad spectrum, triazole antifungal agent and is
indicated in adults and children aged 2 years and
above as follows:
•
Treatment of invasive aspergillosis.
•
Treatment of candidaemia in non-neutropenic patients.
•
Treatment of fluconazole-resistant serious invasive_ Candida_
infections (including_ C. krusei_).
•
Treatment of serious fungal infections caused by_ Scedosporium_ spp.
and_ Fusarium_ spp.
Voriconazole Rowex should be administered primarily to patients with
progressive, possibly life-threatening infections.
Prophylaxis of invasive fungal infections in high risk allogeneic
hematopoietic stem cell transplant (HSCT) recipients.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Electrolyte disturbances such as hypokalaemia, hypomagnesaemia and
hypocalcaemia should be monitored and
corrected, if necessary, prior to initiation and during voriconazole
therapy (see section 4.4).
Voriconazole Rowex is also available as 50 mg and 200 mg film-coated
tablets and 200 mg powder for solution for
infusion.
Treatment
_Adults_
Therapy must be initiated with the specified loading dose regimen of
either intravenous or oral Voriconazole Rowex to
achieve plasma concentrations on Day 1 that are close to steady state.
On the basis of the high oral bioavailability
(96%; see section 5.2), switching between intravenous and oral
administration is appropriate when clinically indicated.
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