Verria 200 mg film-coated tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

VORICONAZOLE

Available from:

Medochemie Limited 1-10 Constantinoupleos Street, 3011 Limassol, Cyprus

ATC code:

J02AC03

INN (International Name):

VORICONAZOLE 200 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

VORICONAZOLE 200 mg

Prescription type:

POM

Therapeutic area:

ANTIMYCOTICS FOR SYSTEMIC USE

Authorization status:

Authorised

Authorization date:

2017-01-11

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
VERRIA 50 MG FILM-COATED TABLETS
VERRIA 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, 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, pharmacist or nurse.
This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What Verria is and what it is used for
2.
What you need to know before you take Verria
3.
How to take Verria
4.
Possible side effects
5.
How to store Verria
6.
Content of the pack and other information
1.
WHAT VERRIA IS AND WHAT IT IS USED FOR
Verria contains the active substance voriconazole. Verria 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).
Verria 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.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE VERRIA
DO NOT TAKE VERRIA:
If you are allergic to voriconazole or any of the other

Summary of Product characteristics

SPCvorictabs-1.7MT
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Verria 50 mg film-coated tablets
Verria 200 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
[For 50 mg strength:]
Each tablet contains 50 mg voriconazole.
Excipient with known effect: lactose monohydrate 67.8 mg.
[For 200 mg strength:]
Each tablet contains 200 mg voriconazole.
Excipient with known effect: lactose monohydrate 271.2 mg.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
[For 50 mg strength:]
White to off-white, round film-coated tablets
of approximately 7.2 mm in diameter.
[For 200 mg strength:]
White to off-white, capsule-shaped film-coated tablets of
approximately 15.9 x 8.0 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.
Verria
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.
SPCvorictabs-1.7MT
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).
Verria is also available as 200 mg/ [50 mg] film-coated tablets.
Treatment
_Adults_
Therapy must be initiated with the specified loading dose regimen of
either intravenous or oral
voriconazole 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
betw