Voriconazole Actavis 200mg Film coated Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

VORICONAZOLE

Available from:

Actavis Group PTC ehf

ATC code:

J02AC03

INN (International Name):

VORICONAZOLE

Pharmaceutical form:

FILM-COATED TABLET

Composition:

VORICONAZOLE 200 mg

Prescription type:

POM

Therapeutic area:

ANTIMYCOTICS FOR SYSTEMIC USE

Authorization status:

Authorised

Authorization date:

2015-07-17

Patient Information leaflet

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PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
VORICONAZOLE ACTAVIS 50 MG FILM-COATED TABLETS
VORICONAZOLE ACTAVIS 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.
-
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. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Voriconazole Actavis is and what it is used for
2.
What you need to know before you take Voriconazole Actavis
3.
How to take Voriconazole Actavis
4.
Possible side effects
5.
How to store Voriconazole Actavis
6.
Contents of the pack and other information
1.
WHAT VORICONAZOLE ACTAVIS IS AND WHAT IT IS USED FOR
Voriconazole Actavis contains the active substance voriconazole.
Voriconazole Actavis 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 Actavis 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 t

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Voriconazole Actavis 50 mg film-coated tablets
Voriconazole Actavis 200 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50 mg voriconazole.
Each tablet contains 200 mg voriconazole.
Excipient with known effect: each tablet contains 44.95 mg lactose
monohydrate.
Excipient with known effect: each tablet contains 179.78 mg lactose
monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
White, 7 mm round biconvex film-coated tablet, debossed “VC50” on
one side.
White, 15.5 x 7.9 mm oval biconvex film-coated tablet, debossed
“VC200” on one side.
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 candidemia 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 Actavis 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).
Other strengths and pharmaceutical forms of voriconazole may be
available.
Treatment
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_Adults _
Therapy must be initiated with the specified loading dose regimen of
either intravenous or oral Voriconazole
Actavis 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), swit