VORICONAZOLE ACTAVIS 200 Milligram Film Coated Tablet

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

VORICONAZOLE

Available from:

Actavis Group PTC ehf

ATC code:

J02AC03

INN (International Name):

VORICONAZOLE

Dosage:

200 Milligram

Pharmaceutical form:

Film Coated Tablet

Administration route:

Oral use

Units in package:

blister in cartons of 10, 14, 20, 28, 30, 50, 56, 98 or 100 film-coated tablets

Prescription type:

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

Manufactured by:

Actavis Ltd

Therapeutic group:

Antimycotics for systemic use, triazole derivatives

Therapeutic area:

Triazole derivatives

Therapeutic indications:

It 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

Authorization status:

Authorised

Authorization date:

2015-07-17

Patient Information leaflet

V001 
1 
CRN: 2147864 
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_. (

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Voriconazole Actavis 200mg Film Coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 200 mg voriconazole.
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, 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 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 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, such as 200 mg powder for solution for infusion and 40
mg/ml powder for oral suspension, may be available.
Treatment
_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 bioavailabili