Voriconazole 200mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Voriconazole

Available from:

Pfizer Ltd

ATC code:

J02AC03

INN (International Name):

Voriconazole

Dosage:

200mg

Pharmaceutical form:

Tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05020100; GTIN: 5013457011715

Patient Information leaflet

Page 1 of 9
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
VORICONAZOLE 50 MG FILM-COATED TABLETS
VORICONAZOLE 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 Voriconazole is and what it is used for
2.
What you need to know before you take Voriconazole
3.
How to take Voriconazole
4.
Possible side effects
5.
How to store Voriconazole
6.
Content of the pack and other information
1. WHAT VORICONAZOLE IS AND WHAT IT IS USED FOR
Voriconazole contains the active substance voriconazole. Voriconazole
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 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 VORICONA

Summary of Product characteristics

OBJECT 1
VORICONAZOLE 50MG TABLETS
Summary of Product Characteristics Updated 20-Jun-2018 | Pfizer
Limited
1. Name of the medicinal product
Voriconazole Pfizer 50 mg film-coated tablets
Voriconazole Pfizer 200 mg film-coated tablets
2. Qualitative and quantitative composition
Each tablet contains 50 or 200 mg voriconazole.
Excipient with known effect
Voriconazole Pfizer 50 mg film-coated tablets
Each tablet contains 63.42 mg lactose monohydrate.
Voriconazole Pfizer 200 mg film-coated tablets
Each tablet contains 253.675 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film coated tablets
Voriconazole Pfizer 50 mg film coated tablets
White to off-white, round tablet, debossed “Pfizer” on one side
and “VOR50”on the reverse.
Voriconazole Pfizer 200 mg film-coated tablets
White to off-white, capsule-shaped tablet, debossed “Pfizer” on
one side and “VOR200”on the reverse.
4. Clinical particulars
4.1 Therapeutic indications
Voriconazole Pfizer 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 Pfizer 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 Pfizer is also available as 200 mg powder for solution
for infusion and 40 mg/ml powder
for oral suspension.
Treatment
_Adult