Voriconazole 50mg 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:

50mg

Pharmaceutical form:

Tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05020100; GTIN: 5013457011708

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 13-Feb-2019 | Pfizer
Limited
•
1. Name of the medicinal product
•
2. Qualitative and quantitative composition
•
3. Pharmaceutical form
•
4. Clinical particulars
•
4.1 Therapeutic indications
•
4.2 Posology and method of administration
•
4.3 Contraindications
•
4.4 Special warnings and precautions for use
•
4.5 Interaction with other medicinal products and other forms of
interaction
•
4.6 Fertility, pregnancy and lactation
•
4.7 Effects on ability to drive and use machines
•
4.8 Undesirable effects
•
4.9 Overdose
•
5. Pharmacological properties
•
5.1 Pharmacodynamic properties
•
5.2 Pharmacokinetic properties
•
5.3 Preclinical safety data
•
6. Pharmaceutical particulars
•
6.1 List of excipients
•
6.2 Incompatibilities
•
6.3 Shelf life
•
6.4 Special precautions for storage
•
6.5 Nature and contents of container
•
6.6 Special precautions for disposal and other handling
•
7. Marketing authorisation holder
•
8. Marketing authorisation number(s)
•
9. Date of first authorisation/renewal of the authorisation
•
10. Date of revision of the text
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