Voriconazole 200mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Voriconazole

Available from:

Dr Reddy's Laboratories (UK

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

Patient Information leaflet

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.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT VORICONAZOLE IS AND WHAT IT IS
USED FOR
Voriconazole tablets contain 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
VORICONAZOLE
DO NOT TAKE VORICONAZOLE
If you are allergic to voriconazole or any of the other
ingredients of this medicine (listed in section 6).
It is very important that you inform your doctor or
pharmacist if you are taking or have taken any other
medicines, even those that are obtained without a
prescription, or herbal medicines.
The medicines in the following list must not be taken
during your course of Voriconazole treatment:
•
TERFENADINE (used for allergy)
•
ASTEMIZOLE (used for allergy)
•
CISAPRIDE (used for stomach problems)
•
PIMOZIDE (used for treating mental illness)
•
QUINIDINE (used for irregular heart beat)
•
RIFAMPICIN (used for treating tuberculosis)
•
EFAVIRENZ (used for t

Summary of Product characteristics

OBJECT 1
VORICONAZOLE 200MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 14-Dec-2016 | Dr. Reddy's
Laboratories (UK) Ltd
1. Name of the medicinal product
Voriconazole 200 mg film-coated tablets
2. Qualitative and quantitative composition
Each tablet contains 200 mg voriconazole.
Excipient with known effect
Each tablet contains 239.1 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet
White to off white, modified capsule shaped, biconvex film-coated
tablet debossed with “V” on one side
and “200” on other 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 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 is available as 50 mg film-coated tablets, 200 mg
film-coated tablets, 200 mg powder for
solution for infusion, 200 mg powder and solvent for solution for
infusion and 40 mg/mL powder for oral
suspension.
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