Voriconazole 200mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Voriconazole

Available from:

Actavis UK 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: 5012617025739

Patient Information leaflet

Voriconazole 50mg & 200mg 28 Tablets PIL - UK
item no: AAAI7841
print proof no: 5
origination date: 19.02.16
originated by: S.Anson
revision date: 17.05.16
revised by: S.Anson
dimensions: 190 x 380
pharmacode:
colours/plates:
approved for print/date
Non Printing Colours
1. Black
2.
3.
4.
5.
6.
1.
2.
3.
date sent: N/A
supplier: Malta Zejtun
approved: N/A
min pt size: 9
TECHNICAL APPROVAL
* Please note that only Actavis Global Artwork Studios are permitted
to make changes to the above
artwork. No changes are permitted by any 3rd party other than added
notes and mark ups for
required changes.
T00075-01 Malta Zejtun 190x380 PIL 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.
• The full name of this medicine is Voriconazole
50mg and 200mg Film-coated Tablets but
within the leaflet it will be referred to as
Voriconazole Tablets.
WHAT IS IN THIS LEAFLET
1.
What Voriconazole Tablets are and what they
are used for
2.
What you need to know before you take
Voriconazole Tablets
3. How to take Voriconazole Tablets
4. Possible side effects
5. How to store Voriconazole Tablets
6. Contents of the pack and other information
1.
WHAT VORICONAZOLE TABLETS ARE AND WHAT
THEY ARE USED FOR
Voriconazole Tablets contains the active
substance voriconazole. Voriconazole Tablets
are 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 _

Summary of Product characteristics

OBJECT 1
VORICONAZOLE ACTAVIS 200MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 29-Nov-2016 | Accord-UK Ltd
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, 7 mm round 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 Tablets 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 Tablets 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),
switching between intravenous and oral
administration is appropriate when clinically indicated.
Detailed