Valcyte 450mg film-coated Tablets

Maa: Malta

Kieli: englanti

Lähde: Medicines Authority

Aktiivinen ainesosa:

VALGANCICLOVIR

Saatavilla:

Roche Products Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom

ATC-koodi:

J05AB14

INN (Kansainvälinen yleisnimi):

VALGANCICLOVIR 450 mg

Lääkemuoto:

FILM-COATED TABLET

Koostumus:

VALGANCICLOVIR 450 mg

Prescription tyyppi:

POM

Terapeuttinen alue:

ANTIVIRALS FOR SYSTEMIC USE

Valtuutuksen tilan:

Withdrawn

Valtuutus päivämäärä:

2013-12-16

Pakkausseloste

Page 1 of 7 PACKAGE LEAFLET: INFORMATION FOR THE USER
VALCYTE
® 450 MG FILM-COATED TABLETS
valganciclovir
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 Valcyte is and what it is used for
2.
What you need to know before you take Valcyte
3.
How to take Valcyte
4.
Possible side effects
5.
How to store Valcyte
6.
Contents of the pack and other information
1.
WHAT VALCYTE IS AND WHAT IT IS USED FOR
Valcyte belongs to a group of medicines, which work directly to
prevent the growth of viruses. In
the body the active ingredient in the tablets, valganciclovir, is
changed into ganciclovir. Ganciclovir
prevents a virus called cytomegalovirus (CMV) from multiplying and
invading healthy cells. In
patients with a weakened immune system, CMV can cause an infection in
the body’s organs. This
can be life threatening.
Valcyte is used:

for the treatment of CMV-infections of the retina of the eye in adult
patients with acquired
immunodeficiency syndrome (AIDS). CMV-infection of the retina of the
eye can cause
vision problems and even blindness.

to prevent CMV-infections in adults and children who are not infected
with CMV and who
have received an organ transplant from somebody who was infected by
CMV.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE VALCYTE
DO NOT TAKE VALCYTE:

if you are allergic to valganciclovir or any of the other ingredients
of this medicine (listed in
section 6).

if you are allergic to ganciclovir, acyclovir or valaciclovir, which
are medicines used to treat
other virus

Valmisteyhteenveto

Page 1 of 21
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Valcyte 450 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 496.3 mg of valganciclovir
hydrochloride equivalent to 450 mg of
valganciclovir (as free base).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablets
Pink, convex oval film-coated tablets, with “VGC” embossed on one
side and “450” on the other
side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Valcyte is indicated for the induction and maintenance treatment of
cytomegalovirus (CMV)
retinitis in adult patients with acquired immunodeficiency syndrome
(AIDS).
Valcyte is indicated for the prevention of CMV disease in CMV-negative
adults and children (aged
from birth to 18 years) who have received a solid organ transplant
from a CMV-positive donor.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
CAUTION – STRICT ADHERENCE TO DOSAGE RECOMMENDATIONS IS ESSENTIAL TO
AVOID OVERDOSE (SEE
SECTIONS 4.4_ _AND 4.9).
Valganciclovir is rapidly and extensively metabolised to ganciclovir
after oral dosing. Oral
valganciclovir 900 mg b.i.d. is therapeutically equivalent to
intravenous ganciclovir 5 mg/kg b.i.d.
TREATMENT OF CYTOMEGALOVIRUS (CMV) RETINITIS
_Adult patients _
_Induction treatment of CMV retinitis: _
For patients with active CMV retinitis, the recommended dose is 900 mg
valganciclovir (two
Valcyte 450 mg tablets) twice a day for 21 days and, whenever
possible, taken with food.
Prolonged induction treatment may increase the risk of bone marrow
toxicity (see section _4.4_).
Page 2 of 21
_Maintenance treatment of CMV retinitis: _
Following induction treatment, or in patients with inactive CMV
retinitis, the recommended dose is
900mg valganciclovir (two Valcyte 450 mg tablets) once daily and,
whenever possible, taken with
food. Patients whose retinitis worsens may repeat induction treatment;
however, consideration
should be given to the possibility of viral drug resistance.
P