Valcyte 450 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Valganciclovir

Available from:

CHEPLAPHARM Arzneimittel GmbH

ATC code:

J05AB; J05AB14

INN (International Name):

Valganciclovir

Pharmaceutical form:

Film-coated tablet

Therapeutic area:

Nucleosides and nucleotides excl. reverse transcriptase inhibitors; valganciclovir

Authorization status:

Marketed

Authorization date:

2002-09-13

Patient Information leaflet

1
IE_PIL_Valcyte_ Film Coated Tablets_
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, ganciclovir or any of the other
ingredients of this medicine
(listed in section 6).
•
if you are breast-feeding.
WARNINGS AND PRECAUTIONS:
Talk to your docto

Summary of Product characteristics

Health Products Regulatory Authority
28 October 2022
CRN00D03Y
Page 1 of 17
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).
_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
possibil