Valganciclovir Accord Tablet, film coated 450mg

Nazione: Malta

Lingua: inglese

Fonte: Medicines Authority

Principio attivo:

VALACICLOVIR HYDROCHLORIDE

Commercializzato da:

Accord Healthcare Limited

Codice ATC:

J05AB14

INN (Nome Internazionale):

VALACICLOVIR HYDROCHLORIDE

Forma farmaceutica:

FILM-COATED TABLET

Composizione:

VALACICLOVIR HYDROCHLORIDE 450 mg

Tipo di ricetta:

POM

Area terapeutica:

ANTIVIRALS FOR SYSTEMIC USE

Stato dell'autorizzazione:

Authorised

Foglio illustrativo

PACKAGE LEAFLET: INFORMATION FOR THE USER
VALGANCICLOVIR 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
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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.
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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 Valganciclovir tablet is and what it is used for
2. What you need to know before you take Valganciclovir tablets
3. How to take Valganciclovir tablets
4. Possible side effects
5. How to store Valganciclovir tablets
6. Contents of the pack and other information 1. WHAT VALGANCICLOVIR TABLET IS AND WHAT IT
IS USED FOR
Valganciclovir 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.
Valganciclovir tablet 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
VALGANCICLOVIR TABLETS
DO NOT TAKE VALGANCICLOVIR TABLETS:
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if you are allergic to valganciclovir or any of the other
ingredients of this medicine (listed in section 6)

Scheda tecnica

Page 1 of 21
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Valganciclovir 450 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 496.3 mg 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 tablet.
16.7 x 7.8 mm approx., pink, oval, biconvex film coated tablets
debossed with ‘J’ on one side and ‘156’
on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Valganciclovir tablet is indicated for the induction and maintenance
treatment of cytomegalovirus
(CMV) retinitis in adult patients with acquired immunodeficiency
syndrome (AIDS).
Valganciclovir tablet 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: _
Page 2 of 21
For patients with active CMV retinitis, the recommended dose is 900 mg
valganciclovir (two
Valganciclovir 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
900 mg valganciclovir (two Valganciclovir 450 mg tablets) once daily
and, whenever possible, taken
with food. Patients whose retinitis worsens may repeat induction
treatment; however, considerati