VALTREX TABLETS 500 MG

Land: Israel

Språk: engelsk

Kilde: Ministry of Health

Aktiv ingrediens:

VALACICLOVIR AS HYDROCHLORIDE

Tilgjengelig fra:

GLAXO SMITH KLINE (ISRAEL) LTD

ATC-kode:

J05AB11

Legemiddelform:

FILM COATED TABLETS

Sammensetning:

VALACICLOVIR AS HYDROCHLORIDE 500 MG

Administreringsrute:

PER OS

Resept typen:

Required

Produsert av:

GLAXO WELLCOME SA, SPAIN

Terapeutisk gruppe:

VALACICLOVIR

Terapeutisk område:

VALACICLOVIR

Indikasjoner:

Varicella zoster virus (VZV) infections – herpes zoster:Valtrex is indicated for the treatment of herpes zoster (shingles) and ophthalmic zoster in immunocompetent adults.Valtrex is indicated for the treatment of herpes zoster in adult patients with mild or moderate immunosuppression.Herpes simplex virus (HSV) infections:Valtrex is indicated for the treatment and suppression of HSV infections of the skin and mucous membranes including- treatment of first-episode of genital herpes in immunocompetent adults and adolescents and in immunocompromised adults- treatment of recurrences of genital herpes in immunocompetent adults and adolescents, and in immunocompromised adults- suppression of recurrent genital herpes in immunocompetent adults and adolescents and in immunocompromised adultsTreatment and suppression of recurrent ocular HSV infections in immunocompetent adults and adolescents and in immunocompromised adults Clinical studies have not been conducted in HSV-infected patients immunocompromised for other causes than HIV-infection.Cytomegalovirus (CMV) infections:Valtrex is indicated for the prophylaxis of CMV infection and disease following solid organ transplantation in adults and adolescents

Autorisasjon dato:

2021-02-28

Informasjon til brukeren

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986
The medicine is dispensed with a physician’s prescription only
VALTREX TABLETS 500 MG
EACH TABLET CONTAINS 500 MG VALACICLOVIR (AS HYDROCHLORIDE)
The list of additional ingredients is detailed in section 6.
READ THE LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE.
This
leaflet contains concise information about the medicine. If you have
further
questions, refer to the physician or pharmacist.
This medicine has been prescribed to treat your illness. Do not pass
it on to
others. It may harm them, even if it seems to you that their illness
is similar.
1.
WHAT IS THE MEDICINE INTENDED FOR?
Valtrex works by killing or stopping the growth of viruses called
herpes
simplex (HSV), varicella zoster (VZV) and cytomegalovirus (CMV).
Valtrex is intended to:
•
Treat shingles in adults.
•
Treat
VZV
infections
of
the
eye
(ophthalmic
zoster)
in
adults
with
a
weakened immune system.
•
Treat HSV infections of the skin (e.g., cold sores) and genital herpes
in
adults and adolescents. It is also used to help prevent recurrence of
these
infections.
•
Treat and prevent recurrence of HSV infections of the eye in adults
and
adolescents.
•
Prevent
infection
with
CMV
after
organ
transplants
in
adults
and
adolescents.
THERAPEUTIC GROUP: Valtrex belongs to a group of medicines called
antivirals.
2.
BEFORE USING THE MEDICINE
DO NOT USE THE MEDICINE IF:
You
are
sensitive
(allergic)
to
valaciclovir
or
aciclovir
or
to
any
of
the
additional ingredients contained in the medicine (as detailed in
section 6).
SPECIAL WARNINGS REGARDING USE OF THE MEDICINE
BEFORE TREATMENT WITH VALTREX, TELL THE PHYSICIAN IF:
•
You have kidney problems.
•
You have liver problems.
•
You are over 65 years of age.
•
Your immune system is weak.
TAKE SPECIAL CARE WITH VALTREX - IMPORTANT INFORMATION:
Drug reaction with eosinophilia and systemic symptoms (also called
DRESS)
has been reported with the use of valaciclovir. DRESS appears
initially as
fl

Preparatomtale

Page 1 of 13
VALTREX TABLETS 500 MG
_ _
1.
NAME OF THE MEDICINAL PRODUCT
VALTREX TABLETS 500
MG
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains valaciclovir (as hydrochloride) equivalent to 500
mg valaciclovir
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablets
500 mg tablet
White, biconvex, elongated tablet with a white to off-white core,
engraved “GX CF1” on one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Varicella zoster virus (VZV) infections – herpes zoster
Valtrex
is
indicated
for
the
treatment
of
herpes
zoster
(shingles)
and
ophthalmic
zoster
in
immunocompetent adults (see section 4.4).
Valtrex is indicated for the treatment of herpes zoster in adult
patients with mild or moderate
immunosuppression (see section 4.4).
Herpes simplex virus (HSV) infections
Valtrex is indicated
•
for the treatment and suppression of HSV infections of the skin and
mucous membranes
including:
-
treatment
of
first-episode
of
genital
herpes
in
immunocompetent
adults
and
adolescents and in immunocompromised adults.
-
treatment
of
recurrences
of
genital
herpes
in
immunocompetent
adults
and
adolescents, and in immunocompromised adults.
-
suppression of recurrent genital herpes in immunocompetent adults and
adolescents
and in immunocompromised adults.
•
Treatment and suppression of recurrent ocular HSV infections in
immunocompetent adults and
adolescents and in immunocompromised adults (see section 4.4)
Clinical studies have not been conducted in HSV-infected patients
immunocompromised for other
causes than HIV-infection (see section 5.1).
_ _
Cytomegalovirus (CMV) infections
Valtrex
is
indicated
for
the
prophylaxis
of
CMV
infection
and
disease
following
solid
organ
transplantation in adults and adolescents (see section 4.4).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Varicella zoster virus (VZV) infections – herpes zoster and
ophthalmic zoster
Patients should be advised to start treatment as soon as possible
after a diagnosis of herpes zoster.
Page 2