Valtrex Tablet, Film-coated 500mg

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

VALACICLOVIR

Available from:

The Wellcome Foundation 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom

ATC code:

J05AB11

INN (International Name):

VALACICLOVIR 500 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

VALACICLOVIR 500 mg

Prescription type:

POM

Therapeutic area:

ANTIVIRALS FOR SYSTEMIC USE

Authorization status:

Withdrawn

Authorization date:

2005-06-04

Patient Information leaflet

(GSK LOGO) GLAXOSMITHKLINE 

PACKAGE LEAFLET: INFORMATION FOR THE USER 

VALTREX® 250 MG FILM-COATED TABLETS 
500 MG FILM-COATED TABLETS 

VALACICLOVIR 

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. 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 Valtrex is and what it is used for 
2. 
What you need to know before you take Valtrex 
3. 
How to take Valtrex 
4. 
Possible side effects 
5. 
How to store Valtrex 
6. 
Contents of the pack and other information 

1. 
WHAT VALTREX IS AND WHAT IT IS USED FOR 

Valtrex belongs to a group of medicines called antivirals.
It works by killing or stopping the growth of 
viruses called herpes simplex (HSV), varicella zoster (VZV) and
cytomegalovirus (CMV). 
Valtrex can be used to: 
• 
treat shingles (in adults) 
• 
treat HSV infections of the skin and
genital herpes (in adults and adolescents over 12 years 
old). It is also used to
help prevent these infections from returning. 
• 
treat cold sores (in adults and adolescents over 12 years
old) 
• 
prevent infection with CMV after organ transplants (in
adults and adolescents over 12 years 
old)  
• 
treat and
prevent HSV infections of the eye that continue to come back (in
adults and 
adolescents over 12 years old) 

2. 
WHAT YOU NEED TO KNOW BEFORE YOU TAKE VALTREX

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Valtrex 500 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains valaciclovir hydrochloride equivalent to 500 mg
valaciclovir
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
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 sections 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)
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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 possibl