VALACICLOVIR ACTAVIS 500 Milligram Film Coated Tablet

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

VALACICLOVIR HYDROCHLORIDE MONOHYDRATE

Available from:

Actavis Group PTC ehf

ATC code:

J05AB11

INN (International Name):

VALACICLOVIR HYDROCHLORIDE MONOHYDRATE

Dosage:

500 Milligram

Pharmaceutical form:

Film Coated Tablet

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Nucleosides and nucleotides excl. reverse transcriptase inhibitors

Authorization status:

Authorised

Authorization date:

2009-05-28

Patient Information leaflet

Valaciclovir 500mg Film-coated Tablets  PIL - Ireland
item no: AAAF8097
print proof no: 4 
origination date: 20.08.13 
originated by: SA
revision date: 28.08.13  
revised by: SA 
dimensions: 170 x 320
pharmacode:
colours/plates:
approved for print/date
Non Printing Colours
1. Black
2.
3.
4.
5.
6.
1.
2.
3.
date sent: 20.08.13
supplier: Actavis Iceland
technically app. date: 20.08.13
min pt size:
TECHNICAL APPROVAL
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 VALACICLOVIR ACTAVIS IS AND WHAT IT IS USED 
FOR
2
  WHAT YOU NEED TO KNOW BEFORE YOU TAKE 
VALACICLOVIR ACTAVIS
3
  HOW TO TAKE VALACICLOVIR ACTAVIS
4
  POSSIBLE SIDE EFFECTS
5
  HOW TO STORE VALACICLOVIR ACTAVIS
6
  CONTENTS OF THE PACK AND OTHER INFORMATION
1

WHAT VALACICLOVIR ACTAVIS IS AND WHAT IT IS USED 
FOR
Valaciclovir Actavis 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).
Valaciclovir Actavis 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.
2
  W

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Valaciclovir Actavis 500 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 500 mg valaciclovir (as valaciclovir
hydrochloride monohydrate).
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
Oval, white, biconvex, film-coated tablets, 17.6 x 8.8 mm with VC2 on
one side
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
_Varicella zoster virus (VZV) infections – herpes zoster_
Valaciclovir Actavis is indicated for the treatment of herpes zoster
(shingles) and ophthalmic zoster in
immunocompetent adults (see sections 4.4).
Valaciclovir Actavis 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_
Valaciclovir Actavis 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 (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_:
Valaciclovir Actavis 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.
There are no data on treatment started mor