Valaciclovir 500 mg film-coated tablets

国: アイルランド

言語: 英語

ソース: HPRA (Health Products Regulatory Authority)

有効成分:

Valaciclovir

から入手可能:

Accord Healthcare Ireland Ltd.

ATCコード:

J05AB; J05AB11

INN（国際名）:

Valaciclovir

投薬量:

500 milligram(s)

医薬品形態:

Film-coated tablet

治療領域:

Nucleosides and nucleotides excl. reverse transcriptase inhibitors; valaciclovir

認証ステータス:

Marketed

承認日:

2018-06-01

情報リーフレット

PACKAGE LEAFLET: INFORMATION FOR THE USER
VALACICLOVIR 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 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 is and what it is used for
2.
What you need to know before you take Valaciclovir
3.
How to take Valaciclovir
4.
Possible side effects
5.
How to store Valaciclovir
6.
Contents of the pack and other information
1.
WHAT VALACICLOVIR IS AND WHAT IT IS USED FOR
Valaciclovir 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 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 VALACICLOVIR
DO NOT TAKE VALACICLOVIR
-
if you are allergic to valaciclovir or aciclovir or any of the other
ingredients of this
medicine (listed in Section 6).
-
Do not take Valaciclovir if this applies to you. If you are not sure,
talk to your doctor or
pharmacist before taking Valaciclovir.
- If you have ever developed an extended rash associated with

製品の特徴

Health Products Regulatory Authority
26 February 2024
CRN00F1KX
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Valaciclovir 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
White to off white, oval, biconvex, film-coated tablets, debossed with
"KS" on one side and plain on other side. The tablets are
approximately 17.6 x 8.8mm in size.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
_Varicella zoster virus (VZV) infections – herpes zoster_
Valaciclovir is indicated for the treatment of herpes zoster
(shingles) and ophthalmic zoster in immunocompetent adults (see
sections 4.4).
Valaciclovir 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 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_:
Valaciclovir 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 vi