Zovirax 200 mg Dispersible Tablets

国家: 爱尔兰

语言: 英文

来源: HPRA (Health Products Regulatory Authority)

有效成分:

Aciclovir

可用日期:

IMED Healthcare Ltd.

ATC代码:

J05AB; J05AB01

INN（国际名称）:

Aciclovir

药物剂型:

Dispersible tablet

治疗领域:

Nucleosides and nucleotides excl. reverse transcriptase inhibitors; aciclovir

授权日期:

2022-12-02

资料单张

PACKAGE LEAFLET: INFORMATION FOR THE USER
ZOVIRAX 200 MG DISPERSIBLE TABLETS
aciclovir
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 symptoms 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 Zovirax is and what it is used for
2.
What you need to know before you take Zovirax
3.
How to take Zovirax
4.
Possible side effects
5.
How to store Zovirax
6.
Contents of the pack and other information
1.
WHAT ZOVIRAX IS AND WHAT IT IS USED FOR
Zovirax 200 mg Dispersible Tablets (called ‘Zovirax’ in this
leaflet)
contains a medicine called aciclovir. This belongs to a group of
medicines called antivirals. It works by stopping the growth of
viruses.
Zovirax 200 mg Dispersible Tablets can be used to:

treat chickenpox

treat shingles, and when started right after the rash appears, it
can help reduce the nerve pain that can exist after the shingles
rash has cleared

treat cold sores, genital herpes and other herpes simplex
infections (but not to be used to treat herpes simplex infections in
newborn infants or severe herpes simplex infections in children
whose immune systems work less well, which means their bodies
are less able to fight infections)

stop cold sores and genital herpes returning after you have had
them

prevent cold sores and genital herpes in people whose immune
systems work less well.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ZOVIRAX
DO NOT USE ZOVIRAX IF:

you are allergic (hypersensitive) to aciclovir, valaciclovir or any of
the other ingredients (listed in Section 6)
Do not take Zovirax if the above applies to you. If you are not

产品特点

Health Products Regulatory Authority
02 December 2022
CRN00D701
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zovirax 200 mg Dispersible Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 200 mg aciclovir
Excipient(s) with known effect:
This product contains sodium as Sodium starch glycollate
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Dispersible Film-coated tablet.
_Product imported from Spain_
Zovirax 200 mg tablets are white, round film-coated tablets branded
with 'GXCF3' on one side and plain on the other.
4 CLINICAL PARTICULARS
As per PA1077/084/007
5 PHARMACOLOGICAL PROPERTIES
As per PA1077/084/007
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
CORE:
Microcrystalline cellulose (E460)
Aluminium magnesium silicate
Sodium starch glycollate (type A)
Povidone K30
Magnesium stearate (E572)
FILM COAT:
Hypromellose
Titanium dioxide (E171)
Macrogol 400
Macrogol 8000
6.2 INCOMPATIBILITIES
Not applicable
6.3 SHELF LIFE
The shelf-life expiry date of this product is the date shown on the
container and outer package of the product on the market in
the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Health Products Regulatory Authority
02 December 2022
CRN00D701
Page 2 of 2
Do not store above 30°C.
Store in the original package.
6.5 NATURE AND CONTENTS OF CONTAINER
PVC/PVDC/Aluminium/Paper child resistant foil blister packs. Pack
size: 25 dispersible tablets.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL
No special requirements
7 PARALLEL PRODUCT AUTHORISATION HOLDER
IMED Healthcare Ltd,
Unit 625 Kilshane Avenue,
Northwest Business Park,
Ballycoolin,
Dublin 15,
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA1463/199/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 2
nd
December 2022
10 DATE OF REVISION OF THE TEXT