Zovirax 200 mg dispersible tablets

Negara: Irlandia

Bahasa: Inggris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Acyclovir

Tersedia dari:

PCO Manufacturing Ltd.

Kode ATC:

J05AB; J05AB01

INN (Nama Internasional):

Acyclovir

Dosis:

200 milligram(s)

Bentuk farmasi:

Dispersible tablet

Jenis Resep:

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

Area terapi:

Nucleosides and nucleotides excl. reverse transcriptase inhibitors; aciclovir

Status otorisasi:

Authorised

Tanggal Otorisasi:

2007-03-16

Selebaran informasi

_ _
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 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 sure,
talk
to you

Karakteristik produk

Health Products Regulatory Authority
16 March 2021
CRN00C77K
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.
For the full list of excipients, see 6.1.
3 PHARMACEUTICAL FORM
Dispersible film-coated tablet (Dispersible 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
Microcrystalline cellulose (E460)
Aluminium magnesium silicate
Sodium starch glycolate
Povidone K30
Magnesium stearate (E572)
Hypromellose
Macrogol 400
Titanium dioxide (E171)
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
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 containing
25 dispersible tablets.
Health Products Regulatory Authority
16 March 2021
CRN00C77K
Page 2 of 2
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
PCO Manufacturing Ltd.
Unit 10, Ashbourne Business Park
Rath
Ashbourne
Co. Meath
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA0465/038/005
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 16th March 2007
Date of last renewal: 16th March 2012
10 DATE OF REVISION OF THE TEXT
March 2021