Zovirax 800 mg Dispersible Tablets

Land: Irland

Sprache: Englisch

Quelle: HPRA (Health Products Regulatory Authority)

Wirkstoff:

ACICLOVIR

Verfügbar ab:

Imbat Limited

ATC-Code:

J05AB; J05AB01

INN (Internationale Bezeichnung):

ACICLOVIR

Dosierung:

800 milligram(s)

Darreichungsform:

Dispersible tablet

Verschreibungstyp:

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

Therapiebereich:

Nucleosides and nucleotides excl. reverse transcriptase inhibitors; aciclovir

Berechtigungsstatus:

Authorised

Berechtigungsdatum:

2013-12-20

Gebrauchsinformation

Page 1 of 2
PACKAGE LEAFLET: INFORMATION FOR THE USER
ZOVIRAX
® 800MG 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 800mg Dispersible Tablets (called ‘Zovirax’ in this
leaflet) contain 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.
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 have Zovirax if the above applies to you. If you are
not sure, check with
your doctor or pharmacist before taking
Zovirax.
WARNINGS AND PRECAUTIONS
Check with your doctor or pharmacist before taking Zovirax
if:

you have kidney problems

you are over 65 years of age

you are thirsty. You must make sure you drink plenty of
liquids such as water whilst taking this medicine

your immune system is weak.
If you are not sure if the above apply to you, check with
your
doctor or pharmacist before taking Zovirax.

Fachinformation

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zovirax 800mg Dispersible Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 800mg aciclovir
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Dispersible Tablets
_Product imported from the UK_
White, oval tablets marked ‘GXCG1’ on one side.
4 CLINICAL PARTICULARS
As per PA 1077/084/009
5 PHARMACOLOGICAL PROPERTIES
As per PA 1077/084/009
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Microcrystalline cellulose
Aluminium magnesium silicate
Sodium starch glycollate
Povidone K30
Magnesium stearate
Hypromellose
Polyethylene glycol 400
Titanium Dioxide (E171)
Polyethylene glycol 8000
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf-life expiry date of this product is the date shown on the
blister and outer package of the product as marketed
in the country of origin
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6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 30°C.
Keep the blisters in the outer carton in order to protect from light
and moisture
6.5 NATURE AND CONTENTS OF CONTAINER
Outer carton containing blister strips
Pack size: 35
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR
WASTE MATERIALS DERIVED FROM
SUCH MEDICINAL PRODUCT AND OTHER HANDLING OF THE PRODUCT
No special requirements.
7 PA