Zovirax 800 mg Dispersible Tablets

देश: आयरलैंड

भाषा: अंग्रेज़ी

स्रोत: HPRA (Health Products Regulatory Authority)

सक्रिय संघटक:

Aciclovir

थमां उपलब्ध:

Lexon Pharmaceuticals (Ireland) Limited

ए.टी.सी कोड:

J05AB; J05AB01

INN (इंटरनेशनल नाम):

Aciclovir

फार्मास्यूटिकल फॉर्म:

Dispersible tablet

चिकित्सीय क्षेत्र:

Nucleosides and nucleotides excl. reverse transcriptase inhibitors; aciclovir

प्राधिकरण की तारीख:

2023-04-14

सूचना पत्रक

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 symptons 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
What Zovirax is and what it is used for
What you need to know before you take Zovirax
How to take Zovirax
Possible side effects
How to store Zovirax
Contents of the pack and other information WHAT ZOVIRAX IS AND WHAT IT IS USED FOR
Zovirax 800 mg 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 800 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 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.
Zovirax is also available as a liquid suspension.
CHILDREN
There is no data available to support the use of this medicine in

उत्पाद विशेषताएं

Health Products Regulatory Authority
14 April 2023
CRN00DF05
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zovirax 800 mg Dispersible Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dispersible tablet contains 800 mg aciclovir
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Dispersible Tablets
_Product imported from Greece_
_ _
White, oval, film-coated tablets marked with "GXCG1" on one side.
4 CLINICAL PARTICULARS
As per PA1077/084/009
5 PHARMACOLOGICAL PROPERTIES
As per PA1077/084/009
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Microcrystalline cellulose
Aluminium magnesium silicate
Sodium starch glycolate
Povidone K30
Magnesium stearate
Hypromellose
Titanium dioxide (E171)
Polyethylene glycol
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf-life expiry date of this product shall be the date shown on
the blister 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. Keep the blisters in the outer carton in
order to protect from light and moisture.
Health Products Regulatory Authority
14 April 2023
CRN00DF05
Page 2 of 2
6.5 NATURE AND CONTENTS OF CONTAINER
Each pack contains 35 dispersible tablets. 7 dispersible tablets per
blister.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
Lexon Pharmaceuticals (Ireland) Limited
Block 3
Harcourt Centre
Harcourt Road
Dublin 2
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA23176/058/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 14
th
April 2023
10 DATE OF REVISION OF THE TEXT