Zovirax 800 mg Dispersible Tablets

देश: आयरलैंड

भाषा: अंग्रेज़ी

स्रोत: HPRA (Health Products Regulatory Authority)

सक्रिय संघटक:

Aciclovir

थमां उपलब्ध:

Merit Pharmaceuticals 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:

2023-06-23

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
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 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.
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, 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
23 June 2023
CRN00DG38
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, biconvex, elongated, film-coated tablet, impressed with 'GX
CG1' on one face and plain on the other.
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 glycollate
Povidone K30
Magnesium stearate
Hypromellose
Titanium dioxide (E171)
Polyethylene glycol 400
Polyethylene glycol 8000
6.2 INCOMPATIBILITIES
There are no special requirements for use on handling of this product.
6.3 SHELF LIFE
The shelf life expiry date for this product shall be the date shown on
the blister and the 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.
6.5 NATURE AND CONTENTS OF CONTAINER
Each pack contains 35 dispersible tablets. 7 dispersible tablets per
child-resistant foil blister.
Health Products Regulatory Authority
23 June 2023
CRN00DG38
Page 2 of 2
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
Merit Pharmaceuticals Limited
Unit C4/C3
Metropoint Business Park
Kettles Lane
Swords
Co Dublin
K67 RH92
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA23080/029/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 23
rd
June 2023
10 DATE OF REVISION OF THE TEXT