Zovirax 800 mg Dispersible Tablets

देश: आयरलैंड

भाषा: अंग्रेज़ी

स्रोत: HPRA (Health Products Regulatory Authority)

सक्रिय संघटक:

Aciclovir

थमां उपलब्ध:

IMED Healthcare Ltd.

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:

2023-05-12

सूचना पत्रक

PACKAGE LEAFLET: INFORMATION FOR THE USER
ZOVIRAX 800 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 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
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 takin

उत्पाद विशेषताएं

Health Products Regulatory Authority
12 May 2023
CRN00DHZ2
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 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.
6.5 NATURE AND CONTENTS OF CONTAINER
Health Products Regulatory Authority
12 May 2023
CRN00DHZ2
Page 2 of 2
Each pack contains 35 dispersible tablets. 7 dispersible tablets per
child-resistant foil blister.
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
PPA1463/199/002
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 12
th
May 2023
10 DATE OF REVISION OF THE TEXT