Zovirax 800 mg Dispersible Tablets

देश: आयरलैंड

भाषा: अंग्रेज़ी

स्रोत: HPRA (Health Products Regulatory Authority)

सक्रिय संघटक:

Aciclovir

थमां उपलब्ध:

PCO Manufacturing Ltd.

ए.टी.सी कोड:

J05AB; J05AB01

INN (इंटरनेशनल नाम):

Aciclovir

डोज़:

800 milligram(s)

फार्मास्यूटिकल फॉर्म:

Dispersible tablet

प्रिस्क्रिप्शन प्रकार:

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

चिकित्सीय क्षेत्र:

Nucleosides and nucleotides excl. reverse transcriptase inhibitors; aciclovir

प्राधिकरण का दर्जा:

Authorised

प्राधिकरण की तारीख:

2017-03-31

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 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 800mg 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 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 befo

उत्पाद विशेषताएं

Health Products Regulatory Authority
22 October 2021
CRN00C467
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 6.1
3 PHARMACEUTICAL FORM
Dispersible Tablets
_Product imported from the UK and Greece:_
White, oval tablet, 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 glycollate
Povidone K30
Magnesium stearate
hypromellose
polyethylene glycol 400
titanium dioxide
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
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. Keep the blisters in the outer carton in
order to protect from light and moisture.
6.5 NATURE AND CONTENTS OF CONTAINER
Blister packs containing 35 dispersible tablets.
Health Products Regulatory Authority
22 October 2021
CRN00C467
Page 2 of 2
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL
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
PPA0465/038/007
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 31
st
March 2017
10 DATE OF REVISION OF THE TEXT
October 2021