Zovirax 200 mg Dispersible Tablets

Country: Իռլանդիա

language: անգլերեն

source: HPRA (Health Products Regulatory Authority)

active_ingredient:

ACICLOVIR

MAH:

LTT Pharma Limited

ATC_code:

J05AB; J05AB01

INN:

ACICLOVIR

dosage:

200 milligram(s)

pharmaceutical_form:

Dispersible tablet

prescription_type:

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

therapeutic_area:

Nucleosides and nucleotides excl. reverse transcriptase inhibitors; aciclovir

authorization_status:

Authorised

authorization_date:

2016-11-11

PIL

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:
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 200 mg Dispersible Tablets (called ‘Zovirax’ in this
leaflet) contains a
medicine called aciclovir. This belongs to a group of medicines called
antivirals. It works by stopping the growth of viruses.
Zovirax 200 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
*
treat cold sores, genital herpes and other herpes simplex infections
(but not
to be used to treat herpes simplex infections in newborn infants or
severe
herpes simplex infections in children whose immune systems work less
well, which means their bodies are less able to fight infections)
*
stop cold sores and genital herpes returning after you have had them
*
prevent cold sores and genital herpes in people whose immune systems
work less well.
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 be

SPC

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zovirax 200 mg Dispersible Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 200 mg aciclovir
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Dispersible film-coated tablet. (Dispersible tablet).
_Product imported from Spain._
Zovirax 200mg tablets are white, round film-coated tablets branded
with ‘GXCF3’ on one side and plain on the other.
4 CLINICAL PARTICULARS
As per PA1077/084/007
5 PHARMACOLOGICAL PROPERTIES
As per PA1077/084/007
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Microcrystalline cellulose
Aluminium magnesium silicate
Sodium carboxymethyl starch
Povidone K30
Magnesium stearate
Film Coat
Hypromellose
Macrogol 400
Titanium dioxide
Polish
Macrogol 8000
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date for this product shall be the date shown on
the blister and outer package of the product on the
market in the country of origin.
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6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 30°C.
Store in the original container.
6.5 NATURE AND CONTENTS OF CONTAINER
Blister strips of dispersible tablets in a cardboard outer container.
Pack size: 25 dispersible tablets.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR
WASTE MA