Zovirax 800 mg Dispersible Tablets

Country: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

Aciclovir

Fáanlegur frá:

Originalis B.V.

ATC númer:

J05AB01

INN (Alþjóðlegt nafn):

Aciclovir

Lyfjaform:

Dispersible tablet

Lækningarsvæði:

aciclovir

Leyfisdagur:

2024-01-26

Upplýsingar fylgiseðill

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 taking Zovirax.
Zovirax is also available as a liquid suspension.
Children
There is no data availab

Vara einkenni

Health Products Regulatory Authority
26 January 2024
CRN00DW51
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.
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
Health Products Regulatory Authority
26 January 2024
CRN00DW51
Page 2 of 2
Each pack contains 35 dispersible tablets. 7dispersible tablets per
child-resistant foil blister.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
Originalis B.V.,
Joop Geesinkweg 901,
1114 AB Amsterdam-Duivendrecht,
Netherlands
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA2306/030/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 26th January 2024
10 DATE OF REVISION OF THE TEXT