Zovirax 200 mg/5 mL oral suspension

国: アイルランド

言語: 英語

ソース: HPRA (Health Products Regulatory Authority)

有効成分:

Aciclovir

から入手可能:

PCO Manufacturing Ltd.

ATCコード:

J05AB01

INN（国際名）:

Aciclovir

投薬量:

200 mg/5ml

医薬品形態:

Oral suspension

処方タイプ:

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

治療領域:

aciclovir

認証ステータス:

Authorised

承認日:

2017-05-19

情報リーフレット

_ _
PACKAGE LEAFLET: INFORMATION FOR THE USER
ZOVIRAX 200 MG/5 ML ORAL SUSPENSION
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 200 mg/5 mL Oral Suspension (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/5 mL Oral Suspension can be used to:

treat chicken-pox

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.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ZOVIRAX
DO NOT USE ZOVIRAX IF:

you are allergic (hypersensitive) to aciclovir or valaciclovir or any
of
the other ingredients (listed in Section 6).
Do not take Zovirax if the above applies to you. If

製品の特徴

Health Products Regulatory Authority
31 May 2021
CRN00CCPH
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zovirax 200 mg/5 mL oral suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Oral suspension containing 200 mg aciclovir per 5 mL.
Excipient(s) with known effect:
Sorbitol Liquid (non-crystallising)
Methyl parahydroxybenzoate
Propyl parahydroxbenzoate
Propylene glycol (E1520)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral suspension.
_Product imported from Germany_
Off-white, banana flavoured, suspension
4 CLINICAL PARTICULARS
As per PA1077/084/005
5 PHARMACOLOGICAL PROPERTIES
As per PA1077/084/005
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Sorbitol Liquid (non-crystallising) (E420)
Glycerol
Microcrystalline cellulose
Carmellose sodium
Vanillin
Banana flavour (contains propylene glycol (E1520))
Purified water
Methyl parahydroxybenzoate (E218)
Propyl parahydroxybenzoate (E216)
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.
Diluted: 4 weeks
Health Products Regulatory Authority
31 May 2021
CRN00CCPH
Page 2 of 2
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25°C.
6.5 NATURE AND CONTENTS OF CONTAINER
62.5 mL amber glass bottle with white, child resistant cap containing
a homogenous opaque white, viscous suspension having
the taste and odour of banana. The pack contains 2 x 62.5 mL bottles
and a double ended 5 mL/2.5 mL spoon.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL
For administration of 100 mg dose e.g. 2.5 mL of Zovirax 200 mg/5 mL
oral suspension, use the measuring spoon provided or
alternatively a graduated syringe.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
PCO Manufacturing Ltd.
Unit 10, Ashbourne Business Park
Rath
Ashbourne
Co. Meath
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA0465/038/008
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisa