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)

即購入

ダウンロード 製品の特徴 (SPC)
30-11-2021

有効成分:

Aciclovir

から入手可能:

GlaxoSmithKline (Ireland) Limited

ATCコード:

J05AB; 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:

Nucleosides and nucleotides excl. reverse transcriptase inhibitors; aciclovir

認証ステータス:

Marketed

承認日:

1986-03-24

情報リーフレット

                                (GSK LOGO)
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 yo
                                
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製品の特徴

                                Health Products Regulatory Authority
29 November 2021
CRN009VNJ
Page 1 of 8
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.
Excipients with known effect:
Liquid Sorbitol solution (non-crystallising) (E420) 2.25 g/5 mL
Methyl parahydroxybenzoate (E218) 5 mg/5 mL
Propyl parahydroxybenzoate (E216) 1.0 mg/5 mL
Propylene glycol (E1520) <1.0 mg/5mL
For full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Oral suspension.
Off-white, banana flavoured, suspension
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Zovirax Suspension is indicated for the treatment of Herpes simplex
virus infections of the skin and mucous membranes,
including initial and recurrent genital herpes (excluding neonatal HSV
and severe HSV infections in immunocompromised
children).
Zovirax Suspension is indicated for the suppression (prevention of
recurrences) of recurrent Herpes simplex infections in
immunocompetent patients.
Zovirax Suspension is indicated for the prophylaxis of Herpes simplex
infections in immunocompromised patients.
Zovirax Suspension is indicated for the treatment of Varicella
(chickenpox) and Herpes zoster (shingles) infections. Studies have
shown that early treatment of shingles with Zovirax has a beneficial
effect on pain and can reduce the incidence of
post-herpetic neuralgia (zoster-associated pain).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
DOSAGE FOR TREATMENT OF HERPES SIMPLEX IN ADULTS.
For treatment of Herpes simplex infections_,_ 200 mg Zovirax should be
taken five times daily at approximately four-hourly
intervals omitting the night time dose. Treatment should continue for
5 days, but in severe initial infections may have to be
extended.
In severely immunocompromised patients (e.g. after marrow transplant)
or in patients with impaired absorption from the gut
the dose can be doubled to 400 mg Zovirax or, alternatively,
intravenous dosing could be considere
                                
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