Zovirax 200 mg/5mL Oral Suspension

Страна: Малта

Език: английски

Източник: Malta Medicines Authority

Активна съставка:

ACICLOVIR

Предлага се от:

Glaxo SmithKline Ireland Limited 12, Riverwalk, Citywest Business Campus, Dublin 24, Ireland

АТС код:

J05AB01

INN (Международно Name):

ACICLOVIR 200 mg/5ml

Лекарствена форма:

ORAL SUSPENSION

Композиция:

ACICLOVIR 200 mg/5ml

Вид предписание :

POM

Терапевтична област:

ANTIVIRALS FOR SYSTEMIC USE

Статус Оторизация:

Authorised

Дата Оторизация:

2006-04-17

Листовка

(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
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
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

Данни за продукта

SUMMARY OF PRODUCT CHARACTERISTICS
ZOVIRAX SUSPENSION
1.
NAME OF THE MEDICINAL PRODUCT
Zovirax 200 mg/5mL Oral Suspension.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Oral Suspension containing 200mg aciclovir per 5mL.
Excipients with known effect:
Liquid Sorbitol (non-crystallising) (E420) 2.25 g/5 mL
Methyl parahydroxybenzoate (E218) 5 mg/5 mL
Propyl parahydroxybenzoate (E216) 1.0 mg/5 mL
For full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Oral Suspension.
Off-white, banana flavoured oral 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
_,_
200mg 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 400mg
Zovirax or, alternatively,
intravenous dosing could be considered.
2
Dosing should begin as early as possible after the start of an
infection; for recurrent epi