ACICLOVIR

Страна: Ирландия

Език: английски

Източник: HPRA (Health Products Regulatory Authority)

Активна съставка:

ACICLOVIR

Предлага се от:

SYRI Limited, t/a Thame Laboratories

АТС код:

J05AB01

INN (Международно Name):

ACICLOVIR

дозиране:

400/5 Mg/Ml

Лекарствена форма:

Oral Suspension

Вид предписание :

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

Терапевтична област:

aciclovir

Статус Оторизация:

Not Marketed

Дата Оторизация:

2016-05-26

Листовка

TURN OVER
PACKAGE LEAFLET: INFORMATION FOR THE USER
ACICLOVIR 400MG/5ML ORAL SUSPENSION
1. WHAT ACICLOVIR ORAL
SUSPENSION IS AND WHAT IT IS USED
FOR
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PIL/IE/MFG108/03/v1
3. HOW TO TAKE ACICLOVIR ORAL SUSPENSION
2. WHAT YOU NEED TO KNOW
BEFORE YOU TAKE ACICLOVIR ORAL
SUSPENSION
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 only. Do not pass it on to
others. It may harm them, even if
their signs of illness 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.
The name of your medicine is Aciclovir
400mg/5ml Oral Suspension but it will
be referred to as Aciclovir Oral
Suspension throughout this leaflet.
WHAT IS IN THIS LEAFLET
1.
WHAT ACICLOVIR ORAL SUSPENSION
IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE
YOU TAKE ACICLOVIR ORAL
SUSPENSION
3.
HOW TO TAKE ACICLOVIR ORAL
SUSPENSION
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE ACICLOVIR ORAL
SUSPENSION
6.
CONTENTS OF THE PACK AND OTHER
INFORMATION
Aciclovir oral suspension contains the
active substance aciclovir. This belongs
to a group of medicines called
antivirals. It works by killing or
stopping the growth of viruses.
Aciclovir Oral Suspension can be used
to:

Treat chickenpox and shingles.

Treat cold sores and genital herpes
and other herpes simplex
infections.

Stop these problems returning after
you have had them.

Stop these problems in people
whose immune systems work less
well, which means their bodies are
less able to fight infections.
DO NOT TAKE ACICLOVIR ORAL
SUSPENSION IF:

You are allergic (hypersensitive) to
aciclovir or valaciclovir or any of
the other ingredients of this
medicine (listed in section 6).
Do not take Aciclovir Oral Suspension if

Данни за продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Aciclovir 400mg/5ml Oral Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
The active substance is aciclovir.
Each 5ml of oral suspension contains 400mg aciclovir.
Excipient(s) with known effect:
Each 5ml of suspension contains 2.25g sorbitol liquid
(non-crystallising) (E420) and 10mg of methyl
parahydroxybenzoate (E218).
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Oral Suspension
White to off-white uniform oral suspension with orange and vanilla
odour
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Aciclovir 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).
Aciclovir Suspension is indicated for the suppression (prevention of
recurrences) of recurrent herpes simplex infections
in immunocompetent patients.
Aciclovir Suspension is indicated for the prophylaxis of herpes
simplex infections in immunocompromised patients.
Aciclovir Suspension is indicated for the treatment of varicella
(chickenpox) and herpes zoster (shingles) infections.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Dosage in Adults_
_Treatment of herpes simplex infections_:
200mg Aciclovir suspension 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 this 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 Aciclovir suspension or
alternatively intravenous dosing could be considered.
Dosing should begin as early as possible after the start of an
infection; for recurrent episodes this should preferably be
during the prodromal period or when lesions first appear.
_Suppression of herpes simplex infections in immunocompetent
p