Aciclovir 200mg/5ml Oral Suspension

Kraj: Irlandia

Język: angielski

Źródło: HPRA (Health Products Regulatory Authority)

Składnik aktywny:

ACICLOVIR

Dostępny od:

SYRI Limited, t/a Thame Laboratories

Kod ATC:

J05AB; J05AB01

INN (International Nazwa):

ACICLOVIR

Dawkowanie:

200/5 milligram(s)/millilitre

Forma farmaceutyczna:

Oral suspension

Typ recepty:

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

Dziedzina terapeutyczna:

Nucleosides and nucleotides excl. reverse transcriptase inhibitors; aciclovir

Status autoryzacji:

Not marketed

Data autoryzacji:

2016-05-26

Ulotka dla pacjenta

TURN OVER
PACKAGE LEAFLET: INFORMATION FOR THE USER
ACICLOVIR 200MG/5ML ORAL SUSPENSION
1. WHAT ACICLOVIR ORAL SUSPENSION IS AND WHAT IT IS USED FOR

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
200mg/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
the above applies to you. If you are not
sure, talk to your doctor or pharmacist
before taking Aciclovir Oral Suspension.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before
taking Aciclovir Oral Suspension if:

You have kidney problems.

You are over 65

Charakterystyka produktu

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Aciclovir 200mg/5ml Oral Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
The active substance is aciclovir.
Each 5ml of oral suspension contains 200mg 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