Virucid 800mg Tablets

Country: Malta

Lingwa: Ingliż

Sors: Medicines Authority

Ingredjent attiv:

ACICLOVIR

Disponibbli minn:

Delorbis Pharmaceuticals Limited 17 Athinon Str, Ergates Industrial Area, 2643 Ergates, PO Box 28629, 2081 Lefkosia, Cyprus

Kodiċi ATC:

J05AB01

INN (Isem Internazzjonali):

ACICLOVIR 800 mg

Għamla farmaċewtika:

TABLET

Kompożizzjoni:

ACICLOVIR 800 mg

Tip ta 'preskrizzjoni:

POM

Żona terapewtika:

ANTIVIRALS FOR SYSTEMIC USE

L-istatus ta 'awtorizzazzjoni:

Authorised

Data ta 'l-awtorizzazzjoni:

2006-06-01

Fuljett ta 'informazzjoni

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
VIRUCID 800 MG TABLETS
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 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.
WHAT IS IN THIS LEAFLET
1.
What Virucid is and what it is used for
2.
What you need to know before you take Virucid
3.
How to take Virucid
4.
Possible side effects
5.
How to store Virucid
6.
Contents of the pack and other information
1. WHAT VIRUCID IS AND WHAT IT IS USED FOR
Virucid 800 mg tablets (called “Virucid” in this leaflet) contain
a medicine called aciclovir. This belongs
to group of medicines called antivirals. It works by killing or
stopping the growth of viruses.
Virucid can be used to:
•
treat chickenpox and shingles.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE VIRUCID
DO NOT USE VIRUCID:
•
if you are allergic to aciclovir or valaciclovir or any of the other
ingredients of this medicine (listed in
Section 6).
Do not take Virucid if the above applies to you. If you are not sure,
talk to your doctor or pharmacist
before taking Virucid.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Virucid if:
•
you have kidney problems
•
you are over 65 years of age.
If you are not sure if the above apply to you, talk to your doctor or
pharmacist before taking Virucid. It is
important that you drink plenty of water while taking Virucid.
OTHER MEDICINES AND VIRUCID
Tell your doctor or pharmacist if you are taking, have recently taken
or might take any other medicines.
This includes medicines obtained without a prescription, including
herbal medicines.
2
In particular

Karatteristiċi tal-prodott

1.
NAME OF THE MEDICINAL PRODUCT
Virucid 800 mg Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 800 mg of aciclovir.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablets
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Virucid 800 mg tablets are indicated for the treatment of varicella
(chickenpox) and herpes zoster
(shingles)
infections
(excluding
neonatal
HSV
and
severe
HSV
infections
in
immunocompromised children).
Virucid 800 mg is recommended in children over the age of 6.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_ _
Dosage in adults:
Treatment of varicella and herpes zoster infections: 800 mg Virucid
should be taken five times
daily at approximately four-hourly intervals, omitting the night time
dose. Treatment should
continue for seven days.
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In severely immunocompromised patients (e.g. after marrow transplant)
or in patients with
impaired absorption from the gut, consideration should be given to
intravenous dosing.
Dosing should begin as early as possible after the start of an
infection: Treatment of herpes zoster
yields better results if initiated as soon as possible after the onset
of the rash. Treatment of
chickenpox in immunocompetent patients should begin within 24 hours
after the onset of the
rash.
Dosage in children:
Treatment of varicella infections:
6 years and over: 800 mg Virucid four times daily.
Treatment should continue for five days.
No specific data are available on the treatment of herpes zoster
infections in immunocompetent
children.
For treatment of neonatal herpes virus infections, intravenous
acyclovir is recommended.
Dosage in the elderly:
The possibility of renal impairment in the elderly must be considered
and the dosage should be
adjusted accordingly (see Dosage in renal impairment below).
Adequate hydration of elderly patients taking high oral doses of
aciclovir should be maintained.
Dosage in renal impairment:
Caution
is
advised
when
administering
aciclovir
to
patients
with
impaired
renal
function.
Adequate hydra