Virucid

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

ACICLOVIR

Available from:

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

ATC code:

J05AB01

INN (International Name):

ACICLOVIR 200 mg

Pharmaceutical form:

TABLET

Composition:

ACICLOVIR 200 mg

Prescription type:

POM

Therapeutic area:

ANTIVIRALS FOR SYSTEMIC USE

Authorization status:

Authorised

Authorization date:

2006-06-01

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
VIRUCID 200 MG TABLETS
VIRUCID 400 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 might 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 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 contains a medicine called aciclovir. This belongs to a group
of medicines called
antivirals. It works by killing or stopping the growth of viruses.
Virucid can be used to:
•
treat chickenpox and shingles
•
treat cold sores and genital herpes
•
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
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE VIRUCID
DO NOT TAKE 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.
2
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
Please tel

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICAL PRODUCT
Virucid 200 mg Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 200 mg aciclovir.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablets.
Virucid 200 mg tablets are white, concave, round tablets, scored on
one side.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Virucid Tablets are 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).
Virucid Tablets are indicated for the suppression (prevention of
recurrences) of recurrent herpes
simplex infections in immunocompetent patients.
Virucid Tablets are indicated for the prophylaxis of herpes simplex
infections in immuno-compromised
patients.
Virucid Tablets are indicated for the treatment of varicella
(chickenpox) and herpes zoster (shingles)
infections.
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Route of administration: Oral
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Ensure that patients on high doses of aciclovir are adequately
hydrated.
Dosage in adults
Treatment
of
herpes
simplex
infections:
200
mg
Virucid
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 400 mg Virucid 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 patients:
200 mg Virucid should be
taken four times daily at approximately six-hourly intervals.
Many patients may be conveniently managed