MEDOVIR CREAM 5% WW

Država: Malezija

Jezik: angleščina

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Aktivna sestavina:

ACYCLOVIR

Dostopno od:

KOMEDIC SDN BHD

INN (mednarodno ime):

ACYCLOVIR

Enote v paketu:

5gm mcg/mL; 5gm %w/w

Izdeluje:

MEDOCHEMIE LTD

Navodilo za uporabo

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
_ _
_ _
MEDOVIR CREAM
Acyclovir (5% w/w)
1
WHAT IS IN THIS LEAFLET
1.
What Medovir is used for
2.
How Medovir works
3.
Before you use Medovir
4.
How to use Medovir
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Medovir
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT MEDOVIR IS USED FOR
Medovir is to treat cold sores, genital
herpes
and
other
herpes
simplex
infections caused by herpes simplex
virus that affects the skin area. The
cream
may
be
used
for
initial
and
recurrent herpes treatment. It is not to
be used on the eyes.
HOW MEDOVIR WORKS
Medovir is an antiviral agent. It treats
infection caused by herpes virus by
inhibiting the production of the virus.
BEFORE YOU USE MEDOVIR
_-When you must not use it_
You should not use Medovir:
-
if
you
have
allergic
reaction
to
acyclovir, valaciclovir or to any of
the
other
ingredients
of
this
medicine
(listed
in
product
description
_ _
_-Before you start to use it _
-
Medovir
cream
is
not
recommended
for
application
to
mucous membranes such as in the
mouth, eye or vagina, as it may be
irritant.
_Pregnancy and Breastfeeding: _
If you are pregnant or breast-feeding,
or think you may be pregnant or are
planning
to
have
a
baby,
ask
your
doctor or pharmacist for advice before
using this medicine. Acyclovir has
been detected in breast milk.
_ _
_-Taking other medicines _
Tell your doctor if you are taking any
other
medicines,
including
any
that
you buy without a prescription from a
pharmacy, supermarket or health food
shop. Inform your doctor if you are
using probenecid (used to treat gout or
high uric acid).
HOW TO USE MEDOVIR
_-How much to use _
Apply it on the affected areas.
_ _
_-When to use it _
Use
as
directed
by
your
doctor
or
pharmacist. Usefive times a day, at
every
three
to
four
intervals,
but
missing the night time applications.
_-How long to use it _
It should be used continuously for five
days. If healing is not complete at this
time, treatment m

Lastnosti izdelka

_SPCaciccream1.2-CY _
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
MEDOVIR 5% w/w cream
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Aciclovir
Each 5g or 10g tube of cream contains aciclovir 5% w/w.
Excipients with known effect: propylene glycol and cetostearyl
alcohol.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Cream
White, soft, homogenous, smooth, odourless cream for cutaneous use.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
MEDOVIR cream is indicated for the treatment of _herpes simplex_ virus
infections of the skin, including initial and
recurrent herpes. Not for ophthalmic use.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The cream should be applied five times a day, at every three to four
hour intervals, but missing the night time
application. It should be continued for five days. If healing is not
complete at this time, treatment may be
continued for an additional five days. It is better to apply MEDOVIR
cream in the very early stages of infection.
4.3.
CONTRAINDICATIONS
Hypersensitivity to the active substance, valaciclovir or to any of
the excipients listed in section 6.1
4.4.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
MEDOVIR cream is not recommended for application to mucous membranes
such as in the mouth, eye or vagina,
as it may be irritant. Particular care should be taken to avoid
accidental introduction into the eye.
The results of a wide range of mutagenicity tests _in vitro_ and _in
vivo_ indicate that aciclovir does not pose a genetic
risk to man. Aciclovir was not found to be carcinogenic in long term
studies in the rat and the mouse.
There has been no experience of the effect of aciclovir cream on human
fertility. Two generation studies in mice
did not reveal any effect of (orally administered) aciclovir on
fertility. Aciclovir tablets have been shown to have
no definite effect upon sperm count, morphology or motility in man.
4.5.
INTERACTIONS WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
Probenecid increases the