Acyclovir Auxilto Cream 5% ww

Χώρα: Μαλαισία

Γλώσσα: Αγγλικά

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

Δραστική ουσία:

ACYCLOVIR

Διαθέσιμο από:

STADPHARM SDN. BHD.

INN (Διεθνής Όνομα):

ACYCLOVIR

Μονάδες σε πακέτο:

10 gm

Κατασκευάζεται από:

Farmalabor Produtos Farmaceuticos S.A

Φύλλο οδηγιών χρήσης

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
ACYCLOVIR AUXILTO CREAM
Acyclovir (5% w/w)
1
What is in this leaflet
1.
What Acyclovir Auxilto Cream is
used for.
2.
How Acyclovir Auxilto Cream
works.
3.
Before you use Acyclovir Auxilto
Cream.
4.
How to use Acyclovir Auxilto
Cream.
5.
While you are using it.
6.
Side effects.
7.
Storage and disposal of Acyclovir
Auxilto Cream.
8.
Product description.
9.
Manufacturer and
Product
Registration Holder.
10.
Date of revision.
11.
Serial Number
WHAT ACYCLOVIR AUXILTO CREAM IS
USED FOR
Acyclovir Auxilto Cream is used to
treat cold sores and genital infections
caused by the Herpes simplex virus.
HOW ACYCLOVIR AUXILTO CREAM WORKS
Acyclovir Auxilto Cream contains a
medicine called aciclovir. This belongs
to a group of medicines called
antivirals. It works by killing or
stopping the growth of viruses that
cause cold sores or genital herpes.
BEFORE YOU USE ACYCLOVIR AUXILTO
CREAM
_When you must not use it _
Do not use Acyclovir Auxilto Cream
if:
•
you
are
allergic
to
acyclovir,
valacyclovir or any other ingredients
listed at the end of this leaflet
•
_Before you start to use it _
Tell your doctor or pharmacist if:
•
you
have
a
condition
where
your
immune system works less well, and
your
body
is
less
able
to
fight
infections
(e.g.
if
you
have
human
immunodeficiency
virus
(HIV)
or
AIDS
or
if
you
have
had
a
bone
marrow transplant).
_Pregnancy and breast-feeding _
Ask your doctor or pharmacist before
using any medicine.
_Taking other medicines _
Please tell your doctor or pharmacist if
you are taking or have recently taken
any other medicines. This includes
traditional products or medicines
bought without a prescription.
HOW TO USE ACYCLOVIR AUXILTO CREAM
_How much to use _
Always use Acyclovir Auxilto Cream
exactly as your doctor has told you.
You should check with your doctor or
pharmacist if you are not sure.
_ _
_Adults and children _
•
Apply a thin layer of cream to the
affected area five times a day.
•
You should space each application of
Acyclovir
Auxilto
Cream

Αρχείο Π.Χ.Π.

ACYCLOVIR AUXILTO CREAM 5% W/W
1. NAME OF THE MEDICINAL PRODUCT
Acyclovir Auxilto Cream 5% w/w
2. COMPOSITION
Active Substance:
Each gram of cream contains 50 mg of acyclovir (5% of acyclovir, w/w).
List of Excipients:
Cetostearyl alcohol, liquid paraffin, propylene glycol, sodium
laurilsulfate,
poloxamer 407, white soft paraffin and purified water.
3. PHARMACEUTICAL FORM
Cream.
Acyclovir Auxilto Cream 5% w/w appears as a smooth, white cream, with
a
characteristic odour, free from clumps, clots or foreign particles.
4. INDICATIONS
Acyclovir Auxilto Cream 5% w/w is indicated for the treatment of
herpes
simplex virus infections of the skin including initial and recurrent
genital
herpes and herpes labialis.
5. ADMINISTRATION AND DOSAGE
Administration
For topical use
Dosage
Adults and children:
Acyclovir Auxilto Cream 5% w/w should be applied five times daily at
approximately four hourly intervals omitting the night time
application.
Acyclovir Auxilto Cream 5% w/w should be applied to the lesions or
impending lesions as soon as possible, preferably during the earliest
stages
(prodrome or erythema). Treatment can also be started during the later
(papule
or blister) stages. Treatment should be continued for at least 4 days
for
_herpes _
_labialis_
and for 5 days for genital herpes. If healing has not occurred
treatment
may be continued for up to 10 days.
6. CONTRAINDICATIONS
Hypersensitivity to acyclovir or to any of the excipients.
7. SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Acyclovir
Auxilto
Cream
5%
w/w
should
not
be
applied
to
mucous
membranes, namely in the mouth, eyes or vagina, since it may be
irritating.
Patients should take precautions in order to avoid transmitting the
virus,
particularly when active lesions are present.
Acyclovir Auxilto Cream 5% w/w contains propylene glycol, which may
cause skin irritation.
Acyclovir Auxilto Cream 5% w/w contains cetostearyl alcohol, which may
cause local skin reactions (e.g., contact dermatitis).
8. PREGNANCY AND LACTATION
_Pregnancy_
No studies have been conducted concer