Medovir cream 5%

Land: Malta

Tungumál: enska

Heimild: Malta Medicines Authority

Virkt innihaldsefni:

ACICLOVIR

Fáanlegur frá:

Medochemie Limited 1-10 Constantinoupleos Street, 3011 Limassol, Cyprus

ATC númer:

D06BB03

INN (Alþjóðlegt nafn):

ACICLOVIR 5 % (W/W)

Lyfjaform:

CREAM

Samsetning:

ACICLOVIR 5 % (W/W)

Gerð lyfseðils:

OTC

Lækningarsvæði:

ANTIBIOTICS AND CHEMOTHERAPEUTICS FOR DERMATOLOGICAL USE

Leyfisstaða:

Authorised

Leyfisdagur:

2007-04-26

Upplýsingar fylgiseðill

PACKAGE LEAFLET: INFORMATION FOR THE USER
MEDOVIR CREAM 5%
Aciclovir
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
ALWAYS USE THIS MEDICINE EXACTLY AS DESCRIBED IN THIS LEAFLET OR AS
YOUR DOCTOR OR PHARMACIST
HAVE TOLD YOU.
-Keep this leaflet. You may need to read it again.
-Ask your pharmacist if you need more information or advice.
-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.
-
You must talk to a doctor if you do not feel better or if you feel
worse after 10 days.
WHAT IS IN THIS LEAFLET
1.
What Medovir is and what it is used for
2.
What you need to know before you use Medovir
3.
How to use Medovir
4.
Possible side effects
5
How to store Medovir
6.
Contents of the pack and other information
1.
WHAT MEDOVIR IS AND WHAT IT IS USED FOR
Acyclovir is an anti-viral used to treat herpes simplex infections.
This cream it is used to treat
cold sores, genital herpes and other skin infections caused by herpes
simplex virus. It is not for
use in your eyes or inside your mouth or vagina.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE MEDOVIR
DO NOT USE MEDOVIR:
1
•
If you are allergic to aciclovir or valaciclovir, or any of the other
ingredients of this
medicine (listed in section 6),
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using aciclovir:
•
if you have any problems which might weaken your immune system, HIV
infection, a
bone marrow transplant or cancer treatment.
OTHER MEDICINES AND MEDOVIR
Tell your doctor or pharmacist if you are using, have recently used or
might use any other
medicines.
It is especially important if you are taking:
• Probenecid (used for gout).
PREGNANCY, BREAST-FEEDING AND FERTILITY
If you are pregnant or breast-feeding, think you may be pregnant or
are planning to have a baby,
ask your doctor or pharmacist for advice before taking this medicine.
MEDOVIR CONTAINS PROPYLENE GLYCOL AND CETOSTEARYL ALC

Vara einkenni

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Medovir cream 5%.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Medovir cream contains 5% w/w aciclovir.
Excipients with known effect: propylene glycol, cetostearyl alcohol.
Each 1 g of Medovir cream contains 0.15 g propylene glycol.
Each 1 g of Medovir cream contains 0.045 g cetostearyl alcohol.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
White, soft, homogenous, smooth, odourless cream.
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 genital herpes and herpes labialis. It
is not for use in the eye,
mouth or genital tract.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults _
The cream should be applied five times a day, at about four hour
intervals, but
missing
the
night
time
application.
It
should
be
continued
for
five
days.
If
healing
is
not
Page 1 of 8
complete at this time, treatment may be continued for an additional
five days.
_Paediatric population _
As for adults.
_Elderly _
As for adults.
_Renal impairment _
No adjustment needed for topical application.
Method of administration
The cream should be applied to the lesion, or impending lesion, as
quickly as possible after
the start of infection. Initiation of treatment in the prodromal
period or when lesions first
appear is especially important in recurrent episodes.
4.3.
CONTRAINDICATIONS
•
Hypersensitivity to the active substance 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.
In severely immunocompromised patients (e.g. AIDS patients or bone
marrow transplant
recipients) oral Medovir dosing should be considered. Such patients
should be encouraged to
consult a physici