Zovirax Duo 50 mg/g and 10 mg/g Cream

Ülke: İrlanda

Dil: İngilizce

Kaynak: HPRA (Health Products Regulatory Authority)

Aktif bileşen:

ACICLOVIR PH. EUR.; HYDROCORTISONE PH. EUR.

Mevcut itibaren:

Haleon Ireland Limited

ATC kodu:

D06BB; D06BB53

INN (International Adı):

ACICLOVIR PH. EUR.; HYDROCORTISONE PH. EUR.

Doz:

50mg/g +10 milligram(s)/gram

Farmasötik formu:

Cream

Reçete türü:

Product subject to prescription which may not be renewed (A)

Terapötik alanı:

Antivirals; aciclovir, combinations

Yetkilendirme durumu:

Not marketed

Yetkilendirme tarihi:

2017-04-13

Bilgilendirme broşürü

1 PACKAGE LEAFLET: INFORMATION FOR THE USER
ZOVIRAX DUO 50 MG/G AND 10 MG/G CREAM
Aciclovir and Hydrocortisone
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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.
-
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. This includes any
possible side effects not listed in
this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What Zovirax Duo is and what it is used for
2.
What you need to know before you use Zovirax Duo
3.
How to use Zovirax Duo
4.
Possible side effects
5.
How to store Zovirax Duo
6.
Contents of the pack and other information
1.
WHAT ZOVIRAX DUO IS AND WHAT IT IS USED FOR
Zovirax Duo contains two active substances: aciclovir and
hydrocortisone. Aciclovir is an antiviral that helps
to fight the virus that causes cold sores. Hydrocortisone is a mild
steroid that reduces the inflammation
associated with a cold sore.
Zovirax Duo cream is used for the treatment of early signs and
symptoms (e.g. tingling, itching or redness)
of cold sores on the lips and skin close to the lips to reduce the
chance of a cold sore progressing to a blister
in adults and adolescents (12 years and older).
Even if your cold sore does develop into a blister, Zovirax Duo will
shorten the healing process by
approximately half to one day compared with the cream without the
active substances.
A cold sore is caused by a virus called herpes simplex. The virus
causes blisters and sores primarily on the
lips but sometimes also in other areas on the face. A cold sore can
develop when the body’s immune system
is weakened, for example when you have a cold or other infection.
Stress, strong sunlight, cold temperatures
or menstruation can also trigger a cold sore.
You must talk to a doctor if your symptoms persist 5

Ürün özellikleri

Health Products Regulatory Authority
18 April 2023
CRN00DGFF
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zovirax Duo 50 mg/g and 10 mg/g Cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 gram cream contains 50 mg aciclovir and 10 mg hydrocortisone.
Excipients with known effect: 67,5 mg cetostearyl alcohol, 8 mg sodium
laurilsulphate and 200 mg propylene glycol / gram
cream.
For the full list of excipients, see section 6.
3 PHARMACEUTICAL FORM
Cream
White to yellowish cream
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of early signs and symptoms of recurrent herpes labialis
(cold sores) to reduce the progression of cold sore episodes
to ulcerative lesions in immunocompetent adults and adolescents (12
years of age and older).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology.
_Adults and adolescents (12 years of age and older)._
Zoviduo should be applied five times per day for 5 days, (i.e.
approximately every 3-4 hours omitting the night time
application). Treatment should be initiated as early as possible,
preferably immediately after the first signs or symptoms. A
sufficient quantity of the cream should be applied each time to cover
the affected area including the outer margin of the
lesions, if present.
Treat for 5 days. If lesions are still present 5 days after completed
treatment, users should be advised to consult a doctor.
_Paediatric population _
The safety and efficacy of Zoviduo in children below 12 years have not
yet been established.
Method of administration
Cutaneous use only.
Users should wash their hands before and after applying the cream and
avoid unnecessary rubbing of the lesions or touching
them with a towel, to avoid aggravating or transferring the infection.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substances, valaciclovir or to any of
the excipients listed in section 6.1.
Health Products Regulatory Authority
18 April 2023
CRN00DGFF
Page 2 of 6
Use for skin lesions caused by any virus other than herpes simplex, or
for fungal, ba