Zoviduo 50mg/g and 10mg/g Cream

Valsts: Malta

Valoda: angļu

Klimata pārmaiņas: Malta Medicines Authority

Aktīvā sastāvdaļa:

ACICLOVIR, HYDROCORTISONE

Pieejams no:

Haleon Hellas Single Member Societe Anonyme, under the distinctive title of Haleon Hellas, 274, Kifissias Ave, 15232 chalandri, Athens, Greece

ATĶ kods:

D06BB53

SNN (starptautisko nepatentēto nosaukumu):

ACICLOVIR 50 mg HYDROCORTISONE 10 mg

Zāļu forma:

CREAM

Kompozīcija:

ACICLOVIR 50 mg HYDROCORTISONE 10 mg

Receptes veids:

OTC

Ārstniecības joma:

ANTIBIOTICS AND CHEMOTHERAPEUTICS FOR DERMATOLOGICAL USE

Autorizācija statuss:

Authorised

Autorizācija datums:

2017-03-09

Lietošanas instrukcija

Page 1 of 6
PACKAGE LEAFLET: INFORMATION FOR THE USER
ZOVIDUO 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.
Always use this medicine exactly as described in this leaflet or as
your doctor or pharmacist
has 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 your symptoms persist 5 days after you
have completed the
treatment
WHAT IS IN THIS LEAFLET:
1.
What Zoviduo is and what it is used for
2.
What you need to know before you use Zoviduo
3.
How to use Zoviduo
4.
Possible side effects
5.
How to store Zoviduo
6.
Contents of the pack and other information
1.
WHAT ZOVIDUO IS AND WHAT IT IS USED FOR
Zoviduo 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.
Zoviduo 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, Zoviduo 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.
P

Produkta apraksts

Page 1 of 7
SUMMARY OF THE PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Zoviduo 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 6.1.
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.
Page 2 of 7
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.
Use for skin lesions caused by any virus other than herpes simplex, or
for fungal, bacterial or
parasitic skin infections.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
For cutaneous use only: