Zovirax Cold Sore 5% w/w Cream

Riik: Iirimaa

keel: inglise

Allikas: HPRA (Health Products Regulatory Authority)

Toimeaine:

Aciclovir

Saadav alates:

Haleon Ireland Limited

ATC kood:

D06BB; D06BB03

INN (Rahvusvaheline Nimetus):

Aciclovir

Annus:

5.0 percent weight/weight

Ravimvorm:

Cream

Retsepti tüüp:

Product not subject to medical prescription

Terapeutiline ala:

Antivirals; aciclovir

Volitamisolek:

Marketed

Loa andmise kuupäev:

1993-07-16

Infovoldik

Patient information leaflet
PLEASE READ RIGHT THROUGH THIS LEAFLET BEFORE YOU START USING THIS
MEDICINE. This
medicine is available without prescription, but you still need to use
Zovirax Cold
Sore Cream carefully to get the best results from it.
•
Keep this leaflet, you may need to read it again.
•
If you have any further questions, ask your pharmacist.
IN THIS LEAFLET:
1.
What Zovirax does
2.
Check before you use Zovirax
3.
How to use Zovirax
4.
Possible side effects
5.
How to store Zovirax
6.
Further information
1. What Zovirax does
ZOVIRAX IS USED FOR THE TREATMENT OF COLD SORES. The active ingredient
is aciclovir,
an antiviral agent. APPLY AT THE FIRST SIGNS OF A COLD SORE (such as
tingling and
itching). It can also be used to speed up healing if one has already
appeared and
shorten the duration of pain.
2. Check before you use Zovirax
DO NOT USE ZOVIRAX:
•
IF YOU HAVE EVER HAD AN ALLERGIC REACTION to aciclovir, valaciclovir,
propylene
glycol or any of the other ingredients (listed in Section 6).
•
INSIDE YOUR NOSE OR MOUTH (e.g. for MOUTH ULCERS), or for ANYTHING
OTHER than a
COLD SORE.
•
in the EYES or GENITAL AREA.
TAKE SPECIAL CARE WITH ZOVIRAX
•
ALWAYS WASH YOUR HANDS before and after applying Zovirax.
•
DO NOT TOUCH YOUR EYES until you have washed your hands after
application.
•
IF YOU ACCIDENTALLY GET CREAM IN YOUR EYE, wash out thoroughly with
warm water. Consult your doctor if you are concerned.
•
DO NOT SWALLOW the cream. If you accidentally swallow any cream, it
is unlikely to cause any ill effects but consult your doctor if you
are
concerned.
•
AVOID TOUCHING A COLD SORE to prevent transferring the infection or
making it worse.
•
If you have been told by your doctor that you have a WEAKENED
IMMUNE SYSTEM, contact your doctor before treating any type of
infection.
•
IF YOU ARE IN ANY DOUBT IF YOU HAVE A COLD SORE, contact your doctor.
•
IF YOUR COLD SORE GETS VERY SEVERE, contact your doctor.
USING OTHER MEDICINES
Tell your doctor or pharmacist before use if you are takin

Toote omadused

Health Products Regulatory Authority
05 July 2023
CRN00DPJ2
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zovirax Cold Sore 5% w/w Cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
5% w/w aciclovir
Excipients with known effects: contains 40 %w/w propylene glycol (E
1520), 6.75%w/w Cetostearyl alcohol and 0.75 %w/w
sodium laurilsulfate
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Cream.
A smooth white to off white cream.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Zovirax Cold Sore Cream is indicated for the treatment of Herpes
simplex virus infections of the skin, lips and face (recurrent
herpes labialis).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults:
Zovirax Cold Sore Cream should be applied five times daily at
approximately four hourly intervals omitting the night time
application. Treatment should be continued for at least 4 days. If
healing has not occurred, treatment may be continued for up
to 10 days. If lesions are still present after 10 days users should be
advised to consult a doctor.
Zovirax cold sore cream should be applied as soon as possible,
preferably during the earliest stages (prodome or erythema).
Treatment can also be started during the later (papule or blister)
stages.
Children:
Children should use the adult dose.
4.3 CONTRAINDICATIONS
Hypersensitivity to aciclovir, valaciclovir, propylene glycol or to
any of the excipients listed in section 6.1.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Zovirax Cold Sore Cream should only be used on cold sores on the lips
and face. It is not recommended for application to
mucous membranes, such as in the mouth or eye. Particular care should
be taken to avoid contact with the eye.
In severely immunocompromised patients (e.g. AIDS patients or bone
marrow transplant recipients) oral dosing should be
considered. Such patients should be encouraged to consult a physician
concerning the treatment of any infection.
People with particular severe recurrent herpes labialis should be
encouraged to seek