Vectavir Cold Sore Cream

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Penciclovir

Available from:

Chefaro Ireland DAC

ATC code:

D06BB; D06BB06

INN (International Name):

Penciclovir

Dosage:

1 %w/w

Pharmaceutical form:

Cream

Prescription type:

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

Therapeutic area:

Antivirals; penciclovir

Authorization status:

Not marketed

Authorization date:

2001-02-28

Patient Information leaflet

Package Leaflet
CONFIDENTIAL
Page 1
Vectavir Cold Sore Cream
PACKAGE LEAFLET: INFORMATIOM FOR THE USER
VECTAVIR COLD SORE CREAM
Penciclovir
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 or pharmacist.
•
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 or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Vectavir is and what it is used for
2.
What you need to know before you use Vectavir
3.
How to use Vectavir
4.
Possible side effects
5.
How to store Vectavir
6.
Contents of the pack and other information
1.
WHAT VECTAVIR IS AND WHAT IT IS USED FOR
Vectavir is used for the treatment of cold sores (Herpes labialis). A
cold sore is caused by a viral
infection. The virus can remain inactive for extended periods of time,
but when triggered the virus
multiplies and a cold sore develops. This can occur, for example when
you are run-down, when you
have a cold or flu, or when you have been out in strong sunlight. The
virus causes painful blistering of
the lips.
Vectavir contains penciclovir and is an antiviral medicine which stops
the virus multiplying. Applying
Vectavir means your cold sore heals faster and the duration of pain
will be shorter. The time your cold
sore is infectious will also be shorter, although applying Vectavir
will not stop you spreading your cold
sores to another person.
You must talk to a doctor if you do not feel better or if you feel
worse after 4 days.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE VECTAVIR
DO NOT USE VECTAVIR:
If you are allergic to penciclovir, famciclovir or any of the other
ingredients of Vectavir (listed in
section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharma

Summary of Product characteristics

Health Products Regulatory Authority
29 November 2022
CRN00CPK4
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Vectavir Cold Sore Cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram of the cream contains 10 mg penciclovir.
Excipients with known effect:
cetostearyl alcohol, propyleneglycol.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cream
Smooth white cream of homogeneous appearance.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Vectavir Cold Sore Cream is indicated for the treatment of cold sores
(herpes labialis) in adults (including older people) and
children over 12 years of age.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults (including older people)and children over12 years ofage:
Vectavir Cold Sore Cream should be applied at approximately two hourly
intervals during waking hours.
Paediatric population
Children (under 12 years):
The safety and efficacy of Vectavir Cold Sore Cream in children below
12 years of age have not been established.
No data are available.
Method of administration
Vectavir Cold Sore Cream may be applied with a clean finger, or with a
single-use applicator (for packages which contain
applicators), in the amount required for the size of the affected area
of skin. Treatment should becontinued for 4 days.
Treatment should be started as early as possible after the first sign
of an infection.
4.3 CONTRAINDICATIONS
Hypersensitivity to penciclovir, famciclovir or to any of
theexcipients listed in section 6.1.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Health Products Regulatory Authority
29 November 2022
CRN00CPK4
Page 2 of 5
The cream should only be used on cold sores on the lips and around the
mouth. It is not recommended for application to
mucous membranes (e.g. in the eyes, mouth, or nose or on the
genitals). Particular care should be taken to avoid application in
or near the eyes.
Severely immunocompromised patients (eg AIDs patients or bone marrow
transplant recipients) should be encouraged to
consult a ph