Vectatone
SUMMARY OF PRODUCTS CHARACTERISTICS
NAME OF THE MEDICINAL PRODUCT
Vectatone 1%
cream
1 gram of Vectatone cream contains 10 mg penciclovir.
Excipients with known effect: Cetostearyl alcohol, propylene glycol.
For the full list of excipients, see section 6.1.
3 Pharmaceutical form
Cream
The cream is beige to light brown.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Vectatone cream is indicated for the treatment of cold
sores (herpes labialis) caused by herpes simplex virus in
immune competent
patients.
4.2 Posology and method of administration
Adults (including older people) and children over 12 years of age:
Vectatone cream should be applied at approximately two hourly intervals during waking hours. Vectatone cream shall be applied with a clean finger in the amount required for the size of the affected area of skin. Treatment should be continued for 4 days.
Treatment should be started as early as possible after the first sign of an infection; but effect is also shown when the treatment is started later in the process (when the papule or vesicle has developed).
Paediatric population
Children (below 12 years of age):
No data are available for children below 12 years of age.
4.3 Contraindications
Hypersensitivity to
penciklovir, famciclovir or any of the excipients listed in section
6.1.
4.4 Special warnings and precautions for use
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, nose or genitals). Particular care should be taken to avoid application in or near the eyes.
Treatment of HSV-infection with patients having concomitant dermatitis of other origin per oral has not been studied.
The cream should not be given to strongly immunosuppressed individuals such as AIDS-patients and transplanted patients since an increased risk of development of resistance cannot be excluded for these patients. Such patients must be advised to consult a physician before the treatment of any infection.
The cream contains
cetostearyl alcohol, which may cause local skin reactions (e.g.
contact dermatitis). It also contains propylene glycol, which may
cause skin irritations.
4.5 Interaction with other medicinal products and other forms of interaction
No interaction
studies have been performed. Clinical trial experience has not
identified any interactions resulting from concomitant
administration of topical or systemic drugs with Vectatone
cream.
4.6 Fertility, pregnancy and lactation
Pregnancy
There is unlikely to be any cause for concern regarding adverse effects when the cream is used in pregnant women as systemic absorption of penciclovir following topical administration of Vectatone cream has been shown to be minimal (see Section 5.2).
Breast-feeding
There is no information on the excretion of penciclovir in human milk. There is unlikely to be any cause for concern regarding adverse effects when the cream is used in lactating women as systemic absorption of penciclovir following topical administration of Vectatone cream has been shown to be minimal (see Section 5.2).
Like all drugs,
pregnant and breastfeeding women should avoid taking this product
unless benefits outweigh the risks in view of the treating
physician.
4.7 Effects on ability to drive and use machines
Vectatone has no
influence on the ability to drive and use machines.
4.8 Undesirable effects
Clinical trial experience has shown that there was no difference between Vectatone cream and placebo in the frequency or type of adverse reactions reported. The most common adverse reactions are application site reactions.
Adverse reactions are listed
below by system organ class and frequency. Frequencies are defined
as: very
common(>1/10);
common(>1/100 to < 1/10); uncommon(>1/1,000
to <1/100);
rare(> 1/10,000 to < 1/1,000); very rare(<1/10,000), not known (cannot be estimated from the
available data). Within each frequency grouping, undesirable
effects are presented in order of decreasing seriousness.
General disorders and administration site
conditions
Common Application site reactions (including skin burning sensation, pain of skin, hypoaesthesia)
Post-marketing surveillance has revealed the following
adverse reactions (all reactions were either localised or
generalised). The frequency of adverse reactions from
post-marketing surveillance is difficult to calculate, hence, the
frequency is defined as not known.
Immune system disorders
Hypersensitivity, urticaria
Skin and subcutaneous tissue disorders
Dermatitis allergic (including rash, pruritus, blisters and oedema)
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in
[To be completed
nationally]
4.9 Overdose
No untoward effects
would be expected even if the entire contents of a container of
Vectatone cream were ingested orally; penciclovir is poorly
absorbed following oral administration. However, some irritation in
the mouth could occur. No specific treatment is necessary if
accidental oral ingestion occurs.
5 PHARMACOLOGICAL PROPERTIES
Pharmacotherapeutic group: Aantivirals, ATC code: D06BB06
Mechanism of action
Penciclovir has demonstrated in vivoand
in vitro activity against herpes simplex viruses (types 1 and
2) and varicella zoster virus. Penciclovir affetcs virus-infected
cells and is rapidly converted to triphosphate (mediated via
virus-induced thymidine kinase).
Pharmacodynamic
effects
Penciclovir triphosphate is present in infected cells for more than 12 hours and inhibits replication of viral DNA. The half-live of penciclovir triphosphate is 9, 10 and 20 hours, respectively, in cells infected with varicella zoster virus, herpes simplex virus type 1 and herpes simplex virus type 2, respectively.In uninfected cells exposed to penciclovir, concentrations of penciclovir triphosphate are barely detectable. Accordingly, uninfected cells are unlikely to be affected by therapeutic concentrations of penciclovir.
Clinical efficacy and safety
Treatment with Vectatone cream
reduces the time for excretion of virus, for pain and for healing
with up to 24 hours.
Following application of Vectatone cream in a healthy human volunteer study at a daily dose of 180 mg penciclovir (approximately 67 times the proposed therapeutic daily dose), to occluded and abraded skin for 4 days, penciclovir was not quantifiable in plasma and urine.
Local administration of penciclovir 5% cream for 4 weeks to rats and rabbits was well tolerated. There was no evidence of local reactions when administrered to guinea pigs.
A full preclinical programme has been conducted for penciclovir administrated intravenously. The results of these studies did not raise any safety concerns regarding local use of penciclovir cream. There is a minimal systemic absorption of penciclovir following local administration.
The
results of extensive mutagenicity studies in vitroand in
vivodo not indicate that
locally administered penciclovir poses a genotoxic systemic risk to
human.
6 Pharmaceutical particulars
6.1 List of excipients
Paraffin, soft white
Paraffin, liquid
Cetostearyl alcohol
Propylene glycol
Macrogol cetostearyl ether 1000
Iron oxide, red and yellow (E172)
Water,
purified
6.2 Incompatibilities
Not
applicable
6.3 Shelf life
3 years
6.4 Special precautions for storage
Store below 30
°C.Do not
freeze.
6.5 Nature and contents of container
2 g and 5 g aluminium tube closed with a plastic screw cap (polyethene). The tube is lined on the inside with an epoxy-phenol resin lacquer.
Not all pack sizes may
be marketed.
6.6 Special precautions for disposal and other handling
No special
requirements.
marketing authorisation number(s)
[To
be completed nationally]
date of revision of the text
2014-06-12