Fenlips Color

/ Perrigo

Adults (including the elderly) and children over 12 years of age: This drug should be applied at approximately two hourly intervals during waking hours (approximately 8 times a day). 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 be continued for 4 days. If the condition gets worse or does not improve after 4 days treatment, seek medical advice. Treatment should be started as early as possible after the first sign of an infection; moreover the product has been shown to be beneficial in accelerating lesion healing, reducing lesion pain and shortening the duration of viral shedding even in patients who begin treatment later in the disease (e.g. when the papule or vesicle has developed).
Children (under 12 years): No work has been carried out in children below 12 years of age.

Topical treatment of cold sores (herpes labialis) suspected to be caused by Herpes simplex virus. Penciclovir significantly shortens healing time, reduces lesion-associated pain and significantly shortens the duration of viral shedding.

Known hypersensitivity to penciclovir, famciclovir or any of the excipients in the formulation (e.g. propylene glycol).

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, such as in the mouth or eye, or on the genitals.
It must not be used in ocular or genital herpes. Particular care should be taken to avoid application in or near the eyes.
Patients with particularly severe cold sores should be encouraged to seek medical advice.
Patients should be advised to avoid transmitting the virus, particularly when active lesions are present.
Severely immunocompromised patients (e.g. AIDS patients or bone marrow transplant recipients) should be encouraged to consult a physician in case oral therapy is indicated.
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.

Common application site reactions (including skin burning sensation, pain of
skin, hypoaesthesia).
See prescribing information for full details.

Clinical trial experience has not identified any interactions resulting from concomitant administration of topical or systemic drugs with this drug.

Pregnancy: There is unlikely to be any cause for concern regarding adverse effects when the cream is used in pregnant and/or lactating women as systemic absorption of penciclovir following topical administration has been shown to be minimal.
Lactation: There is no information on excretion of penciclovir in human milk.
See prescribing information for full details.

No untoward effects would be expected even if the entire contents of a container of the drug was 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.

Storage: Store below 30°C. Do not freeze.