Adco Acyclovir Topical Cream

Application to the lips in the early treatment of recurrent Herpes simplex virus infection.

Adults and children: The topical cream may be applied five or six times daily every three or four hours for periods of five to ten days. Topical treatment of lesions caused by Herpes simplex should be initiated as early as possible. It is particularly important to start treatment of recurrent episodes during the prodromal period or when the lesions first appear.

Paediatric population: As applicable to adults.

Method of administration: Topical application.

• Hypersensitivity to acyclovir and propylene glycol or to any of the excipients of ADCO-ACYCLOVIR TOPICAL CREAM listed in section 6.1.
• Safety of ADCO-ACYCLOVIR TOPICAL CREAM in pregnancy and lactation has not been established.

Topical applications of acyclovir may sometimes produce burning or erythema.

Severe cutaneous adverse reactions (SCARs): Drug reaction with eosinophilia and systemic symptoms (DRESS) DRESS, which can be life-threatening or fatal, has been reported in association with ADCO-ACYCLOVIR TOPICAL CREAM treatment. At the time of prescription, patients should be advised of the signs and symptoms and monitored closely for skin reactions. If signs and symptoms suggestive of DRESS appear, ADCO-ACYCLOVIR TOPICAL CREAM should be withdrawn immediately, and an alternative treatment considered (as appropriate). If the patient has developed DRESS with the use of ADCO-ACYCLOVIR TOPICAL CREAM, treatment with ADCO-ACYCLOVIR TOPICAL CREAM must not be restarted in this patient at any time.

In severely immune compromised patients (e.g., AIDS patients or bone marrow transplant recipients or cancer treatment) topical ADCO-ACYCLOVIR TOPICAL CREAM may be inappropriate. Such individuals should be encouraged to consult a physician concerning the treatment of an infection.

ADCO-ACYCLOVIR TOPICAL CREAM is intended for cutaneous use only and is not recommended for application to mucous membranes, such as in the mouth, eye or vagina. Particular care should be taken to avoid accidental introduction into the eye. ADCO-ACYCLOVIR TOPICAL CREAM contains a specially formulated base and should not be diluted or used as a base for the incorporation of other medicaments. ADCO-ACYCLOVIR TOPICAL CREAM contains cetostearyl alcohol and may cause local skin reactions (e.g., contact dermatitis). ADCO-ACYCLOVIR TOPICAL CREAM contains propylene glycol and may cause skin irritation. ADCO-ACYCLOVIR TOPICAL CREAM contains benzyl alcohol and may cause allergic reactions and mild local irritation.

Probenecid increases the mean half-life and area under the plasma concentration curve of systemically administered acyclovir. Other medicines affecting renal physiology could potentially influence the pharmacokinetics of acyclovir. However, clinical experience has not identified other drug interactions with acyclovir. No clinically significant interactions have been identified.

Pregnancy: The safety of ADCO-ACYCLOVIR TOPICAL CREAM in pregnancy has not been established.

Breastfeeding: The safety of ADCO-ACYCLOVIR TOPICAL CREAM in lactation has not been established. Limited human data show that acyclovir does pass into breast milk.

Fertility: There is no information on the effect of ADCO-ACYCLOVIR TOPICAL CREAM on human female fertility. In a reported study of 20 male patients with normal sperm count, oral acyclovir administered at doses of up to 1 g per day for up to six months has been shown to have no clinically significant effect on sperm count, motility or morphology.

This medicine has no influence on ability to drive or operate machinery.

Tabulated list of adverse reactions

MedDRA system organ Class Frequency Side effects

Skin and subcutaneous tissue disorders Less frequent Transient stinging, burning or erythema may occur. Mild drying and flaking of the skin may occur. Itching. Contact dermatitis following application. Where sensitivity tests have been conducted, the reactive substances have most often been shown to be components of the cream rather than acyclovir.

Immune system disorders Less frequent Immediate hypersensitivity reactions including angioedema and urticaria. Frequency unknown Drug reaction with eosinophilia and systemic symptoms (DRESS) (see section 4.4)*

*Post-marketing experience

Treatment is symptomatic and supportive if accidental ingestion has occurred. Acyclovir is dialysable (See section 4.8 and section 4.4).