Adco Acyclovir Topical Cream

S4 Aciclovir is effective in the treatment of viral infections due to Herpes simplex type 1 and type 2 of the skin and genitalia in the initial and recurrent situation.

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 aciclovir 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 associate 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 If signs and symptoms suggestive of DRESS appear, ADCO-ACYCLOVIR TOPICAL CREAM should be withdrawn immediately and an alternative treatment considered (as appropriate).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) oral acyclovir dosing should be considered. Such patients should be encouraged to consult a physician concerning the treatment of any infection. ADCO-ACYCLOVIR TOPICAL CREAM is not recommended for application to mucous membranes such as in the mouth, eye or vagina, as it may be irritant. 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 30 mg per gram of cetostearyl alcohol and may cause local skin reactions (e.g., contact dermatitis). ADCO-ACYCLOVIR TOPICAL CREAM contains 100 mg per gram of propylene glycol and may cause skin irritation. ADCO-ACYCLOVIR TOPICAL CREAM contains 7.5 mg per gram of benzyl alcohol and may cause allergic reactions and mild local irritation.

Probenecid increases the mean half-life and area under the plasma concentration curve. Other medicines affecting renal physiology could potentially influence the pharmacokinetics of acyclovir. However, clinical experience has not identified other medicines 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 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 or burning, erythema. 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 uricaria.

Drug reaction with eosinophilia and systemic symptoms (DRESS) (see section 4.4)*

*Post-marketing experience

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the ADCO-ACYCLOVIR TOPICAL CREAM is important. It allows continued monitoring of the benefit/risk balance of the ADCO-ACYCLOVIR TOPICAL CREAM. Health care providers are requested to report any suspected adverse drug reactions to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA website.

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