Beta- Vira Topical Cream

BETA-VIRA TOPICAL CREAM is applied to the lips in the early treatment of recurrent Herpes simplex virus infections.

Posology
Adults and Children: BETA-VIRA TOPICAL CREAM may be applied five to six times daily or every three to 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.

Method of administration
Topical application on lesions.

BETA-VIRA TOPICAL CREAM is contraindicated in: Patients with known hypersensitivity to acyclovir, valacyclovir and propylene glycol or to any of the excipients in the formulation (see section 6.1).

Topical applications of BETA-VIRA TOPICAL CREAM may produce burning or erythema. In severely immune compromised patients (e.g., AIDS patients or bone marrow transplant recipients), topical application of BETA-VIRA TOPICAL CREAM may be inappropriate. BETA-VIRA 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. Care should be taken to avoid accidental introduction into the eye. Resistance has been reported with varicella zoster virus. BETA-VIRA TOPICAL CREAM contains cetostearyl alcohol and may cause local skin reactions such as contact dermatitis. BETA-VIRA TOPICAL CREAM contains propylene glycol and may cause skin irritation. BETA-VIRA TOPICAL CREAM contains benzyl alcohol and may cause allergic reactions and mild local irritation. 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 BETA-VIRA 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 If signs and symptoms suggestive of DRESS appear, BETA-VIRA TOPICAL CREAM should be withdrawn immediately, and an alternative treatment considered (as appropriate). If the patient has developed DRESS with the use of BETA-VIRA TOPICAL CREAM, treatment with BETA-VIRA TOPICAL CREAM must not be restarted in this patient at any time.

Probenecid increases the acyclovir mean half-life and area under the plasma concentration curve. Other medicines affecting renal physiology could potentially influence the pharmacokinetics of acyclovir. No clinically significant interactions have been identified.

Pregnancy: The safety of BETA-VIRA TOPICAL CREAM in pregnancy has not been established.
Breastfeeding: The safety of BETA-VIRA TOPICAL CREAM in lactation has not been established. Limited human data show that acyclovir does pass into breast milk.
Fertility: Information on the effect of BETA-VIRA TOPICAL CREAM on human female fertility is not available. No clinical significance of the effect BETA-VIRA TOPICAL CREAM on male fertility has been established.

The effects on ability to drive and use of machines has not been established with the use of BETA-VIRA TOPICAL CREAM.

The following undesirable effects are classified according to MedDRA system organ class using the following convention: frequent, less frequent and frequency unknown.
Frequency System organ class Undesirable effects
Less frequent Skin and subcutaneous tissue disorders u2022 transient burning or stinging; u2022 Erythema or mild drying and flaking of the skin; u2022 Itching; u2022 Contact dermatitis following application.
Less frequent Immune system disorders u2022 Immediate hypersensitivity reactions including angioedema. Post-marketing experience: The following adverse reaction has been identified during post approval use of BETA-VIRA TOPICAL CREAM. Immune system: Drug reaction with eosinophilia and systemic symptoms (DRESS) (see Section 4.4). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Health care providers are asked to report any suspected adverse reactions to SAHPRA via the u201c6.04 Adverse Drug Reactions Reporting Formu201d, found online under SAHPRAu2019s publications: https://www.sahpra.org.za/Publications/Index/8. Adverse Drug Reactions may also report to Adcock Ingram Limited using the following email: [email protected]

Treatment of overdosage of BETA-VIRA TOPICAL CREAM is symptomatic and supportive. In overdose, side effects can be precipitated and /or be of increased severity (see section 4.8).