Beta – Vira Topical 0,05 g Cream

BETA - VIRA TOPICAL CREAM contains acyclovir, which belongs to a class of medicine known as antivirals. BETA - VIRA TOPICAL CREAM is used in the early treatment of cold sores (Herpes simplex virus). It slows the growth of the virus and speeds up the healing of cold sore blisters.

Do not use BETA - VIRA TOPICAL CREAM

• If you are allergic to acyclovir and propylene glycol or to any of the other ingredients of BETA - VIRA TOPICAL CREAM (listed in section 6).

Warnings and precautions

Special care should be taken with BETA - VIRA TOPICAL CREAM

• If burning occurs or you develop erythema (redness of the skin).
• Do not use on mucous membranes such as in the mouth, eye or vagina as the cream can cause irritation.
• Do not use this cream if you have severe cold sores; you must see a doctor for advice on how to treat it.
• Avoid accidental introduction into the eyes.
• There is reduced effectiveness of BETA - VIRA TOPICAL CREAM in treating varicella zoster virus (virus causing chickenpox).
• If you develop local skin reactions, such as contact dermatitis (itchy rash).

Do not share medicines prescribed for you with any other person. FOR EXTERNAL USE ONLY. Always use BETA - VIRA TOPICAL CREAM exactly as described in this leaflet, or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. 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 cold sore blisters (topical lesions) caused by Herpes simplex (viral infection) should be started as early as possible. In repeated cases of cold sore blisters, start treatment as soon as possible when the cold sore blisters appear.

If you use more BETA - VIRA TOPICAL CREAM than you should

If you use more BETA - VIRA TOPICAL CREAM than you should or if you or a child accidentally swallow the cream, contact your doctor or nearest hospital immediately. Take the packet with you to help with identification. If you overdose, side - effects can be of increased severity.

If you forget to use BETA - VIRA TOPICAL CREAM

If you miss a treatment, apply the cream as soon as you remember, and apply the remaining doses for that day at evenly spaced intervals.

BETA - VIRA TOPICAL CREAM can have side effects. Not all side effects reported for BETA - VIRA TOPICAL CREAM are included in this leaflet. Should your general health worsen or if you experience any untoward effects while using BETA - VIRA TOPICAL CREAM, please consult your health care provider for advice. If any of the following happens, stop using BETA - VIRA TOPICAL CREAM and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of the lips, face and/or eyelids.
• rash, itchy skin, weal.

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to BETA - VIRA TOPICAL CREAM. You may need urgent medical attention or hospitalization. Tell your doctor if you notice any of the following:

Less frequent side effects:

• A burning or stinging feeling after applying the cream that goes away;
• Erythema (reddening of the skin) or mild drying and flaking of the skin;
• Itching;
• An itchy rash caused by direct contact with BETA - VIRA TOPICAL CREAM;
• Immediate hypersensitivity reactions including angioedema (painless swelling under the skin).

Frequency unknown side effects:

• Serious skin reaction that may affect one or more organs (see Section 2).

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor or pharmacist. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of BETA - VIRA TOPICAL CREAM. Adverse Drug Reactions may also be reported to Adcock Ingram Limited using the following email: [email protected]

Store at or below 25 °C. Protect from light. KEEP OUT OF REACH OF CHILDREN.