Benzac Ac Gel
PDF Leaflet Revision Date: 02 May 2022
Clinical Summary
Quick overview from the medicine insert
Indication
Topical treatment of acne vulgaris.
Dosage (summary)
Apply once or twice daily; once daily for sensitive skin.
Pregnancy & Breastfeeding
Safety in pregnancy and lactation not established; caution advised.
Key Drug Interactions
- Avoid concurrent use with desquamative, irritant, and drying agents.
- PABA-containing sunscreens may cause skin discoloration.
Contraindications
- Hypersensitivity to benzoyl peroxide or excipients.
Common side effects
- Dry skin
- Erythema
- Skin peeling
- Burning sensation
- Allergic contact dermatitis
Counselling Points
- Clean and dry skin before application.
- Use sunscreen to protect from UV exposure.
- Report severe irritation to a healthcare provider.
Serious warnings
- For external use only.
- May cause severe irritation; discontinue if severe symptoms occur.
- Avoid contact with eyes and sensitive areas.
Important Disclaimer
The Benzac Ac Gel professional information leaflet below is the property of Galderma Laboratories South Africa and is provided on Medinsert exactly as issued, with no.. alterations or editorial changes. We make every effort to keep content current by updating documents as soon as new versions become available. Medinsert serves as a trusted access point for healthcare professionals, but does not replace official sources or clinical judgement. For more details, please read our full disclaimer. read more>>
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Clinical Particulars
Section 4 of the official insert — extracted exactly as issued, no alterations
4.1 Therapeutic indications
BENZACu00ae AC 5 GEL is indicated for the topical treatment of acne vulgaris.
4.2 Posology and method of administration
Posology
Before each application, the skin should be cleaned and dried. BENZAC u00ae AC 5 GEL should be applied once or twice daily to cover affected areas after washing with a mild cleanser and water. Persons with sensitive skin should be directed to apply the gel once daily before going to bed. Paediatric Population: No data available.
4.3 Contra-indications:
Hypersensitivity to the active or any of the excipients listed in section 6.1.
4.4 Special warnings and precautions for use
BENZAC u00ae AC 5 GEL contains:
- Propylene glycol that can be irritating to the skin.
FOR EXTERNAL USE ONLY
A mild burning sensation will probably be felt on first application and some reddening and peeling of the skin will occur within a few days. During the first weeks of treatment a sudden increase in peeling will occur in most patients. This is not harmful and will normally subside within a day or two if treatment is temporarily discontinued.
If severe irritation occurs, patients should be directed to use the medication less frequently, to temporarily discontinue use or to discontinue use altogether. BENZAC u00ae AC 5 GEL may cause swelling and blistering of the skin, if any of these symptoms occur, medication should be discontinued. Avoid contact with the eyes, eyelids, mouth, angles of the nose and mucous membranes. If accidental contact occurs, rinse thoroughly with water. Contact with any materials (e.g. hair or fabric) may result in bleaching or discolouration. Caution should be exercised when applying BENZAC u00ae AC 5 GEL to the neck and other sensitive areas. Repeated exposure to sunlight or UV radiation should be avoided. Due to the risk of sensitisation, BENZAC u00ae AC 5 GEL should not be applied on damaged skin.
4.5 INTERACTIONS with other medicines and other forms of interaction
There are no known interactions with other medications which might be used cutaneously and concurrently with BENZAC u00ae AC 5 GEL; however, medicines with desquamative, irritant and drying effects should not be used concurrently with BENZAC u00ae AC 5 GEL. Concurrent use with PABA-containing sunscreens may result in transient discolouration of the skin. If excessive irritation develops, a medical practitioner should be consulted.
4.6 Fertility, pregnancy and lactation:
Pregnancy
Safety in pregnancy has not been established.
Lactation
Safety in lactation has not been established. Caution should be exercised when benzoyl peroxide is administered to a nursing woman and the preparation should not be applied on the chest to avoid accidental transfer to the infant.
4.7 Effects on ability to drive and the use of machines
BENZAC u00ae AC 5 GEL has no or negligible influence on the ability to drive and use machines.
4.8 Undesirable effects
Allergic contact dermatitis and dryness have been reported with BENZAC u00ae AC 5 GEL therapy. If severe irritation develops, discontinue use and consult a doctor. After the reaction clears, treatment may often be resumed with less frequent application. The adverse reactions resulting from clinical trials are all skin disorders. They are reversible when treatment is reduced in frequency or discontinued. The following categories are used to indicate the frequency of occurrence of adverse effects:
Very common (u2265 1/10)
Common (u22651/100 to <1/10)
Uncommon (u2265 1/1,000 to <1/100)
Rare (u22651/10,000 to <1/1,000)
Very rare (<1/10,000)
Unknown (Frequency not assessable based on the available data).
4.9 Overdose
Refer to section 4.8 and section 4.4
BENZAC u00ae AC 5 GEL is indicated for topical treatment only. If BENZAC u00ae AC 5 GEL is applied excessively, no more rapid or better results will be obtained and severe irritation might develop. In this event, treatment must be discontinued and appropriate symptomatic therapy should be instituted.
