This information is intended for use by health professionals
1. Name of the medicinal product
BAZUKA EXTRA STRENGTH GEL
2. Qualitative and quantitative composition
Salicylic Acid 26.0% w/w.
3. Pharmaceutical form
Collodion-like gel application.
4. Clinical particulars
4.1 Therapeutic indications
For the topical treatment of warts, verrucas, corns and calluses.
4.2 Posology and method of administration
For adults, children and the elderly: Bazuka Extra Strength Gel should be applied once daily. The gel should be applied once every night. Treatment can take several weeks for resistant lesions to disappear and it is necessary to persevere with the treatment.1. Every night, soak the affected site in warm water for 2 to 3 minutes.2. Dry thoroughly with the patient's own towel.3. Carefully apply one or two drops of the gel to the lesion and allow to dry over its surface. Take care to avoid surrounding normal skin. No adhesive plaster is necessary.4. The following evening, carefully remove and discard the elastic film formed from the previous application, and re-apply the gel. Occasionally, if removal of the elastic film proves difficult, carefully re-apply the gel over it and allow to dry. This should help thicken the film to assist removal. If necessary, such re-application may be made on two or three successive days.5. Once a week, gently rub away the treated surface using an emery board, as provided, or pumice stone used only for this purpose, before re-applying the gel.6. The wart, verruca, corn or callus may take several weeks to disappear and it is important to persevere with the treatment. 7. At the end of treatment, if the elastic film is difficult to remove, it may be allowed to remain on the skin until it sheds.
Not to be used on or near the face, neck, intertriginous or anogenital regions, or by diabetics or individuals with impaired peripheral blood circulation.Not to be used on moles, birthmarks, hairy warts or on any other skin lesions for which the gel is not indicated.Not to be used in cases of sensitivity to any of the ingredients.
4.4 Special warnings and precautions for use
Keep away from the eyes, mucous membranes and from cuts and grazes.The gel should be applied carefully to the wart, verruca, corn or callus only, to avoid possible irritation of surrounding normal skin.Do not use excessively.Some mild, transient irritation may be expected, but in cases of more severe or persistent pain/irritation, the treatment should be suspended and/or discontinued. See also section Undesirable Effects.Avoid inhaling vapour, and keep cap firmly closed when not in use.Contact with clothing, fabrics, plastics and other materials may cause damage, and should be avoided.For external use only.Keep all medicines out of reach and sight of children.
4.5 Interaction with other medicinal products and other forms of interaction
4.6 Pregnancy and lactation
No special precautions necessary.
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
Bazuka Extra Strength Gel may be irritant in certain patients, which in rare instances may appear as a temporary blemish on the skin. See also section Special Warnings and Precautions for Use. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
Any excessive use of Bazuka Extra Strength Gel could cause irritation of the skin. If this occurs, Bazuka Extra Strength Gel should be used more sparingly or applied less frequently.
5. Pharmacological properties
5.1 Pharmacodynamic properties
The active ingredient, salicylic acid, is a well-established pharmacopoeial substance, which has been used extensively in dermatological therapy for its keratolytic properties.When applied topically, and in high enough concentrations, salicylic acid acts by achieving a slow, painless destruction of the thickened stratum corneum. It softens and destroys the thickened stratum corneum of the affected tissue by reducing the adhesiveness of the corneocytes while causing the cornified epithelium to swell, soften, macerate and finally desquamate. In the treatment of warts and verrucas, a mild inflammatory reaction, which may render the virus more prone to immunologic attack, may assist resolution of the condition.The use of topical salicylic acid formulated in simple dosage forms at high concentrations and in evaporative vehicles designed to concentrate in use, thereby localising the keratolytic precisely over circumscribed small areas of skin, is commonplace. It has become exceedingly popular with doctors and patients alike, where its safety and efficacy have been very well established through widespread use over many decades.
5.2 Pharmacokinetic properties
Bazuka Extra Strength Gel presents 26% salicylic acid in an evaporative collodion-like gel application which dries to form a cohesive and adhesive film on the skin.The formulation offers the highest concentration of salicylic acid commensurate with presenting it in a convenient collapsible aluminium tube fitted with a special applicator nozzle, allowing it to be dispensed precisely to the affected area(s). This minimises the spread of the preparation onto the surrounding healthy skin, which could otherwise lead to inflammation, irritation and poor patient compliance.The film-forming characteristics of the collodion-like gel vehicle also offer distinct advantages in clinical usage. The gel quickly forms a surface film, well before it dries completely, thereby prolonging the period during which the keratolytic solution can properly infiltrate and achieve intimate contact with the surface layers of the thickened stratum corneum.Furthermore, even when the film appears to dry completely, a proportion of the salicylic acid remains in solution within the vehicle, thus permitting continued release of the keratolytic, which may otherwise be entrapped within the dried collodion-like film. The gel yields a robust flexible film which is firmly anchored to the skin, and can therefore be used, even on the sole of the foot, without the added protection of a plaster.The availability of salicylic acid has been demonstrated by applying the gel to the normal skin of human volunteers, whereupon the salicylic acid produced a marked irritant effect similar to that of existing preparations. In clinical use, its application will, of course, be restricted to the hyperkeratotic lesions.
5.3 Preclinical safety data
No special information.
6. Pharmaceutical particulars
6.1 List of excipients
Camphor; Povidone; Pyroxylin; Ethanol; Acetone; Isopropyl Alcohol.
6.3 Shelf life
6.4 Special precautions for storage
Highly flammable - keep away from flames.Do not store above 25°C.
6.5 Nature and contents of container
Collapsible tube containing 5g, complete with special applicator, emery board and instructions.
6.6 Special precautions for disposal and other handling
7. Marketing authorisation holder
Diomed Developments LimitedTatmore Place, GosmoreHitchin, Herts SG4 7QR, UK
8. Marketing authorisation number(s)
9. Date of first authorisation/renewal of the authorisation
19 July 2009.
10. Date of revision of the text