 |
|
|
|
Lamisil Once is a single dose treatment for Athlete’s Foot. It contains 10 mg of the fungicidal active substance Terbinafine (as hydrochloride) per 1 g of solution.
|
|
Each gram contains 10 mg terbinafine (as hydrochloride).
Cutaneous solution
Treatment for tinea pedis (athlete's foot).
|
|
Adults 18 years of age and over: single administration.
Lamisil Once should be applied once on both feet, even if lesions are visible on one foot only. This ensures elimination of the fungi (dermatophytes) that might be found in areas of the foot where no lesions are visible.
Patients should wash and dry both feet and hands before applying the product. They should treat one foot, then the other.
Starting between the toes, patients should apply a thin layer evenly between and all around the toes, as well as cover the sole and sides of the foot for up to 1.5 cm. The product should be applied in the same way to the other foot, even if the skin looks healthy. The product should be left to dry to a film for 1-2 minutes. Patients should then wash their hands. Lamisil Once should not be massaged into skin.
For the best results, the treated area should not be washed for 24 hours after application. It is therefore recommended to apply Lamisil Once after a shower or bath and wait until the same time the following day before washing the feet again.
Patients should use the quantity they need to cover both feet as instructed above. Any unused medication is to be discarded.
Relief of clinical symptoms usually occurs within a few days. If there are no signs of improvement after one week, patients should see a doctor. There are no data on repeated treatment with Lamisil Once. Therefore a second treatment cannot be recommended within a particular episode of athlete's foot.
Children:
Lamisil Once has not been studied in the paediatric population. Its use is therefore not recommended in patients below 18 years of age.
The elderly:
There is no evidence to suggest that elderly patients require different dosages or experience side effects different from those in younger patients.
|
|
Hypersensitivity to terbinafine or any of the excipients:
Acrylates/octylacrylamide copolymer;
hydroxypropylcellulose;
medium chain triglycerides;
ethanol.
|
|
Undesirable effects include mild and transient reactions at the site of application. In very rare instances, allergic reactions may occur.
Skin and subcutaneous tissue disorders:
Very rare (<1/10,000, including isolated reports): allergic reactions such as rash, pruritus, dermatitis bullous and urticaria.
General disorders and administration site conditions
Uncommon ( >1/1,000, <1/100): application site reactions such as skin dryness, skin irritation or burning sensation.
|
|
|
