Lamisil Once 1 % cut. sol. 4 g

Lamisil 1% Once Cutaan 4 opl

Therapeutic Indications:

Treatment of tinea pedis (athlete's foot, also known as athletes foot or athlete's foot) (see section 'Special warnings and precautions for use' ).

Qualitative and quantitative composition:

Each gram
solution for cutaneous use contains 10 mg terbinafine (as hydrochloride).
For a full list of excipients, see section 'List of excipients '.

Pharmaceutical form:

Solution for cutaneous use.
Clear to slightly opaque

viscous solution.

Posology and method of administration:

Adults: Occasionally application.
Lamisil Once should once on both feet to be fitted , even if only a fungal infection rate shows. This ensures the removal of the fungi (dermatophytes) that might be found in areas on the foot where no visible fungal infection.
Patients need both feet and hands thoroughly before washing and drying the product to make. They are one foot after another deal.
Patients have a thin layer starting with the toes (and everywhere between the toes), and the sole of the foot and sides, lateral to a height of about 1.5 cm. The medicine is in the same way on the other foot to be made, even if the skin will look healthy. The drug is 1 to 2 minutes to dry until a film is formed. After
patients should wash their hands again.
Lamisil Once should not be massaged into the skin.
For best results, not wash the treated area for 24 hours after application. Hence it is recommended to apply Lamisil Once after a shower or a bath and wait until the next day at around the same time gently wash feet again. After having washed the feet, they should be gently blotted dry.
Patients should use the amount they need to have both feet completely and according to instructions above cover. The unused part of the solution should be discarded.
Usually occurs after only a few days an improvement in clinical symptoms. If after one weeks would be no noticeable improvement, the diagnosis should be re-made and the patient is a doctor. As no data on repeated treatment with Lamisil Once available, it can treat half for the same episode (attack) of athlete foot athlete's foot or not recommended.
Children and Youth.
Since there is no investigation into the use of Lamisil Once in children, the use of this medicine is not recommended in patients under 18 years.
Older people.
The dosage not be adjusted.

This is a medicine, no prolonged use without medical advice, keep away from children, read the leaflet carefully. Ask your doctor or pharmacist. In case of side effects, contact your doctor.

Contraindications:

Hypersensitivity to terbinafine or any of the excipients (see section 'List of excipients).

Special warnings and precautions for use

Lamisil Once is not recommended for the treatment of chronic hyperkeratotic plantar tinea pedis (moccasin type).
Lamisil Once is for external use only.
It should never be placed on the face, because of possible irritation of the eyes. Should accidental eye contact would come with the product, they should be rinsed with abundant running water.
If an allergic reaction occurs, the film of the feet to be removed using an organic solvent, such as denatured alcohol, and then the feet with warm water and soap.
Contains ethanol, away from open flames keep.

Pregnancy and lactation:

Pregnancy.
There are no clinical data on the use of terbinafine in pregnant women available. Fetal toxicity and fertility studies in animals showed no adverse events (see section 'Preclinical safety data). The use of Lamisil Once should be avoided during pregnancy unless absolutely necessary.
Lactation.
Since terbinafine in the breast milk, the use of Lamisil Once to be avoided in lactating women.

Side effects:

The adverse effects included mild transient reactions at the application site. Very rarely allergic reactions.
Skin and subcutaneous tissue disorders.
Very rare (disorders and general disorders near the application site.
Uncommon (>1/1.000,

Effects on ability to drive and use machines :

The cutaneous use of Lamisil Once is not about driving or operating machinery.

Overdose:

The risk of overdose is unlikely, given the solution for a single administration for cutaneous use of a tube and only contains the required amount for a single application.
Accidental tube with an intake of 4 g of solution, where 40 mg of terbinafine in it, is in itself less dangerous than a single tablet of 250 mg Lamisil (oral unit dose). Only if multiple tubes could be swallowed and we might expect to effects similar to those in overdose Lamisil tablets are established (eg: headache, nausea, epigastric pain and dizziness).

List of excipients:

Acrylate / octylacrylamide copolymer - Hyprolose - Medium chain length triglycerides - Ethanol.

Interaction with other medicinal products and other forms of interaction:

There was no interaction studies conducted. It is therefore not recommended for confounding foot treatment products to market, even though there are no known interactions with other drugs the pharmacovigilance other Lamisil topical forms.

Incompatibilities:

Not applicable.