1% cutaneous solution
What Lamisil Single Dose is and what it is used for
Lamisil Singeldos is a one-time treatment for an athlete’s foot ( tinea pedis ).
Lamisil Singeldos works by killing the fungi that cause foot fungus ( tinea pedis ). After application to the feet, it leaves a smooth, barely visible film that remains on the skin. Via the film, the active ingredient that treats an athlete’s foot ( tinea pedis ) is transferred to the skin.
How do you know if you have foot fungus ( tinea pedis )?
Foot fungus ( tinea pedis ) only appears on the feet. It often begins between the toes and can spread to the soles of the feet and the sides of the feet.
The most common form of athlete’s foot ( tinea pedis ) causes the skin to crack or flake, but you may also have slight swelling, blisters, or oozing sores. Foot fungus is often associated with itching or a burning sensation.
If you are not sure if your problems are caused by foot fungus ( tinea pedis ), talk to your doctor or pharmacist before using Lamisil Singeldos.
What you need to know before using Lamisil Single Dose
Do not use Lamisil Single Dose
– if you are allergic to terbinafine or any of the other ingredients of this medicine (listed in section 6 and at the end of section 2).
Talk to your doctor or pharmacist if this applies to you and do not use Lamisil Singeldos.
Warnings and cautions
Talk to your doctor or pharmacist before using Lamisil Singeldos.
- If you suffer from a long-term fungal infection on the soles of the feet or heels with thickening and / or prolonged peeling of the skin, you should not use this medicine . If you think you are suffering from this, you should contact your doctor as you may need other treatment.
- Lamisil Single Dose is for topical use only . Do not use it in your mouth, do not swallow it.
- Avoid contact of the solution with the face, eyes, or damaged skin as alcohol may be irritating (after sun exposure or severe dandruff).
- If you accidentally get the solution in your eyes, rinse thoroughly with running water. If discomfort persists, consult a physician.
- Use only to treat the skin on your feet and toes.
- Lamisil Single dose contains alcohol. Keep out of reach of open flames.
- Keep out of sight and reach of children.
Children and young people
Children and adolescents under 18 years of age should not use Lamisil Single Dose.
Other medicines and Lamisil Singeldos
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not apply other medicines (including non-prescription ones) to the treated areas.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Lamisil Single dose should not be used during pregnancy unless necessary.
This medicine can pass into breast milk. If you are breastfeeding, talk to your doctor before using this medicine.
Do not allow infants to come into contact with treated skin areas.
Driving and using machines
The use of Lamisil Singeldos does not affect the ability to drive and use machines.
Lamisil Singeldis contains ethanol (96%)
Each daily dose of this drug contains 3316.8 mg of alcohol ( ethanol ), which is equivalent to 863.75 mg / g ethanol (96%).
It can cause a burning sensation on damaged skin.
How to use Lamisil Single Dose
Always use this medicine exactly as described in this leaflet or as your doctor advised. Ask your doctor or pharmacist if you are unsure.
The recommended dose is once applied as described below.
How the solution is used:
Adults 18 years and older:
Lamisil Single dose should be applied after a shower or bath.
• The treatment is performed with a single application.
• Wash both feet and dry them thoroughly.
• Wash and dry your hands.
• Unscrew the cover from the tube.
Treat both feet – use about half the tube for one foot, as much as needed to cover the skin. Finish one foot at a time.
• Apply the medicine to both feet with your fingers as shown below: first apply between, under, and overall toes. Then over the sole and the sides of the foot.
• Do not massage into the skin.
• Treat the other foot in the same way, even if the skin looks healthy. This is to ensure that you get rid of the fungus – it can be on the other foot even if it is not visible.
Let the product dry to a film for 1-2 minutes, before putting on socks or shoes.
Put the cap back on the tube and discard any leftover product (see section 5 of the Package Leaflet for more information on disposing of unused medicines). Do not save the leftover product and do not give away leftover product to anyone else.
• Wash your hands with warm soapy water after the treatment.
Do not wash or splash your feet for the first 24 hours after you have been treated with Lamisil Singeldos. Gently pat dry after washing.
• Do not apply a second time.
How often and for how long should you use Lamisil Single Dose?
Apply only once. Do not apply a second time.
Lamisil Singeldos starts killing the fungus immediately. The film that remains after the drug has been applied, even though it is barely visible, continues to work for several days to kill the fungal infection.
The skin should improve within a few days.
If you have not seen any improvement within 1 week after application, consult a pharmacist to ensure that the product has been used correctly or consult a doctor to re-evaluate the diagnosis.
Do not use the product again during the same outbreak of athlete’s foot if it did not help the first time.
You should apply Lamisil Single Dose on both feet even if signs of an athlete’s foot are only visible on one foot. This ensures that the fungus disappears completely as the fungus that caused the infection can be found on asymptomatic parts of the feet.
When the drug is applied to the skin, it dries quickly to a colorless film. The medicine in the tube is enough for both feet.
Lamisil Singeldos transfers the active ingredient to the skin where it stays for several days to remove the fungus that causes the athlete’s foot. For best results, feet should not be washed or soaked for 24 hours after application.
Facilitate the treatment:
Keep the affected area clean by washing it regularly after the first 24 hours. Dry it thoroughly without rubbing. Try not to scratch the area even if it itches. It can lead to further damage and delay the healing process or spread the infection.
Because these infections can be transmitted to other people, use your towel and clothes and do not share them with others. These should be washed frequently to protect you from a new infection.
If you accidentally swallow the medicine
If you accidentally get the product on your face or eyes
If you accidentally get the medicine in your eyes, rinse thoroughly with running water. If discomfort persists, consult a physician.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Users may be allergic to Lamisil Single Dose which may cause swelling and pain, itching, blistering of the skin, rash, or hives. This has been reported in very rare cases ( may affect up to 1 in 10,000 users).
If you get an allergic reaction or any of the above symptoms while using this medicine, remove the film with denatured alcohol (available at a pharmacy), wash your feet with warm soapy water, rinse and consult a doctor or pharmacist.
The following side effects have also been reported:
Uncommon (may affect up to 1 in 100 people): Application site reactions, including dry skin, skin irritation, or burning sensation. They are usually mild and transient.
Has been reported (occurs in an unknown number of users): Discoloration of the skin, peeling, redness, pain at the application site.
If Lamisil Singeldos inadvertently comes into contact with the eyes, eye irritation may occur.
The Medical Products Agency
751 03 Uppsala
How to store Lamisil Singeldos
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and tube after EXP. date… The expiration date is the last day of the specified month.
Store in the original package. Sensitive to light. Do not store above 30 ° C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the package and other information
– The active substance is terbinafine (as hydrochloride). Each gram of cutaneous solution contains 10 mg of terbinafine (as hydrochloride).
The other ingredients are acrylates/octyl acrylamide copolymer, hydroxypropyl cellulose, medium-chain triglycerides, and ethanol.
What the medicine looks like and contents of the pack
Lamisil Single Dose is clear to the slightly cloudy gel-like solution. It is available in tubes of 4 g.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
GlaxoSmithKline Consumer Healthcare ApS
PO Box 61
GlaxoSmithKline Consumer Healthcare ApS
Delta Park 37
2665 Vallensbæk Strand, Denmark