Lamisil Dermgel

It works by killing the fungus or preventing its growth .

Terbinafine is applied to the skin to treat:

• ringworm of the body (tinea corporis);


• ringworm of the foot (interdigital and plantar tinea pedis; athlete`s foot);


• ringworm of the groin (tinea cruris; jock itch);


• tinea versicolor (sometimes called a€śsun fungusa€ť); and


• yeast infections of the skin (cutaneous candidiasis).

This medicine is available both over-the-counter (OTC) and with your doctor`s prescription.

This product is available in the following dosage forms:

• Gel/Jelly


• Cream


• Solution


• Spray

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of terbinafine in children under the age of 12 with use in other age groups.

Geriatric

Many medicines have not been studied specifically in older people . Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of terbinafine in the elderly with use in other age groups, this medicine is not expected to cause different side effects or problems in older people than it does in younger adults.

Pregnancy

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Cyclosporine


• Metoprolol


• Nortriptyline


• Warfarin

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Fungus infection of the nailsa€”condition may decrease the effect of terbinafine when this medicine is used to treat a type of ringworm of the foot (plantar tinea pedis)

Proper Use

Apply enough terbinafine cream to cover the affected and surrounding skin areas and rub in gently.

Apply enough terbinafine solution to wet and cover the affected and surrounding skin areas. Allow it to dry.

Keep this medicine away from the eyes, nose, mouth, and other mucous membranes. The solution may be especially irritating to the eyes.

Terbinafine spray solution contains alcohol and should not be applied to the face.

Do not apply an occlusive dressing (airtight covering, such as a tight bandage or plastic kitchen wrap) over this medicine unless you have been directed to do so by your doctor .

Dosing

The dose of this medicine will be different for different patients. Follow your doctor`s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For topical dosage form (cream):
  
  
  
  • For cutaneous candidiasis:
    
    
    
    • Adultsa€”Use one or two times a day for seven to fourteen days.
    
    
    • Childrena€”Use and dose must be determined by your doctor .
    
    
    
    
  
  
  • For tinea corporis or tinea cruris:
    
    
    
    • Adults and children 12 years of age and oldera€”Use one or two times a day for seven to twenty-eight days.
    
    
    • Infants and children younger than 12 years of agea€”Use and dose must be determined by your doctor .
    
    
    
    
  
  
  • For tinea pedis (interdigital):
    
    
    
    • Adults and children 12 years of age and oldera€”Use two times a day for seven to twenty-eight days.
    
    
    • Infants and children younger than 12 years of agea€”Use and dose must be determined by your doctor .
    
    
    
    
  
  
  • For tinea pedis (plantar):
    
    
    
    • Adults and children 12 years of age and oldera€”Use two times a day for fourteen days.
    
    
    • Infants and children younger than 12 years of agea€”Use and dose must be determined by your doctor .
    
    
    
    
  
  
  • For tinea versicolor:
    
    
    
    • Adultsa€”Use one or two times a day for fourteen days.
    
    
    • Childrena€”Use and dose must be determined by your doctor .
    
    
    
    
  
  
  
  


• For topical dosage form (spray solution):
  
  
  
  • For tinea corporis or tinea cruris:
    
    
    
    • Adultsa€”Use once a day for seven days.
    
    
    • Childrena€”Use and dose must be determined by your doctor .
    
    
    
    
  
  
  • For tinea pedis or tinea versicolor:
    
    
    
    • Adultsa€”Use two times a day for seven days.
    
    
    • Childrena€”Use and dose must be determined by your doctor .
    
    
    
    
  
  
  
  

To help clear up your infection completely, it is very important that you keep using terbinafine for the full time of treatment , even if your symptoms begin to clear up after a few days. Since fungus infections may be very slow to clear up, you may have to continue using this medicine every day for several weeks or more. If you stop using this medicine too soon, your symptoms may return. Do not miss any doses .

Missed Dose

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions

Discontinue using this medicine and check with your doctor if increased irritation or possible sensitization (redness, itching, burning, blistering, swelling, or oozing) occurs while using the medication .

If your skin problem does not improve within 4 to 7 weeks, or if it becomes worse, check with your doctor .

To help clear up your infection completely and to help make sure it does not return, good health habits are also needed. The following measures will help reduce chafing and irritation and will also help keep the area cool and dry.

• For patients using terbinafine for ringworm of the body:
  
  
  
  • Carefully dry yourself after bathing.
  
  
  • Avoid too much heat and humidity if possible. Try to keep moisture from building up on affected areas of the body .
  
  
  • Wear well-ventilated, loose-fitting clothing.
  
  
  • Use a bland, absorbent powder (for example, talcum powder) once or twice a day. Be sure to use the powder after terbinafine cream or solution has been applied and has disappeared into the skin .
  
  
  
  


• For patients using terbinafine for ringworm of the groin:
  
  
  
  • Avoid wearing underwear that is tight-fitting or made from synthetic (man-made) materials (for example, rayon or nylon). Instead, wear loose-fitting, cotton underwear.
  
  
  • Use a bland, absorbent powder (for example, talcum powder) on the skin . It is best to use the powder between the times you use terbinafine.
  
  
  
  


• For patients using terbinafine for ringworm of the foot:
  
  
  
  • Carefully dry the feet, especially between the toes, after bathing.
  
  
  • Avoid wearing socks made from wool or synthetic materials (for example, rayon or nylon). Instead, wear clean, cotton socks and change them daily or more often if the feet sweat a lot.
  
  
  • Wear sandals or well-ventilated shoes (for example, shoes with holes).
  
  
  • Use a bland, absorbent powder (for example, talcum powder) between the toes, on the feet, and in socks and shoes once or twice a day. It is best to use the powder between the times you use terbinafine.
  
  
  
  

If you have any questions about these measures, check with your health care professional .

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention .

Check with your doctor as soon as possible if any of the following side effects occur:

Rare

• Dryness


• Redness


• Itching


• Burning


• Peeling


• Rash


• Stinging


• Tingling


• Or other signs of skin irritation not present before use of this medicine

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional .

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.