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Please read this as well as any other information your doctor gives you about Lamisil (terbinafine HCl tablets) Tablets and fungal infections of the toenail or fingernail. Only a doctor or other qualified healthcare professional has the training necessary to determine if Lamisil Tablets are right for you.

Lamisil Tablets

Lamisil Tablets are a prescription medicine for the treatment of onychomycosis (ON-i-ko-my-KO-sis).

Onychomycosis is a fungal infection of fingernails or toenails. Because the fungus infects the area underneath the nail and in the place where the nail forms, it can be very stubborn and difficult to cure. The infection may cause some or all of the following: the nail can turn colors like white, yellow or brown, and become thickened and brittle. Additionally, it may be painful for some people.

When you take Lamisil Tablets, the active ingredient, terbinafine, travels to the infected area under the toenail or fingernail. Because terbinafine accumulates and lingers in the area of the nail that is growing, it can continue to work for months even after your prescription is finished, allowing the nail to heal naturally over a period of time.

Patients take one 250 mg tablet per day (it may be taken with or without food). You should follow your doctor's advice on how to take Lamisil Tablets. Be sure to take the complete course of your medicine. For toenail infections, treatment time is 12 weeks.

For fingernail infections, treatment time is 6 weeks. It is important to note that the complete healing process often takes at least 10 to 12 months for toenails and 4 months for fingernails. This is due to the length of time it takes for the new nails to grow in.

Lamisil Tablets should not be taken by anyone allergic to any of its ingredients. You should be aware of these warnings and precautions when taking Lamisil Tablets:
As with all medications, you should discuss any side effects you experience with your doctor or healthcare professional.

Rare instances of serious liver problems or skin reactions have been reported in patients using Lamisil Tablets. In such cases, treatment with Lamisil Tablets should be discontinued. Your doctor may ask you to undergo tests before and during treatment with Lamisil Tablets.

In clinical studies, 0.9% of patients taking Lamisil Tablets discontinued therapy because of a skin rash. In rare cases, these skin reactions could indicate a serious side effect. If you notice a rash, stop taking Lamisil Tablets and call your doctor.
Isolated cases of decreases in white blood cell count have been reported. In all of the reported cases to date, these have been reversible.

Patients with liver disease or kidney problems should not take Lamisil Tablets.
If you have problems with your immune system, your doctor may need to monitor your white blood cell count carefully if you take Lamisil Tablets for more than 6 weeks. In some cases, Lamisil therapy may need to be discontinued.

Changes in the retina and lens of the eye have been reported following the use of Lamisil Tablets. The significance of these changes is not known. In clinical studies, 0.9% of patients discontinued taking Lamisil Tablets because of visual disturbances.

The tumor-causing potential of Lamisil Tablets has been examined in numerous studies in mice, rats, dogs, and monkeys. Male rats, given a daily dosage approximately 13.8 times the maximum recommended human dose based on body weight, showed a marginal increase in the incidence of liver tumors. No increase in tumors was noted in a wide range of studies in mice, dogs, and monkeys. These tests suggest that this is a finding specific to rats.

No studies with pregnant women have been done to evaluate the safety of Lamisil Tablets. Because treatment of onychomycosis can be delayed until after pregnancy is completed, Lamisil Tablets should not be taken by pregnant women.

The active ingredient of Lamisil Tablets, terbinafine, is present in the breast milk of nursing mothers. Therefore, Lamisil Tablets should not be taken by nursing mothers.

No studies have been done in children to evaluate the safety of Lamisil Tablets.

Talk to your doctor or healthcare professional before combining Lamisil Tablets with any other medications. Certain medications, including Tagamet and rifampin, may affect the rate at which Lamisil Tablets are eliminated from the body. However, unlike some other antifungal medications, Lamisil Tablets have been used safely with many commonly prescribed medications, such as Zantac, Lanoxin, or Zocor.

Side Effects

Most patients tolerate treatment with Lamisil Tablets very well. However, like all prescription drugs, Lamisil Tablets may cause some side effects in some people.

These side effects, as determined by three clinical studies, were mild and in general did not lead to discontinuation of treatment with Lamisil Tablets.

The most commonly reported side effects were headache, which occurred in 12.9% of patients, gastrointestinal symptoms, including diarrhea (5.6%), upset stomach (4.3%), taste disturbances (2.8%), nausea (2.6%), abdominal pain (2.4%), flatulence (2.2%), rash (5.6%), itching (2.8%), hives (1.1%), and abnormalities in laboratory tests of liver enzymes (3.3%). In some cases, these complaints were no more frequent than in patients taking placebo (sugar pill).

Lamisil Tablets were prescribed only for you. Do not share Lamisil Tablets with anyone else. Keep Lamisil Tablets and all other medications away from children. For more information about Lamisil Tablets and fingernail or toe nail fungus infections, talk to your doctor or other healthcare professional.


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