Lamisil

DRUG DESCRIPTION

Lamisil (terbinafine) Tablets contain the synthetic allylamine antifungal compound terbinafine hydrochloride.

Chemically, terbinafine hydrochloride is (E)-N-(6,6-dimethyl-2-hepten-4-ynyl)-N-methyl-1-naphthalenemethanamine hydrochloride. The empirical formula C21H26CIN with a molecular weight of 327.90, and the following structural formula:

LAMISIL® (terbinafine hydrochloride) Structural Formula Illustration

Terbinafine hydrochloride is a white to off-white fine crystalline powder. It is freely soluble in methanol and methylene chloride, soluble in ethanol, and slightly soluble in water.

Each tablet contains:

Active Ingredients: terbinafine hydrochloride (equivalent to 250 mg base)

Inactive Ingredients: colloidal silicon dioxide NF, hydroxypropyl methylcellulose USP, magnesium stearate NF, microcrystalline cellulose NF, and sodium starch glycolate NF.

What are the possible side effects of terbinafine (Lamisil)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Some people taking terbinafine have developed severe liver damage leading to liver transplant or death. It is not clear whether terbinafine actually caused the liver damage in these patients. In most cases, the patient had a serious medical condition before taking terbinafine.

Call your doctor at once if you have symptoms of liver damage, such as nausea, stomach...

Read All Potential Side Effects and See Pictures of Lamisil »

What are the precautions when taking terbinafine (Lamisil)?

Before taking terbinafine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: liver disease.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: immune system problems, kidney disease, lupus.

Limit alcoholic beverages. Daily use of alcohol may increase your chance for serious side effects.

During pregnancy, this medication should be used only when clearly needed. Fungal nail infection...

Read All Potential Precautions of Lamisil »


Lamisil Consumer (continued)

SIDE EFFECTS: Diarrhea, stomach upset, or temporary change or loss of taste may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these rare but very serious side effects occur: new signs of infection (e.g., fever, chills, persistent sore throat), vision changes.

This drug has rarely caused very serious (possibly fatal) liver disease. Tell your doctor immediately if you develop symptoms of liver disease, including persistent nausea, loss of appetite, severe stomach/abdominal pain, dark urine, vomiting, yellowing eyes/skin.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking terbinafine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: liver disease.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: immune system problems, kidney disease, lupus.

Limit alcoholic beverages. Daily use of alcohol may increase your chance for serious side effects.

During pregnancy, this medication should be used only when clearly needed. Fungal nail infection treatment can usually wait until after you have had your baby. Discuss the risks and benefits with your doctor.

This medication passes into breast milk and may have undesirable effects on a nursing infant. Therefore, breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.


Lamisil Patient Information Including Side Effects

Brand Names: Lamisil

Generic Name: terbinafine (Pronunciation: ter BIN na feen)

  • What is terbinafine (Lamisil)?
  • What are the possible side effects of terbinafine (Lamisil)?
  • What is the most important information I should know about terbinafine (Lamisil)?
  • What should I discuss with my healthcare provider before taking terbinafine (Lamisil)?
  • How should I take terbinafine (Lamisil)?
  • What happens if I miss a dose (Lamisil)?
  • What happens if I overdose (Lamisil)?
  • What should I avoid while taking terbinafine (Lamisil)?
  • What other drugs will affect terbinafine (Lamisil)?
  • Where can I get more information?

What is terbinafine (Lamisil)?

Terbinafine is an antifungal antibiotic.

Terbinafine is used to treat infections caused by fungus that affect the fingernails or toenails. Terbinafine oral granules are used to treat a fungal infection of scalp hair follicles in children who are at least 4 years old.

Terbinafine may also be used for other purposes not listed in this medication guide.

What are the possible side effects of terbinafine (Lamisil)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Some people taking terbinafine have developed severe liver damage leading to liver transplant or death. It is not clear whether terbinafine actually caused the liver damage in these patients. In most cases, the patient had a serious medical condition before taking terbinafine.

Call your doctor at once if you have symptoms of liver damage, such as nausea, stomach pain, loss of appetite, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes). These events can occur whether or not you have ever had liver problems before.

Stop taking terbinafine and call your doctor at once if you have a serious side effect such as:

  • joint pain or swelling, swollen glands, patchy skin color, or a butterfly-shaped skin rash over your cheeks and nose;
  • fever, chills, body aches, flu symptoms;
  • changes in your vision;
  • weight loss due to taste changes;
  • scaly, itchy, and flaky skin rash; or
  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash.

Less serious side effects may include:

  • stomach pain, heartburn, diarrhea;
  • headache;
  • tired feeling;
  • runny or stuffy nose, sore throat, cold symptoms;
  • mild skin rash or itching;
  • unusual or unpleasant taste in your mouth; or
  • decreased taste sensation.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about terbinafine (Lamisil)?

Before using terbinafine, tell your doctor if you have liver or kidney disease, or an autoimmune disorder such as lupus or psoriasis.

Take this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Terbinafine will not treat a viral infection such as the common cold or flu.

Some people taking terbinafine have developed severe liver damage leading to liver transplant or death. It is not clear whether terbinafine actually caused the liver damage in these patients. In most cases, the patient had a serious medical condition before taking terbinafine.

Call your doctor at once if you have symptoms of liver damage, such as nausea, stomach pain, loss of appetite, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes). These events can occur whether or not you have ever had liver problems before.

To be sure this medication is not causing harmful effects, your blood may need to be tested on a regular basis. Your liver function may also need to be tested. Do not miss any scheduled appointments.

It may take several months for your nails to return to their normal appearance after your treatment with terbinafine.

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