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

Call your doctor at once if you have:

• severe burning, stinging, or irritation where the medicine was applied;
• swelling or redness;
• sudden dizziness or drowsiness after medicine is applied;
• confusion, blurred vision, ringing in your ears; or
• unusual sensations of temperature.

Common side effects include:

• mild irritation where the medication is applied; or
• numbness in places where the medicine is accidentally applied.

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.

Avoid touching the sticky side of a lidocaine skin patch while applying it.

Avoid accidentally injuring treated skin areas while they are numb. Avoid coming into contact with very hot or very cold surfaces.

It is not likely that other drugs you take orally or inject will have an effect on topically applied lidocaine. But many drugs can interact with each other. Tell each of your health care providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.

Gently apply a small amount onto the affected area 2 to 4 times daily and rub it in well, as needed or as directed by the doctor. This product is not normally used on sensitive skin areas (e.g., face, underarms, or groin) unless specified by the doctor. Do not cover the area with dressings unless instructed to do so by your doctor.

Apply this product cautiously on lesions close to the eye. Severe irritation is possible if the medication contacts the eye. Should this occur, immediately flush the eye with a large volume of water.

Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are using the medication without consulting your doctor.

It is important to use this medication exactly as prescribed by your doctor. If you miss a dose, apply it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not apply a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent. The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• burning, dryness, irritation, itching, or redness of skin (usually mild and temporary)
• increased redness or scaling of skin sores (usually mild and temporary)
• skin rash (usually mild and temporary)

Although most of these side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

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

• blood-containing blisters on skin
• lack of healing of skin condition
• numbness in fingers
• painful, red or itchy, pus-containing blisters in hair follicles
• raised, dark red, wart-like spots on skin, especially when used on the face
• skin infection
• thinning of skin with easy bruising

Stop taking the medication and seek immediate medical attention if any of the following occur:

• symptoms of a serious allergic reaction (e.g., severe rash, hives, swollen face or throat, or difficulty breathing)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. As well, some forms of this medication may not be used for all of the conditions discussed here. If you have not discussed this with your doctor or are not sure why you are being given this medication, speak to your doctor. Do not stop using this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to use this medication if their doctor has not prescribed it.

LIDEMOL should not be used by anyone who:

• is allergic to fluocinonide or to any of the ingredients of the medication
• has untreated bacterial, tubercular, fungal, or most viral lesions of the skin (including herpes simplex, vaccinia, and chickenpox)

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Infection: You may experience a secondary infection while using a topical (skin-applied) corticosteroid. If this is the case, contact your doctor for instruction regarding treatment.

Internal absorption: Significant internal absorption may result when steroids are applied over large areas of the body. To minimize this possibility when long-term therapy is anticipated, your doctor may instruct you to periodically interrupt treatment or to treat one area of the body at a time.

Medical conditions: People with stasis dermatitis and other skin diseases associated with impaired circulation should discuss with their doctor how this medication may affect their medical condition, how their medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Medical treatment: Inform all your doctors that you have used a corticosteroid.

Response to treatment: If your skin condition does not improve within a few days to a week, contact your doctor.

Thinning of skin: Prolonged use of topical corticosteroid products may produce thinning of the skin and of tissues under it. If this is noticed, call your doctor.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: Corticosteroids such as fluocinonide may pass into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

There may be an interaction between LIDEMOL and any of the following:

• other topical medications that contain corticosteroids or that have irritating effects

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

LEVAQUIN comes in the various forms:

• Film coated oral tablets of 250 milligrams (mg), 500 mg, and 750 mg
• Oral solutions of 25 mg per milliliter (mL), which should be taken 1 hour before or 2 hours after eating
• Premixed, single-use injection in flexible containers, containing a solution equivalent to 250 mg, 500 mg, or 750 mg of levofloxacin
• Single-use injection vials containing concentrated levofloxacin solution equivalent to 500 mg or 750 mg, which need to be further diluted with the appropriate solution

Only take LEVAQUIN as advised by your doctor.

Dosage and length of treatment differs depending on the type of infection that needs to be treated; adults with kidney problems, as well as children, must follow an adjusted treatment schedule.

LEVAQUIN Overdose

According to animal studies, LEVAQUIN is toxic in high doses, causing a number of muscular and nervous system symptoms, such as tremors, convulsions, and loss of control of bodily movements.

Call your local poison control center or visit the nearest emergency hospital room if you've overdosed on LEVAQUIN to have your stomach emptied.

Call 9-1-1 if you think someone has overdosed and has collapsed or isn't breathing.

Missed Dose of LEVAQUIN

Take the missed dose as soon as you remember it, unless it's almost time for next dose.

Never double your dose to make up for a missed dose of LEVAQUIN.

The most common side effects of LEVAQUIN are:

• Nausea
• Headache
• Diarrhea
• Insomnia
• Constipation
• Dizziness

Other common side effects include yeast infections, vaginitis, severe itching, chest pain, and swelling from water buildup (edema).

Severe Side Effects of LEVAQUIN

Though rare, LEVAQUIN can result in numerous serious side effects that may require medical attention, including:

• Central nervous system effects, including seizers, hallucinations, nightmares, depression, confusion, paranoia, suicidal thoughts, and tremors
• Gastrointestinal infections and disorders
• Potentially irreversible peripheral neuropathy (damage to the nerves outside the brain and spinal cord)
• Serious heart rhythm changes
• Joint problems
• Changes in blood sugar
• Sensitivity to sunlight
• Severe diarrhea from the difficult-to-treat bacteria Clostridium difficile

Additionally, children taking LEVAQUIN may develop musculoskeletal disorders, such as arthritis and gait abnormalities.

The risk of tendonitis and tendon ruptures is greater for people over 60 years old, people taking corticosteroid drugs, and people with kidney, heart, or lung transplants.

Physical activity or exercise, kidney failure, and having previous tendon problems, such as rheumatoid arthritis, can also increase your risk of tendon issues while taking LEVAQUIN.

You should not take LEVAQUIN if you have a known sensitivity or allergy to levofloxacin and other quinolones (the family of antibiotics that encompasses fluoroquinolones).

You should also avoid the drug if you have the neuromuscular disease myasthenia gravis, as the drug could worsen your muscle weakness.

Some people experience other serious and sometimes life-threatening reactions from taking LEVAQUIN, such as:

• Dangerous skin disorders, including toxic epidermal necrolysis and Stevens- Johnson Syndrome
• Blood vessel inflammation, joint pain, and muscle pain
• Allergic pneumonitis, an inflammation of the walls of the lung's air sacs
• Interstitial nephritis (a kidney disorder) and kidney failure
• Hepatitis (liver inflammation), jaundice (yellowing of the skin and eyes), liver cell death, and liver failure
• Blood-related issues, including deficiencies in red blood cells or white blood cells

Pregnancy and LEVAQUIN

It's unknown if LEVAQUIN can harm a developing fetus because no adequate and well-controlled studies have been carried out in pregnant women.

However, the drug's antimicrobial benefits to the mother may outweigh the potential risks to her unborn child.

Levofloxacin is presumed to be present in breast milk, and the drug has the potential to cause serious side effects in infants.

Breastfeeding mothers taking LEVAQUIN should either discontinue the drug or stop breastfeeding.

LEVAQUIN may interact with:

• Antacids, multivitamins, and supplements containing magnesium, aluminum, iron, or zinc
• Sucralfate (Carafate)
• Didanosine (Videx)
• Warfarin (Coumadin, Jantoven)
• Antidiabetic medicine
• Non-steroidal anti-inflammatory drugs, including aspirin and ibuprofen
• Theophylline (Theo-24, Theolair)

Make sure to tell your doctor about any medications, drugs, and supplements you take, especially steroid medications, anti-psychotic drugs, tricyclic antidepressants, diuretics, and heart-rate medications.

LEVAQUIN and Other Interactions

LEVAQUIN may produce a false-positive urine test for opiates.

You should tell your doctor or other healthcare professional that you’re taking LEVAQUIN when submitting a urine sample.

Usual dose:

Your doctor will tell you the amount of LANVIS you need to take and how frequently. The usual initial dose is approximately 2 mg/kg body weight/day, orally. The dosage may be cautiously increased to 3 mg/kg/day after 4 weeks.

Overdose:

In the event you accidentally take more doses than prescribes immediately contact your doctor or hospital emergency department or the nearest poison control centre.

You may experience the following while taking LANVIS.

• Low white blood cells. This means that you are at greater risk of having an infection. Wash your hands often, keep your mouth and skin clean and healthy, avoid people who are sick, call your doctor or nurse if you have a fever or other flu-like symptoms.
• Low red blood cells. This means that you may feel tired or look pale. Rest if you need to. Talk to your doctor or nurse if it gets worse.
• Low platelets. These are tiny pieces of cells that help your blood to clot after you have an injury. When the platelets count is low you may be more likely to bleed or bruise abnormally. Try not to bump into things or cut yourself. Blow your nose gently. Avoid getting constipated. Brush your teeth gently with a soft toothbrush. Avoid products containing aspirin or ibuprofen. Call your doctor immediately if you notice blood in your urine, black tarry stools, lots of bruising, or tiny red dots on your skin.
• Increase in liver enzymes and/or bilirubin. This may cause your skin to look yellow. Call your doctor if you notice this.
• Increase in uric acid. This may cause symptoms like gout, including joint pain.
• Loss of appetite. Try to eat small meals frequently throughout the day.
• Nausea and vomiting. Talk to your doctor, nurse or pharmacist. Eat small meals. Drink fluids.
• Swelling of mouth and throat. Call your doctor.

If you feel unwell or have any symptoms that you do not understand, contact your doctor immediately.

This is not a complete list of side effects. For any unexpected effects while taking LANVIS, contact your doctor or pharmacist.

LANVIS is a potent drug and should be used only by physicians experienced with cancer chemotherapeutic drugs.

LANVIS is not recommended for maintenance therapy or similar long term continuous treatments.

BEFORE you use LANVIS talk to your doctor or pharmacist if:

• you have a history of hypersensitivity (an allergic reaction) to any ingredient in LANVIS.
• you are pregnant or likely to become pregnant.
• you are breastfeeding a baby.
• you have been vaccinated, or are planning to be vaccinated with a live vaccine.
• the results of your blood test show that you are not able to receive LANVIS, your doctor will tell you.
• you have kidney disease.
• you have liver problems.

LANVIS is not recommended for maintenance therapy or long term continuous treatment.

It is important that your doctor know about all your medication so that you get the best possible treatment. Tell your doctor about all the medications you are taking including those you have bought yourself.

There is usually complete cross-resistance between PURINETHOL (mercaptopurine) and LANVIS.

Use aminosalicylate derivatives (antibacterial drugs), e.g. olsalazine, mesalazine or sulphasalazine with caution if you are receiving these concurrently with LANVIS.

If you have a weak immune system, vaccination with live viral vaccines is not recommended.

To help clear up your infection completely, it is very important that you keep taking this medicine for the prescribed treatment period, even if your symptoms begin to clear up or you begin to feel better after a few days. Since fungal infections may be very slow to clear up, stopping your medication too soon can cause the symptoms and the fungal infection to flare up again.

Usual adult dose:

Follow your doctor's instructions carefully. Do not exceed the recommended dosage. If you have the impression that the effect of LAMISIL is too strong or too weak, talk to your doctor or pharmacist.

Oral: LAMISIL tablets:

Adults: 250 mg once daily.

Taking LAMISIL at the same time each day will help you remember when to take your medicine. LAMISIL tablets can be taken on an empty stomach or after a meal.

You can take LAMISIL tablets if you are aged 65 years and over at the same dose as younger adults.

The duration of treatment varies according to the indication and the severity of infection.

LAMISIL tablets:

As with all medicines, some patients taking LAMISIL tablets may experience some unwanted effects (side effects), although not everybody gets them.

The following side effects have been reported with LAMISIL tablets:

Very common (likely to affect more that 1 in every 10 patients): headache, nausea, mild abdominal pain, stomach discomfort after meal (heartburn), diarrhea, swelling or bloating (a feeling of fullness) of the abdomen, loss of appetite, skin rashes (itchy), joint pain and muscle pain.

Common (likely to affect 1 to 10 in every 100 patients): mood disorder (depression), disturbance or loss of sense of taste, dizziness, eye disorder and tiredness. If you suffer dizziness, do not drive or operate machinery.

Uncommon (likely to affect 1 to 10 in every 1000 patients): If you notice abnormal pale skin, mucosal lining or nail beds, unusual tiredness or weakness or breathlessness on exertion (possible signs of a disease that affects the level of red blood cells), anxiety, tingling or numbness and decreased skin sensitivity, increased sensitivity of the skin to sun, noises (e.g. hissing) in ears, fever and weight loss.

Rare (likely to affect less than 1 to 10 in every 10 000 patients): yellow eyes or skin (liver problems) and abnormal liver function test results.

Very rare (likely to affect less than 1 in every 10 000 patients): decrease in certain types of blood cells, lupus (an autoimmune disease), serious skin reactions, allergic reactions, psoriasis-like skin eruptions (rash with silver coloured appearance), worsening of psoriasis, skin rash with flaking or peeling and hair loss.

If you experience smell, taste, visual or hearing disorders or symptoms of depression, then stop using LAMISIL and call your doctor.

If any of the listed side effects affect you severely, discuss this with your doctor.

Other side effects not listed above may also occur in some patients. If you notice any other side effects not mentioned in this leaflet, inform your doctor or pharmacist.

Some side effects could be serious:

• if you develop fever, shivering, a sore throat or mouth ulcers due to infections and weakness or if you get infections more frequently or
• if you experience difficulty in breathing, dizziness, swelling mainly of the face and throat, flushing, crampy abdominal pain and loss of consciousness or if you experience symptoms such as joint pain, stiffness, rash, fever or swollen/enlarged lymph nodes (possible signs of severe allergic reactions).
• if you develop any skin problems such as rash, red skin, blistering of the lips, eyes or mouth, skin peeling, fever.
• if you experience severe upper stomach pain with radiation to the back (possible signs of pancreas inflammation).
• if you experience unexplained muscle weakness and pain or dark (red-brown) urine (possible signs of muscle necrosis).

Serious Warnings and Precautions

LAMISIL (terbinafine hydrochloride) tablets must not be used if you have pre-existing chronic or active liver disease. Serious and life-threatening cases of liver failure, including death, or requiring liver transplant, have been reported in patients with or without pre-existing chronic or active liver disease receiving LAMISIL Tablets.

Stop taking LAMISIL tablets and consult your doctor immediately should you develop jaundice (yellowness of skin and/or eyes or other symptoms). See Table of Serious Side Effects.

Your doctor may order blood tests before you start LAMISIL and during LAMISIL treatment.

Before you use LAMISIL, talk to your doctor if you:

• have or have had a history of any other medical problems such as liver or kidney problems, blood diseases (e.g. anemia), serious skin reactions, or alcohol abuse
• if you have or have had liver problems, your doctor may require blood tests before and during LAMISIL treatment to test liver function
• are allergic to any other medicines (either prescription or non-prescription) or foods
• are pregnant or intend to become pregnant while using LAMISIL.
• are breast-feeding; oral LAMISIL is excreted in breast milk. Nursing mothers should avoid topical applications of LAMISIL to the breast and infants should not come into contact with areas treated with topical LAMISIL.

Contact your doctor immediately, while taking LAMISIL, if you develop conditions such as:

• liver problems with symptoms such as persistent nausea, vomiting, abdominal pain, dark urine, pale stools, fatigue, loss of appetite, yellowing of the skin and eyes
• serious skin reactions such as blistering or peeling skin, blistering of the lips, eye or mouth, red/inflamed skin, hives, fever (due to skin reactions), rash (due to high white blood cell count-eosinophilia)
• experience symptoms of lupus erythematosus such as thickened patches of red/silver skin (psoriasis), joint pain, muscle disorder/pain and fever
• blood disorder with symptoms such as weakness, unusual bleeding, bruising, sore throat or frequent infections

Tablets: Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including herbal medicines, oral contraceptives (birth control pills) and non-prescription medicines. Some other medicines may interact with LAMISIL. These include:

• some medicines used to treat infectious diseases called antibiotics (e.g. rifampicin),
• some medicines used to treat mood disorders (some antidepressants such as tricyclic antidepressants, selective serotonine reuptake inhibitors including class 1A, 1B and 1C, monoamine oxidase inhibitors Type B, desipramine),
• some medicines used to treat irregular heart rhythm (antiarrhythmics (e.g. propafenone, amiodarone),
• some medicines used to treat high blood pressure (e.g. beta-blockers such as metoprolol),
• theophylline, a medicine used to relieve bronchospasm in asthma,
• some medicines used to treat cough (e.g. dextromethorphan),
• cyclosporine, a medicine used to control your body's immune system (e.g. in order to prevent rejection of transplanted organs),
• St John's wort [Hypericum perforatum]), a herbal medicine used to treat depression

Some cases of menstrual irregularities and pregnancies have been reported in patients taking LAMISIL concomitantly with oral contraceptives; however, the rate of occurrence appears to be within the background incidence for patients taking oral contraceptives alone.

To help clear up your infection completely, it is very important that you keep taking this medicine for the prescribed treatment period, even if your symptoms begin to clear up or you begin to feel better after a few days. Since fungal infections may be very slow to clear up, stopping your medication too soon can cause the symptoms and the fungal infection to flare up again.

Usual adult dose:

Follow your doctor's instructions carefully. Do not exceed the recommended dosage. If you have the impression that the effect of LAMISIL is too strong or too weak, talk to your doctor or pharmacist.

Oral: LAMISIL tablets:

Adults: 250 mg once daily.

Taking LAMISIL at the same time each day will help you remember when to take your medicine. LAMISIL tablets can be taken on an empty stomach or after a meal.

You can take LAMISIL tablets if you are aged 65 years and over at the same dose as younger adults.

The duration of treatment varies according to the indication and the severity of infection.

LAMISIL tablets:

As with all medicines, some patients taking LAMISIL tablets may experience some unwanted effects (side effects), although not everybody gets them.

The following side effects have been reported with LAMISIL tablets:

Very common (likely to affect more that 1 in every 10 patients): headache, nausea, mild abdominal pain, stomach discomfort after meal (heartburn), diarrhea, swelling or bloating (a feeling of fullness) of the abdomen, loss of appetite, skin rashes (itchy), joint pain and muscle pain.

Common (likely to affect 1 to 10 in every 100 patients): mood disorder (depression), disturbance or loss of sense of taste, dizziness, eye disorder and tiredness. If you suffer dizziness, do not drive or operate machinery.

Uncommon (likely to affect 1 to 10 in every 1000 patients): If you notice abnormal pale skin, mucosal lining or nail beds, unusual tiredness or weakness or breathlessness on exertion (possible signs of a disease that affects the level of red blood cells), anxiety, tingling or numbness and decreased skin sensitivity, increased sensitivity of the skin to sun, noises (e.g. hissing) in ears, fever and weight loss.

Rare (likely to affect less than 1 to 10 in every 10 000 patients): yellow eyes or skin (liver problems) and abnormal liver function test results.

Very rare (likely to affect less than 1 in every 10 000 patients): decrease in certain types of blood cells, lupus (an autoimmune disease), serious skin reactions, allergic reactions, psoriasis-like skin eruptions (rash with silver coloured appearance), worsening of psoriasis, skin rash with flaking or peeling and hair loss.

If you experience smell, taste, visual or hearing disorders or symptoms of depression, then stop using LAMISIL and call your doctor.

If any of the listed side effects affect you severely, discuss this with your doctor.

Other side effects not listed above may also occur in some patients. If you notice any other side effects not mentioned in this leaflet, inform your doctor or pharmacist.

Some side effects could be serious:

• if you develop fever, shivering, a sore throat or mouth ulcers due to infections and weakness or if you get infections more frequently or
• if you experience difficulty in breathing, dizziness, swelling mainly of the face and throat, flushing, crampy abdominal pain and loss of consciousness or if you experience symptoms such as joint pain, stiffness, rash, fever or swollen/enlarged lymph nodes (possible signs of severe allergic reactions).
• if you develop any skin problems such as rash, red skin, blistering of the lips, eyes or mouth, skin peeling, fever.
• if you experience severe upper stomach pain with radiation to the back (possible signs of pancreas inflammation).
• if you experience unexplained muscle weakness and pain or dark (red-brown) urine (possible signs of muscle necrosis).

Serious Warnings and Precautions

LAMISIL (terbinafine hydrochloride) tablets must not be used if you have pre-existing chronic or active liver disease. Serious and life-threatening cases of liver failure, including death, or requiring liver transplant, have been reported in patients with or without pre-existing chronic or active liver disease receiving LAMISIL Tablets.

Stop taking LAMISIL tablets and consult your doctor immediately should you develop jaundice (yellowness of skin and/or eyes or other symptoms). See Table of Serious Side Effects.

Your doctor may order blood tests before you start LAMISIL and during LAMISIL treatment.

Before you use LAMISIL, talk to your doctor if you:

• have or have had a history of any other medical problems such as liver or kidney problems, blood diseases (e.g. anemia), serious skin reactions, or alcohol abuse
• if you have or have had liver problems, your doctor may require blood tests before and during LAMISIL treatment to test liver function
• are allergic to any other medicines (either prescription or non-prescription) or foods
• are pregnant or intend to become pregnant while using LAMISIL.
• are breast-feeding; oral LAMISIL is excreted in breast milk. Nursing mothers should avoid topical applications of LAMISIL to the breast and infants should not come into contact with areas treated with topical LAMISIL.

Contact your doctor immediately, while taking LAMISIL, if you develop conditions such as:

• liver problems with symptoms such as persistent nausea, vomiting, abdominal pain, dark urine, pale stools, fatigue, loss of appetite, yellowing of the skin and eyes
• serious skin reactions such as blistering or peeling skin, blistering of the lips, eye or mouth, red/inflamed skin, hives, fever (due to skin reactions), rash (due to high white blood cell count-eosinophilia)
• experience symptoms of lupus erythematosus such as thickened patches of red/silver skin (psoriasis), joint pain, muscle disorder/pain and fever
• blood disorder with symptoms such as weakness, unusual bleeding, bruising, sore throat or frequent infections

Tablets: Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including herbal medicines, oral contraceptives (birth control pills) and non-prescription medicines. Some other medicines may interact with LAMISIL. These include:

• some medicines used to treat infectious diseases called antibiotics (e.g. rifampicin),
• some medicines used to treat mood disorders (some antidepressants such as tricyclic antidepressants, selective serotonine reuptake inhibitors including class 1A, 1B and 1C, monoamine oxidase inhibitors Type B, desipramine),
• some medicines used to treat irregular heart rhythm (antiarrhythmics (e.g. propafenone, amiodarone),
• some medicines used to treat high blood pressure (e.g. beta-blockers such as metoprolol),
• theophylline, a medicine used to relieve bronchospasm in asthma,
• some medicines used to treat cough (e.g. dextromethorphan),
• cyclosporine, a medicine used to control your body's immune system (e.g. in order to prevent rejection of transplanted organs),
• St John's wort [Hypericum perforatum]), a herbal medicine used to treat depression

Some cases of menstrual irregularities and pregnancies have been reported in patients taking LAMISIL concomitantly with oral contraceptives; however, the rate of occurrence appears to be within the background incidence for patients taking oral contraceptives alone.

To help clear up your infection completely, it is very important that you keep taking this medicine for the prescribed treatment period, even if your symptoms begin to clear up or you begin to feel better after a few days. Since fungal infections may be very slow to clear up, stopping your medication too soon can cause the symptoms and the fungal infection to flare up again.

Usual adult dose:

Follow your doctor's instructions carefully. Do not exceed the recommended dosage. If you have the impression that the effect of LAMISIL is too strong or too weak, talk to your doctor or pharmacist.

Oral: LAMISIL tablets:

Adults: 250 mg once daily.

Taking LAMISIL at the same time each day will help you remember when to take your medicine. LAMISIL tablets can be taken on an empty stomach or after a meal.

You can take LAMISIL tablets if you are aged 65 years and over at the same dose as younger adults.

The duration of treatment varies according to the indication and the severity of infection.

LAMISIL tablets:

As with all medicines, some patients taking LAMISIL tablets may experience some unwanted effects (side effects), although not everybody gets them.

The following side effects have been reported with LAMISIL tablets:

Very common (likely to affect more that 1 in every 10 patients): headache, nausea, mild abdominal pain, stomach discomfort after meal (heartburn), diarrhea, swelling or bloating (a feeling of fullness) of the abdomen, loss of appetite, skin rashes (itchy), joint pain and muscle pain.

Common (likely to affect 1 to 10 in every 100 patients): mood disorder (depression), disturbance or loss of sense of taste, dizziness, eye disorder and tiredness. If you suffer dizziness, do not drive or operate machinery.

Uncommon (likely to affect 1 to 10 in every 1000 patients): If you notice abnormal pale skin, mucosal lining or nail beds, unusual tiredness or weakness or breathlessness on exertion (possible signs of a disease that affects the level of red blood cells), anxiety, tingling or numbness and decreased skin sensitivity, increased sensitivity of the skin to sun, noises (e.g. hissing) in ears, fever and weight loss.

Rare (likely to affect less than 1 to 10 in every 10 000 patients): yellow eyes or skin (liver problems) and abnormal liver function test results.

Very rare (likely to affect less than 1 in every 10 000 patients): decrease in certain types of blood cells, lupus (an autoimmune disease), serious skin reactions, allergic reactions, psoriasis-like skin eruptions (rash with silver coloured appearance), worsening of psoriasis, skin rash with flaking or peeling and hair loss.

If you experience smell, taste, visual or hearing disorders or symptoms of depression, then stop using LAMISIL and call your doctor.

If any of the listed side effects affect you severely, discuss this with your doctor.

Other side effects not listed above may also occur in some patients. If you notice any other side effects not mentioned in this leaflet, inform your doctor or pharmacist.

Some side effects could be serious:

• if you develop fever, shivering, a sore throat or mouth ulcers due to infections and weakness or if you get infections more frequently or
• if you experience difficulty in breathing, dizziness, swelling mainly of the face and throat, flushing, crampy abdominal pain and loss of consciousness or if you experience symptoms such as joint pain, stiffness, rash, fever or swollen/enlarged lymph nodes (possible signs of severe allergic reactions).
• if you develop any skin problems such as rash, red skin, blistering of the lips, eyes or mouth, skin peeling, fever.
• if you experience severe upper stomach pain with radiation to the back (possible signs of pancreas inflammation).
• if you experience unexplained muscle weakness and pain or dark (red-brown) urine (possible signs of muscle necrosis).

Serious Warnings and Precautions

LAMISIL (terbinafine hydrochloride) tablets must not be used if you have pre-existing chronic or active liver disease. Serious and life-threatening cases of liver failure, including death, or requiring liver transplant, have been reported in patients with or without pre-existing chronic or active liver disease receiving LAMISIL Tablets.

Stop taking LAMISIL tablets and consult your doctor immediately should you develop jaundice (yellowness of skin and/or eyes or other symptoms). See Table of Serious Side Effects.

Your doctor may order blood tests before you start LAMISIL and during LAMISIL treatment.

Before you use LAMISIL, talk to your doctor if you:

• have or have had a history of any other medical problems such as liver or kidney problems, blood diseases (e.g. anemia), serious skin reactions, or alcohol abuse
• if you have or have had liver problems, your doctor may require blood tests before and during LAMISIL treatment to test liver function
• are allergic to any other medicines (either prescription or non-prescription) or foods
• are pregnant or intend to become pregnant while using LAMISIL.
• are breast-feeding; oral LAMISIL is excreted in breast milk. Nursing mothers should avoid topical applications of LAMISIL to the breast and infants should not come into contact with areas treated with topical LAMISIL.

Contact your doctor immediately, while taking LAMISIL, if you develop conditions such as:

• liver problems with symptoms such as persistent nausea, vomiting, abdominal pain, dark urine, pale stools, fatigue, loss of appetite, yellowing of the skin and eyes
• serious skin reactions such as blistering or peeling skin, blistering of the lips, eye or mouth, red/inflamed skin, hives, fever (due to skin reactions), rash (due to high white blood cell count-eosinophilia)
• experience symptoms of lupus erythematosus such as thickened patches of red/silver skin (psoriasis), joint pain, muscle disorder/pain and fever
• blood disorder with symptoms such as weakness, unusual bleeding, bruising, sore throat or frequent infections

Tablets: Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including herbal medicines, oral contraceptives (birth control pills) and non-prescription medicines. Some other medicines may interact with LAMISIL. These include:

• some medicines used to treat infectious diseases called antibiotics (e.g. rifampicin),
• some medicines used to treat mood disorders (some antidepressants such as tricyclic antidepressants, selective serotonine reuptake inhibitors including class 1A, 1B and 1C, monoamine oxidase inhibitors Type B, desipramine),
• some medicines used to treat irregular heart rhythm (antiarrhythmics (e.g. propafenone, amiodarone),
• some medicines used to treat high blood pressure (e.g. beta-blockers such as metoprolol),
• theophylline, a medicine used to relieve bronchospasm in asthma,
• some medicines used to treat cough (e.g. dextromethorphan),
• cyclosporine, a medicine used to control your body's immune system (e.g. in order to prevent rejection of transplanted organs),
• St John's wort [Hypericum perforatum]), a herbal medicine used to treat depression

Some cases of menstrual irregularities and pregnancies have been reported in patients taking LAMISIL concomitantly with oral contraceptives; however, the rate of occurrence appears to be within the background incidence for patients taking oral contraceptives alone.

Read the Patient Information Leaflet provided by your pharmacist before you start using this medication and each time you get a refill. Learn all preparation and usage instructions. If you have any questions, consult your doctor or pharmacist.

To apply this medication, wash your hands first. To avoid contamination, do not touch the insert or let it touch any other surface besides the applicator.

If you wear contact lenses, remove them before using this medication. Ask your doctor when you may replace your contact lenses.

Use the supplied applicator to place 1 insert into the eye, usually 1 to 2 times daily or as directed by your doctor.

Rinse the applicator with hot running water after use. Shake off any visible water droplets, and then replace the applicator in the storage container.

Avoid rubbing your eyes when using this medication. If the insert comes out, you may replace it with another one.

Your doctor may direct you to also use an artificial tears solution or saline drops with this medication. Use those medications exactly as prescribed.

Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same time(s) each day.

It may take several weeks to see the full benefit of this medication. Tell your doctor if your condition does not improve or worsens.

Eye discomfort/irritation/redness, tearing, eye sensitivity to light, sticky eyelashes, or temporary blurred vision 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.

Remove the insert and tell your doctor right away if any of these unlikely but serious side effects occur: eye pain, persistent eye redness/irritation, swelling in or around the eyes, vision changes.

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 or at www.fda.gov/medwatch.

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

Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with them first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: other eye medications.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

LAC HYDRIN is usually applied twice a day. Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Shake the lotion form of this medication well just before using it.

Wash your hands before and after applying this medication, unless you are using it to treat a hand condition.

Do not apply LAC HYDRIN to your face unless your doctor has told you to.

Call your doctor if your symptoms do not improve, or if they get worse while using LAC HYDRIN topical.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Apply the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

An overdose is unlikely to occur with the use of LAC HYDRIN topical.

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

Stop using LAC HYDRIN topical and call your doctor at once if you have:

• severe redness or stinging where the medicine was applied.

Common side effects may include:

• mild dryness or skin irritation after use; or
• bruising of discoloration of treated skin.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. 

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

What should I discuss with my healthcare provider before using Lac Hydrin (ammonium lactate topical)?

You should not use this medication if you are allergic to ammonium lactate, glycerin, mineral oil, propylene glycol, or parabens.

Ammonium lactate may be more likely to cause skin irritation in people who have fair or sensitive skin.

FDA pregnancy category C. It is not known whether ammonium lactate topical will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether ammonium lactate topical passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Do not give this medicine to a child without medical advice.

It is not likely that other drugs you take orally or inject will have an effect on topically applied LAC HYDRIN. But many drugs can interact with each other. Tell each of your health care providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.

KYTRIL is usually taken only on the day of treatment with chemotherapy or radiation.

Your doctor may want you to take only one dose, up to 1 hour before chemotherapy or radiation.

For patients undergoing chemotherapy, a second dose of KYTRIL is sometimes given 12 hours after the first dose. Follow your doctor's dosing instructions very carefully.

KYTRIL is not likely to be useful if you keep taking it during times when you are not receiving chemotherapy or radiation treatment.

Apply the patch to clean, dry, and hairless skin on the outer part of your upper arm. Avoid placing the patch on skin that is red, irritated, or damaged. Press the patch firmly into place and make sure it is well sealed around the edges.

Leave the patch in place during your chemotherapy treatment, and for at least 24 hours after your treatment has ended. Peel off the patch gently when removing it.

You may continue wearing a skin patch for up to 7 days if needed, depending on your chemotherapy schedule. Follow your doctor's dosing instructions very carefully.

Choose a different place on your body to wear the patch each time you put on a new one. Do not use the same skin area twice within 7 days.

Do not wear more than one KYTRIL transdermal patch at a time. Using extra skin patches will not make the medicine more effective. Never cut a skin patch.

If a patch falls off, try sticking it back into place. If it does not stick well, put on a new patch and leave it on only for the rest of your wearing time. Do not change your patch removal schedule.

After removing a patch, fold it in half so it sticks together and throw it away in a place where children or pets cannot get to it.

KYTRIL transdermal is not likely to be useful if you keep using it during times when you are not receiving chemotherapy.

Do not share this medicine with another person.

Keep each patch in its foil pouch until you are ready to use it. Store the pouches in their original container at room temperature, away from moisture and heat.

Seek emergency medical attention or call the Poison Help line.

Tell your doctor if you forget to take your dose within 1 hour before chemotherapy or radiation. Do not take extra medicine to make up the missed dose.

Call your doctor at once if you have:

• fast or pounding heartbeats;
• chest pain;
• severe dizziness;
• increased blood pressure--severe headache, buzzing in your ears, anxiety, confusion, shortness of breath; or
• high levels of serotonin in the body--agitation, hallucinations, fever, fast heart rate, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination, fainting.

Common side effects may include:

• headache, weakness;
• diarrhea, constipation;
• stomach pain, indigestion, loss of appetite;
• sleep problems (insomnia); or
• fever, flu symptoms.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

To make sure KYTRIL is safe for you, tell your doctor if you have:

• heart disease;
• a heart rhythm disorder;
• a personal or family history of Long QT syndrome;
• an electrolyte imbalance (such as low levels of potassium or magnesium in your blood); or
• if you have recently had stomach or intestinal surgery.

You should not use KYTRIL if you are allergic to it.

To make sure KYTRIL transdermal is safe for you, tell your doctor if you have:

• a stomach or intestinal disorder;
• if you have recently had stomach or intestinal surgery; or
• if you have ever had an allergic reaction to any type of medicated skin patch.

KYTRIL transdermal is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether KYTRIL transdermal passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Do not cover treated skin with a heating pad. Heat can increase the amount of drug absorbed through your skin and may cause harmful effects.

There are many other medicines that can increase your risk of heart rhythm problems if you use them together with KYTRIL.

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with KYTRIL, especially:

• anagrelide;
• droperidol;
• methadone;
• ondansetron;
• an antibiotic--azithromycin, clarithromycin, erythromycin, levofloxacin, moxifloxacin, pentamidine;
• cancer medicine--arsenic trioxide, vandetanib;
• an antidepressant--citalopram, escitalopram;
• anti-malaria medication--chloroquine, halofantrine;
• heart rhythm medicine--amiodarone, disopyramide, dofetilide, dronedarone, flecainide, ibutilide, quinidine, sotalol; or
• medicine to treat a psychiatric disorder--chlorpromazine, haloperidol, pimozide, thioridazine.

This list is not complete. Other drugs may interact with KYTRIL, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.