Consumer medicine information

Lamisil

Terbinafine

BRAND INFORMATION

Brand name

Lamisil Tablets

Active ingredient

Terbinafine

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Lamisil.

SUMMARY CMI

Lamisil®

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

1. Why am I using Lamisil?

Lamisil contains active ingredient Terbinafine hydrochloride. Lamisil is used to treat ringworm (tinea) infections occurring in groin, body, feet and soles. It is also used to treat fungal infection of finger and toenails.

For more information, see Section 1. Why am I using Lamisil? in the full CMI.

2. What should I know before I use Lamisil?

Do not use if you have ever had an allergic reaction to Lamisil or any of the ingredients listed at the end of the CMI.

Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.

For more information, see Section 2. What should I know before I use Lamisil? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Lamisil and affect how it works.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use Lamisil?

  • Your doctor will advise you on the appropriate dose.
  • For skin infections: take 250 mg Lamisil once a day
  • For fungal infection of finger and toenails: take 250 mg Lamisil once a day

More instructions can be found in Section 4. How do I use Lamisil? in the full CMI.

5. What should I know while using Lamisil?

Things you should do
  • Remind any doctor, dentist, pharmacist or specialist you visit that you are using Lamisil.
  • Tell your doctor immediately if you develop any signs of an allergic reaction.
Things you should not do
  • Do not stop using this medicine suddenly.
  • Do not use Lamisil in children.
Driving or using machines
  • Lamisil may cause dizziness in some people. Avoid driving vehicles or using machines if you are dizzy.
  • Be careful before you drive or use any machines or tools until you know how Lamisil affects you.
Looking after your medicine
  • Store below 30°C.
  • Protect from light.

For more information, see Section 5. What should I know while using Lamisil? in the full CMI.

6. Are there any side effects?

Common side effects include low appetite, headache, dizziness, weakness, vomiting, rash, hives, feeling sick, yellowing of the skin and eyes, light-coloured stools, dark coloured urine, indigestion.

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.



FULL CMI

Lamisil® 125 mg and 250 mg

Active ingredient: Terbinafine hydrochloride

Consumer Medicine Information (CMI)

This leaflet provides important information about using Lamisil. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using Lamisil.

Where to find information in this leaflet:

1. Why am I using Lamisil?
2. What should I know before I use Lamisil?
3. What if I am taking other medicines?
4. How do I use Lamisil?
5. What should I know while using Lamisil?
6. Are there any side effects?
7. Product details

1. Why am I using Lamisil?

Lamisil contains active ingredient Terbinafine hydrochloride. Lamisil belongs to a group of medications called antifungals.

Lamisil is used to treat ringworm (tinea) infections occurring in groin, body, feet (athlete's foot) and soles. It is also used to treat fungal infection of finger and toenails (Onychomycosis). These infections are caused by a group of fungi called dermatophytes. Lamisil help to kill these dermatophytes.

2. What should I know before I use Lamisil?

Warnings

Do not use Lamisil:

  • If you are allergic to Terbinafine hydrochloride, or any of the ingredients listed at the end of this leaflet. Always check the ingredients to make sure you can use this medicine. Symptoms of allergic reaction include swelling of the face, lips, tongue or other parts of the body, difficulty in breathing, redness, itching or rash on the skin, rash, fever.

Check with your doctor if you:

  • have any other medical conditions such as liver problems or any symptoms such as feeling sick, loss of appetite, weakness, vomiting, pain in right upper part of tummy or yellowing of skin or eyes, dark urine or pale stools.
  • suffer from any kidney diseases.
  • take any medicines for any other condition.
  • have any skin diseases like Psoriasis (skin problem that causes a rash with itchy, scaly patches), rash or any other serious skin reactions (e.g. Stevens-Johnson syndrome, a serious disorder of the skin with symptoms such as blisters, weakness, fever or toxic epidermal necrolysis, severe skin problem having symptoms of blistering and peeling of skin)
  • have any problems related to your blood (e.g. unusual bleeding, bruising or frequent infections)

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant.

Lamisil is not recommended during pregnancy. Your doctor will advise you regarding the possible risks and benefits of using Lamisil during pregnancy.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

Do not use Lamisil during breast feeding as Terbinafine hydrochloride passes in breast milk.

Laboratory tests

  • Your doctor might do routine blood tests, liver function test before and during treatment with Lamisil.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines may interfere with Lamisil and affect how it works.

Tell your doctor or pharmacist if you take any of the following:

  • Warfarin, a drug used to prevent blood clots
  • Oral contraceptives (birth control pills)
  • Medicines used to treat heart problems (e.g. metoprolol)
  • Caffeine
  • Drugs used to treat depression and other mental problems (e.g. tricyclic antidepressants: desipramine, selective serotonin reuptake inhibitors (SSRIs), antiarrhythmics Class 1A, 1B, and IC, and monoamine oxidase inhibitors (MAOIs) Type B)
  • Cyclosporin, a medicine used to treat certain problems with the immune system
  • Drugs used for treatment of cough e.g. dextromethorphan

Medicines that may increase the effect of Lamisil:

  • Cimetidine or other similar medicines used to treat stomach problems
  • Other antifungal medicines such as Fluconazole, ketoconazole

Medicines that may reduce the effect of Lamisil:

  • Rifampicin or other similar antibiotics used to treat infections.
    Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect Lamisil.

4. How do I use Lamisil

How much to take

  • Follow the instructions provided and use Lamisil until your doctor tells you to stop.
  • For Skin infections: take 250 mg Lamisil once a day
  • For fungal infection of finger and toenails (Onychomycosis): take 250 mg Lamisil once a day

Duration of Treatment:

  • Your doctor will advise you regarding the duration of treatment.
  • Generally, for skin infections of toes: 2 to 6 weeks
  • For fungal infection of body or the groin: 2 to 4 weeks
  • For fungal infection of finger and toenails (Onychomycosis): 6 weeks - 3 months.
  • For infection in the big toe, treatment may take up to 6 months.
  • If you do not understand your dose, consult your doctor or pharmacist

When to take Lamisil

  • Take Lamisil orally at about the same time each day.

How to take Lamisil

  • Take Lamisil orally with a full glass of water. If you notice that the Lamisil upsets your stomach, try taking it immediately after a light meal.

If you forget to use Lamisil

Lamisil should be used regularly at the same time each day. If you miss your dose at the usual time, take it as soon as you remember, and then go back to taking it as you would normally.

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.

Do not take a double dose to make up for the dose you missed.

If you use too much Lamisil

If you think that you have used too much Lamisil, you may need urgent medical attention.

You should immediately:

  • phone the Poisons Information Centre
    (by calling 13 11 26), or
  • contact your doctor, or
  • go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know while using Lamisil?

Things you should do

Keep the infected areas dry and cool and change clothing which is in direct contact with the infected areas every day.

Call your doctor straight away if you:

  • develop any signs of allergic reaction.
  • become pregnant or if you are breast feeding while using Lamisil.
  • have any problems with your liver, kidney or blood.

Remind any doctor, dentist, pharmacist or specialist you visit that you are using Lamisil.

Things you should not do

  • Do not stop using this medicine suddenly.
  • Do not use Lamisil in children.
  • Do not give Lamisil to anyone else, even if they have the same condition as you.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how Lamisil affects you.

Lamisil may cause dizziness in some people. Avoid driving vehicles or using machines if you are dizzy.

Looking after your medicine

  • Store below 30°C.
  • Protect from light.

Follow the instructions in the carton on how to take care of your medicine properly.

Store it in a cool dry place away from moisture, heat or sunlight; for example, do not store it:

  • in the bathroom or near a sink, or
  • in the car or on window sills.

Keep it where young children cannot reach it.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Less serious side effects

Less serious side effectsWhat to do
General problems:
  • Low appetite
  • Joint pain
  • Muscle pain or weakness, not caused by exercise
  • Headache
  • Dizziness
  • Tiredness
  • Blurred vision
  • Vision problems
  • Fever, chills, body pain, dry cough
Skin problems:
  • Hives
  • Rash
  • Itching
  • Redness of the skin
Tummy problems:
  • Feeling sick
  • Vomiting
  • Uncomfortable feeling in tummy
  • Excessive feeling of gas in the tummy
  • Cramps or pain in tummy
  • Diarrhoea
  • Indigestion
  • Excessive burping
  • Swelling of your belly.
Other problems:
  • Anxiety
  • Depression
Speak to your doctor if you have any of these less serious side effects and they worry you.

Serious side effects

Serious side effectsWhat to do
General problems:
  • Allergic reaction such as swelling of the face, lips, tongue or other parts of the body, difficulty in breathing, redness, itching or rash on the skin, rash, fever.
  • Problems with your blood vessels having symptoms like fever, weight loss, tiredness, rash.
Tummy problems:
  • Pain in tummy, vomiting, blood in the stools (swelling of the stomach lining)
  • Yellowing of the skin and eyes, feeling sick, light-coloured stools, dark colour urine
Skin problems:
  • Itchy rash, fever, joint pains
  • Fever, red rash, painful red areas, blisters, peeling of layers of skin (may indicate serious skin reaction)
Abnormal blood tests:
  • Dark-coloured urine, weakness
  • Weakness, feeling sick, swelling on arms, legs, or face
  • Yellowing of skin or eyes, loss of appetite, vomiting
  • Unexplained weakness, tummy problems,
  • Weakness, shortness of breath dizziness or lightheadedness pale skin, headaches
  • Fever and chills, mouth sores, sore throat
  • Chest pain, weakness, fever, muscle stiffness
Other problems:
  • Hearing problems
  • Partial loss of hearing
  • Taste disturbance
  • Loss of taste
  • Decreased ability to smell or detect odours
  • Loss of the sense of smell
Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects.

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor's prescription.

What Lamisil contains

Active ingredient
(main ingredient)		Terbinafine hydrochloride
Other ingredients
(inactive ingredients)		magnesium stearate, hypromellose, sodium starch glycollate, and cellulose - microcrystalline. Lamisil 250 mg tablet also contain silica-colloidal anhydrous.
Potential allergensLamisil 125 mg tablet contain lactose

Do not take this medicine if you are allergic to any of these ingredients.

What Lamisil looks like

Lamisil 250 mg tablet: 11 mm, white to yellow tinged, circular, biconvex, bevelled edges, scored on one side and coded “LAMISIL 250” (circular) on the other side.

Lamisil 125 mg tablet: 9 mm, white to white-tinged yellow, circular, biconvex, bevelled edges, scored and coded LP on one side.

Lamisil 250 mg tablet is available in blister packs of 42, 14*, and 28*

Lamisil 125 mg tablet is available in blister packs of 28*.

* Not all presentations or pack sizes may be marketed.

Who distributes Lamisil

Lamisil is supplied in Australia by:
NOVARTIS Pharmaceuticals Australia Pty Limited
ABN 18 004 244 160
54 Waterloo Road
Macquarie Park NSW 2113
Telephone 1 800 671 203
Web site: www.novartis.com.au

® = Registered Trademark

This leaflet was prepared in June 2025.

Internal document code:
lam070220c_v2 based on PI lam070220i

Published by MIMS August 2025

BRAND INFORMATION

Brand name

Lamisil Tablets

Active ingredient

Terbinafine

Schedule

S4

 

1 Name of Medicine

Terbinafine hydrochloride.

2 Qualitative and Quantitative Composition

Terbinafine hydrochloride is a white to off-white, finely crystalline powder. It is soluble in isopropyl alcohol (> 70 mg/mL at 25°C) and ethanol (> 70 mg/mL at 25°C), and slightly soluble in water (6.3 mg/mL at 25°C).
Each Lamisil tablet contains terbinafine hydrochloride equal to either 125 mg or 250 mg terbinafine base.
Each tablet also contains magnesium stearate, hypromellose, sodium starch glycollate, and cellulose - microcrystalline. Lamisil 250 mg tablets also contain silica-colloidal anhydrous.

Excipients with known effect.

Lamisil 125 mg tablets contain lactose.

3 Pharmaceutical Form

Lamisil 250 mg tablet.

250 mg terbinafine, as the hydrochloride (11 mm, white to yellow-tinged, circular, biconvex, bevelled edges, scored on one side and coded "LAMISIL 250" (circular) on the other side).

Lamisil 125 mg tablet.

125 mg terbinafine, as the hydrochloride (9 mm, white to white-tinged yellow, circular, biconvex, bevelled edges, scored and coded LP on one side).

4 Clinical Particulars

4.1 Therapeutic Indications

Treatment in adults of ringworm (tinea corporis, tinea cruris and tinea pedis) due to infection caused by dermatophytes such as Trichophyton (e.g. T. rubrum, T. mentagrophytes, T. verrucosum, T. violaceum), Microsporum canis and Epidermophyton floccosum, where oral therapy is considered appropriate owing to the site, severity or extent of the infection, and the infection is not responsive to topical therapy.
Onychomycosis in adults (fungal infection of the nail) caused by dermatophyte fungi.

4.2 Dose and Method of Administration

Recommended dosages and intervals.

Adults.

Skin infections.

250 mg once a day.

Onychomycosis.

250 mg once a day.

Administration.

Lamisil tablets should be taken orally. The bioavailability of terbinafine is not affected by a light meal.

Duration of treatment.

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

Skin infections.

Likely durations of treatment are as follows.
Tinea pedis (interdigital, plantar/ moccasin type): 2 to 6 weeks.
Tinea corporis, cruris: 2 to 4 weeks.
Complete resolution of the signs and symptoms of infection may not occur until several weeks after mycological cure.

Onychomycosis.

For most patients the duration for successful treatment is between six weeks and three months.
Infections of finger and toenails (other than big toe) usually respond to the shorter duration of treatment, particularly in patients of younger age with a normal rate of nail outgrowth. In patients with slow nail growth, treatment for up to three months is usually adequate. However, infections in the big toe, or if nail growth is very poor, treatment for up to 6 months may be necessary.
Optimal clinical effect is seen some months after mycological cure and cessation of treatment. This is related to the period required for outgrowth of healthy nail tissue.

4.3 Contraindications

Hypersensitivity to terbinafine or to any of the excipients in the formulation.
Severe, chronic, or active hepatic disease (see Section 4.4 Special Warnings and Precautions for Use).

4.4 Special Warnings and Precautions for Use

Effect on vision.

During high-dose studies in monkeys, refractile irregularities were observed in the retina at doses that were 30 to 60 times the human dose (non-toxic effect level 50 mg/kg). The clinical relevance of this observation is unknown. However, the ocular effects in monkeys were not confirmed in humans in the placebo-controlled trials, where the incidence of ophthalmic abnormalities was lower in the Lamisil tablet-treated patients (1.1%) compared with those who received placebo (1.5%).

Effect on blood.

Patients taking Lamisil tablets are at risk of developing agranulocytosis, thrombocytopenia, pancytopenia and neutropenia, which are very rarely associated with terbinafine. The problem usually resolves within a few days to a week of withdrawal of Lamisil tablets. Patients taking Lamisil tablets should be advised to report symptoms of infections. Prescribers should examine the patient to determine the correct aetiology of any blood dyscrasias that occur in patients treated with Lamisil tablets, and consideration should be given to a possible change in medication regimen, including discontinuation of treatment with Lamisil tablets.

Dermatological effects.

Serious skin reactions (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms) have been very rarely reported in patients taking Lamisil tablets. If progressive skin rash occurs, Lamisil tablet treatment should be discontinued.
Terbinafine should be used with caution in patients with pre-existing psoriasis or lupus erythematosus as precipitation and exacerbation of psoriasis and cutaneous and systemic lupus erythematosus have been reported in a postmarketing setting.

Use in hepatic impairment.

Lamisil tablets are contraindicated for patients with chronic or active hepatic disease. Before prescribing Lamisil tablets, liver function tests should be performed since hepatotoxicity may occur in patients with and without pre-existing liver disease. Therefore periodic monitoring (after 4-6 weeks of treatment) of liver function tests is recommended. Lamisil should be immediately discontinued in case of elevation of liver function tests. Very rare cases of liver failure (some leading to liver transplant or death) have been reported with the use of Lamisil tablets. In the majority of hepatic failure cases, the patients had underlying systemic conditions (see Section 4.8 Adverse Effects (Undesirable Effects)). Patients prescribed Lamisil tablets should be warned to report immediately any symptoms of persistent nausea, anorexia, fatigue, vomiting, right upper abdominal pain or jaundice, dark urine or pale stools. Patients with these symptoms should discontinue taking oral terbinafine and the patient's hepatic function should be immediately evaluated.

Use in renal impairment.

The use of Lamisil tablets in patients with impaired renal function (creatinine clearance less than 50 mL/min or serum creatinine of more than 300 micromol/L) has not been adequately studied and therefore is not recommended.

Use in the elderly.

There is no evidence to suggest that elderly patients require different dosages or experience side effects different from those in younger patients. When using Lamisil tablets in this age group, the possibility of impairment of liver or kidney function should be considered.

Paediatric use.

There is no experience with terbinafine in children and its use cannot be recommended. Lamisil tablets should be kept out of reach of children.

Effects on laboratory tests.

Transient decreases in absolute lymphocyte counts (ALC).

Transient decreases in absolute lymphocyte counts (ALC) have been observed in controlled clinical trials. In placebo-controlled trials, 8/465 Lamisil tablet-treated patients (1.7%) and 3/137 placebo-treated patients (2.2%) had decreases in ALC to below 1000/mm3 on two or more occasions. The clinical significance of this observation is unknown. However, in patients with known or suspected immunodeficiency, physicians should consider monitoring complete blood counts in individuals using Lamisil tablet therapy for greater than six weeks.

Effect on lipids.

In chronic toxicity studies in rats, oral terbinafine, at a dose of 309 mg/kg per day, increased serum cholesterol levels. This effect was more marked in female, than in male, rats. Effects on triglycerides levels were not consistent among the various studies. In monkeys a daily dose of 300 mg/kg increased triglyceride levels and chylomicron concentrations. In a small clinical study, a daily dose of 250 mg for 8 weeks did not result in detectable changes in the plasma lipid profile. In other clinical trials there was no evidence of a significant change in the plasma lipid profile of patients.

4.5 Interactions with Other Medicines and Other Forms of Interactions

The plasma clearance of terbinafine may be accelerated by drugs, which induce metabolism and may be inhibited by drugs, which inhibit cytochrome P450. Where coadministration of such agents is necessary, the dosage of Lamisil tablets may need to be adjusted accordingly.
There have been spontaneous reports of increase or decrease in prothrombin time in patients taking oral terbinafine and warfarin concomitantly. However, a causal relationship between Lamisil tablets and these changes has not been established.
Cautious use of Lamisil tablets is advised in women taking oral contraceptives since a few cases of menstrual disorders have been reported in patients taking this drug combination, although the incidence of these disorders remains within the background incidence of patients taking oral contraceptives alone.

The following medicinal products may increase the effect or plasma concentration of terbinafine.

Cimetidine.

Decreased the clearance of terbinafine by 33%.

Fluconazole.

Significantly increased the Cmax and AUC of terbinafine, due to inhibition of both CYP2C9 and CYP3A4 enzymes. Similar increase in exposure may occur when other drugs which inhibit both CYP2C9 and CYP3A4, such as ketoconazole and amiodarone, are concomitantly administered with terbinafine.

The following medicinal products may decrease the effect or plasma concentration of terbinafine.

Rifampicin.

Increased the clearance of terbinafine by 100%.

Effect of terbinafine on other medicinal products.

In vitro and in vivo studies showed negligible potential for interaction with the drugs that are metabolised via the CYP450 system except those with CYP2D6-mediated metabolism (see below).
Terbinafine does not interfere with the clearance of antipyrine or digoxin. Terbinafine clearance is unaffected by cyclosporin.
There was no effect of terbinafine on the pharmacokinetics of fluconazole. Further there was no clinically relevant interaction between terbinafine and the potential comedications cotrimoxazole (trimethoprim and sulfamethoxazole), zidovudine or theophylline.

Terbinafine may increase the effect or plasma concentration of the following medicinal products.

Compounds predominantly metabolised by CYP2D6.

Terbinafine inhibits the CYP2D6-mediated metabolism, therefore patients receiving concomitant treatment with drugs predominantly metabolised by this enzyme, such as tricyclic antidepressants (TCAs, e.g. desipramine), beta-blockers, selective serotonin reuptake inhibitors (SSRIs), antiarrhythmics class 1A, 1B, and 1C, and monoamine oxidase inhibitors (MAOIs) type B, should be followed, especially if the co-administered drug has a narrow therapeutic window.
In studies in healthy subjects characterized as extensive metabolisers of dextromethorphan (antitussive drug and CYP2D6 probe substrate), terbinafine significantly increased the dextromethorphan/ dextrorphan metabolic ratio in urine. Thus, terbinafine may convert extensive CYP2D6 metabolisers to poor metaboliser status.

Caffeine.

Terbinafine decreased the clearance of caffeine administered intravenously by 19%.

Terbinafine may decrease the effect or plasma concentration of the following medicinal products.

Cyclosporin.

Terbinafine increased the clearance of cyclosporin by 15%.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
(Category B1)
Foetal toxicity and fertility studies in animals suggest no adverse effects.
Since clinical experience in pregnant women is not available, Lamisil tablets should not be used during pregnancy unless the potential benefits outweigh any potential risks.
 Terbinafine is excreted in breast milk. Therefore, mothers receiving oral treatment with Lamisil tablets should not breast-feed.

4.7 Effects on Ability to Drive and Use Machines

No studies on the effects of Lamisil tablets treatment on the ability to drive and use machines have been performed. Patients who experience dizziness as an undesirable effect should avoid driving vehicles or using machines.

4.8 Adverse Effects (Undesirable Effects)

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems.
In general Lamisil tablets are well tolerated. In clinical trials, adverse events occurred in 10.4% of patients taking terbinafine tablets and 5.6% of patients taking placebo. Most adverse events were mild to moderate in severity and of a short duration.
Adverse drug reactions from clinical trials experience are listed by MedDRA system organ class. Within each system organ class, the adverse drug reactions are ranked under heading by frequency, with the most frequent reactions first. The frequency category for each adverse drug reaction is based on the following convention (CIOMS III): very common (≥ 1/10); common (≥ 1/100 to, < 1/10); uncommon (≥ 1/1,000 to, < 1/100); rare (≥ 1/10,000 to, < 1/1,000); very rare (< 1/10,000).

Gastrointestinal disorders.

Very common: nausea, vomiting, flatulence, mild abdominal discomfort, abdominal cramps, anorexia, diarrhoea, dyspepsia/ gastritis, belching, abdominal distension, decreased appetite.

Immune system disorders.

Very rare: anaphylactoid reactions (including angioedema), cutaneous and systemic lupus erythematosus.

Psychiatric disorders.

Common: depression.
Uncommon: anxiety.

Skin and subcutaneous tissue disorders.

Very common: urticaria, rash.
Common: pruritus, erythema.
Uncommon: photosensitivity reactions.
Very rare: psoriaform eruptions or exacerbation of psoriasis, Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, acute generalised exanthematous pustulosis, toxic skin eruption, dermatitis exfoliative, dermatitis bullous, alopecia. In the event of an allergic or severe skin reaction, Lamisil tablet treatment should be discontinued.

Musculoskeletal and connective tissue disorders.

Very common: musculoskeletal reactions (arthralgia, myalgia).

Hepatobiliary disorders.

Rare: transient increases in liver enzymes, hepatobiliary dysfunction, cholestatic jaundice, liver failure (some leading to liver transplant or death). In the majority of liver failure cases, the patients had underlying systemic conditions (see Section 4.3 Contraindications).

Blood and lymphatic system disorders.

Uncommon: anemia.
Very rare: haematological disorders such as neutropenia, agranulocytosis, pancytopenia and thrombocytopenia.

Nervous system disorders.

Very common: headache.
Common: dysgeusia* including ageusia*, dizziness, tiredness/ fatigue.
Uncommon: paraesthesia and hypoaesthesia.
Very rare: sedation, light-headedness, chest pain.

Eye disorders.

Common: visual impairment.

Ear and labyrinth disorders.

Uncommon: tinnitus.

General disorders.

Uncommon: pyrexia.

Investigations.

Uncommon: weight decreased.**

Effect on laboratory tests.

Transient increases in serum urea, serum creatinine, and liver enzymes.
Transient decreases in haematocrit, haemoglobin, and leucocytes.
* Hypogeusia, including ageusia, which usually recover within several weeks after discontinuation of the drug. Isolated cases of prolonged hypogeusia have been reported.
** Weight decreased secondary to dysgeusia.

Other adverse drug reactions from postmarketing spontaneous reports.

The following adverse drug reactions have been derived from post-marketing experience with Lamisil via spontaneous case reports and literature cases. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency, which is therefore categorized as not known. Adverse drug reactions are listed according to system organ classes in MedDRA.

Immune system disorders.

Anaphylactic reaction, serum sickness-like reaction.

Psychiatric disorders.

Anxiety and depressive symptoms secondary to taste disturbances.

Ear and labyrinth disorders.

Hypoacusis, impaired hearing.

Eye disorders.

Vision blurred, visual acuity reduced.

Vascular disorders.

Vasculitis.

Nervous system disorders.

Anosmia including permanent anosmia, hyposmia.

Skin and subcutaneous tissue disorders.

Drug rash with eosinophilia and systemic symptoms.

Gastrointestinal disorders.

Pancreatitis.

Musculoskeletal and connective tissue disorders.

Rhabdomyolysis.

General disorders and administration site conditions.

Influenza-like illness.

Investigations.

Blood creatine phosphokinase increased.

4.9 Overdose

A few cases of overdosage (up to 5 g) have been reported.

Signs and symptoms.

Studies in animals suggest that in a high dose situation, such as accidental overdose, central nervous symptoms (CNS) may appear. The relevance of those effects to man is unknown. However, these effects can be monitored.

Central nervous system.

Headache and dizziness.

Gastrointestinal system.

Nausea and epigastric pain.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).
The recommended treatment of overdosage consists in eliminating the drug, primarily by the administration of activated charcoal, and giving symptomatic supportive therapy, if needed. Activated charcoal may reduce absorption of the drug if given within one or two hours after ingestion. In patients who are not fully conscious or have impaired gag reflex, consideration should be given to administering activated charcoal via a nasogastric tube, once the airway is protected.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: oral antifungal agent, ATC code: D01B A02.
Terbinafine is an allylamine with antifungal activity mainly against dermatophytes, including Trichophyton (e.g. T. rubrum, T. mentagrophytes, T. verrucosum, T. violaceum), Microsporum canis, and Epidermophyton floccosum.

Mechanism of action.

Terbinafine interferes specifically with fungal sterol biosynthesis at an early step. This leads to a deficiency in ergosterol and to an intracellular accumulation of squalene, resulting in fungal cell death. Terbinafine acts by inhibition of squalene epoxidase in the fungal cell membrane. The enzyme squalene epoxidase is not linked to the cytochrome P450 system. When given orally, the drug concentrates in skin and nails at levels associated with antifungal activity.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Absorption.

Following oral administration, terbinafine is well absorbed (> 70%) and the bioavailability of terbinafine hydrochloride from Lamisil tablets as a result of first-pass metabolism is approximately 40%. A single oral dose of 250 mg terbinafine results in peak plasma concentration (Cmax) of 0.83 microgram/mL within two hours of administration. The absorption half-life is 0.8 hours and the distribution half-life is 4.6 hours.
An increase in the AUC of terbinafine of less than 20% is observed when Lamisil tablets are administered with food. At steady-state, in comparison to a single dose, peak concentration of terbinafine is 25% higher and plasma AUC increases by a factor of 2.5. The increase in plasma AUC is consistent with an effective half-life of ~ 36 hours.

Distribution.

Terbinafine binds strongly to plasma proteins (99%). It concentrates in the lipophilic stratum corneum. Terbinafine is also secreted in sebum, thus achieving high concentrations in hair follicles, hair and sebum-rich skins. There is also evidence from animal studies that terbinafine is distributed into the nail plate in the first few weeks after commencing therapy.
Animal studies also indicate that terbinafine accumulates in all lipophilic tissues, including the retinal and choroid tissues. In studies conducted so far, no ophthalmological abnormalities attributable to Lamisil tablets have been reported in humans.

Metabolism.

Terbinafine is extensively metabolised in the body. Biotransformation results in metabolites with no antifungal activity.

Excretion.

Terbinafine and its metabolites are excreted predominantly in the urine. No age-dependent changes in pharmacokinetics have been observed. In patients with renal impairment (creatinine clearance ≤ 50 mL/min) or with pre-existing liver disease, the clearance of terbinafine is decreased by approximately 50% compared to normal volunteers.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

In a 2-year rat carcinogenicity study, small but significant increases in hepatocellular carcinomas, adenomas and combined tumours were seen in males at a dietary dose of 69 mg/kg per day. No increase in hepatic tumours was seen in female rats at a dietary dose of 97 mg/kg per day.

6 Pharmaceutical Particulars

6.1 List of Excipients

See Section 2 Qualitative and Quantitative Composition.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 30°C. Protect from light. Keep out of reach of children.

6.5 Nature and Contents of Container

Lamisil 250 mg tablet.

Blister packs of 42, 14*, and 28*.

Lamisil 125 mg tablet.

Blister packs of 28*.
* Not all presentations or pack sizes may be marketed.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

6.7 Physicochemical Properties

Chemical structure.


Chemical name: (E)-N)-(6,6-dimethyl-2-hepten-4-ynyl)-N-methyl-1- naphthalenemethanamine hydrochloride.
Molecular formula: C21H26ClN.
Molecular weight: 327.90.

CAS number.

78628-80-5.

7 Medicine Schedule (Poisons Standard)

S4.

Summary Table of Changes