125 mg and 250 mg
Terbinafine hydrochloride
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.
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.
3. What if I am taking other medicines?
Some medicines may interfere with Lamisil and affect how it works.
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
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.
|
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.
125 mg and 250 mg
Active ingredient:
Terbinafine
hydrochloride
Full 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?
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 effects
|
What 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 effects
|
What 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
|
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Other ingredients
(inactive ingredients)
|
magnesium stearate, hypromellose, sodium starch glycollate, and cellulose - microcrystalline.
Lamisil 250 mg tablet also contain silica-colloidal anhydrous.
|
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Potential allergens
|
Lamisil 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
® = Registered Trademark
This leaflet was prepared in June 2025.
Internal document code:
lam070220c_v2 based on PI lam070220i