terbinafine
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about Lamisil tablets. It does not contain
information about other forms of Lamisil that are available without a prescription
from your pharmacy.
It does not contain all the available information about Lamisil tablets. It does not
take the place of talking to your doctor or pharmacist.
The information in this leaflet was last updated on the date listed on the last page.
Some more recent information on the medicine may be available.
You should ensure that you speak to your pharmacist or doctor to obtain the most up
to date information on the medicine. You can also download the most up to date leaflet
from www.novartis.com.au.
Those updates may contain important information about the medicine and its use of
which you should be aware.
All medicines have risks and benefits. Your doctor has weighed the risks of you taking
this medicine against the benefits they expect it will provide.
If you have any concerns about this medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine.
You may need to read it again.
What Lamisil tablets are used for
Lamisil tablets are used to treat:
fungal infections of the finger nails and toe nails
tinea (ringworm) infections of the groin and body
tinea infections of the feet, commonly called "athlete's foot."
These infections are caused by a group of fungi called dermatophytes.
Terbinafine, the active ingredient in Lamisil tablets, works by killing the dermatophytes.
Ask your doctor if you have any questions about why this medicine has been prescribed
for you.
Your doctor may have prescribed it for another reason.
Lamisil tablets are only available with a doctor's prescription. This medicine is
not addictive.
There is not enough information to recommend the use of this medicine in children.
Before you take Lamisil tablets
When you must not take it
Do not take Lamisil if you have ever had an allergic reaction to:
terbinafine, the active ingredient, or to any of the other ingredients listed at the
end of this leaflet
any other medicines, foods, preservatives or dyes
Your doctor will want to know if you are prone to allergies.
Some of the symptoms of an allergic reaction may include:
shortness of breath
wheezing or difficulty breathing
swelling of the face, lips, tongue or other parts of the body
rash, itching or hives on the skin.
Do not take Lamisil tablets:
if you have any problems with your kidneys
if you have or ever had a problem with your liver
This medicine is not recommended if you currently have a liver problem because it
may make the problem worse. If you had a liver problem in the past and your liver
is functioning normally now, your doctor may prescribe Lamisil tablets but may want
to check your liver function before and during treatment with this medicine. Your
doctor might take blood tests to monitor your liver function. In case of abnormal
test results he or she may ask you to stop taking Lamisil.
Do not take Lamisil tablets after the expiry date printed on the pack, or if the packaging
is torn or shows signs of tampering.
In that case, return it to your pharmacist.
Before you start to take it
Tell your doctor if you:
1. are pregnant or intend to become pregnant
There is no experience with use of Lamisil tablets during pregnancy. If your doctor
thinks it is necessary for you to take it, he/she will discuss with you the benefits
and risks involved.
Breastfeeding is not recommended since terbinafine, the active ingredient in Lamisil
tablets, passes into breast milk. There is a possibility that your baby could be affected.
3. have any skin problems such as rash, red skin, blistering of the lips, eyes or mouth,
skin peeling, fever (possible signs of serious skin reactions), rash due to high level
of a specific type of white blood cells (eosinophilia)
4. have any blood disorders
or experience weakness, unusual bleeding, bruising or frequent infections
5. have or experience thickened patches of red/silver skin (psoriasis)
or facial rash, joint pain, muscle disorder, fever (cutaneous and systemic lupus erythematosus)
If you are not sure whether you should start taking Lamisil tablets, talk to your
doctor or pharmacist.
Taking other medicines
Tell your doctor if you are taking any other medicines, including any that you buy
without a prescription from a pharmacy, supermarket or health food shop.
Some medicines and Lamisil tablets may interfere with each other. These include:
some medicines used to treat depression and other mental disorders, including obsessive-compulsive
disorders and panic attacks (e.g. some antidepressants such as tricyclic antidepressants,
selective serotonin reuptake inhibitors including class 1A, 1B and 1C, monoamine oxidase
inhibitors Type B, desipramine)
some medicines for Parkinson's disease
some medicines used to treat an irregular heartbeat, heart problems, high blood pressure
and migraines (e.g. metoprolol)
some medicines used to treat stomach ulcers (e.g. cimetidine)
some medicines called antibiotics used to treat infectious diseases (e.g. rifampicin)
caffeine
cyclosporin, a medicine used to help prevent organ transplant rejection or to treat
certain problems with the immune system
oral contraceptives (birth control pills). You may have problems, such as bleeding
between periods, while you are taking Lamisil tablets.
warfarin, a medicine used to prevent blood clots
You may need to take different amounts of your medicines or you may need to take different
medicines.
Your doctor and pharmacist have more information.
If you have not told your doctor about any of these things, tell him/her before you
start taking this medicine.
How to take Lamisil tablets
Follow all directions given to you by your doctor and pharmacist carefully.
These directions may differ from the information contained in this leaflet.
If you do not understand the instructions on the label, ask your doctor or pharmacist
for help.
How much to take
Follow your doctor's instructions on how many Lamisil tablets to take.
The usual dose of Lamisil is one tablet (250 mg) each day. If you have kidney problems,
the dose may be reduced to one-half a tablet each day.
How to take it
Take the Lamisil tablet with a full glass of water. If you find that the Lamisil tablet
upsets your stomach, try taking it immediately after a light meal.
Take the tablet at about the same time each day.
Taking your tablet at the same time each day will have the best effect. It will also
help you remember when to take it.
How long to take it
The length of your treatment will depend on the type of infection you have, what part
of the body is affected and how well you respond to treatment.
Fungal skin infections (tinea):
If you have a tinea infection of the feet (athlete's foot), you will usually take
the tablets for 2 to 6 weeks.
If you have a tinea infection of the body or groin, you will usually take the tablets
for 2 to 4 weeks.
The signs and symptoms of infection may last for several weeks after the fungi (dermatophytes)
have been killed.
Fungal nail infections:
Fungal nail infections usually take longer to heal than fungal skin infections. You
will usually take the tablets for anywhere from 6 weeks to 3 months. But, if you have
a nail infection of the big toe or your nails grow very slowly, you may need to take
the tablets for up to 6 months.
It may take several months after you stop taking Lamisil tablets for your nail to
look completely normal. That is because the deformed part of the nail has to grow
out and be replaced by a healthy nail.
If you forget to take it
If it is almost time for your next dose (within 4 hours), skip the dose you missed
and take the next dose when you are meant to.
Otherwise, take it as soon as you remember, and then go back to taking it as you would
normally.
Do not take a double dose to make up for the one that you missed.
This may increase the chance of you getting an unwanted side effect.
If you are not sure what to do, ask your doctor or pharmacist.
If you have trouble remembering when to take your medicine, ask your pharmacist for
some hints.
If you take too much (Overdose)
Immediately telephone your doctor or Poisons Information Centre (telephone number
13 11 26), or go to Accident and Emergency at your nearest hospital if you think that
you or anyone else may have taken too many Lamisil tablets. Do this even if there
are no signs of discomfort or poisoning. Keep the telephone numbers for these places
handy.
Some of the symptoms of an overdose may include headache, nausea (feeling sick), stomach
pain and dizziness.
While you are taking Lamisil tablets
Things you must do
Make sure to take your tablet every day and continue taking it until your doctor tells
you to stop.
This will ensure that all of the infection is gone and will lessen the chance of the
infection coming back once you stop taking this medicine.
Make sure to have any blood tests done that are ordered by your doctor.
Any side effects on your liver, kidneys or blood can be detected by blood tests.
Tell your doctor immediately if you notice any of the following:
fever
sore throat
mouth ulcers
"flu-like" symptoms (chills, aching joints, swollen glands, lack of energy)
any other signs of infection, apart from the fungal infection you are being treated
for
If you become pregnant while taking Lamisil tablets, tell your doctor immediately.
Your doctor can discuss with you the risks and benefits of taking it during pregnancy.
Remind your doctor and pharmacist that you are taking Lamisil tablets if you are about
to be started on any new medicine.
Tell any other doctor, dentist or pharmacist who treats you that you are taking Lamisil
tablets.
Things you must not do
Do not give this medicine to anyone else, even if their condition seems similar to
yours.
Do not use it to treat any other complaints unless your doctor tells you to.
Things to be careful of
Be careful driving, operating machinery or doing jobs that require you to be alert
while you are taking Lamisil tablets until you know how it affects you.
This medicine can cause tiredness, sleepiness, dizziness or light-headedness in some
people. If you have any of these symptoms, do not drive, use machines, or do anything
else that could be dangerous.
Be careful to keep the infected areas dry and cool and change clothing that is in
direct contact with the infected areas every day.
This will help to clear up the infection and make sure that it does not return.
Side effects
Tell your doctor or pharmacist as soon as possible if you do not feel well while you
are taking Lamisil tablets, even if you do not think it is connected with the medicine.
All medicines can have side effects. Sometimes they are serious, but most of the time
they are not. You may need medical treatment if you get some of the side effects.
Do not be alarmed by these lists of possible side effects. You may not experience
any of them. Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor immediately or go to Accident and Emergency at your nearest hospital
if you notice any of the following:
chest pain
signs of a severe allergic reaction such as swelling of the face, lips, tongue, throat
or other part of the body; shortness of breath, wheezing or troubled breathing; dizziness,
redness, itching or rash on the skin; flushing, crampy abdominal pain, loss of consciousness;
joint pain, stiffness, rash, fever or swollen/enlarged lymph nodes
possible signs of a serious liver problem such as persistent nausea, loss of appetite,
unusual tiredness, vomiting, pain in the upper right abdomen, yellowing of the skin
and/or eyes, dark urine or pale bowel motions
possible signs of a serious skin reaction such as painful red areas, large blisters,
peeling of layers of skin, bleeding in the lips, eyes, mouth, nose or genitals. These
signs may be accompanied by fever and chills, aching muscles and feeling generally
unwell
possible signs of a blood problem such as constant "flu-like" symptoms (fever, sore
throat, mouth ulcers, chills, swollen glands, lack of energy)
possible signs of diseases that affect certain types of blood cells: unusual bleeding
or bruising
possible signs of a disease that affects the level of red blood cells including abnormal
pale skin, mucosal lining or nail beds, unusual tiredness or weakness or breathlessness
on exertion
possible signs of blood vessel inflammation: rash, fever, itching, tiredness or if
you notice appearance of purplish-red spots under the skin surface
possible signs of pancreas inflammation: severe upper stomach pain with radiation
to the back
possible signs of muscle necrosis: unexplained muscle weakness and pain or dark (red-brown)
urine.
The above are serious side effects that need medical attention. Serious side effects
are rare.
Tell your doctor if you notice any of the following and they worry you:
nausea (feeling sick) or vomiting
upset stomach (heartburn, cramps, wind, belching)
loss of appetite
diarrhoea
aching joints or muscles
headache
light headedness
tiredness, sleepiness
skin rash due to high level of a specific type of white blood cells
loss of or change in sense of taste, which usually returns to normal within several
weeks of stopping Lamisil tablet treatment
blurred vision, decreased sharpness of vision
other skin problems
psoriasis (thickened patches of red skin, often with silvery scales)
hair loss
tingling or numbness
decreased physical sensitivity
smell disorders or loss of smell.
anxiety (with symptoms such as sleep disturbances, fatigue, loss of energy or diminished
ability to think or concentrate) and depressive symptoms (e.g. depressed mood) due
to taste disturbances
decreased hearing, impaired hearing and/or perception of noises in the absence of
sound (e.g. hissing, ringing) in ears.
Tell your doctor if you notice anything else that is making you unwell.
Some people may have other side effects not yet known or mentioned in this leaflet.
After using Lamisil tablets
Storage
Keep your medicine in the original container until it is time to take it.
Store it in a cool, dry place below 30°C and protected from light.
Do not store Lamisil tablets or any other medicine in the bathroom or near a sink.
Do not leave it in the car or on window sills.
Keep the medicine where children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place
to store medicines.
Disposal
If your doctor tells you to stop taking this medicine or the expiry date has passed,
ask your pharmacist what to do with any medicine you have left over.
Product description
What it looks like
Lamisil tablets are white to yellow- tinged, round tablets with "LAMISIL 250" in a
circular pattern on one side and a break line on the reverse side.
Lamisil tablets are available in blister packs of 42 tablets.
Ingredients
Active Ingredient
Lamisil tablets contain 250 mg terbinafine (as the hydrochloride salt) per tablet.
Inactive ingredients
Lamisil tablets also contain:
magnesium stearate (E 572)
silica-colloidal anhydrous
hypromellose (E464)
sodium starch glycollate
cellulose-microcrystalline (E 460)
Lamisil tablets do not contain lactose, sucrose, gluten, tartrazine, or any other
azo dyes.
Sponsor
Lamisil tablets are 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
Australian Registration Number:
Lamisil 250 mg tablet AUST R 43523
This leaflet was prepared in January 2018.
(lam180118c.doc based on lam180118i.doc)