terbinafine 250 mg Tablets
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about NOUMED TERBINAFINE.
It does not contain all the available information.
It does not take the place of talking to your doctor or pharmacist.
This leaflet was last updated on the date at the end of this leaflet. More recent information may be available. The latest Consumer Medicine Information is available from https:// www.avallon-pharma.com.au and 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 NOUMED TERBINAFINE against the benefits it is expected to have for you.
If you have any concerns about taking this medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine. You may need to read it again.
What this medicine is used for
NOUMED TERBINAFINE 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 NOUMED TERBINAFINE works by killing the dermatophytes.
Ask your doctor if you have any questions about why NOUMED TERBINAFINE has been prescribed for you. Your doctor may have prescribed it for another reason.
NOUMED TERBINAFINE is not addictive. It is available only with a doctor’s prescription.
There is not enough information to recommend the use of this medicine in children.
Before you take this medicine
When you must not take
Do not take NOUMED TERBINAFINE 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
Some of the symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty in breathing, swelling of the face, lips, tongue or other parts of the body, rash, itching or hives on the skin.
Do not take NOUMED TERBINAFINE:
- 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 NOUMED TERBINAFINE 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 NOUMED TERBINAFINE.
Do not take if the packaging is torn or shows signs of tampering.
Do not take this medicine after the expiry date printed on the pack. If you take this medicine after the expiry date has passed, it may not work as well. If it has expired or is damaged, return it to your pharmacist for disposal.
Before you start to take it
Tell your doctor if you:
- are pregnant or intend to become pregnant
There is no experience with use of NOUMED TERBINAFINE 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.
- are breast-feeding
Breastfeeding is not recommended since terbinafine, the active ingredient in NOUMED TERBINAFINE, passes into breast milk. There is a possibility that your baby could be affected.
- 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)
- have any blood disorders or experience weakness, unusual bleeding, bruising or frequent infections
- 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 NOUMED TERBINAFINE, talk to your doctor or pharmacist.
Taking other medicines
Tell your doctor if you are taking any other medicines, including all prescription medicines, all medicines, vitamins, herbal supplements or natural therapies you buy without a prescription from a pharmacy, supermarket, naturopath or health food shop.
Some medicines and NOUMED TERBINAFINE 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)
- ciclosporin, 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 NOUMED TERBINAFINE.
- 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.
Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking NOUMED TERBINAFINE.
If you have not told your doctor about any of these things, tell him/ her before you start taking this medicine.
How to take NOUMED TERBINAFINE
Follow all directions given to you by your doctor and pharmacist carefully. These instructions may differ from the information contained in this leaflet.
If you do not understand the directions on the label, ask your doctor or pharmacist for help.
How much to take
Follow your doctor’s instructions on how many tablets to take.
The usual dose of NOUMED TERBINAFINE 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 tablet with a full glass of water. If you find that the 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 NOUMED TERBINAFINE 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 your medicines as you would normally.
Do not take a double dose to make up for the dose that you missed. This may increase the chances of your getting unwanted side effect(s).
If you are not sure what to do, ask your doctor or pharmacist.
If you have trouble remembering to take your medicine, ask your pharmacists for some hints.
Taking too much (overdose)
Immediately telephone your doctor or the Poisons Information Centre (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 much NOUMED TERBINAFINE. Do this even if there are no signs of discomfort or poisoning. Keep telephone numbers of these facilities handy.
Some of the symptoms of an overdose may include headache, nausea (feeling sick), stomach pain and dizziness.
While you are taking NOUMED TERBINAFINE
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:
- 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 NOUMED TERBINAFINE, tell your doctor immediately. Your doctor can discuss with you the risks and benefits of taking it during pregnancy.
If you are about to be started on any new medicine, tell your doctor and pharmacist that you are taking NOUMED TERBINAFINE.
Tell any other doctors, dentists and pharmacists who treat you that you are taking this medicine.
Things you must not do
Do not give NOUMED TERBINAFINE to anyone else, even if they have the same condition as you.
Do not use NOUMED TERBINAFINE to treat any other complaints unless your doctor tells you to.
Things to be careful of
Be careful driving or operating machinery until you know how NOUMED TERBINAFINE affects you. This medicine can cause tiredness, sleepiness, dizziness or lightheadedness 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.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking NOUMED TERBINAFINE.
All medicines can have side effects. Sometimes they are serious, 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 the list of possible side effects. 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 as soon as possible 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
- aching joints or muscles
- 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 NOUMED TERBINAFINE 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
Tell your doctor if you notice anything else that is making you feel unwell. Some people may have other side effects not yet known or mentioned in this leaflet.
Ask your doctor or pharmacist if you don’t understand anything in this list.
After taking NOUMED TERBINAFINE
Keep your NOUMED TERBINAFINE in the blister pack until it is time to take them.
Store it in a cool, dry place below 25°C and protected from light.
Do not store it or any other medicine in the bathroom or near a sink. Do not leave it in the car or on a window sill. Heat and dampness can destroy some medicines.
Keep NOUMED TERBINAFINE where young children cannot reach them. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.
If your doctor tells you to stop taking NOUMED TERBINAFINE or the tablets have passed their expiry date, ask your pharmacist what to do with any tablets you have left over.
What NOUMED TERBINAFINE looks like
White to off-white, capsule-shaped, tablets debossed with ‘T’ and ‘250’ on either side of the breakline on one side and a deep breakline on the other side
NOUMED TERBINAFINE tablets are available in blister packs of 42 tablets.
250 mg terbinafine (as the hydrochloride salt) per tablet
Microcrystalline cellulose, sodium starch glycollate type A, hypromellose, colloidal anhydrous silica, magnesium stearate and purified talc.
Avallon Pharmaceuticals Pty Ltd.
Level 5, 7 Eden Park Drive
Macquarie Park NSW 2113
Australian Registration Number
AUST R 324497
This leaflet was prepared in March 2020.
Published by MIMS November 2020