Consumer medicine information

What is in this leaflet

This leaflet answers some common questions about TAMSIL 250 mg tablets. It does not contain information about other forms of terbinafine hydrochloride that are available without a prescription from your pharmacy.

It does not contain all the available information about TAMSIL. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking TAMSIL against the benefits they expect it will provide.

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 TAMSIL tablets are used for

Tamsil 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 Tamsil 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.

Tamsil 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 TAMSIL tablets

When you must not take it

Do not take TAMSIL 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 TAMSIL 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 Tamsil 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 Tamsil.

Do not take TAMSIL 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 TAMSIL 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.

2. Are breast-feeding

Breastfeeding is not recommended since terbinafine, the active ingredient in TAMSIL 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 TAMSIL tablets, talk to your doctor or pharmacist.

Taking other medicines

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

Some medicines and TAMSIL 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 TAMSIL 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 TAMSIL 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 TAMSIL tablets to take.

The usual dose of TAMSIL 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 TAMSIL tablet with a full glass of water. If you find that the TAMSIL 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 TAMSIL 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 your next dose when you are meant to.

Otherwise, take it as soon as you remember, and then go back to taking your tablet(s) as you would normally.

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

If you are not sure what to do, talk to your doctor or pharmacist.

If you have trouble remembering to take your tablets, ask your pharmacist for some hints.

If you take too much (overdose)

Immediately telephone your doctor or Poisons Information Centre (telephone 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 TAMSIL. 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 using TAMSIL 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 TAMSIL 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 TAMSIL 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 TAMSIL 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 TAMSIL 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 TAMSIL, 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 TAMSIL 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 TAMSIL tablets

Storage

Keep your medicines in the blister pack until it is time to take it.

Store it in a cool, dry place below 25°C and protected from light

Do not store TAMSIL 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 meters above the ground is a good place to store medicines.

Disposal

If your doctor tells you to stop taking TAMSIL or the tablets have passed their expiry date, ask your pharmacist what to do with any that are left over.

Product Description

What it looks like

White to off white round tablet embossed “R250” on one side and score (bisect) line on the other side; pack of 42.

Ingredients

The active ingredient in TAMSIL is terbinafine (as hydrochloride). Each tablet contains 250 mg of terbinafine.

Tamsil tablets also contain:

• Microcrystalline cellulose
• Colloidal anhydrous Silica
• Hypromellose
• Magnesium stearate
• Croscarmellose sodium

If you are concerned about which tablet you are taking or any of the above ingredients, talk to your doctor or pharmacist before starting to take TAMSIL.

Name & Address of Sponsor

Tamsil is supplied in Australia by:

Arrotex Pharmaceuticals Pty Ltd
15 – 17 Chapel Street,
Cremorne, VIC 3121
www.arrotex.com.au

TAMSIL 250 mg Tablets AUST R 167577

This leaflet was prepared in July 2022

Published by MIMS September 2022

1 Name of Medicine

Terbinafine hydrochloride.

2 Qualitative and Quantitative Composition

Each tablet contains terbinafine hydrochloride equivalent to terbinafine 250 mg.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Tamsil tablets, equivalent terbinafine base 250 mg (White to off white round, flat bevelled edge tablets embossed "R250" on one side and Score (bisect) line on the other 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

Terbinafine 250 mg once a day, taken orally.
The bioavailability of terbinafine is not affected by a light meal.
The duration if treatment varies according to the indication and the severity of the infection.

Skin infections.

Tinea pedis (interdigital, planar/ moccasin type).

Tinea corporis, cruris.

Onychomycosis.

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

Risk-benefit should be considered when the following medical problems exist.

Transient decreases in absolute lymphocyte counts (ALC).

Effect on blood.

Dermatological effects.

Effect on vision.

Effect on lipids.

Use in hepatic impairment.

Use in renal impairment.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

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 decreased by drugs which inhibit cytochrome P450. 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.
Terbinafine does not interfere with the clearance of antipyrine or digoxin. Terbinafine clearance is increased 100% by rifampicin, a CYP450 enzyme inducer, and decreased by 33% by cimetidine, a CYP450 enzyme inhibitor. Where co-administration of such agents is necessary, the dosage of terbinafine tablets may need to be adjusted accordingly. Terbinafine clearance is unaffected by cyclosporin.
Fluconazole significantly increased the C_max 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.
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 inhibits the CYP2D6 mediated metabolism, therefore patients receiving concomitant treatment with drugs predominantly metabolised by this enzyme, such as tricyclic antidepressants (TCA, e.g. desipramine), beta-blockers, selective serotonin reuptake inhibitors (SSRIs), antiarrhythmics class 1A, 1B, and IC and monoamine oxidase inhibitors (MAOIs) type B, should be followed, 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.
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 terbinafine tablets and these changes has not been established.
Terbinafine decreases the clearance of caffeine by 19% and increases the clearance of cyclosporin by 15%.
Cautious use of terbinafine 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.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

No studies on the effects of terbinafine 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)

In general, terbinafine hydrochloride is well tolerated. In clinical trials, adverse events occurred in 10.4% of patients taking terbinafine and 5.6% of patients taking placebo. Most adverse events were mild to moderate in severity and of a short duration.
The following adverse reactions have been observed during clinical trials and/or post marketing surveillance. Frequency estimate. Very common: greater than or equal to 10%; common: greater than or equal to 1% to < 10%; uncommon: greater than or equal to 0.1% to < 1%; rare: greater than or equal to 0.01% to < 0.1%; very rare: < 0.01%

Gastrointestinal.

Immune system disorders.

Psychiatric disorders.

Dermatological.

Musculoskeletal.

Hepatic.

Renal.

Haematological.

Nervous system disorders.

Eye disorders.

Ear and labyrinth disorders.

General disorders.

Investigations.

Other.

Other adverse drug reactions from post-marketing spontaneous reports.

Immune system disorders.

Psychiatric disorders.

Ear and labyrinth disorders.

Eye disorders.

Vascular disorders.

Nervous system disorders.

Skin and subcutaneous tissue disorders.

Gastrointestinal disorders.

Musculoskeletal and connective tissue disorders.

General disorders and administration site conditions.

Investigations.

Reporting suspected adverse effects.

4.9 Overdose

A few cases of overdosage (up to 5 g) have been reported.
Studies in animals suggest that in a high dose situation such as accidental overdose, central nervous system (CNS) symptoms may appear. The relevance of those effects to man is unknown. However, these effects can be monitored.

Central nervous system.

Gastrointestinal system.

5 Pharmacological Properties

Terbinafine is an allylamine with antifungal activity mainly against dermatophytes.

5.1 Pharmacodynamic Properties

Mechanism of action.

Clinical trials.

5.2 Pharmacokinetic Properties

Absorption.

Distribution.

Metabolism.

Excretion.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica, hypromellose, magnesium stearate.

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 25°C. Protect from light.

6.5 Nature and Contents of Container

Tamsil terbinafine (as hydrochloride) 250 mg tablets are packaged in blister packs of 14, 28 and 42 tablets.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

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).
Chemical Name: Terbinafine hydrochloride.
Molecular formula: C₂₁H₂₅N; Molecular Weight: 291.44.

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription only medicine.

Summary Table of Changes