Consumer medicine information

Tamsil 250 mg Tablets

Terbinafine

BRAND INFORMATION

Brand name

Tamsil Tablets

Active ingredient

Terbinafine

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Tamsil 250 mg Tablets.

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 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 this medicine against the benefits they expect it will provide.

If you have any concern about this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine.

You may need to read it again.

What TAMSIL is used for

TAMSIL is 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 hydrochloride, the active ingredient in TAMSIL, 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 is 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 it

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.

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 if you:

  • have any problems with your kidneys
  • have or ever had a problem with your liver

Do not take TAMSIL until you have discussed these problems with your doctor.

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 but your liver is functioning normally now, your doctor may prescribe TAMSIL but may want to check your liver function before and during treatment with the medicine.

Do not take TAMSIL 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 are pregnant or intend to become pregnant.

There is no experience with use of TAMSIL 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.

Tell your doctor if you are breastfeeding.

Breastfeeding is not recommended since terbinafine, passes into the breast milk. There is a possibility that your baby could be affected.

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 TAMSIL may interfere with each other. These include:

  • some medicines used to treat depression and other mental disorders, including obsessive-compulsive disorders and panic attacks
  • some medicines for Parkinson’s disease
  • some medicines used to treat an irregular heartbeat, heart problems, high blood pressure and migraines (e.g. metaprolol)
  • some medicines used to treat stomach ulcers (e.g. cimetidine)
  • some antibiotics (e.g. rifampicin)
  • caffeine
  • cyclosporin, a medicine used to help prevent organ transplant rejection or 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
  • warfarin, a medicine used to prevent blood clots.

You may need to take different amounts of your medicine 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 it

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

The usual dose of TAMSIL is one tablet (250 mg) each day taken orally. 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 this medicine 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 to 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 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.

Ask your pharmacist for some hints if you have trouble remembering when to take your medicine.

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 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 taking TAMSIL

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) or any other signs of infection, apart from fungal infection you are being treated for.

If you become pregnant while taking TAMSIL, 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 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 this medicine.

Things you must not do

Do not give this medication 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 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 or do anything else that could be dangerous.

Be careful to keep the infected areas dry and cool and change the clothing that is in direct contact with the infected area 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:

  • Signs of allergy such as swelling of the face, lips, tongue or other part of the body: shortness of breath, wheezing or troubled breathing: redness, itching or rash on the skin
  • Signs of a possible 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
  • 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
  • Signs of possible blood problem such as constant “flu-like” symptoms (fever, sore throat, mouth ulcers, chills, swollen glands, lack of energy) or unusual bleeding or bruising
  • Chest pain

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
  • Loss of or change in sense of taste, which usually returns to normal within several weeks of stopping Tamsil 250 mg
  • Psoriasis (thickened patches of red skin, often with silvery scales) [very rare]
  • Hair loss (very rare)
  • Tingling or numbness (very rare)
  • Decreased physical sensitivity (very rare)

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 it

Storage

  • Keep your medicines in the original container until it is time to take it
  • Store it in a cool, dry place below 25 degrees 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 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

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.

BRAND INFORMATION

Brand name

Tamsil Tablets

Active ingredient

Terbinafine

Schedule

S4

 

1 Name of Medicine

Terbinafine hydrochloride.

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.

91161-71-6.

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).

5 Pharmacological Properties

Terbinafine is an allylamine with antifungal activity mainly against dermatophytes.

5.1 Pharmacodynamic Properties

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 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 tablets, as the result of first-pass metabolism is approximately 40%. A single oral dose of terbinafine 250 mg results in peak plasma concentrations 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 terbinafine 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 approximately 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 terbinafine tablets have been reported in humans.

Metabolism.

Terbinafine is extensively metabolised in the body. Biotransformation results in metabolites with no antifungal activity, which are excreted predominantly in the urine.

Excretion.

No age dependent changes in pharmacokinetics have been observed. In patients with renal impairment (creatine clearance less than or equal to 50 mL/minute) 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 two-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/day. No increase in hepatic tumours was seen in female rats at a dietary dose of 97 mg/kg/day.

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.

4.3 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).

Transient decreases in absolute lymphocyte counts (ALC) have been observed in controlled clinical trials. In placebo controlled trials, 8/465 terbinafine tablet treated patients (1.7%) and 3/137 placebo treated patients (2.2%) had decreases in ALC below 1,000/mm3 on two or more occasions. The clinical significance of this observation is unknown. However, in patients with known or suspected immunodeficiency, doctors should consider monitoring complete blood counts in individuals using terbinafine tablet therapy for greater than six weeks.

Effect on blood.

Patients taking terbinafine 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 terbinafine tablets. Patients taking terbinafine 250 mg 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 terbinafine tablets, and consideration should be given to a possible change in medication regimen, including discontinuation of treatment with terbinafine 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 terbinafine tablets. If progressive skin rash occurs, terbinafine 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 post marketing setting.

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 (nontoxic 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 terbinafine hydrochloride treated patients (1.1%) compared with those who received placebo (1.5%).

Effect on lipids.

In chronic toxicity studies in rats, oral terbinafine, at a dose of 309 mg/kg/day, increased serum cholesterol levels. This effect was more marked in female than in male rats. Effects on triglyceride 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 eight 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.

Use in hepatic impairment.

Terbinafine 250 mg tablets are not recommended for patients with chronic or active liver disease. Before prescribing terbinafine 250 mg tablets, pre-existing liver disease should be assessed. 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. Tamsil 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 terbinafine tablets.
In the majority of liver failure cases, the patients had underlying systemic conditions and an uncertain causal association with the administration of terbinafine tablets (see Section 4.8 Adverse Effects (Undesirable Effects)). Patients prescribed terbinafine 250 mg 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 tablets and the patient's liver function should be immediately evaluated.

Use in renal impairment.

The elimination of terbinafine in patients with impaired renal function is lower compared to healthy volunteers.
The use of terbinafine 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 terbinafine 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 terbinafine 250 mg tablets in this age group, the possibility of impairment of liver or kidney function should be considered (see Section 4.4 Special Warnings and Precautions for Use, Use in hepatic impairment, Use in renal impairment).

Paediatric use.

There is no experience with terbinafine in children and its use cannot be recommended. Terbinafine 250 mg should be kept out of reach of children.

Effects on laboratory tests.

Transient increases in serum urea, serum creatinine and liver enzymes. Transient decreases in haematocrit, haemoglobin and leucocytes.

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 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.
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.

Foetal toxicity and fertility studies in animals suggest no adverse effects.
(Category B1)
Since clinical experience in pregnant women is not available, terbinafine 250 mg 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 terbinafine 250 mg should not breastfeed.

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.

Very common: Nausea, vomiting, flatulence, mild abdominal discomfort, abdominal cramps, anorexia, diarrhoea, dyspepsia/gastritis, belching, abdominal distension, feeling of fullness, loss of appetite.
Uncommon: Taste disturbances (including taste loss) which usually recover within several weeks after discontinuation of the drug. Isolated cases of prolonged taste disturbances have been reported. A decrease of food intake leading to significant weight loss was observed in very few cases.

Immune system disorders.

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

Psychiatric disorders.

Common: depression.
Uncommon: anxiety.

Dermatological.

Common: Non-serious forms of skin reactions (e.g. urticaria, pruritus, erythema, rash).
Very rare: Psoriasiform eruptions or exacerbation of psoriasis, serious skin reactions (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, acute generalize exanthematous pustulosis), cutaneous and systemic lupus erythematosus, toxic skin eruption, dermatitis exfoliative, dermatitis bullous, alopecia, hair loss, anaphylactoid reactions (including angioedema). In the event of an allergic or severe skin reaction, terbinafine tablet treatment should be discontinued.
Uncommon: photosensitivity reactions.

Musculoskeletal.

Very common: Muscoskeletal reactions (arthralgia, myalgia).

Hepatic.

Rare: Transient increases in liver enzymes, hepatobiliary dysfunction, cholestatic jaundice.
Very rare: Liver failure (some leading to liver transplant or death). In the majority of liver failure cases, the patients had underlying systemic conditions and an uncertain causal association with the administration of terbinafine tablets (see Section 4.4 Special Warnings and Precautions for Use).

Renal.

Transient rises in serum urea/serum creatinine.

Haematological.

Uncommon: anaemia.
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**.
*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.

Common: Headache.
Very rare: dizziness, paraesthesia and hypoaesthesia, tiredness/fatigue, sedation, light-headedness, chest pain, hair loss.

Other adverse drug reactions from post-marketing spontaneous reports.

The following adverse drug reactions have been derived from post-marketing experience 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.

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.

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 https://www.tga.gov.au/reporting-problems.

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.

Likely treatment durations are as follows.

Tinea pedis (interdigital, planar/ moccasin type).

Two to six weeks.

Tinea corporis, cruris.

Two to four 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 fingers 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, for infections in the big toe, or if the nail growth is very poor, treatment for up to six 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.

4.7 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.

4.9 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.

Headache and dizziness.

Gastrointestinal system.

Nausea and epigastric pain.
Give symptomatic supportive therapy, if needed.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 16 (Australia).

7 Medicine Schedule (Poisons Standard)

S4.

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.

Summary Table of Changes