Consumer medicine information

Tinasil

Terbinafine

BRAND INFORMATION

Brand name

Tinasil

Active ingredient

Terbinafine

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Tinasil.

What is in this leaflet

This leaflet answers some common questions about Tinasil tablets.

It does not contain all the available information about Tinasil 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. 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 taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with your medicine. You may need to read it again.

What Tinasil tablets are used for

Tinasil tablets are used to treat:

  • fungal infections fingernails and toenails
  • 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 Tinasil 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.

Tinasil tablets are only 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 Tinasil tablets

When you must not take it

Do not take Tinasil 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 Tinasil tablets:

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

Tinasil 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 Tinasil 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/she may ask you to stop taking Tinasil.

Do not take Tinasil 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 plan to become pregnant
There is no experience with use of Tinasil 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.
  1. are breast-feeding
Breastfeeding is not recommended since terbinafine, the active ingredient in Tinasil tablets, passes into breast milk. There is a possibility that your baby could be affected.
  1. 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)
  2. have any blood disorders
or experience weakness, unusual bleeding, bruising or frequent infections
  1. 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 Tinasil 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 Tinasil 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
  • 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 Tinasil 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 Tinasil 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 Tinasil tablets to take.

The usual dose of Tinasil 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

Swallow the tablet with a full glass of water.

If your doctor has advised that you take half a tablet, you may divide the tablet in half along the breakline.

If you find that Tinasil upsets your stomach, try taking it immediately after a light meal.

Take Tinasil 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 Tinasil 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 Tinasil 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 medicine as you would normally.

Do not take a double dose to make up for the dose 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 the nearest hospital, if you think that you or anyone else may have taken too much Tinasil 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 Tinasil 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 the tablets.

Make sure to have any blood tests done that are ordered by your doctor.

Any effects of Tinasil 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 Tinasil, 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 about to be started on any new medicine. Tell any other doctors, dentists and pharmacists who treat you that you are taking this medicine.

Things you must not do

Do not give this medicine to anyone else, even if their condition seems similar to yours.

Do not take Tinasil tablets 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 Tinasil 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 Tinasil, 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 this list 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
  • dizziness or 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 Tinasil
  • 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 or pharmacist if you notice anything that is making you feel unwell.

Some people may have other side effects not yet known or mentioned in this leaflet.

After using Tinasil tablets

Storage

Keep your tablets in the original container until it is time to take them.

Keep your tablets in a cool dry place where the temperature stays below 25°C.

Do not store Tinasil tablets or any other medicine in the bathroom or near a sink. Do not leave it on a window sill or in the car. Heat and dampness can destroy some medicines.

Keep it 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 that is left over.

Product description

What it looks like

Tinasil tablets are round, white to off-white tablets marked with "TF" over a breakline over "250" on one side and "G" on the other side. Tinasil tablets are supplied in blister packs containing 42 tablets.

Ingredients

Tinasil tablets contain 250 mg of the active ingredient, terbinafine (as the hydrochloride salt). They also contain the following inactive ingredients:

  • microcrystalline cellulose
  • croscarmellose sodium
  • povidone
  • colloidal anhydrous silica-
  • purified talc
  • magnesium stearate.

Supplier

Tinasil is supplied in Australia by:

Alphapharm Pty Limited
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
www.mylan.com

Australian Registration Number.

Tinasil 250 mg tablet

Blister packs - AUST R 104493

This leaflet was prepared in
March 2020.

Tinasil_cmi\Mar20/00

Published by MIMS May 2020

BRAND INFORMATION

Brand name

Tinasil

Active ingredient

Terbinafine

Schedule

S4

 

1 Name of Medicine

Terbinafine hydrochloride.

6.7 Physicochemical Properties

Terbinafine hydrochloride is a white or almost white powder. It is very slightly or slightly soluble in water, freely soluble in anhydrous ethanol and in methanol, slightly soluble in acetone.

Chemical structure.



Chemical name: (2E)-N,6,6-trimethyl-N- (naphthalene-1-ylmethyl)hept-2-en- 4-yn-1-amine hydrochloride.
Molecular formula: C21H26N.HCl.
Molecular weight: 327.9.

CAS number.

78628-80-5.

2 Qualitative and Quantitative Composition

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

3 Pharmaceutical Form

Tinasil tablets are round, white to off-white biconvex tablets with "TF/250" ("TF" over breakline over "250") on one side and "G" on the other side.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: oral antifungal agent. ATC code: D01BA02.
Terbinafine is an allylamine with antifungal activity mainly against dermatophytes, including Trichophyton (e.g. T. rubrum, T. mentagrophytes, T. verrucosum, T. violaceum), Microsporum canis, and Epidermophyton floccosum.

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 cell 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 a result of first-pass metabolism is approximately 40%. A single oral dose of 250 mg terbinafine results in peak plasma concentration (Cmax) 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 ~ 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.

Excretion.

Terbinafine and its metabolites are excreted predominantly in the urine. No age dependent changes in pharmacokinetics have been observed. In patients with renal impairment (creatinine clearance ≤ 50 mL/min) 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 2 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 per day. No increase in hepatic tumours was seen in female rats at a dietary dose of 97 mg/kg per 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

Use in hepatic impairment.

Terbinafine tablets are contraindicated for patients with chronic or active hepatic disease. Before prescribing terbinafine tablets, liver function tests should be performed since 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. Terbinafine 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 hepatic failure cases, the patients had underlying systemic conditions (see Section 4.8 Adverse Effects (Undesirable Effects)). Patients prescribed terbinafine 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 and the patient's hepatic function should be immediately evaluated.

Use in renal impairment.

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 is not recommended.

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 tablet treated patients (1.1%) compared with those who received placebo (1.5%).

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 treated patients (1.7%) and 3/137 placebo treated patients (2.2%) had decreases in ALC to below 1000/mm3 on two or more occasions. The clinical significance of this observation is unknown. However, in patients with known or suspected immunodeficiency, physicians should consider monitoring complete blood counts in individuals using terbinafine for greater than six weeks.

Effect on blood.

Patients taking terbinafine 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. Patients taking terbinafine 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, and consideration should be given to a possible change in medication regimen, including discontinuation of treatment with terbinafine.

Effect on lipids.

In chronic toxicity studies in rats, oral terbinafine, at a dose of 309 mg/kg per day, increased serum cholesterol levels. This effect was more marked in female than in male rats. Effects on triglycerides 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 8 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.

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. If progressive skin rash occurs, treatment with terbinafine 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 postmarketing setting.

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 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).

Paediatric use.

There is no experience with terbinafine in children and its use cannot be recommended. Terbinafine 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 inhibited by drugs which inhibit cytochrome P450.
Where coadministration of such agents is necessary, the dosage of terbinafine may need to be adjusted accordingly.
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.
Cautious use of terbinafine 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.

The following medicinal products may increase the effect or plasma concentration of terbinafine.

Cimetidine.

Decreased the clearance of terbinafine by 33%.

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.

The following medicinal products may decrease the effect or plasma concentration of terbinafine.

Rifampicin.

Increased the clearance of terbinafine by 100%.

Effect of terbinafine on other medicinal products.

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 (see below).
Terbinafine does not interfere with the clearance of antipyrine or digoxin. Terbinafine clearance is unaffected by ciclosporin.
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 may increase the effect or plasma concentration of the following medicinal products.

Compounds predominantly metabolised by CYP2D6.

Terbinafine inhibits the CYP2D6 mediated metabolism, therefore patients receiving concomitant treatment with drugs predominantly metabolised by this enzyme, such as tricyclic antidepressants (TCAs, e.g. desipramine), beta-blockers, selective serotonin reuptake inhibitors (SSRIs), antiarrhythmics class 1A, 1B and 1C and monoamine oxidase inhibitors (MAOIs) type B, should be followed, especially if the coadministered drug has a narrow therapeutic window.
In studies in healthy subjects characterised 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.

Caffeine.

Terbinafine decreases the clearance of caffeine administered intravenously by 19%.

Terbinafine may decrease the effect or plasma concentration of the following medicinal products.

Ciclosporin.

Terbinafine increases the clearance of ciclosporin by 15%.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

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

4.8 Adverse Effects (Undesirable Effects)

In general terbinafine 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.
Adverse drug reactions from clinical trials experience are listed by MedDRA system organ class. Within each system organ class, the adverse drug reactions are ranked under heading by frequency, with the most frequent reactions first. The frequency category for each adverse drug reaction is based on the following convention (CIOMS III): very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1000 to < 1/100); rare (≥ 1/10,000 to < 1/1000); very rare (< 1/10,000).

Gastrointestinal disorders.

Very common: nausea, vomiting, flatulence, mild abdominal discomfort, abdominal cramps, anorexia, diarrhoea, dyspepsia/ gastritis, belching, abdominal distension, decreased appetite.

Immune system disorders.

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

Psychiatric disorders.

Common: depression.
Very rare: anxiety.

Skin and subcutaneous tissue disorders.

Very common: urticaria, rash.
Common: pruritus, erythema.
Uncommon: photosensitivity reactions.
Very rare: psoriaform eruptions or exacerbation of psoriasis, Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, acute generalised exanthematous pustulosis, toxic skin eruption, dermatitis exfoliative, dermatitis bullous, hair loss. In the event of an allergic or severe skin reaction, terbinafine treatment should be discontinued.

Musculoskeletal and connective tissue disorders.

Very common: musculoskeletal reactions (arthralgia, myalgia).

Hepatobiliary disorders.

Rare: transient increases in liver enzymes, hepatobiliary dysfunction, cholestatic jaundice, liver failure (some leading to death or liver transplant). In the majority of liver failure cases, the patients had underlying systemic conditions (see Section 4.3 Contraindications).

Blood and lymphatic system disorders.

Uncommon: anaemia.
Very rare: haematological disorders such as neutropenia, agranulocytosis, pancytopenia and thrombocytopenia.

Nervous system disorders.

Very common: headache.
Common: dysgeusia1 including ageusia, dizziness, tiredness/ fatigue.
Uncommon: paraesthesia and hypoaesthesia.
Very rare: sedation, lightheadedness, chest pain.

Eye disorders.

Common: visual impairment.

Ear and labyrinth disorders.

Uncommon: tinnitus.

General disorders.

Uncommon: pyrexia.

Investigations.

Uncommon: weight decreased2.
1Hypogeusia, including ageusia, which usually recover within several weeks after discontinuation of the drug. Isolated cases of prolonged hypogeusia have been reported.
2Weight decreased secondary to dysgeusia.

Other adverse drug reactions from postmarketing spontaneous reports.

The following adverse drug reactions have been derived from postmarketing experience with terbinafine 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 categorised as not known. Adverse drug reactions are listed according to system organ classes in MedDRA.

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

4.2 Dose and Method of Administration

Adults.

Skin infections.

250 mg once a day.

Onychomycosis.

250 mg once a day.

Administration.

Terbinafine tablets should be taken orally. The bioavailability of terbinafine is not affected by a light meal.

Duration of treatment.

The duration of treatment varies according to the indication and the severity of the infection.

Skin infections.

Likely durations of treatment are as follows.
Tinea pedis (interdigital, plantar/ moccasin type): 2 to 6 weeks.
Tinea corporis or Tinea cruris: 2 to 4 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 6 weeks and 3 months.
Infections of finger 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 3 months is usually adequate. However, infections in the big toe, or if nail growth is very poor, treatment for up to 6 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 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.

Signs and symptoms.

Studies in animals suggest that in a high dose situation, such as accidental overdose, central nervous symptoms (CNS) 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.

Treatment.

For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).
The recommended treatment of overdosage consists in eliminating the drug, primarily by the administration of activated charcoal, and giving symptomatic supportive therapy, if needed. Activated charcoal may reduce absorption of the drug if given within one or two hours after ingestion. In patients who are not fully conscious or have impaired gag reflex, consideration should be given to administering activated charcoal via a nasogastric tube, once the airway is protected.

7 Medicine Schedule (Poisons Standard)

S4.

6 Pharmaceutical Particulars

6.1 List of Excipients

Tinasil tablets contain the following inactive excipients: magnesium stearate, purified talc, colloidal anhydrous silica, microcrystalline cellulose, povidone and croscarmellose sodium.

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.

6.5 Nature and Contents of Container

Container type: PVC/Al.
Pack sizes: 28 and 42 tablets (blister packs).
Some strengths, pack sizes and/or pack types may not be marketed.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

Summary Table of Changes