Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Terbinafine contains a medicine called terbinafine as terbinafine hydrochloride, which belongs to a group of medicines called antifungals. It is used in adults and older people to treat a number of fungal infections of the skin and nails such as athlete's foot, groin infections, ringworm and also onychomycosis (a fungal infection of the nails). It kills the fungus and stops it growing.
• if you are allergic to terbinafine or any of the other ingredients of this medicine (listed in section 6) • if you have severe kidney problems • if you have or had liver problems • if you are breastfeeding • if you are pregnant or trying to become pregnant. Do not take Terbinafine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Terbinafine. Warnings and precautions Talk to your doctor or pharmacist before taking Terbinafine:
• if you have or have experienced patches of red/silver skin (psoriasis), or facial rash, joint pain, muscle disorder, fever (cutaneous and systemic lupus erythematosus). Terbinafine can make these problems worse. • if you have ever had liver or kidney problems
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If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Terbinafine. Look out for side effects Terbinafine can cause some side effects that may require urgent medical treatment. They include problems with your liver, skin, muscles or blood. See "Stop taking Terbinafine and see a doctor or go to a hospital straight away, if you notice any of the following serious side effects" at the beginning of Section 4 for more information. Children and adolescents Terbinafine tablets can be used in adolescents and children aged 2 years and over. As the patient grows, the doctor will adjust the dose. Terbinafine tablets are not recommended for use in children under 2 years of age since there is no experience in this age group.
Other medicines and Terbinafine Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines including medicines obtained without a prescription, oral contraceptives or herbal medicines. This is because Terbinafine can affect the way some other medicines work. Also some other medicines can affect the way Terbinafine works. In particular, tell your doctor or pharmacist if you are taking any of the following medicines
• rifampicin, used to treat infections • cimetidine, a medicine used to treat stomach problems such as indigestion or stomach ulcers • anti-fungals, used to treat fungal infections such as fluconazole or ketoconazole • anti-depressants including tricyclic anti-depressants such as desipramine, SSRIs (selective serotonin reuptake inhibitors), or MAOIs (monoamine oxidase inhibitors) • oral contraceptives (as irregular periods and breakthrough bleeding may occur in some females) • caffeine, used in some painkillers or cold remedies • betablockers or anti-arrhythmics, used to treat heart problems such as metoprolol, propafenone or amiodarone • ciclosporin, used to control your body's immune system after transplant • dextromethorphan, used in some cough medicines If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Terbinafine.
Food and drink Terbinafine may increase the effects of caffeine in your drinks.
Pregnancy and breast-feeding Do not take Terbinafine if you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby. You should not take this medicine if you are breast-feeding as terbinafine can pass into breast milk. Ask your doctor or pharmacist for advice before taking this medicine.
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Driving and using machines Terbinafine can cause dizziness. If you feel dizzy after taking this medicine, do not drive or use any tools or machines. Terbinafine contains sodium This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially 'sodiumfree'.
• You should take Terbinafine by mouth. • Swallow the tablets whole with a glass of water. • Terbinafine can be taken with or without food. • The score line is not intended for breaking the tablet. Patients with reduced kidney or liver function Terbinafine is not recommended in patients with reduced kidney or liver function. Use in children and adolescents There is no experience with Terbinafine in children under 2 years of age (usually less than 12 kg). The dosage in children above 2 years of age depends on the body weight: Children weighing more than 40 kg 250 mg (one 250 mg tablet) once daily Other terbinafine products should be used for children weighing 20 to 40kg (dose of 125mg) as the tablets cannot be broken into two equal halves. Other form(s) of this medicine may be more suitable for children; ask your doctor or pharmacist.
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Other ways to clear up your infection There are other steps that you can take to help clear up your infection and make sure that it does not return. For example, keep the infected area dry and cool and change clothing that is in direct contact with the infected area daily. If you take more Terbinafine than you should If you take too much Terbinafine tell your doctor or go to the hospital straight away. Take your medicine pack with you so that people can see what you have taken. You may get a headache, feel sick, or dizzy or stomach pain. If you forget to take Terbinafine If you miss taking a Terbinafine tablet, do not worry. Take it as soon as you remember, unless it is less than 4 hours before your next dose is due. In this case, wait and take your next tablet at the usual time. Then carry on as normal until you have finished all the tablets. Do not take a double dose to make up for a forgotten dose. If you stop taking Terbinafine It is important that you finish all the tablets you have been given unless your doctor tells you to stop taking them. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them. Stop taking Terbinafine and see a doctor or go to the hospital straight away if you notice any of the following serious side effects – you may need urgent medical treatment: • severe allergic reaction – the signs may include difficulty breathing, swelling of your lips, face, throat or tongue, flushing, stomach cramps or joint pain, stiffness, rash or swollen lymph glands. You may also become unconscious • yellowing of your skin or eyes. Unusually dark urine or pale faeces, unexplained feeling of sickness, being sick, stomach problems, loss of appetite or unusual tiredness or weakness – these may be signs of liver problems • a sore throat with fever and shivering – signs that the medicine has affected your blood cells • a sore throat, with fever, tiredness and ulcers appearing on your mouth or lips – signs of a problem with your immune system • unusual bleeding or bruising – signs that the medicine has affected your blood cells. • stomach pain which spreads to your back – signs of "pancreatitis" • unexplained muscle weakness and pain or having dark red-brown urine – signs of "muscle necrosis" • feeling unusually tired, weak or breathless and looking pale – signs of "anaemia" • onset or worsening of a condition called psoriasis (a long-term illness with symptoms including thickened patches of red and silver skin) • onset or worsening of a condition called Lupus (a long-term illness with symptoms including fever, facial skin rash and pain in the muscles and joints) • severe skin rash (including light sensitivity, swelling, blistering, scales or wheals) • skin rash, fever, itching, feeling tired or if you notice purplish-reddish spots under your skin – signs that your blood vessels have become inflamed
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If you get any of the serious side effects listed above, stop taking Terbinafine and see a doctor or go to hospital straight away. Other side effects may include: Talk to your doctor or pharmacist if you notice any of the following side effects. Very common: may affect more than 1 in 10 people • headache • diarrhoea • skin rashes (itchy) • joint pain and muscle pain • stomach problems such as loss of appetite, stomach ache, indigestion, feeling bloated or sick Common: may affect up to 1 in 10 people • feeling tired or dizzy • depression • disturbance or loss of sense of taste • eye disorder Uncommon: may affect up to 1 in 100 people • if you notice unusually pale skin, nail beds or when you pull down your eyelids, feeling unusually tired, weak or breathless during physical activity (possible signs of a disease that affects the level of red blood cells), anxiety, tingling or numbness and decreased skin sensitivity, increased sensitivity of the skin to sun, noises (e.g. hissing) in ears, fever and weight loss. Rare: affecting fewer than 1 in 1,000 people • yellow eyes or skin (liver problems) and abnormal liver function test results Very rare: may affect up to 1 in 10,000 people • numbness, tingling or loss of sensitivity to touch • hair loss Not known: frequency cannot be estimated from the available data • loss of sense of smell or reduced ability to smell • blurred vision, decreased sharpness of vision • feeling anxious – signs include trouble sleeping, feeling tired, lack of energy, finding it difficult to think or concentrate • feeling low in mood • increase in blood levels of a muscle enzyme – shown in blood tests • skin rash due to high level of a specific type of white blood cells Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard By reporting side effects you can help provide more information on the safety of this medicine.
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Terbinafine 250 mg Tablets comes as tablet containing 250 mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Terbinafine 250 mg Tablets is terbinafine hydrochloride.
Medicines with the same active substance include: Lamisil 1% w/w Cream, Lamisil AT 1% Cream, Lamisil AT 1% Spray, Lamisil Once, Lamisil Tablets 250mg, Terbinafine 1 % Cream. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Terbinafine 250 mg Tablets, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Fungal infections of the skin caused by Trichophyton (e.g. T. rubrum, T. mentagrophytes, T. verrucosum, T. violaceum) Microsporum canis and Epidermophyton floccosum.
Oral Terbinafine tablets are indicated in the treatment of ringworm (tinea corporis, tinea cruris and tinea pedis where oral therapy is considered appropriate due to the site, severity or extent of the infection.
The treatment of onychomycosis (terbinafine-sensitive fungal infection of the nails) caused by dermatophyte fungi.
N.B. Orally administered terbinafine tablets are not effective against Pityriasis versicolor.
Consideration should be given to official guidance on the appropriate use of antifungal agents.
Posology
Adults
250 mg once daily.
The duration of treatment is varies according to the indication and the degree of severity of the infection.
Skin infections
The likely durations of treatment are as follows:
| Tinea pedis (interdigital, plantar/moccasin-type): Tinea corporis: Tinea cruris : | 2 to 6 weeks 4 weeks 2 to 4 weeks |
Onychomycosis
The duration of treatment for most patients is between 6 weeks and 3 months. Treatment periods of less than 3 months can be anticipated in patients with fingernail infections, toenail infection other than of the big toe, or patiens of younger age.
In the treatment of toenail infection, 3 months is usually sufficient although a few patients may require treatment of 6 months or longer. Poor nail outgrowth during the first weeks of treatment may enable identification of those patients in whom longer therapy is required.
Complete resolution of the signs and symptoms of infection may not occur until several weeks after mycological cure.
Special populations
Paediatric population
There is no data available in children under 2 years of age (usually <12kg).
Children weighing >40kg 250mg (one 250mg tablet) once daily
This formulation is not recommended in children weighing 20-40kg (dose of 125mg) as the tablets cannot be broken into two equal halves, and other formulations should be used.
Hepatic impairment
Terbinafine tablets are contraindicated for patients with chronic or active hepatic disease (see sections 4.3 Contraindications and 4.4 Special warnings and precautions for use).
Renal impairment
The use of terbinafine tablets has not been adequately studied in patients with renal impairment and is therefore not recommended in this population (see section 4.4 Special warnings and precautions for use and section 5.2 Pharmacokinetic properties).
Elderly
There is no evidence to suggest that elderly patients (aged 65 years or above) require different dosages or experience different side effects to those of younger patients. When prescribing terbinafine tablets for patients in this age group, the possibility of pre-existing impairment of hepatic or kidney function should be considered (see section 4.4).
Method of administration
For oral use.
The tablets are to be taken with water. They should preferably be taken at the same time each day and can be taken on an empty stomach or after a meal.
Known hypersensitivity to terbinafine or to any of the excipients listed in section 6.1.
Severe renal impairment.
Chronic or active hepatic disease.
Effect of other medicinal products on terbinafine
The plasma clearance of terbinafine may be accelerated by drugs which induce metabolism (such as rifampicin) and may be inhibited by drugs which inhibit cytochrome P450. Where co-administration of such agents is neccessary, the dosage of terbinafine may need to be adjusted accordingly.
The following medicinal products may increase the effect or plasma concentration of terbinafine:
- Cimetidine decreased the clearance of terbinafine by 33%.
- Fluconazole increased the Cmax and AUC of terbinafine by 52% and 69% respectively, 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%.
Information on other drugs concomitantly used with Terbinafine resulting in no or negligible interactions
According to the results from studies undertaken in-vitro and in healthy volunteers, terbinafine shows negligible potential for inhibiting or enhancing the clearance of most drugs that are metabolised via the cytochrome P450 system (e.g. terfenadine, triazolam, tolbutamide or oral contraceptives) with exception of those metabolised through CYP2D6 (see below).
Terbinafine does not interfere with the clearance of antipyrine or digoxin. 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.
Some cases of menstrual irregularities have been reported in patients taking Terbinafine tablets concomitantly with oral contraceptives, although the incidence of these disorders remains within the background incidence of patients taking oral contraceptives alone.
Terbinafine may increase the effect or plasma concentration of the following medicinal products:
Caffeine: Terbinafine decreased the clearance of caffeine administered intravenously by 19%.
Compounds predominantly metabolised by CYP2D6: In vitro and in vivo studies have shown that terbinafine inhibits the CYP2D6-mediated metabolism. This finding may be of clinical relevance for compounds predominantly metabolised by CYP2D6 e.g. certain members of the following drug classes, tricyclic antidepressants (TCAs), beta-blockers, selective serotonin re-uptake inhibitors (SSRIs), antiarrhythmics (including class 1A, 1B and 1C) and monoamine oxidase inhibitors (MAO-Is) Type B, especially if they also have a narrow therapeutic window (see section 4.4 Special warnings and precautions for use).
Terbinafine decreased the clearance of desipramine by 82%.
In studies in healthy subjects characterised as extensive metabolisers of dextromethorphan (antitussive drug and CYP2D6 probe substrate), terbinafine increased the dextromethorphan/ dextrorphan metabolic ratio in urine by 16- to 97-fold on average. Thus, terbinafine may convert extensive CYP2D6 metabolisers to poor metaboliser status.
Terbinafine may decrease the effect or plasma concentration of the following medicinal products:
- Terbinafine increased the clearance of ciclosporin by 15%.
Women of child-bearing potential
Some cases of menstrual irregularities have been reported in patients taking terbinafine tablets concomitantly with oral contraceptives, although the incidence of these disorders remains within the background incidence of patients taking oral contraceptives alone.
There is no data to support special recommendations for women of child-bearing potential.
Pregnancy:
Foetal toxicity studies in animals suggest no adverse effects. Since documented clinical experience in pregnant women is very limited, terbinafine tablets should not be used during pregnancy unless clinical condition of the woman requires treatment with oral terbinafine and the potential benefits for the mother outweigh any potential risks for the foetus.
Breast-feeding:
Terbinafine is excreted in breast milk and therefore mothers should not receive treatment with terbinafine whilst breast-feeding.
Fertility
There is no relevant information from human experience. Fertility studies in rats indicated no adverse findings in fertility or reproductive performance.
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.
Based on the observed adverse effects in man, the main symptoms of an acute overdosage are likely to be gastrointestinal, e.g. nausea or vomiting. Gastric lavage and/or symptomatic supportive treatment may be required.
Ask anything about Terbinafine 250 mg Tablets. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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