Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Terbinafine 1 % Cream
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Terbinafine hydrochloride may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for
Terbinafine 1% Cream contains the active ingredient terbinafine hydrochloride which is an antifungal. It kills fungi, which cause skin infections. Terbinafine 1% cream is used for the local treatment of fungal infections of the skin only. 2.
What you need to know before you take it
e Terbinafine 1% Cream
Do not use Terbinafine 1% cream
- if you are allergic to terbinafine hydrochloride or any of the other ingredients of this medicine (listed in section 6). Warnings and precautions Talk to your doctor or pharmacist before using Terbinafine 1% Cream. This cream is for external use only. Avoid contact with the eyes. If the cream gets in your eyes accidentally, rinse thoroughly with running water and tell your doctor immediately. In the event of allergic reaction, the cream should be removed and the treatment interrupted. Do not smoke or go near naked flames – risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it. Other medicines and Terbinafine 1% Cream Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
If you are pregnant you should not use Terbinafine 1% cream unless it is clearly necessary and advised to by your doctor. Do not use this cream if you are breast-feeding as terbinafine hydrochloride can pass into breast milk. Ask your doctor or pharmacist for advice before taking this medicine. Driving and using machines Terbinafine 1% cream should not affect your ability to drive or operate machines. Terbinafine 1% cream contains benzyl alcohol, cetyl alcohol and cetostearyl alcohol This medicine contains 10 mg benzyl alcohol in each gram of cream. Benzyl alcohol may cause allergic reactions and mild local irritation. This medicine also contains cetyl alcohol and cetostearyl alcohol which may cause local skin reactions (e.g. contact dermatitis). 3.
How to take it
TERBINAFINE 1% CREAM
Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Adults (including older people) Terbinafine 1% Cream may be applied 1-2 times daily. The recommended duration and frequency of treatment will depend upon the type and area of infection: Tinea pedis (Athlete's foot): 1 week. Tinea cruris (dhobie itch/jock itch) and Tinea corporis: 1-2 weeks. Cutaneous Candida: 2 weeks. Pityriasis versicolor: 2 weeks. Infections usually appear to improve within a few days of starting to use the cream. It is important that you use the cream regularly even if the infection has improved. If you see no improvement in your skin condition after 2 weeks, talk to your doctor. Directions for use
- Cleanse and dry the affected areas thoroughly and wash your hands. Treatment can be helped by keeping the affected areas clean by regular washing and careful drying with your own clean towels and clothes, and not rubbing or scratching the skin.
- Unscrew the cap then gently squeeze out a small amount of the cream onto your finger.
- Apply just enough cream to form a thin layer on the affected skin and surrounding areas.
- Rub in gently. When used between the toes, buttocks or on the groin, the treated area may be covered with a light, fresh gauze strip, especially at night.
- Replace the cap on the tube and wash your hands. Even though you will not be using Terbinafine 1% Cream during the second week for Athlete's foot, full skin healing after the infection has cleared will continue for up to 4 weeks. If you have not noticed any signs of improvement within 2 weeks of first starting treatment, please seek advice from your doctor or pharmacist. Use in children Terbinafine 1% Cream is not recommended for children under 12 years. If you use more Terbinafine 1% Cream than you should
Remove some of the cream if you apply more than a thin layer. If you or someone else swallows the cream, go to your doctor or nearest hospital emergency department immediately. Take any remaining medicine and this leaflet with you if possible. Symptoms of accidental ingestion include headache, nausea (feeling sick), dizziness and stomach pain. If the cream gets in your eyes, rinse thoroughly with running water and tell your doctor immediately. If you forget to use Terbinafine 1% cream If you forget to use the cream, apply it as soon as you remember. If it is time for the next application, carry on as normal. It is important to try to remember to use the cream or you risk the infection returning. If you stop using Terbinafine 1% cream Do not stop using Terbinafine 1% cream before the recommended time, as the infection will be more likely to return. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. STOP using the cream and seek medical help immediately if you have any of the following very rare allergic reactions: Not known (cannot be estimated from the available data):
- difficulty breathing or swallowing, swelling of the mouth, face, lips, tongue or throat (severe allergic reaction).
- severe itching of the skin, with a red rash or raised lumps, hives or blisters. Other side effects Common (may affect up to 1 in 10 people):
- skin peeling, itching. Uncommon (may affect up to 1 in 100 people):
- skin lesions, scab, skin colour changes, redness, burning, pain and irritation at the site of application. These effects are harmless and usually you can continue with the treatment. Rare (may affect up to 1 in 1,000 people):
- eye irritation, dry skin, contact dermatitis, eczema, worsening of symptoms. 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. 5.
How to store it
Terbinafine 1% Cream
Keep this medicine out of the sight and reach of children. Do not use Terbinafine 1% cream after the expiry date stated on the label or carton after EXP. The expiry date refers to the last day of that month. Store in the original container. Do not freeze. Keep the tube tightly closed. Discard the tube 28 days after first opening the tube. Do not throw away any medicine via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment. 6.
Contents of the pack and other information
What Terbinafine 1% cream contains
- The active substance is terbinafine hydrochloride. One gram of cream contains 10 mg of terbinafine hydrochloride equivalent to 8.89 mg of terbinafine.
- The other ingredients are sodium hydroxide, benzyl alcohol, sorbitan monostearate, cetyl palmitate, cetyl alcohol, cetostearyl alcohol (see section 2 "Terbinafine 1% Cream contains cetyl alcohol and cetostearyl alcohol"), polysorbate, isopropyl myristate and purified water. What Terbinafine 1% cream looks like and the contents of the pack Terbinafine 1% Cream is a white or almost white cream with a slight almond odour contained in aluminium tubes of, 7.5 g, 15 g or 30 g. Not all pack sizes may be marketed. Marketing Authorisation Holder Mylan, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom Manufacturer Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland. Gedeon Richter Plc., Gyömrői út 19-21, Budapest H-1103, HUNGARY This leaflet was last revised in 01/2022
Frequently asked questions about Terbinafine 1 % Cream
How do I take Terbinafine 1 % Cream?
Terbinafine 1 % Cream comes as cream. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Terbinafine 1 % Cream?
The active substance in Terbinafine 1 % Cream is terbinafine hydrochloride.
Are there equivalent medicines to Terbinafine 1 % Cream?
Medicines with the same active substance, strength and form include: Lamisil 1% w/w Cream, Lamisil AT 1% Cream. They are interchangeable only if your prescriber or pharmacist says so.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Terbinafine 1 % Cream, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Terbinafine 1 % Cream without a prescription?
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.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: terbinafine hydrochloride
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
The treatment of tinea pedis (athlete's foot) and tinea cruris (dhobie itch/jock itch)
Fungal infections of the skin caused by dermatophytes such as species of Trichophyton (e.g. T. rubrum, T. mentagrophytes, T. verrucosum, T. violaceum), Microsporum canis and Epidermophyton floccosum.
Infections of the skin caused by Candida (e.g. Candida albicans).
Pityriasis (tinea) versicolor caused by Pityrosporum orbiculare (Malassezia furfur).
4.2. Posology and method of administration
Posology
Adults and adolescents (>12 years of age)
Duration and frequency of treatment:
Terbinafine can be applied once or twice daily.
The likely duration of each treatment is as follows:
Tinea pedis: 1 week.
Tinea cruris and Tinea corporis: 1 to 2 weeks.
Cutaneous candida: 2 weeks.
Pityriasis versicolor: 2 weeks.
Relief of symptoms is usually obtained within a few days.
Irregular use or an inadequate treatment period increases the risk of the symptoms returning. If no improvement is obtained after 2 weeks, the diagnosis should be re-evaluated.
Elderly
There has been nothing to indicate that elderly patients require a different dosage or have a side effects profile different from younger patients.
Paediatric population
Terbinafine 1 % Cream is not recommended for children below 12 years of age due to insufficient data on safety. The experience in children is limited.
Method of administration
For cutaneous use.
The skin should be clean and dry. The cream should be applied in a thin layer on and around the affected skin and rubbed in gently. In cases of reddened and weeping infection (under the breasts, between the fingers, buttocks or in the groin) the skin may be covered with a sterile compress after application of the cream, especially at night.
4.3. Contraindications
Hypersensitivity to the active substance, terbinafine, or to any of the excipients listed in section 6.1.
4.4. Special warnings and precautions for use
Terbinafine 1 % Cream cream is for external use only.
Terbinafine 1 % Cream cream may be irritating to the eyes. Contact with the eyes should be avoided. In case of accidental contact with the eyes, rinse eyes thoroughly with running water.
Terbinafine cream should be kept out of the reach of children.
In the event of allergic reaction, the cream should be removed and the treatment interrupted.
Instruct patients not to smoke or go near naked flames - risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it.
Candidiasis: It is not recommended to use acid pH soap. This provides favourable growth conditions for Candida spp.
Excipients
This medicine contains 10 mg benzyl alcohol in each gram of cream. Benzyl alcohol may cause allergic reactions and mild local irritation. This medicine also contains cetyl alcohol and cetostearyl alcohol which may cause local skin reactions (e.g. contact dermatitis).
4.5. Interaction with other medicinal products and other forms of interaction
No drug interactions are known with the topical forms of terbinafine.
4.6. Fertility, pregnancy and lactation
Pregnancy
There is no clinical experience with terbinafine in pregnant women. Foetal toxicity studies conducted in animals suggest no adverse effects (see section 5.3). Terbinafine 1 % Cream should not be used during pregnancy unless clearly necessary.
Breast-feeding
Terbinafine is excreted into breast-milk. After topical use, only a low systemic exposure is expected (see section 5.2). Terbinafine 1 % Cream cream should not be used during breast-feeding. In addition, infants must not be allowed to come into contact with any treated skin, including the breast.
Fertility
No effects of terbinafine on fertility have been seen in animal studies (see section 5.3).
4.7. Effects on ability to drive and use machines
Terbinafine 1 % Cream cream has no influence on the ability to drive and use machines.
4.8. Undesirable effects
Local symptoms such as pruritus, skin exfoliation, application site pain, application site irritation, pigmentation disorder, skin burning sensation, erythema, scab, etc. may occur at the site of application.
These harmless symptoms must be distinguished from hypersensitivity reactions including rash, which are reported in sporadic cases and require discontinuation of therapy.
In case of accidental contact with the eyes terbinafine may be irritating to the eyes.
In rare cases the underlying fungal infection may be aggravated.
Adverse reactions are listed below by system organ class and the frequency. Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100 to <1/10), uncommon (≥ 1/1,000 to <1/100), rare (≥ 1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Immune system disorders
Not known:
Hypersensitivity*
Eye disorders
Rare:
Eye irritation
Skin and subcutaneous tissue disorders
Common:
Skin exfoliation, pruritus
Uncommon:
Skin lesion, scab, skin disorder, pigmentation disorder, erythema, skin burning sensation
Rare:
Dry skin, dermatitis contact, eczema
Not known:
Rash*
General disorders and administration site conditions
Uncommon:
Pain, application site pain, application site irritation
Rare:
Condition aggravated
* Based on post-marketing experience.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation 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 via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
4.9. Overdose
The low systemic absorption of topical terbinafine renders over dose extremely unlikely.
Symptoms
Accidental ingestion of one 30 g tube of terbinafine cream, which contains 300 mg terbinafine hydrochloride, is comparable to ingestion of one terbinafine 250 mg tablet (adult oral unit dose).
Should a larger amount of terbinafine cream be inadvertently ingested, adverse effects similar to those observed with an over dose of terbinafine tablets are to be expected. These include headache, nausea, epigastric pain and dizziness.
Treatment
If accidentally ingested, the recommended treatment of over dose consists of eliminating the active substance, primarily by the administration of activated charcoal, and giving symptomatic supportive therapy if needed.
💬 Ask about this leaflet
Ask anything about Terbinafine 1 % Cream. 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.