Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
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.
for Lamisil 1% w/w Cream is used to treat patients with fungal and certain yeast infections of the skin. It attacks and kills the fungus or yeast which is causing your infection.
and careful drying with your own clean towels and clothes, and not rubbing or scratching the skin.
4. Possible side effects Like all medicines, Lamisil 1% w/w Cream 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:
Lamisil 1% w/w Cream
2. Before you use Lamisil 1% w/w Cream
Adults Your doctor will decide the right amount of Lamisil 1% w/w Cream for you to use and will tell you for how long to use your medication. Apply the cream once or twice a day, for one to two weeks, but this will depend upon the type and area of infection. Infections usually appear to improve within a few days of starting to use Lamisil 1% w/w Cream, but may reappear if the cream is not applied regularly or is stopped too early.
Do NOT use Lamisil 1% w/w Cream if you:
Directions for use:
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.
Lamisil 1% w/w Cream
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6.Further information What Lamisil 1% w/w Cream contains The active ingredient is terbinafine hydrochloride 1% w/w. The other ingredients are sodium hydroxide, benzyl alcohol, sorbitan stearate, cetyl palmitate, cetyl alcohol, stearyl alcohol, polysorbate 60, isopropyl myristate, purified water. (See also end of Section 2 for further information on some of the ingredients). What Lamisil 1% w/w Cream looks like and contents of the pack The cream is a white cream, available in aluminium or laminate tubes of 15 g or 30 g. Not all pack sizes may be marketed. Marketing Authorisation Holder .DUR+HDOWKFDUH$% %R[ 6WRFNKROP 6ZHGHQ Manufacturer .DUR+HDOWKFDUH$% .ODUD1RUUD.UNRJDWD 6WRFNKROP 6ZHGHQ This leaflet was last revised in 'HFHPEHU.
Keep out of the sight and reach of children. Keep the tube closed and in the carton. Do not use this medicine after the expiry (EXP) date shown on the box and tube.
2003530_1/62000000202627
Lamisil 1% w/w Cream comes as cream. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Lamisil 1% w/w Cream is terbinafine hydrochloride.
Medicines with the same active substance, strength and form include: Lamisil AT 1% Cream, Terbinafine 1 % Cream. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Lamisil 1% w/w Cream, 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 (eg. T. Rubrum, T.Mentagrophytes, T. Verrucosum, T. Violaceum), Microsporum canis and Epidermophyton floccosum.
Yeast infections of the skin, principally those caused by the genus Candida (eg. C. albicans).
Pityriasis (tinea) versicolor due to Pityrosporum orbiculare (also known as Malassezia furfur).
LAMISIL can be applied once or twice daily.
Duration and frequency of treatment
The likely duration of each treatment is as follows:
Tinea corporis, cruris:
1 to 2 weeks
Tinea pedis:
1 week
Cutaneous candidiasis:
2 weeks
Pityriasis versicolor:
2 weeks
Relief of clinical symptoms usually occurs within a few days. Irregular use or premature discontinuation of treatment carries the risk of recurrence. If there are no signs of improvement after two weeks, the diagnosis should be verified.
Dosing in special populations:
Paediatric population
The experience with topical LAMISIL in children is still limited and its use cannot therefore be recommended.
Elderly patients
There is no evidence to suggest that elderly patients require different dosages or experience side- effects different to those of younger patients.
Method of administration
For cutaneous use.
Cleanse and dry the affected areas thoroughly before application of LAMISIL. Apply the cream to the affected skin and surrounding area in a thin layer and rub in lightly. In the case of intertriginous infections (submammary, interdigital, intergluteal, inguinal) the application may be covered with a gauze strip, especially at night.
Hypersensitivity to terbinafine or any of the excipients contained in the cream, listed in section 6.1.
LAMISIL Cream is for external use only. Contact with the eyes should be avoided. May be irritating to the eyes. In case of accidental contact with the eyes, rinse the eyes thoroughly with running water.
LAMISIL Cream contains 36 mg benzyl alcohol in each daily dosage which is equivalent to 10 mg/g. Benzyl alcohol may cause allergic reactions.
Lamisil Cream contains cetyl alcohol and stearyl alcohol, which may cause local skin reactions (e.g. contact dermatitis).
There are no known drug interactions with LAMISIL Cream.
Pregnancy
There is no clinical experience with LAMISIL Cream in pregnant women, therefore, unless the potential benefits outweigh any potential risks, LAMISIL Cream should not be administered during pregnancy.
Foetal toxicity studies in animals suggest no adverse effects (see section 5.3).
Breastfeeding
Terbinafine is excreted in breast milk. Therefore mothers should not receive LAMISIL whilst breast-feeding. Infants must not be allowed to come into contact with any treated skin, including the breast.
Fertility
No effect of terbinafine on fertility have been seen in animal studies.
Lamisil Cream has no influence on the ability to drive and use machines.
Local symptoms such as pruritus, skin exfoliation, application site pain, application site irritation, pigmentation disorder, skin burning sensation, erythema and scab may occur at the site of application.
These minor symptoms must be distinguished from hypersensitivity reactions such as widespread pruritis, rash, bullous eruptions and hives which are reported in sporadic cases but require discontinuation.
In case of accidental contact with the eyes terbinafine hydrochloride 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 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), or not known (can not to be estimated from 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,irritation
Rare: condition aggravated
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 (www.mhra.gov.uk/yellowcard).
The low systemic absorption of topical terbinafine cream renders overdosage extremely unlikely. Accidental ingestion of the contents of one 30g tube of LAMISIL Cream, which contains 300mg terbinafine hydrochloride, is comparable to one LAMISIL 250mg tablet (adult oral unit dose).
Should a larger amount of LAMISIL Cream be inadvertently ingested, adverse effects similar to those observed with an overdosage of LAMISIL tablets are to be expected. These include headache, nausea, epigastric pain and dizziness.
If accidentally ingested, the recommended treatment of overdosage consists of eliminating the drug, primarily by the administration of activated charcoal, and giving symptomatic supportive therapy, if needed.
Ask anything about Lamisil 1% w/w 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.
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