Lamisil 1% w/w Cream

Package leaflet: Information for the user

Lamisil 1% w/w Cream

Terbinafine hydrochloride

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

-         Keep this leaflet. You may need to read it again.

-         If you have any further questions, ask your doctor or pharmacist.

-         This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

-         If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

What is in this leaflet:

1.   What Lamisil 1% Cream is and what it is used for

2.   What you need to know before you use Lamisil 1% Cream

3.   How to use Lamisil 1% Cream

4.   Possible side effects

5.   How to store Lamisil 1% Cream

6.   Contents of the pack and other information.

1.      What Lamisil 1% Cream is and what it is used for

Lamisil 1% Cream is used to treat Athlete’s foot (Tinea pedis), Dhobie itch (Tinea cruris), a fungal

infection of the skin known as Pityriasis versicolour and certain yeast infections of the skin (those

caused by the genus Candida). It attacks and kills the fungus or yeast which is causing your infection.

2.      What you need to know before you use Lamisil 1% Cream

Do NOT use Lamisil 1% Cream if you:

·        are allergic (hypersensitive) to any of the ingredients in the product (see Section 6).

The cream is NOT recommended for use on children.

Warnings and precautions

Talk to your doctor or pharmacist before using Lamisil 1% Cream. The cream is for external use only. Do not use on the face. Avoid contact with the eyes. In case of

accidental contact with the eyes, rinse thoroughly with running water.

Other medicines and Lamisil 1% Cream

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines,

including those obtained without a prescription.

Pregnancy and breast-feeding

Do not use the cream if you are pregnant or breastfeeding, unless advised to by your doctor. Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Lamisil 1% Cream is not expected to affect your ability to drive or operate machinery.

Important information about some of the ingredients of Lamisil 1% Cream

The cream contains some ingredients which you may need to be aware of:

·        This medicine contains 150 mg or 300 mg benzyl alcohol in each tube respectively for the 15 g or 30 g pack size, which is equivalent to 10mg/g. Benzyl alcohol may cause mild local irritation.

·        cetyl alcohol and stearyl alcohol: May cause local skin reactions (e.g. contact dermatitis).

For other ingredients see Section 6.

3.      How to use Lamisil 1% Cream

Always use Lamisil 1% Cream exactly as your doctor or pharmacist has told you; you should

check with him/her if you are not sure.

This medicine is for external use only.

Usual dose for adults

Your doctor will decide the right amount of Lamisil 1% 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.

The likely durations of treatment are as follows:

Athlete’s Foot: Once a day for 1 week

Ringworm, Dhobie itch: Once a day for 1 week

Cutaneous candidiasis: Once or twice a day for 1 to 2 weeks

Pityriasis versicolor: Once or twice a day for 2 weeks

Infections usually appear to improve within a few days of starting to use Lamisil 1% Cream, but may

reappear if the cream is not applied regularly or is stopped too early.

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 tube. If it is still sealed, remove the protective foil or pierce it using the point in 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, under the breasts, 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.

If you have not noticed any signs of improvement within 2 weeks of first starting treatment, please seek advice from your doctor or pharmacist.

Children

The cream is NOT recommended for use on children.

If you use more Lamisil 1% Cream than you should

Contact your doctor or nearest hospital emergency department if you, or someone else, has swallowed some cream. Take any remaining medicine and this leaflet with you if possible.

If you forget to use Lamisil 1% Cream

If you miss an application, apply the cream as soon as possible then continue your treatment as

before. If you only remember at the time of your next application, just apply the cream and carry on

as normal. It is important to try to use the cream at the correct times as forgotten applications could carry a risk of the infection recurring.

If you stop using Lamisil 1% Cream

Infections may come back if you do not use the cream regularly, or if you stop the treatment too early.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4.      Possible side effects

Like all medicines, Lamisil 1% 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:

·        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.

Lamisil 1% Cream can occasionally cause redness, stinging, peeling, itching, pain, irritation or

scabbing at the application site. There may also be some change in skin colour at the application site.

These effects are usually harmless and you can carry on using the cream.

Some side effects are common: (may affect up to 1 in 10 people): skin peeling, itching.

Some side effects are uncommon: (may affect up to 1 in every 100 people): skin lesions, scab,

skin colour changes, redness, burning, pain and irritation at the site of application.

Some side effects are rare: (may affect up to 1 in a 1000 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 HPRA

Pharmacovigilance, website: www.hpra.ie.

By reporting side effects you can help provide more information on the safety of this medicine.

5.      How to store Lamisil 1% Cream

Keep out of the sight and reach of children.

Do not store above 30°C.

Do not use this medicine after the expiry (EXP) date shown on the box and tube. The expiry date

refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6.      Contents of the pack and other information

What Lamisil 1% Cream contains

The active ingredient is terbinafine hydrochloride 1.0% 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% Cream looks like and contents of the pack

Lamisil 1% Cream is a white cream. Lamisil 1% Cream is available in packs of 15g and 30g cream. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Karo Pharma AB, Box 16184, 103 24 Stockholm, Sweden.

Manufacturer:

Karo Healthcare AB, Klara Norra Kyrkogata 33, 111 22 Stockholm, Sweden

This leaflet was last revised in June 2025