Lamisil 10 mg/g solution for cutaneous spray

Patient Information Leaflet

Introduction

Patient Information Leaflet

Lamisil 10 mg/g cutaneous spray solution

terbinafine hydrochloride

Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Lamisil is and what it is used for
2. What you need to know before using Lamisil
3. How to use Lamisil
4. Possible side effects
5. How to store Lamisil
6. Contents of the pack and other information

1. What Lamisil is and what it is used for

Lamisil is an antifungal agent intended for use on the skin. It works by preventing the growth of fungi responsible for skin problems.

Lamisil is used to treat:

• Athlete's foot (Tinea pedis)
• Fungal skin infection affecting the groin area known as Tinea cruris
• Fungal skin infection affecting any part of the body known as Tinea corporis
• Skin infection caused by yeasts known as pityriasis versicolor.

2. What you need to know before using Lamisil

Do not use Lamisil:

• if you are allergic to terbinafine or to any of the other ingredients of this medicine (listed in section 6 and at the end of section 2).

Inform your doctor or pharmacist if this applies to you and do not use this medicine.

Warnings and precautions

Talk to your doctor or pharmacist before using Lamisil.

• Children under 18 years of age should not use Lamisil. In newborns (premature infants and full-term newborns), high concentrations of ethanol may cause severe local reactions and systemic toxicity due to significant absorption through immature skin (especially in case of occlusion).
• Do not apply the solution on the face or on areas where the skin is broken or inflamed, as alcohol (ethanol) could be irritating.
• Lamisil contains alcohol. Flammable product. Avoid using near open flames, lit cigarettes, or certain devices (e.g., hair dryers).
• For external use only. Do not use in the mouth or swallow.
• Avoid contact with the eyes, as it may be irritating. If the medicine accidentally gets into your eyes, rinse them thoroughly with plenty of water and consult your doctor if discomfort persists.

Other medicines and Lamisil

• Do not apply other medicines or treatments to the affected area (including those obtained without a prescription) at the same time as Lamisil.

• Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines, including those obtained without a prescription.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine. Lamisil should not be used during pregnancy unless strictly necessary.

Do not use Lamisil while breastfeeding.

Breastfed infants should be prevented from coming into contact with any treated skin area, including the breast.

Driving and operating machinery

The use of this medicinal product does not affect your ability to drive or operate machinery.

Important information about some of the components of Lamisil spray solution for cutaneous use

This medicinal product contains 48.54 mg of propylene glycol in each ml of spray solution. It also contains 6.83 g of alcohol (ethanol) in each container, equivalent to 227.8 mg/ml. It may cause a burning sensation on damaged skin.

3. How to use Lamisil

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

How long to use Lamisil

Apply the topical spray solution to the affected area one or two times daily as indicated below, unless your doctor instructs otherwise.

• Tinea pedis (athlete's foot): once daily for one week.
• Tinea cruris and Tinea corporis: once daily for one week.
• Pityriasis versicolor: twice daily for one week.

Instructions for use

Follow these instructions carefully:

• Clean and dry the affected skin areas and surrounding regions, then wash your hands.
• Unscrew the cap and gently squeeze the bottle.
• Apply enough solution to completely wet the affected skin area and surrounding skin.
• Replace the cap on the bottle.
• Wash your hands after applying the solution; otherwise, you could spread the infection to other areas of your own skin or to other people.

If there are no signs of improvement after one week of treatment with Lamisil, consult your doctor or pharmacist.

Discard any remaining solution 12 weeks after first opening.

To help your treatment

Keep the affected skin area clean by washing it regularly. Dry it carefully by gently patting—do not rub. Try not to scratch the area, even if it itches, as this could harm the skin, slow healing, or spread the infection.

Since these infections can easily spread to others, remember to use your own towel and clothing and do not share them with anyone. To protect yourself from reinfection, wash your clothes and towels frequently.

If you use more Lamisil than you should

If you accidentally swallow any of the product, inform your doctor immediately. They will advise you on what to do.

In case of overdose or accidental ingestion, contact the Toxicology Information Service. Telephone: 91 562 04 20.

If you forget to use Lamisil

If you forget to apply the topical spray solution, apply it as soon as you remember, then continue with the next dose at the usual time. If you remember at the time of the next scheduled application, simply apply the normal amount and continue as usual.

Do not apply a double dose to make up for a missed dose.

Use the topical spray solution as directed. This is important because the infection may recur if you miss several applications.

If you stop using Lamisil treatment prematurely

Use this medicine for the full recommended treatment period, even if the infection appears to improve within a few days. The infection may return if treatment is stopped too early.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

STOP using Lamisil and seek immediate medical help if you experience any of the following symptoms, which may be signs of an allergic reaction:

• difficulty breathing or swallowing
• swelling of the face, lips, tongue, or throat
• severe skin itching, with a red rash or appearance of pimples

Some adverse effects are common (may affect up to 1 in 10 people)

Skin peeling, itching.

Some adverse effects are uncommon (may affect up to 1 in 100 people)

Skin lesion, crusting, skin disorder, changes in skin color, skin redness (erythema), burning sensation, pain, pain at application site, irritation at application site.

Some adverse effects are rare (may affect up to 1 in 1,000 people)

Dry skin, rash and itching (contact dermatitis), redness and burning (eczema).

Eye irritation.

Worsening of skin condition.

Other reported adverse effects (frequency not known)

Allergic reaction (hypersensitivity)
Rash

If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet.

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor, pharmacist, or nurse, even if they are possible adverse effects not mentioned in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products (www.notificaRAM.es). By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Lamisil

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 30°C. Do not refrigerate.

Replace the cap on the bottle after use. Discard any remaining solution 12 weeks after first opening.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their containers to the SIGRE point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Lamisil 10 mg/g cutaneous spray solution

• The active substance is terbinafine hydrochloride. One gram of Lamisil cutaneous spray solution contains 10 mg of terbinafine hydrochloride, equivalent to 8.8 mg of terbinafine base.
• The other components are: purified water, ethanol (23.5% w/w), propylene glycol (E-1520), macrogol cetostearyl ether.

Appearance of the medicinal product and contents of the container

Lamisil cutaneous spray solution is a clear, colourless to slightly yellowish liquid. It is supplied in 30 ml bottles.

Marketing Authorization Holder

Novartis Farmacéutica, S.A.

Gran Via de les Corts Catalanes, 764

08013 – Barcelona

Spain

Manufacturer Responsible

Novartis Farmacéutica, S.A.

Gran Via de les Corts Catalanes, 764

08013 – Barcelona

Spain

Further information on this medicinal product is available upon request by contacting the local representative of the Marketing Authorization Holder:

Novartis Farmacéutica, S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona
Spain

Date of the most recent review of this leaflet: March 2022

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/