LAMISIL KRĒMS 1% 15G

ATC code: D01AE15 

Active substances: Terbinafinum

Vendor, principal: Novartis Consumer Health. 
No prescription needed/Patient care products, dressings, gloves, medical devices,...

LAMISIL DERMGEL 10MG/1G 15G

Package leaflet: Information for the patient (Over-the-counter medicine*)

Lamisil DermGel, 1% gel

Terbinafine

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

Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you.
-   Keep this leaflet. You may need to read it again.
-   Ask your pharmacist if you need more information or advice.
-   If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
-   You must talk to a doctor if you do not feel better or if you feel worse after 14 days.

What is in this leaflet:

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

1. What Lamisil DermGel is and what it is used for

Lamisil is an antifungal gel that destroys skin-infecting fungi.
Lamisil DermGel is used for fungal foot infections (tinea pedis).
Lamisil DermGel has a long-lasting effect. If the gel is used according to prescription, the disease reoccurs in only 10% of patients with a fungal foot infection.

How Lamisil DermGel acts

Fungal foot infections only occur on the feet (usually on both, but not always), often in between the toes. The disease may occur on the instep, heel or other areas of the foot. The symptoms are cracking or flaking of the skin. However, mild swelling, blisters or damp ulcers may also develop.
If you suffer from a fungal nail infection (fungus in or under the nail) with characteristic changes in the colouring and structure of the nails (thick, layered nails), you should talk to your doctor as Lamisil DermGel is not indicated for treatment of this type of fungal disease.

2. What you need to know before you use Lamisil DermGel Do not use Lamisil DermGel:

-   if you are allergic to terbinafine or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before using Lamisil Dermgel.
-   For external use only.
-   Do not use orally and do not swallow.
-   Avoid contact with your face, eyes or damaged skin (visibly swollen skin areas), where alcohol could cause irritation. If accidental contact with eyes occurs, wipe the gel off and flush your eyes thoroughly with clean water. If discomfort persists, contact your doctor.

Children and adolescents

Lamisil Dermgel is not recommended for use in children and adolescents under 18 years of age due to insufficient safety and efficacy data.
Other medicines and Lamisil Dermgel
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. Do not simultaneously apply other medicines to the damaged area.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Lamisil Dermgel should not be used during pregnancy, unless it is clearly indicated.
Do not use Lamisil DermGel while breast-feeding.
The infant should not be allowed to come into contact with the mother’s treated skin area, including the breasts.

Driving and using machines

Lamisil DermGel has no effect on the ability to drive and use machines.

Lamisil DermGel contains butylated hydroxytoluene

Lamisil DermGel contains butylated hydroxytoluene (E321), which may cause local skin reactions (e.g. contact dermatitis) or irritation of the eyes or mucous membranes.

3. How to use Lamisil DermGel

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
It is important to use Lamisil Dermgel correctly. Follow the instructions.
If you suffer from a fungal nail infection (fungus in or under the nail) with characteristic changes in the colouring and structure of the nails (thick, layered nails), you should talk to your doctor as Lamisil DermGel is not indicated for treatment of this type of fungal disease. For a fungal nail infection you should use Lamisil tablets, which is a prescription medicine.

Instructions for use

Adults:
•   Wash and dry your hands and the affected skin area.
•   Open the tube. If using the medicine for the first time, use the point in the cap to pierce the top of the tube, then gently squeeze out the gel.
•   Apply a thin layer of the gel to the affected skin area and surrounding areas.
•   Lightly rub the gel into the skin.
•   Screw the cap on again.
•   Wash your hands after touching the affected skin area to prevent the infection from spreading to other skin areas or to other people.

Frequency and duration of Lamisil Dermgel use

The recommended dose of Lamisil Dermgel for treatment of fungal foot infections (tinea pedis) is once daily for 1 week.
Continue to use the cream for the recommended treatment period even if the symptoms subside in a few days. You will notice improvement in a few days. However, the infection may reoccur if you do not use the cream on a regular basis or if you stop the treatment too soon.
Lamisil Dermgel cream provides improvement in a few days. Complete healing of the affected skin areas takes more time, up to 4 weeks. The effect of Lamisil DermGel persists after cessation of treatment. The healing process continues regardless of discontinued use of the gel.
If the symptoms have not subsided in 2 weeks, you should contact your doctor.

Promoting the healing process

Treatment can be helped by keeping the affected areas clean by regular washing. Dry the skin carefully, without rubbing. Despite itchiness, try not to scratch the affected area as this increases the skin injury and delays the healing process or may spread the infection.
These infections may spread to other people. Therefore do not let anyone else use your towel or clothes. Wash your towel and clothes frequently to protect yourself against reinfection.

If you use more Lamisil Dermgel than you should

Should you or anyone else accidentally swallow the gel, inform your doctor. The doctor will tell you what to do.

If you forget to use Lamisil Dermgel

If you forget to use Lamisil Dermgel, use it as soon as possible and thereafter continue as usual. If it is already time for the next application, use the prescribed amount and then continue as usual.
It is important to follow the treatment regimen because forgotten applications may increase the likelihood of disease recurrence.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Most patients get better after using Lamisil Dermgel.
Stop using Lamisil Dermgel and seek medical help immediately if any of the following symptoms occur, as these may be potential signs of allergy:
-   difficulty breathing or swallowing
-   swelling of the face, lips, tongue or throat
-   severe itching of the skin, with redness and pimply rash.
Some side effects are common (may affect up to 1 in 10 people): peeling of the skin, itching.
Some side effects are uncommon (may affect up to 1 in 100 people):
lesions or scabs on the skin, skin damage, changes in skin colouration, redness, pain and irritation on the site of administration.
Some side effects are rare (may affect up to 1 in 1,000 people): dry skin, eczema.
Lamisil Dermgel may cause eye irritation if the gel is mistakenly administered to the eyes.

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

5. How to store Lamisil DermGel

Keep this medicine out of the sight and reach of children.
Keep the tube sealed in the external package. Do not store above 30 °C.
Keep the tube sealed. Throw the rest of the medicine away 16 weeks after first opening.
Do not use this medicine after the expiry date which is stated on the label and carton after {date DD.MM.YYYY}. 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 protect the environment.

6. Contents of the pack and other information What Lamisil Dermgel contains:

-   The active substance is terbinafine. 1 g of gel contains 10 mg (1%) of terbinafine.
-   The other excipients are: purified water, 96% ethanol, isopropyl myristate, polysorbate 20, carbomer, sorbitan laurate, benzyl alcohol, sodium hydroxide, butylated hydroxytoluene (E321).

What Lamisil Dermgel looks like and contents of the pack

Lamisil DermGel is available in a membrane-coated aluminium or laminated screw cap tube, with an inside coating of epoxy-phenolic lacquer. The tube is sealed with a polypropylene screw-cap. Lamisil DermGel is a shiny white to whitish gel.
The aluminium tube contains 15 g of gel (over-the-counter medicine).

Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder

GlaxoSmithKline Consumer HealthCare (UK) Trading Ltd.
980 Great West Road, Brentford Middlesex, TW8 9GS United Kingdom

Manufacturer

Novartis Consumer Health GmbH,
Zielstattstrasse 40,
81379 Munich,
Germany.
GSK Consumer Healthcare GmbH & Co. KG Barthstraße 4 80339 Munich,
Germany
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
GlaxoSmithKline Eesti OÜ Phone: +372 6676 900 [email protected]

This leaflet was last revised in October 2016.

* Explanation: 15 g package- over the counter medicine