Lamisil 1 % cream

Lamisil 1% - Cream is a medicine used to treat fungal infections of the skin.

Application

1. WHAT IS LAMISIL 1% - CREAM AND WHAT IS IT USED FOR?

Lamisil 1% - Cream is a medicine used to treat fungal infections of the skin. It works by killing the fungus that causes skin problems.

Lamisil 1% cream is available without prescription for self-treatment of the following skin infections (however, you must use it carefully to get the best results):

. . .

-	Fungal infection of the feet (tinea pedis)*
-	Fungal infection on the thighs and body (ringworm = tinea corporis)*
-	Fungal infection on the lower legs (tinea cruris)*
-	Sprotozoal infections of the skin, mainly caused by the genus Candida (= skin-
Candidiasis)*
-	Smallpox of the skin (pityriasis versicolor)*

* see ,,How can you tell that you have one of the above diseases?"

Lamisil 1% - cream has a long-lasting effect. When used according to the dosage recommendation, less than10 people out of 100 experience a new athlete's foot infection within 3 months of starting treatment.

How can you tell that you have one of the above diseases?
Tinea pedis (athlete's foot)
Tinea pedis (athlete's foot) only occurs on the feet (usually both, but not always), often between the toes. The fungus can also be found on the instep, on the soles, or in other areasError! No text of specified style in document.
of the feet occur. The most common type of athlete's foot causes cracking or scaling of the skin, but mild swelling, blisters or weeping ulcers may also occur. Lamisil 1% cream is recommended for athlete's foot that occurs between the toes.

If you have a fungal nail infection (fungus in and under the nail) with discolouration of the nails and changes in the nail structure (thick, scaly), you should consult your doctor, as Lamisil1% cream is not suitable for this type of infection. Prescription tablets containing terbinafine should be taken to treat nail fungus.

Tinea corporis (ringworm)
Tinea corporis (ringworm) can occur anywhere on the body, often in wrinkled areas of the body, especially with moist skin. It often affects the groin and inner thigh area (usually both sides, but often one side more). The fungus can spread between the legs, to the buttocks or to the abdomen. It can also appear in the crease under the breasts, in the armpits or in other wrinkled areas. The rash has a clear border and may have blisters that itch. If the fungal infection occurs on the head, neck, face and arms, ringworm causes circular patches of red rash, but scaly patches and itching may also occur.

Tinea cruris (fungal infection of the lower legs)
Tinea cruris (fungal infection of the lower legs) occurs mainly on the outside of the lower legs and causes red, pea-sized nodules with scaly edges, which are often associated with severe itching.

Skin candidiasis
Skin candidiasis (intertrigo or sweat rash) occurs in wrinkled, sweaty areas of the skin, e.g. under the breasts or in the armpits. Candidiasis usually occurs in older or overweight patients or those with other conditions such as diabetes. There is redness, itching, scaling.

Pityriasis versicolor (Lichen of Kleienpilz)
Pityriasis versicolor (fungal lichen) appears on the skin as scaly patches that form white areas due to loss of pigment in the skin. The spots are most prominent in summer, when the surrounding skin is normally tanned. The lichen generally appears on the trunk(below the neck to the waist), neck and arms, and can recur within months, especially in hot weather and through sweat.

If you are not sure of the cause of your infection, please talk to your doctor or pharmacist before using Lamisil 1% cream.

If you do not feel better or even worse after 2 weeks, consult your doctor.

How is it applied?

WHAT IS LAMISIL 1% - CREAM AND WHAT IS IT USED FOR?

Lamisil 1% - Cream is a medicine used to treat fungal infections of the skin. It works by killing the fungus that causes skin problems.

Lamisil 1% - cream is used in adults and adolescents (12 years and over).

Lamisil 1%- cream is available without prescription for self-treatment of the following infections of the skin (however, you must use it carefully to get the best results):

• Fungal infection of the feet (tinea pedis)*
.
• Fungal infection on the thighs and body (ringworm = tinea corporis)*
.
• Fungal infection on the lower legs (tinea cruris)*
.
• Sprouting fungal infections of the skin, mainly caused by the genus Candida (= skin candidiasis)*
.
• Smallpox of the skin (pityriasis versicolor)*
.

* see "How can you tell that you have one of the above diseases?"

Lamisil 1% - cream has a long-lasting effect. When used according to the dosage recommendation, less than 10 people out of 100 will suffer a new athlete's foot infection within 3 months of starting treatment.
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How can you tell that you have one of the above diseases?
Tinea pedis (athlete's foot)
Tinea pedis (athlete's foot) only occurs on the feet (usually both, but not always), often between the toes. The fungus can also appear on the instep, on the soles, or in other areas of the feet. The most common type of athlete's foot causes cracking or scaling of the skin, but mild swelling, blisters or weeping ulcers may also occur. Lamisil 1% - cream is recommended for athlete's foot that occurs between the toes.

If you have a fungal nail infection (fungus in and under the nail) with discolouration of the nails and changes in the nail structure (thick, scaly), you should consult your doctor, as Lamisil 1% - cream is not suitable for this type of infection. Prescription tablets containing terbinafine should be taken to treat nail fungus.

Tinea corporis (ringworm)
Tinea corporis (ringworm) can occur anywhere on the body, often in wrinkled areas of the body, especially if the skin is moist. The groin area and the inner thigh area are often affected (usually both sides, but often one side more). The fungus can spread between the legs, to the buttocks or further to the abdomen. It can also appear in the crease under the breasts, in the armpits or in other wrinkled areas. The rash has a clear border and may have blisters that itch. If the fungal infection occurs on the head, neck, face and arms, ringworm causes circular patches of red rash, but scaly patches and itching may also occur.

Tinea cruris (fungal infection of the lower legs)
Tinea cruris (fungal infection of the lower legs) occurs mainly on the outer side of the lower legs and causes red, pea-sized nodules with scaly edges that are often associated with severe itching.

Skin candidiasis
Skin candidiasis (intertrigo or sweat rash) occurs in wrinkled sweaty wet areas of the skin, e.g. under the breasts or in the armpits. Candidiasis usually occurs in older or overweight patients or those with other conditions such as diabetes. There is redness, itching, scaling.

Pityriasis versicolor (pityriasis fungus)
Pityriasis versicolor (lichen of Kleien fungus) appears on the skin as scaly patches that form white areas due to loss of pigment in the skin. The spots are most prominent in summer, when the surrounding skin is normally tanned. The lichen generally appears on the trunk (below the neck to the waist), neck and arms, and can reappear within months, especially in hot weather and through sweat.

If you do not know the cause of your infection for sure, please talk to your doctor. or pharmacist before using Lamisil 1% - Cream.

If you do not feel better or even worse after 2 weeks, consult your doctor.

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What should you pay attention to before taking it?

What SHOULD YOU TAKE INTO ACCOUNT BEFORE USING LAMISIL 1% - CREAM ?
Lamisil 1% - Cream must not be used
- if you are allergic to terbinafine or any of the other ingredients of this medicine listed in section 6.


Warnings and precautions
Please talk to your doctor or pharmacist before using Lamisil 1% - Cream.

• For external use only.
• Avoid application to the face.
• Do not apply Lamisil 1% - Cream in the mouth. Do not swallow.
• The preparation should not come into contact with eyes, mucous membranes or open wounds. In case of accidental contact, rinse these areas thoroughly under running water. Seek medical advice if persistent discomfort occurs after accidental contact
.
• Application of Lamisil 1% - Cream in the genital or anal area can lead to a reduction in the tear resistance of latex condoms and thus to an impairment of the safety of this contraceptive.

Children under 12 years
The use of Lamisil 1% - Cream in children under 12 years of age is not recommended.


Use of Lamisil 1% - Cream together with other medicines .
Do not use any other medicines or treatments in the affected area during treatment with Lamisil 1% - Cream, even if they are non-prescription medicines.
Inform your doctor or pharmacist if you are taking/using, have recently taken/used or intend to take/use any other medicines.


Pregnancy, lactation and reproductive capacity
If you are pregnant or breast-feeding, or if you suspect you may be pregnant or intend to become pregnant, ask your doctor or pharmacist for advice before using this medicine.

Lamisil 1% - cream should only be used during pregnancy if clearly necessary.

Mothers who are breast-feeding should not use Lamisil 1% - Cream. Infants must not come into contact with treated skin, including the breast.


Driving ability and ability to operate machines
Lamisil 1% - cream has no effect on the ability to drive or use machines.


Lamisil 1% - Cream contains cetyl alcohol and stearyl alcohol.
These substances may cause localised skin irritation (e.g. contact dermatitis). Version 04, 02/2016



Lamisil 1% - Cream contains 10 mg benzyl alcohol/g gel. Benzyl alcohol may cause mild local irritation.

How should the medicine be taken?

How TO USE LAMISIL 1% - CREAM?

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 1% - Cream correctly. Follow the instructions carefully.

If you have a fungal nail infection (fungus in and under the nail) with discolouration of the nails and changes in the nail structure (thick, scaly), consult your doctor as Lamisil 1% - Cream is NOT suitable for this type of infection.

Type of application
Only for use on the skin.

Adults and adolescents (from 12 years):

• Before first use, the sealing membrane of the tube must be pierced with the spike in the screw cap.
• Wash and dry the affected skin areas and surrounding areas and wash your hands.
• Open the tube and put a small amount of the cream on your finger.
• Put the cap back on the tube.
• Apply a thin layer of cream to the affected skin areas and the surrounding areas.
• Gently rub the cream into the skin.
• Wash your hands after applying the cream, otherwise the infection may spread to other areas of the skin or other people.

When treating an infection in the skin folds, you can cover the affected area with a gauze strip, especially at night. If you do this, use a fresh, clean gauze strip each time you apply the cream.

Duration and frequency of treatment
Apply Lamisil 1% cream to the infected areas as follows:

• Fungal infection of the feet (tinea pedis): apply for 1 week, 1 x daily.
• Fungal infection of the thighs and body (ringworm = tinea corporis): Apply 1 x daily for 1 week.
• Fungal infection on the lower legs (tinea cruris): apply for 1 week, 1 x daily.
• Fungal infections triggered by yeast fungi (candida, skin candidiasis): apply 1-2 weeks, 1- 2 times daily.
  This fungal infection may look like ringworm or a fungal infection of the groin, but it occurs in older or overweight patients with moist areas in the overlapping folds of skin, or in those with other conditions such as diabetes. The longer treatment period (2 weeks) may be necessary to treat candidiasis.
• Smallpox of the skin (pityriasis versicolor): apply for 1 week, 2 x daily.

Use the cream for the recommended duration of treatment, even if the infection improves after a few days. Infections usually get better within a few days, but they can be Version 04, 02/2016


recur if the cream is not applied regularly or the treatment is stopped too soon.

Lamisil 1% - cream is said to improve the condition of your skin in a few days. However, complete healing of the skin after the infection has healed takes longer, possibly up to 4 weeks. Lamisil 1% - Cream continues to work even after you have finished the treatment.

Older patients (over 65 years)
There is no evidence that older patients require a different dosage or experience side effects not seen in younger patients.

Use in children under 12 years of age.
The use of Lamisil 1% - Cream in children under 12 years of age is not recommended.

If there is no improvement two weeks after starting treatment or if you have nail fungus, tell your doctor.

Please talk to your doctor or pharmacist if you have the impression that the effect of Lamisil 1% - Cream is too strong or too weak.

What measures can be taken to support treatment?

• Keep the affected areas clean and wash them regularly. Dry them carefully without rubbing or dab them gently. Even if the skin areas are itchy, try not to scratch, as this can worsen the discomfort and slow down the healing process or spread the infection further.
• Use your own towels and clothes and do not exchange them with other people, as these infections are easily transmissible. Wash your clothes and towels frequently to protect yourself from reinfection.

If you have used a larger amount of Lamisil 1% - Cream than you should
If you or someone else has accidentally swallowed Lamisil 1% - Cream, please inform a doctor, he will advise you what to do.


If you have forgotten to use Lamisil 1% cream.
If you forget to apply the cream, reapply as soon as possible and continue with the treatment as usual. If you do not remember until the time of the next treatment, apply only the usual amount and continue with the treatment as usual. Do not use twice the amount if you have forgotten to use it before.

Always use the cream according to the instructions. This is important because if applications are missing, there is a risk that the infection will reoccur.


If you stop using Lamisil 1% cream.
Inregular use or premature discontinuation of treatment carries the risk of relapse. Therefore, follow the dosage instructions carefully and use Lamisil 1% - Cream for the entire prescribed treatment period.

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

What are the possible side effects?

HOW TO STORE LAMISIL 1% - CREAM?

Store in the original packaging (tube sealed in the outer carton) to protect the contents from light.
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Store this medicine out of the reach of children.

You must not use this medicinal product after the expiry date which is stated on the carton and tube after "Use by". The expiry date refers to the last day of the month indicated.

Aluminium tube: Shelf life 4 months after first opening of the tube.
Laminated tube: Shelf life 1 month after first opening of the tube.

Do not dispose of medicines in waste water or household waste. Ask your pharmacist how to dispose of the medicine when you stop using it. In doing so, they contribute to the protection of the environment.

Special instructions for storage

5. HOW TO STORE LAMISIL 1% - CREAM?

Store in the original packaging (tube sealed in the outer carton) to protect the contents from light.

Keep this medicine out of the reach of children.

Do not use this medicine after the expiry date which is stated on the carton and tube. The expiry date refers to the last day of the month indicated.Error! No text of specified style in document.
Aluminium tube: Shelf life 4 months after first opening of tube.
Laminated tube: Shelf life 1 month after first opening of tube.

Do not dispose of medicines in waste water or household waste. Ask your pharmacist how to dispose of the medicine when you stop using it. In this way, they contribute to the protection of the environment.

Special notes on the content

Contents of the pack and other information

What Lamisil 1% - Cream contains
- The active substance is: terbinafine hydrochloride.
1 g cream contains 10 mg terbinafine hydrochloride, corresponding to 8.8 mg terbinafine.
- The other ingredients are: Sodium hydroxide, benzyl alcohol (as preservative), sorbitan stearate, cetyl palmitate, cetyl alcohol, stearyl alcohol, polysorbate 60, isopropyl myristate, purified water.


How Lamisil 1% - Cream looks and contents of the pack
Lamisil 1% - Cream is available in an aluminium tube with an inner protective varnish or in a laminated tube with or without a membrane (aluminium) and a polypropylene screw cap.

White, smooth or almost smooth, glossy cream

Available in tubes of 15 and 30 g.
Not all pack sizes may be placed on the market.