LENIL ANTIMIKOTIKO 1 % Cream

Зміст інструкції

1. LENIL ANTIMICOTICO 10 mg/g cream
   1. What is LENIL ANTIMICOTICO and what is it used for
   2. What you need to know before using LENIL ANTIMICOTICO
   3. How to use LENIL ANTIMICOTICO
   4. Possible side effects
   5. How to store LENIL ANTIMICOTICO
   6. Contents of the pack and other information

LENIL ANTIMICOTICO 10 mg/g cream

Read this leaflet carefully before using this medicine as it contains important
information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen after 3-4 weeks.

Contents of this leaflet:

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

1. What is LENIL ANTIMICOTICO and what is it used for

LENIL ANTIMICOTICO contains the active ingredient clotrimazole, belonging to a group of medicines
called antifungals, active against fungal growth.
This medicine is indicated for the treatment of skin and skin fold infections caused
by fungi (mycoses), such as pityriasis versicolor, cutaneous candidiasis, tinea pedis or athlete's foot, tinea corporis.

2. What you need to know before using LENIL ANTIMICOTICO

Do not use LENIL ANTIMICOTICO

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

Warnings and precautions
Consult your doctor or pharmacist before using LENIL ANTIMICOTICO.
Consult your doctor if you have previously suffered from these conditions (recurrences of mycoses).
Do not ingest the cream and avoid contact with the eyes.
The use of LENIL ANTIMICOTICO, especially if for prolonged periods, may cause allergic reactions (sensitization) such as erythema (localized redness in the area of skin where the
medicine is applied) and itching. In this case, it is necessary to interrupt the treatment and consult your doctor or
pharmacist.
Inform your doctor if you do not notice improvements after 3-4 weeks or if you experience worsening or
recurrence of symptoms (recurrences).

Children
If the skin infection is in the diaper area (diaper dermatitis), it is not recommended to use
a non-breathable diaper (with an "occlusive" effect) after applying the cream.

Other medicines and LENIL ANTIMICOTICO
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
No medicines are known to alter the effect of LENIL ANTIMICOTICO.

LENIL ANTIMICOTICO with food
No foods are known to alter the effect of LENIL ANTIMICOTICO.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
If you are in the first three months of pregnancy, you should consult your doctor before using LENIL
ANTIMICOTICO.
Breastfeeding
LENIL ANTIMICOTICO can be used during breastfeeding. If used locally on the nipple area, wash your breasts before breastfeeding your baby.

Driving and operating machinery
This medicine does not or negligibly alters the ability to drive vehicles or operate
machinery.

LENIL ANTIMICOTICO contains cetostearyl alcohol, benzyl alcohol, polysorbate 60
This medicine contains cetostearyl alcoholwhich may cause localized skin reactions (e.g.
contact dermatitis).
This medicine contains 10 mg/g of benzyl alcohol. Benzyl alcohol can cause allergic reactions and
mild local irritation.
This medicine contains polysorbate 60. Polysorbates can cause allergic reactions.

3. How to use LENIL ANTIMICOTICO

Use this medicine following exactly as described in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Before using this medicine, wash and dry the area to be treated thoroughly.
Apply a small amount of cream to the affected area, 2-3 times a day, massaging gently to promote absorption.
Do not apply large amounts of product, for example, half a centimetre of cream is sufficient to treat an area the size of a hand.

Warning: do not exceed the indicated doses without the advice of your doctor.
LENIL ANTIMICOTICO is particularly indicated for the treatment of infections of hairless skin areas (glabrous).

Duration of treatment
Generally, the duration of treatment is three to four weeks.
To prevent the occurrence of new infections and to consolidate the therapeutic results obtained, it is recommended to continue treatment for at least another 2 weeks after the disappearance of symptoms.
If, after 3-4 weeks of continuous use, you do not notice appreciable results, consult your doctor.
Consult your doctor if the disorder recurs or if you have noticed any recent change in its characteristics.

Health education notes
To prevent fungal infection and recurrence of the infection, it is useful to follow some hygienic rules, such as:

• Avoid walking barefoot in public places such as swimming pools, gyms, hotel rooms, etc.
• If you play sports, use breathable and comfortable footwear, the insoles of which should be changed or washed periodically.
• Limit the use of clothing containing synthetic fibres.
• Change the baby's nappy frequently to prevent urine or faeces from stagnating on the skin.
• Have dogs and cats examined by a veterinarian before welcoming them into the home environment.
• Observe further hygienic precautions, such as changing underwear and towels frequently, keeping clothes separate and washing them at high temperature, if a family member develops a fungal infection.

If you use more LENIL ANTIMICOTICO than you should
In case of ingestion/accidental intake of this medicine, immediately notify your doctor or go to the nearest hospital.
There is no risk of acute poisoning as it is unlikely to occur after a single cutaneous application of an excessive dose (extended application under conditions favourable to absorption) or involuntary oral intake. There is no specific antidote.

If you forget to apply LENIL ANTIMICOTICO
Do not use a double dose to make up for a missed dose.
Continue treatment as prescribed by your doctor.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur:

Frequency not known(the frequency of which cannot be estimated on the basis of available data):

• immune system disorders: angioedema (swelling), anaphylactic reaction, hypersensitivity;
• skin and subcutaneous tissue disorders: blisters, contact dermatitis, erythema (skin redness), paraesthesia, skin peeling (loss of cells from the most superficial layer of the skin), itching, rash, urticaria, skin stinging pain, skin burning sensation;
• general disorders and conditions related to the site of administration: irritationat the application site, reaction at the application site, oedema, pain;
• vascular disorders: hypotension (low blood pressure), syncope;
• respiratory, thoracic and mediastinal disorders: dyspnoea (shortness of breath).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects you can help to provide more information on the safety of this
medicine.

5. How to store LENIL ANTIMICOTICO

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after “Scad.” The expiry date refers to the last day of that month. The expiry date refers to the product in
intact packaging correctly stored.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What LENIL ANTIMICOTICO contains

• The active ingredient is clotrimazole. 1 g of cream contains 10 mg of clotrimazole.
• The other ingredients are: sorbitan monostearate, polysorbate 60, spermaceti, cetostearyl alcohol, 2-octyldodecanol, benzyl alcohol, purified water.

Description of the appearance of LENIL ANTIMICOTICO and contents of the pack
LENIL ANTIMICOTICO is a cream for cutaneous use. The pack contains a tube of 30 g.

Marketing Authorisation Holder
Zeta Farmaceutici S.p.A.
Via Mentana 38 - 36100 Vicenza

Manufacturer
Doppel Farmaceutici S.r.l., Via Martiri delle Foibe, 1 - 29016 Cortemaggiore (PC) - Italy