LENIL ANTIFUNGAL

Package leaflet: Information for the user

LENIL ANTIMYCOTIC 10 mg/g cream

Read this leaflet carefully before using this medicine because it contains important information for you.
Use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If any of the side effects occur, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice any improvement or if your symptoms worsen after 3–4 weeks.

Contents of this leaflet:

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

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

LENIL ANTIMICOTICO contains the active substance clotrimazole, which belongs to a group of medicines called antifungals, effective 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 (athlete's foot), and tinea corporis.

2. What you need to know before using LENIL ANTIMICOTIC

Do not use LENIL ANTIMICOTIC

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

Warnings and precautions
Talk to your doctor or pharmacist before using LENIL ANTIMICOTIC.
Consult your doctor if you have previously experienced recurrent fungal infections (recurrences).
Do not swallow the cream and avoid contact with the eyes.
The use of LENIL ANTIMICOTIC, especially if prolonged, may cause allergic-type reactions (sensitization) such as erythema (localized redness of the skin where the medicine is applied) and itching. In this case, treatment must be discontinued and you should consult your doctor or pharmacist.
Inform your doctor if you do not notice any improvement after 3–4 weeks, or if symptoms worsen or recur (recurrences).
Children
If the skin infection is in the diaper area (diaper dermatitis), it is not recommended to use an occlusive, non-breathable diaper after applying the cream.
Other medicines and LENIL ANTIMICOTIC
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines.
No medicines are known to alter the effect of LENIL ANTIMICOTIC.
LENIL ANTIMICOTIC and food
No foods are known to alter the effect of LENIL ANTIMICOTIC.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning a pregnancy, or 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 must consult your doctor before using LENIL ANTIMICOTIC.
Breastfeeding
LENIL ANTIMICOTIC may be used during breastfeeding. If applied locally to the nipple area, wash the breast before breastfeeding.
Driving and using machines
This medicine does not affect or has a negligible effect on the ability to drive or operate machinery.
LENIL ANTIMICOTIC contains cetyl stearyl alcohol, benzyl alcohol, and polysorbate 60
This medicine contains cetyl stearyl alcohol, which may cause localized skin reactions (e.g. contact dermatitis).
This medicine contains benzyl alcohol (10 mg/g). Benzyl alcohol may cause allergic reactions and mild local irritation.
This medicine contains polysorbate 60. Polysorbates may cause allergic reactions.

3. How to use LENIL ANTIMICOTICO

Use this medicine exactly as stated in this leaflet or as instructed by your
doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Before applying this medicine, wash and thoroughly dry the affected area.
Apply a small amount of cream to the affected area, 2–3 times a day, gently massaging it to promote absorption.
Do not apply large amounts of the product; for example, half a centimeter of cream is sufficient to treat an area the size of a hand.
Warning: Do not exceed the recommended doses without medical advice.
LENIL ANTIMICOTICO is particularly indicated for the treatment of infections on hairless (glabrous) skin areas.
Duration of treatment
Generally, treatment lasts three to four weeks.
To prevent the occurrence of new infections and to consolidate the therapeutic results achieved, it is recommended to continue treatment for at least another two weeks after symptoms have disappeared.
If after 3–4 weeks of continuous use you have not noticed any significant improvement, consult your doctor.
Consult your doctor if the condition recurs repeatedly or if you have noticed any recent changes in its characteristics.
Health education notes
To prevent fungal infections and their recurrence, it is helpful to follow certain hygienic measures, such as:

• Avoid walking barefoot in public places such as swimming pools, gyms, hotel rooms, etc.
• If you practice sports, wear breathable and comfortable footwear, and periodically change or wash the insoles.
• Limit the use of clothing made from synthetic fibres.
• Change the baby’s diaper frequently to avoid prolonged contact of urine or feces with the skin.
• Have dogs and cats examined by a veterinarian before introducing them into the household.
• Observe additional hygiene precautions, such as frequently changing underwear and towels, keeping clothes separate, and washing them at high temperatures, especially if a family member has a fungal infection.

If you use more LENIL ANTIMICOTICO than you should
In case of accidental ingestion or oral intake of this medicine, contact your doctor immediately or go to the nearest hospital.
No risk of acute intoxication is expected, since it is unlikely that such an event would occur following a single excessive topical application (extensive application under conditions favorable to absorption) or after accidental oral ingestion. There is no specific antidote.
If you forget to apply LENIL ANTIMICOTICO
Do not apply a double dose to make up for the missed dose.
Continue treatment following the dose prescribed by your doctor.
If you have any doubts about how to use this medicine, consult 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 (frequency cannot be estimated from the available data):

• Immune system disorders: angioedema (swelling), anaphylactic reaction, hypersensitivity;
• Skin and subcutaneous tissue disorders: blisters, contact dermatitis, erythema (redness of the skin), paresthesia, desquamation (loss of cells from the outermost layer of the skin), itching, rash, urticaria, stinging skin pain, burning sensation of the skin;
• General disorders and administration site conditions: irritation at the application site, application site reaction, edema, pain;
• Vascular disorders: hypotension (low blood pressure), syncope;
• Respiratory, thoracic and mediastinal disorders: dyspnea (shortness of breath).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help 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 stated on the packaging after "Exp.". The expiry date refers to the last day of that month. The expiry date applies to the product in its original, unopened packaging, correctly stored.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What LENIL ANTIMICOTIC contains

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

Description of the appearance of LENIL ANTIMICOTIC and contents of the pack
LENIL ANTIMICOTIC is a cream for topical use. The pack contains one 30 g tube.
Marketing Authorization 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