LENIRIT 1 % Cream

Зміст інструкції

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

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

1. What is CLOTRIMAZOLO EG and what is it used for

CLOTRIMAZOLO EG contains the active ingredient clotrimazole, belonging to a group of medicines
called antifungals, active against the growth of fungi.
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), tinea corporis.
Consult your doctor if you do not feel better or if you feel worse after 3-4 weeks or if you notice the reappearance
of symptoms (recurrences).

2. What you need to know before using CLOTRIMAZOLO EG

Do not use CLOTRIMAZOLO EG

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

Warnings and precautions
Talk to your doctor or pharmacist before using CLOTRIMAZOLO EG.
Do not ingest the cream and avoid contact with the eyes.
Use of CLOTRIMAZOLO EG, especially for prolonged periods, may cause sensitization reactions. In this case, it is necessary to stop treatment and consult a doctor.

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

Other medicines and CLOTRIMAZOLO EG
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
No interactions with other medicines are known.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
If you are in the first three months of pregnancy, use this medicine only if absolutely necessary and under strict medical supervision.

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

CLOTRIMAZOLO EG contains cetostearyl alcohol
It may cause local skin reactions (e.g. contact dermatitis).

Health education notes
To prevent fungal infections and their recurrence, it is useful to follow some hygienic and health rules, such as:

• In public places such as swimming pools, gyms, hotel rooms etc. avoid walking barefoot.
• For those who practice sports, it is important to use breathable and comfortable footwear, the insoles of which should be changed or washed periodically.
• Limit the use of clothing containing synthetic fibers.
• In newborns, avoid stagnation of urine or feces on the skin by changing the diaper frequently.
• Take dogs and cats to the veterinarian before welcoming them into the home environment.
• If a family member develops a fungal infection, it is advisable to observe further hygiene precautions, such as keeping clothes separate and washing them at high temperature.

3. How to use CLOTRIMAZOLO EG

Use this medicine following 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 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.
Half a centimetre of cream is sufficient to treat an area the size of a hand.
Do not exceed the indicated doses without consulting your doctor.
CLOTRIMAZOLO EG is particularly indicated for the treatment of infections of hairless skin areas (glabrous).
In general, the duration of treatment is 3-4 weeks.
To avoid the appearance of new infections, it is recommended to continue treatment for at least another 2 weeks after the symptoms have disappeared.
To avoid recurrences, which are very common in fungal infections (mycoses), observe the hygiene rules reported in paragraph 2 “Health education notes”.

If you use more CLOTRIMAZOLO EG than you should
In case of accidental ingestion of this medicine, immediately inform your doctor or go to the nearest hospital.

If you forget to apply CLOTRIMAZOLO EG
Continue treatment as per the recommended dosage.
If you have any doubts about the use of 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 available data)

• allergic reactions with symptoms such as temporary loss of consciousness (syncope), low blood pressure (hypotension), difficulty breathing (dyspnea), urticaria;
• skin disorders such as blisters, discomfort and pain, swelling due to fluid retention (edema), irritation, loss of the upper skin layer (desquamation), itching, rash, burning sensation.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system at
www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects you can help provide more
information on the safety of this medicine.

5. How to store CLOTRIMAZOLO EG

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 “Exp.”. The expiry date
refers to the last day of that month.
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 CLOTRIMAZOLO EG contains

• The active ingredient is clotrimazole. 100 g of cream contains 1 g of clotrimazole.
• The other ingredients are: sorbitan monostearate, polysorbate 60, spermaceti, cetostearyl alcohol, 2-octyldodecanol, benzyl alcohol, purified water.

Description of the appearance of CLOTRIMAZOLO EG and contents of the pack
CLOTRIMAZOLO EG is a cream contained in a tube of 30 g.

Marketing Authorisation Holder
EG S.p.A. - Via Pavia, 6 – 20136 Milano

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