Patient Information Leaflet

antimicotico same 1% cream

clotrimazole
Please read all of this leaflet carefully before you start 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 instructed you.

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

Contents of this leaflet:

What Antimicotico Same is and what it is used for
What you need to know before using Antimicotico Same
How to use Antimicotico Same
Possible side effects
How to store Antimicotico Same
Contents of the pack and other information

1. What Antimicotico Same is and what it is used for

Antimicotico Same is a topical cream containing the active substance
clotrimazole, an antifungal agent effective against fungi and bacteria. Antimicotico Same is indicated:

for all fungal and yeast skin infections: these may occur between the fingers (athlete's foot - tinea pedis), in hairless areas (tinea corporis), in the groin area (tinea inguinalis - Hebra's marginated eczema), or may appear as irregular patches (pityriasis versicolor);
for skin infections such as primary pyodermitis and erythrasma (scaly pink-brown skin patches);
for the preventive and curative treatment of secondary skin infections caused by yeasts (saccharomycetes) and Gram-positive bacteria.

Consult your doctor if you do not feel better or if you feel worse after 3-4 weeks.

2. What you need to know before using Antimicotico Same

Do not use Antimicotico Same

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 Antimicotico Same.

The use, especially if prolonged, of topical skin products may lead to sensitization reactions (allergy to one or more components). If this occurs, stop treatment and consult your doctor (see section 4 “Possible side effects”).
Use Antimicotico Same under direct medical supervision if you have a very extensive infection.
Consult your doctor if you have previously suffered from these conditions (fungal infection recurrences) and if after 3-4 weeks of continuous use you do not observe noticeable improvement.
Avoid contact of the medicine with the eyes.

Children
In very early infancy, the product should be administered under direct medical supervision. In diaper dermatitis, the use of non-breathable (occlusive) diapers after cream application is not recommended.
Other medicines and Antimicotico Same
Inform your doctor or pharmacist if you are using, have recently used, or might use any other medicines.
No interactions with other commonly used medicines have been reported with Antimicotico Same.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicine.
If you are pregnant, use this medicine only if clearly needed and under direct medical supervision.
Driving and using machines
Antimicotico Same does not affect the ability to drive vehicles or operate machinery.
Antimicotico Same contains cetyl stearyl alcohol
It may cause local skin reactions (e.g., contact dermatitis).

3. How to use Antimicotico Same

Use this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Apply Antimicotico Same 2 or 3 times daily, gently rubbing until the cream is fully absorbed.
Do not use large amounts of the product for each application, as this is unnecessary.

For the treatment of infections such as erythrasma and pityriasis versicolor, continue therapy for at least 3 weeks; for the treatment of all other fungal infections (mycoses), continue treatment for at least 4 weeks, even if inflammatory symptoms disappear.

To prevent recurrences, which are common in mycoses, follow these hygiene measures:

change underwear and towels frequently, and disinfect them using chemical agents or high temperatures;
avoid exchanging clothes and linen with other people;
treat your partner simultaneously with a course of vaginal tablets, etc.

Do not ingest this medicine. If Antimicotico Same is accidentally swallowed or ingested, contact your doctor immediately or go to the nearest hospital.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine may cause adverse reactions, although not everybody experiences them.
The topical application of Antimicotico Same does not lead to systemic absorption, making the occurrence of effects on the body highly unlikely.
During the use of Antimicotico Same, rare local intolerance reactions may occur, such as: irritation, burning sensation and itching, allergic contact dermatitis.
Following the instructions provided in this leaflet reduces the risk of adverse reactions.
Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist. You may also report adverse reactions directly via the national reporting system at the website
www.agenziafarmaco.gov.it/it/responsabili. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. How to store Antimicotico Same

This medicine does not require any special storage conditions.
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.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Antimicotico Same contains

The active substance is clotrimazole. 100 g of cream contain 1 g of clotrimazole.
The other components are: sorbitan monostearate, polysorbate 60, cetyl palmitate, cetylstearyl alcohol, 2-octyldodecanol, benzyl alcohol, purified water.

Description of the appearance of Antimicotico Same and contents of the pack
Antimicotico Same is a cream contained in a 30-gram tube.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Savoma Medicinali S.p.A. - Via Baganza, 2/A - 43125 Parma
Manufacturer
Doppel Farmaceutici S.r.l. – Via Martiri delle Foibe, 1 - 29016 Cortemaggiore (PC)