Label: information for the user

Fungowas 10 mg/g cream

ciclopirox olamine

Read this label carefully before starting to use this medication,because it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you and should not be given to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist,eveniftheydo not appear in this label. See section 4.

Fungowasbelongs tothe group of topical antifungal medications, which are usedto treat skin infections caused by fungi.

It is indicated for the topical treatment of:

• athlete's foot,body ringworm
• cutaneous candidiasis (skin diseases caused by the fungusCandida sp.)
• pitiriasis versicolor (a skin disease caused by a fungus, characterized by rounded brown, pink, or white patches, mainly on the trunk and arms)
• balanitis candidiásica (inflammation of the head of the peniscaused by a fungal infection)
• as a complementary treatment for women with local genital infection (vaginitis and vulvovaginitis caused by the fungusCandida sp.)
• erythrasma

Do not use Fungowas

• If you are allergic to ciclopirox olamina or to any of the other components of this medication (listed in section 6).
• This medication contains peanut oil (arachis oil). Do not use in case of peanut or soy allergy.

Warnings and precautions

• Avoid contact with the eyes. If this occurs, rinse them abundantly with water.
• Do not apply this medication to open wounds.

Consult your doctor or pharmacist before starting to use Fungowas.

Other medications and Fungowas

Inform your doctor or pharmacist if you are using, have used recently, or may have to use any other medication, including those acquired without a prescription.

Pregnancy and breastfeeding

The safety during pregnancy and breastfeeding has not been established. As a precaution, it is not recommended to use this medication in pregnant women or breastfeeding women, unless your doctor advises otherwise.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

The influence of Fungowas on the ability to drive and operate machinery is negligible or insignificant.

Fungowas contains propylene glycol, lanolin, methyl parahydroxybenzoate, and peanut oil

This medication contains 18 mg of propylene glycol in each gram of cream.

It may cause local skin reactions (such as contact dermatitis) because it contains lanolin.

It may produce allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate.

This medication contains Arachis oil (peanut oil). Do not use this medication in case of peanut or soy allergy.

Follow exactly the administration instructions for Fungowas as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Dosage

Use in adults

Apply Fungowas to the affected skin area twice a day(once in the morning and once at night).

Although improvement of the lesions usually occurs within the first week, you should continue treatment for 1-2 weeks after the lesions have disappeared to avoid recurrences and treatment resistance.

If the lesions do not disappear after 4 weeks of treatment, you should visit your doctor again.

Use in children

Fungowas is not recommended for use in children.

Administration form

This medication is for topical use.

Wash your hands before and after use.

Apply the cream to the affected skin area with a gentle massage.

In case of balanitis candidiásica or to prevent reinfections in the case of female partners with gynecological infection, you should extend the cream over the glans (head of the penis)and the inner part of the prepuce (skin covering the head of the penis).

If you use more Fungowas than you should

Due to the administration form of this medication, it is unlikely that an overdose will occur.

In case of overdose or accidental ingestion,consult your doctor or pharmacist immediately,or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount used/ingested.

If you forgot to use Fungowas

Do not apply a double dose to compensate for the missed dose.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

Adverse effects are more frequent in the first days of treatment and very rarely lead to treatment suspension.

Frequent Adverse Effects (may affect up to 1 in 10 people)

The most frequently reported adverse effects during initial applications are transient signs of worsening at the application site (burning sensation, redness, itching); these effects are brief and treatment should not be interrupted.

Less Frequent Adverse Effects (may affect up to 1 in 100 people)

Less frequent adverse effects include local reactions, such as vesicles and general allergic reactions. If any of these effects occur, treatment should be stopped immediately and a doctor consulted as soon as possible.

Unknown Frequency (frequency cannot be estimated from available data)

Contact dermatitis (skin rash like eczema).

If long-term treatment is being performed on a large area, on skin with wounds, on mucous membranes, or under occlusive dressings, the risks associated with the medication passing into the bloodstream should be taken into account, even if no systemic effects have been reported.

If you consider any of the adverse effects you are experiencing to be severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es

By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

This medication does not require special conditions for conservation.

Keep out of sight and reach of children.

Do not use Fungowas after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Deposit the packaging and medicines you no longer need at the SIGRE Point of the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition of Fungowas

• The active ingredient is ciclopirox olamina. Each gram of cream contains 10 mg of ciclopirox olamina.
• The other components are stearic acid, lanolin, ceraanionic emulsifier, peanut oil, ethylene glycol/polyethylene glycol palmitoestearate, methyl parahydroxybenzoate, propylene glycol, lactic acid (for pH adjustment), purified water.

Appearance of the product and contents of the container

Fungowas is presented in the form of a white creamy cream and odorless in containers that contain 1 aluminum tube with 30 g of cream.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

CHIESI ESPAÑA, S.A.U.

Plaça d’Europa, 41-43, 10th floor

08908 L'Hospitalet de Llobregat

Barcelona (Spain)

Responsible for manufacturing

B. BRAUN MEDICAL, S.A.

Huelma, 5

Los Olivares Industrial Estate

23009 Jaén (Spain)

Last review date of this leaflet:December 2024.

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es).

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