Package Insert: Information for the User

Fungowas 10 mg/ml Topical Solution

cCiclopirox Olamine

Read this package insert carefully before starting to use the medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed for you, and you should not give it to others who have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Fungowas belongs to the 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 penis caused by a fungal infection)
• as a complementary treatment for women with local gynecological infection (vaginitis and vulvovaginitis caused by the fungusCandida sp.)
• erythrasma

Do not use Fungowas

• If you are allergic to ciclopirox olamine or any of the other components of this medication (listed in section 6).

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 need to use any other medication, including those obtained 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 methyl parahydroxybenzoate and propylene glycol

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

This medication contains 1.04 g of propylene glycol in each ml of solution. Propylene glycol may cause skin irritation. Do not use this medication in babies under 4 weeks with open wounds or large areas of damaged skin (such as burns) without consulting your doctor or pharmacist first.

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 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 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 solution to the affected skin area with a gentle massage and let it dry.

In the case of balanitis candidiásica or to prevent reinfections in the case of female partners with gynecological infections, you should extend the solution 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 should not interrupt treatment.

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

Less frequent adverse effects are local reactions, such as vesicles and general allergic reactions. If any of these effects occur, immediately discontinue treatment and consult your doctor as soon as possible.

Unknown Frequency (frequency cannot be estimated from available data)

Contact dermatitis (skin rash like eczema).

If a long-term treatment is being performed on a very extensive area, on a skin with wounds, on a mucous membrane, or under an occlusive dressing, consider the risks related to the passage of the medication into the bloodstream, 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 about the safety of this medication.

This medication does not require special conservation conditions.

Keep out of the 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 unused medicines at the SIGRE collection pointat the pharmacy. Ask your pharmacist how to dispose of the packaging and unused medicines. By doing so, you will help protect the environment.

Composition of Fungowas

• The active principle is ciclopirox olamina. Each ml of topical solution contains 10 mg of ciclopirox olamina.
• The other components are propylene glycol and methyl parahydroxybenzoate.

Appearance of the product and contents of the packaging

Fungowas is presented as a clear, transparent, colorless, and odorless topical solution in containers containing 1 plastic bottle with 30 ml of solution.

Holder of the marketing authorization and manufacturer responsible

Holder of the marketing authorization

CHIESI ESPAÑA, S.A.U.

Plaça d’Europa, 41-43, 10th floor

08908 L'Hospitalet de Llobregat

Barcelona (Spain)

Manufacturer responsible

B. BRAUN MEDICAL, S.A.

Huelma, 5

Los Olivares Industrial Estate

23009 Jaén (Spain)

Last review date of this leaflet:December 2024.

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

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