FUNGOWAS 10 MG/ML CUTANEOUS SOLUTION

Spain

It is used to treat skin infections caused by fungi, such as athlete's foot, ringworm, cutaneous candidiasis, pityriasis versicolor, candidal balanitis, and erythrasma.

Brand name FUNGOWAS 10 MG/ML CUTANEOUS SOLUTION
Dosage form solution, cutaneous
Active substance / Dosage
Prescription type Prescription Only Medicine
Registration number 56990
FUNGOWAS 10 MG/ML CUTANEOUS SOLUTION solution, cutaneous

Frequently asked questions

How should I apply Fungowas?

The solution should be applied to the affected area with a gentle massage and allowed to dry. It is important to wash your hands before and after use. In cases of balanitis or to prevent reinfection in a partner, it should be spread over the glans and the inner part of the foreskin.

What is the recommended dose for adults?

It should be applied twice a day, once in the morning and once at night. Although improvement may be noticed in the first week, it is necessary to continue treatment for 1 or 2 weeks after the lesions have disappeared to prevent relapses.

When should I not use this medication?

It should not be used if you are allergic to ciclopirox olamine or any of its components. It should also not be applied to open wounds, nor should it be used in children (its use is not recommended in the pediatric population).

What side effects can Fungowas cause?

It is common to feel burning, redness, or itching in the area where it is applied, although these symptoms are usually temporary. In less frequent cases, blisters or general allergic reactions may appear. If this occurs, you must stop using it and consult a doctor.

Can I use it if I am pregnant or breastfeeding?

As a precautionary measure, its use is not recommended in pregnant or breastfeeding women unless directed by your doctor.

What should I do if I miss an application?

Do not apply a double dose to make up for the one you forgot.

What precautions should I take when using it?

Avoid contact with the eyes; if this happens, rinse them with plenty of water. Inform your doctor if you are taking any other medication.

Instructions for use

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Fungowas 10 mg/ml cutaneous solution

ciclopirox olamine

Read the entire leaflet carefully before you start using the medicine, because it contains important information for you.

  • Keep this leaflet, as you may need to read it again.
  • If you have any questions, consult your doctor or pharmacist.
  • This medicine has been prescribed for you. Do not give it to other people, even if they have the same symptoms as you, because it may harm them.
  • If you experience adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What Fungowas is and what it is used for

Fungowas belongs to the group of antifungal medicines known as topical antifungals, which are used to treat fungal skin infections.

It is indicated for topical treatment of:

  • athlete's foot (tinea pedis), tinea corporis (ringworm of the body)
  • cutaneous candidiasis (skin infections caused by the fungus Candida sp.)
  • pityriasis versicolor (a skin condition caused by a fungus, characterized by round patches of brown, pink, or white color, mainly appearing on the trunk and arms)
  • candidal balanitis (inflammation of the glans penis caused by a fungal infection)
  • as complementary treatment for the male partner of women with local genital fungal infection (vaginitis and vulvovaginitis caused by the fungus Candida sp.)
  • erythrasma

2. What you need to know before using Fungowas

Do not use Fungowas

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

Warnings and precautions

  • Avoid contact with the eyes. If contact occurs, rinse thoroughly with plenty of water.
  • Do not apply this medicine to open wounds.

Consult your doctor or pharmacist before starting to use Fungowas.

Other medicines and Fungowas

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.

Pregnancy and breastfeeding

The safety of this medicine during pregnancy and breastfeeding has not been established. As a precautionary measure, use of this medicine is not recommended in pregnant or breastfeeding women, unless otherwise directed by your doctor.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

The influence of Fungowas on the ability to drive and use machinery is none or negligible.

Fungowas contains methyl parahydroxybenzoate and propylene glycol

May cause allergic reactions (possibly delayed) as it contains methyl parahydroxybenzoate.

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

3. How to use Fungowas

Follow exactly the administration instructions for Fungowas provided by your doctor. If in doubt, consult your doctor or pharmacist again.

Dosage

Use in adults

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

Although improvement of lesions usually occurs within the first week, treatment should be continued for 1–2 weeks after the lesions have disappeared in order to prevent relapses and the development of treatment resistance.

If lesions have not disappeared after 4 weeks of treatment, you should consult your doctor again.

Use in children

The use of Fungowas in children is not recommended.

Method of administration

This medicine is for topical (cutaneous) use only.

Wash your hands before and after use.

Apply the solution to the affected area of skin with gentle massage and allow it to dry.

In cases of candidal balanitis or to prevent reinfection in partners of women with gynecological infection, the solution should be applied to the glans (tip of the penis) and the inner surface of the foreskin (the skin covering the tip of the penis).

If you use more Fungowas than you should

Due to the route of administration of this medicine, intoxication is unlikely.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount used or ingested.

If you forget to use Fungowas

Do not apply a double dose to make up for missed doses.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.

Adverse effects are more common during the first days of treatment and very rarely lead to discontinuation of treatment.

Common 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.

Uncommon adverse effects (may affect up to 1 in 100 people)

Uncommon adverse effects include local reactions such as vesicles and general allergic reactions. If any of these effects occur, treatment must be stopped immediately and you should consult your doctor as soon as possible.

Frequency not known (frequency cannot be estimated from available data)

Contact dermatitis (skin rash such as eczema).

If you are undergoing long-term treatment over a large area, on wounded skin, on a mucous membrane, or under an occlusive dressing, the risks related to the medicine passing into the bloodstream should be considered, even if systemic effects have not been reported.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

Reporting of 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 leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Fungowas

This medicine does not require any special storage conditions.

Keep out of the sight and reach of children.

Do not use Fungowas after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Fungowas

  • The active substance is ciclopirox olamine. Each ml of cutaneous solution contains 10 mg of ciclopirox olamine.
  • The other components are propylene glycol and methyl parahydroxybenzoate.

Appearance of the product and contents of the container

Fungowas is presented as a clear, transparent, colourless and odourless cutaneous solution in containers containing 1 serigraphed plastic bottle with 30 ml of solution.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

CHIESI ESPAÑA, S.A.U.

Plaça d’Europa, 41-43, Planta 10

08908 L'Hospitalet de Llobregat

Barcelona (Spain)

Manufacturer

  • BRAUN MEDICAL, S.A.

Huelma, 5

Polígono Industrial Los Olivares

23009 Jaén (Spain)

Date of the most recent revision of this leaflet: December 2024.

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es).

PR 03_02a

The original data is available in the language of the country of manufacture.

Data source: Online Medicines Information Centre (CIMA) — AEMPS

Data last verified: September 21, 2026