FUNGOWAS 10 mg/ml CUTANEOUS SOLUTION

Introduction

Package Leaflet: Information for the User

Fungowas 10 mg/ml Cutaneous Solution

ciclopirox olamine

Read the entire package leaflet carefully before starting to use the medicine, as it contains important information for you.

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

Contents of the Package Leaflet:

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 side effects
5. Storage of Fungowas
6. Contents of the pack and further information

1. What Fungowas is and what it is used for

Fungowas belongs to the group of medicines called topical antifungals, which are used to treat skin infections caused by fungi.

It is indicated for the topical treatment of:

• athlete's foot (tinea pedis), body ringworm
• cutaneous candidiasis (skin diseases caused by the fungus Candida sp.)
• pityriasis versicolor (a skin disease caused by a fungus, characterized by rounded brown, pink, or white patches, mainly on the trunk and arms)
• candidal balanitis (inflammation of the head of the penis caused by a fungal infection)
• as a complementary treatment for the partner of women with local gynecological 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 any of the other ingredients of this medicine (listed in section 6).

Warnings and Precautions

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

Consult your doctor or pharmacist before starting to use Fungowas.

Other Medicines and Fungowas

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medicine, including those obtained without a prescription.

Pregnancy and Breastfeeding

Safety during pregnancy and breastfeeding has not been established. As a precaution, do not use this medicine in pregnant or breastfeeding women unless your doctor advises you to do so.

Consult your doctor or pharmacist before using any medicine.

Driving and Using Machines

The influence of Fungowas on the ability to drive and use machines is negligible or nonexistent.

Fungowas contains methylparaben and propylene glycol

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

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 babies under 4 weeks 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 your doctor's instructions for using Fungowas exactly. If you are unsure, consult your doctor or pharmacist again.

Dosage

Adult Use

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

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

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

Use in Children

Fungowas is not recommended for use in children.

Method of Administration

This medicine is for cutaneous 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 candidal balanitis or to prevent reinfections in the case of female partners with gynecological infection, the solution should be applied to the glans (head of the penis) and the inner part of the foreskin (skin covering the head of the penis).

If you use more Fungowas than you should

Due to the method of administration of this medicine, overdose is unlikely.

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

If you forget to use Fungowas

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

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

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

Side effects are more common in the first few days of treatment and very rarely lead to discontinuation of treatment.

Common Side Effects (may affect up to 1 in 10 people)

The most frequently reported side effects during initial applications are transient signs of worsening at the application site (burning sensation, redness, itching); such effects are brief and should not lead to discontinuation of treatment.

Uncommon Side Effects (may affect up to 1 in 100 people)

Uncommon side effects are local reactions, such as vesicles and general allergic reactions. If any of these effects occur, you should discontinue treatment immediately and consult your doctor as soon as possible.

Frequency Not Known (frequency cannot be estimated from available data)

Contact dermatitis (skin rash like eczema).

If you are undergoing long-term treatment on a large area, on damaged skin, on a mucous membrane, or under an occlusive dressing, you should consider the risks associated with the passage of the medicine into the bloodstream, even if no systemic effects have been reported.

If you think any of the side effects you are experiencing is serious or if you notice any side effect not mentioned in this package leaflet, tell your doctor or pharmacist.

Reporting Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaram.es

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

5. Storage of Fungowas

This medicine does not require special storage conditions.

Keep out of sight and reach of children.

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

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the pharmacy's SIGRE collection point. Ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Contents of the Pack and Further Information

Composition of Fungowas

• The active ingredient is ciclopirox olamine. Each ml of cutaneous solution contains 10 mg of ciclopirox olamine.
• The other ingredients are propylene glycol and methylparaben.

Appearance of the Product and Contents of the Pack

Fungowas is presented as a clear, transparent, colorless, and odorless cutaneous solution in packs containing 1 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 Last Revision of this Package Leaflet:December 2024.

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

PR 03_02a