FUNGOWAS 10 mg/g CREAM

Introduction

Package Leaflet: Information for the User

Fungowas 10 mg/g Cream

ciclopirox olamine

Read the entire package leaflet carefully before starting to use this medication, 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 medication has been prescribed to you only, 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 is Fungowas and what is it 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. Package Contents and Additional Information

1. What is Fungowas and what is it used for

Fungowas belongs to the group of topical antifungal medications used to treat fungal skin infections.

It is indicated for the topical treatment of:

• athlete's foot (tinea pedis), tinea corporis
• 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 penis head 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 10 mg/g Cream

Do not use Fungowas

• If you are allergic to ciclopirox olamine or any of the other components of this medication (listed in section 6).
• This medication contains peanut oil (arachis oil). It should not be used 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 recently used, or may need to use any other medication, including those purchased without a prescription.

Pregnancy and Breastfeeding

Safety during pregnancy and breastfeeding has not been established. As a precautionary measure, this medication is not recommended for use in pregnant or breastfeeding women, unless your doctor advises you to do so.

Consult your doctor or pharmacist before using any medication.

Driving and Using Machines

The influence of Fungowas on the ability to drive and use machinery is negligible or non-existent.

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

This medication contains 18 mg of propylene glycol per 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.

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 within the first week, you should continue treatment for 1-2 weeks after the disappearance of the lesions 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 medication is for topical use.

Wash your hands before and after using it.

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

In case of candidal balanitis or to prevent reinfections in the case of female partners with gynecological infection, the cream should be applied to the glans (penis head) and the inner part of the foreskin (skin covering the penis head).

If you use more Fungowas than you should

Due to the method of administration 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 Toxicology Information Service, phone 91 562 04 20, indicating the medication 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 medication, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Side effects are more common in the first few days of treatment and 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 include 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 (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 medication 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, inform your doctor or pharmacist.

Reporting Side Effects

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

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

5. Storage of Fungowas

This medication 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.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medications at the SIGRE collection point in your pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6.

Composition of Fungowas

• The active ingredient is ciclopirox olamine. Each gram of cream contains 10 mg of ciclopirox olamine.
• The other ingredients are stearic acid, lanolin, anionic emulsifying wax, peanut oil, ethylene glycol/polyethylene glycol palmitostearate, methyl parahydroxybenzoate, propylene glycol, lactic acid (for pH adjustment), purified water.

Appearance of the Product and Package Contents

Fungowas is presented as a white, creamy cream without odor in aluminum tubes containing 30 g of cream.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

CHIESI ESPAÑA, S.A.U.

Plaça d’Europa, 41-43, 10th floor

08908 L'Hospitalet de Llobregat

Barcelona (Spain)

Manufacturer

• BRAUN MEDICAL, S.A.

Huelma, 5

Polígono Industrial Los Olivares

23009 Jaén (Spain)

Date of the Last Revision of this Package Leaflet:December 2024.

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

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