FUNGAREST 20 mg/g cream

Introduction

Package Leaflet: Information for the User

FUNGAREST 20 mg/g Cream

ketoconazole

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Fungarest and what is it used for
2. What you need to know before you use Fungarest
3. How to use Fungarest
4. Possible side effects
5. Storage of Fungarest

1. Contents of the pack and further information

1. What is Fungarest and what is it used for

Ketoconazole belongs to a group of medicines called antifungals (medicines used to treat infections caused by fungi and yeasts).

This medicine is indicated in adults for the treatment of the following superficial skin infections:

• Cutaneous candidiasis, infections that normally affect humid and warm areas of the skin and mucous membranes.
• Pityriasis versicolor, a disease characterized by the appearance of spots on the skin.
• Seborrheic dermatitis, a disease that mainly affects the face and chest and causes redness and scaling of the skin.

• Tinea, a disease that can affect the trunk (tinea corporis), groin (tinea cruris), feet (tinea pedis), and hands (tinea manuum).

2. What you need to know before you use Fungarest

Do not use Fungarest

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

Warnings and precautions

Consult your doctor or pharmacist before starting to use Fungarest.

For external use only. Contact with the eyes should be avoided. If accidental contact with the eyes occurs, rinse with plenty of water and consult an ophthalmologist if necessary.

If you are using corticosteroids in cream, ointment, or lotion, inform your doctor or pharmacist before starting treatment with this medicine. You can start your treatment with this medicine, but you should not stop applying the corticosteroid from one day to the next. The skin may react and cause redness or itching. Continue your treatment as follows:

• apply a mild corticosteroid to the skin in the morning and Fungarest cream in the evening for one week;
• then apply the corticosteroid in the morning every two or three days and Fungarest cream in the evenings for 1 to 2 weeks;
• stop using the corticosteroid completely and, if necessary, continue only with this medicine.

In case of an allergic reaction, you should wash the cream off the skin, stop treatment, and go to your doctor immediately.

Children and adolescents

The safety and efficacy of ketoconazole cream in children and adolescents have not been established.

Other medicines and Fungarest

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

As a precautionary measure, it is preferable to avoid using this medicine during pregnancy and breastfeeding.

Driving and using machines

Given the characteristics of this medicine, no effect on driving or using machines is expected.

Fungarest contains propylene glycol, cetyl alcohol, and stearyl alcohol

This medicine contains 200 mg of propylene glycol per gram.

Propylene glycol may cause skin irritation.

This medicine contains propylene glycol; do not use on open wounds or large areas of damaged skin (such as burns) without consulting your doctor or pharmacist first.

This medicine may cause local skin reactions (such as contact dermatitis) because it contains cetyl alcohol and stearyl alcohol.

3. How to use Fungarest

Follow exactly the administration instructions of this medicine given by your doctor. In case of doubt, consult your doctor or pharmacist again.

This medicine will be applied once or twice a day depending on the type of infection.

The recommended dose is:

• Cutaneous candidiasis: 2 to 3 weeks
• Pityriasis versicolor: 2 to 3 weeks
• Tinea corporis: 3-4 weeks
• Tinea cruris: 2-4 weeks
• Tinea pedis: 4-6 weeks
• Tinea manuum, your doctor will indicate how and for how long you should apply this medicine.

For skin infections with brownish-red spots and yellow or white scaling (seborrheic dermatitis), apply Fungarest cream once or twice a day. Skin infections usually improve after 2 to 4 weeks.

Normally, you will see signs of improvement after 4 weeks. If this is not the case, talk to your doctor.

Continue using the cream until a few days after all symptoms have disappeared.

Sometimes it is necessary to apply the cream once a week or once every two weeks, even after the skin is completely cured. This prevents the symptoms from coming back.

Elderly patients

There are no specific dosage recommendations for these patients.

Method of administration

Topical use.

Wash and dry the infected skin before applying the medicine. Rub the cream gently into the skin with your fingertips. Do not treat only the infected part; also apply the cream around the affected area. Wash your hands carefully after applying the cream (this is important to avoid infecting other parts of the body or other people).

To open the tube, unscrew the cap and use the top of the cap to puncture the seal of the tube.

If you use more Fungarest than you should

If you apply more Fungarest than your doctor has indicated, you may feel a certain burning sensation, redness, or swelling that will disappear after stopping treatment.

This medicine should not be ingested. If it is accidentally ingested, contact your doctor.

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.

If you forget to use Fungarest

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

If you stop treatment with Fungarest

Do not stop treatment without consulting your doctor, as the symptoms of your disease may come back or get worse.

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

4. Possible side effects

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

Common side effects(may affect up to 1 in 10 people)

• Burning sensation on the skin.
• Redness of the skin at the application site.
• Itching in the area of administration.

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

• Allergic reactions (hypersensitivity).
• Localized eczema (contact dermatitis).
• Skin rash.
• Hives.
• Skin exfoliation (scaling).
• Sticky oily skin.
• Other reactions at the site of administration: bleeding, discomfort, dryness, inflammation, irritation, paresthesia (tingling, numbness).

Rare side effects(cannot be estimated from the available data)

• Urticaria.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Fungarest

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and on the tube after EXP. The expiry date is the last day of the month stated.

No special storage conditions are required.

Dispose of the packaging once the treatment is finished.

Do not use this medicine if you notice signs of deterioration.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Fungarest

The active substance is ketoconazole. Each gram of cream contains 20 mg of ketoconazole.

The other ingredients (excipients) are:

• propylene glycol (E-1520),
• stearyl alcohol,
• cetyl alcohol,
• sorbitan monostearate,
• polysorbate 60,
• polysorbate 80,
• isopropyl myristate,
• sodium sulfite (E-221), and
• purified water.

Appearance and packaging of the product

White and homogeneous cream.

This medicine is available in 30-gram tubes.

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

Manufacturer

JANSSEN PHARMACEUTICA, N.V.

Turnhoutseweg, 30

2340 Beerse (Belgium)

or

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

Date of the last revision of this leaflet:June 2021

Other sources of information

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