Fungarest 20 mg/g crema

Label: information for the user

FUNGAREST 20 mg/g cream

ketoconazole

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

• Keep this label, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.

• This medication has been prescribed only 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 label. See section 4.

6. Contents of the container and additional information

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

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

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

-Ringworm, a disease that can affect the trunk (body ringworm), groin (inguinal ringworm), feet (ringworm of the feet), and hands (ringworm of the hands).

Do not use Fungarest

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

Warnings and precautions

Consult your doctor or pharmacist before starting to use Fungarest.

For external use only. Avoid contact with the eyes. If accidental contact with the eyes occurs, rinse with abundant water and consult an ophthalmologist if necessary.

If you are using corticosteroids in cream, lotion, or ointment, inform your doctor or pharmacist before starting treatment with this medication. You can start your treatment with this medication, but do 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;
• Subsequently, apply the corticosteroid in the morning every two or three days and Fungarest cream in the evenings over 1 to 2 weeks;
• Stop using the corticosteroid completely and if necessary, continue only with this medication.

In case of an allergic reaction, you must clean the cream from the skin, interrupt treatment, and immediately consult your doctor.

Children and adolescents

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

Other medications and Fungarest

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Pregnancy and breastfeeding

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

As a precaution, it is recommended to avoid using this medication during pregnancy and breastfeeding.

Driving and operating machines

Given the characteristics of this medication, no effect on driving or operating machines is expected.

Fungarest contains propylene glycol, cetomacrogol and cetearyl alcohol

This medication contains 200 mg of propylene glycol in each gram.

Propylene glycol may cause skin irritation.

This medication contains propylene glycol and should not be used on open wounds or large areas of damaged skin (such as burns) without consulting your doctor or pharmacist first.

This medication may cause local skin reactions (such as contact dermatitis) due to the presence of cetomacrogol and cetearyl alcohol.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

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

The recommended dose is:

• Cutaneous candidiasis:2 to 3weeks
• Pityriasis versicolor:2 to 3weeks
• Body lice: 3-4weeks
• Ingrown lice: 2-4weeks
• Foot lice: 4-6weeks
• Hand lice, your doctor will indicate how and for how long to apply this medication.

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

Normally, you will see signs of improvement after 4weeks. If not, 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 for two weeks, even after the skin is fully cured. This prevents symptoms from reappearing.

Patients with advanced age

No specific dosage recommendations are available for these patients.

Form of use

Cutaneous use.

Clean and dry the infected skin before applying the medication. Gently rub the cream into the skin with your fingertips. Do not treat only the infected area, apply the cream to the surrounding area as well. 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 with the top of the cap pierce the tube seal.

If you use more Fungarest than you should

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

This medication should not be ingested. If ingested accidentally, contact your doctor.

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.

If you forgot to use Fungarest

Do not apply a double dose to compensate for the missed doses.

If you interrupt the treatment with Fungarest

Do not stop treatment without consulting your doctor, as symptoms may reappear or worsen.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medications,this medicationcan produce adverse effects, although not all people will experience them.

Frequent Adverse Effects(may affect up to 1 in 10 patients)

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

Less Frequent Adverse Effects(may affect up to 1 in100 patients)

• Allergic reactions (hypersensitivity).
• Localized eczema (contact dermatitis).
• Skin rash.
• Hives.
• Exfoliation of the skin (peeling).
• Oily sticky skin.
• Others reactions at the administration site: bleeding, discomfort, dryness, inflammation, irritation, paresthesia (tingling, numbness).

Adverse Effects of Unknown Frequency(cannot be estimated from available data)

• Urticaria.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctororpharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

Do not use this medication after the expiration date that appears on the box and on the tube after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Dispose of the packaging once the treatment is completed.

Do not use this medication if you observe signs of deterioration.

Medications should not be disposed of through drains or in the trash. Deposit the packaging and medications you no longer need at the SIGRE collection point at the pharmacy.Ask your pharmacist how to dispose of the packaging and medications you no longer need if you are unsure. By doing so, you will help protect the environment.

Composition ofFungarest

The active ingredient is ketoconazol. Each gram of cream contains 20 mg of ketoconazol.

The other components (excipients) are:

• propylene glycol (E-1520),
• stearic acid alcohol,
• cetilic alcohol,
• monoestearate of sorbitan,
• polysorbate 60,
• polysorbate 80,
• isopropyl myristate,
• sodium sulfite (E-221) and
• purified water.

Appearance of the product and content of the container

White and homogeneous cream.

This medication is presented in tubes of30 grams.

Holder of the Marketing Authorization

STADA, S.L. Laboratory

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

Responsible for manufacturing

JANSSEN PHARMACEUTICA, N.V.

Turnhoutseweg, 30

2340 Beerse (Belgium)

or

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

Last review date of this leaflet:June 2021

Other sources of information

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