CICLOCHEM 10 MG/G CREAM

Introduction

Package Leaflet: Information for the Patient

Ciclochem 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 or nurse.
• 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 or nurse, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Ciclochem 10 mg/g Cream and what is it used for
2. What you need to know before starting to use Ciclochem 10 mg/g Cream
3. How to use Ciclochem 10 mg/g Cream
4. Possible side effects
5. Storage of Ciclochem 10 mg/g Cream
6. Package Contents and Additional Information

1. What is Ciclochem 10 mg/g Cream and what is it used for

Ciclochem 10 mg/g Cream contains an active ingredient called ciclopirox olamine, which belongs to the group of medications known as "antifungals".

Ciclochem 10 mg/g Cream is used for the topical treatment of superficial mycoses of the skin and mucous membranes, such as dermatophytosis: Tinea pedis(athlete's foot), Tinea corporis(ringworm), Tinea cruris(jock itch), candidiasis (moniliasis), pityriasis versicolor, and erythrasma.

You should consult a doctor if it worsens or does not improve after 4 weeks.

2. What you need to know before starting to use Ciclochem 10 mg/g Cream

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

Warnings and Precautions

Consult your doctor or pharmacist or nurse before starting to use Ciclochem 10 mg/g Cream.

Other Medications and Ciclochem 10 mg/g Cream

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

Pregnancy, Breastfeeding, and Fertility

Given the high penetration power of ciclopirox olamine and the limited data on its use in pregnant women, this medication is not recommended for pregnant women or women of childbearing age who do not use contraceptives.

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

Driving and Using Machines

No effects on the ability to drive or operate machines have been reported.

This Medication Contains Benzyl Alcohol, Cetyl Alcohol, and Stearyl Alcohol.

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

This medication contains 10 mg of benzyl alcohol per gram of cream. Benzyl alcohol may cause allergic reactions.

3. How to Use Ciclochem 10 mg/g Cream

Apply Ciclochem 10 mg/g Cream to the affected areas and surrounding skin twice a day, morning and night. The required treatment duration is variable, depending on the etiological agent and the location of the lesion. In general, symptoms disappear after the first week of treatment, but it is advisable to continue therapy for one or two weeks to avoid relapses.

Patients with "Pityriasis Versicolor" usually present clinical cure after two weeks of treatment, with elimination of the etiological agent.

After applying Ciclochem 10 mg/g Cream, it is recommended to perform a gentle massage on the lesion.

Clinical improvement is usually observed within the first week of treatment. If the patient does not show improvement after four weeks of application, the diagnosis should be revised.

Follow the administration instructions of the medication contained in this package leaflet or as indicated by your doctor or pharmacist or nurse. In case of doubt, ask your doctor or pharmacist or nurse.

Use in Children and Adolescents

It can be administered to children over 6 years old. Ciclochem 10 mg/g Cream should only be administered to children under 6 years old in very special cases, after carefully evaluating the benefit-risk ratio.

4. Possible Side Effects

The following terms are used to describe the frequency of side effects:

Very common side effects (may affect more than 1 in 10 people) Common side effects (may affect up to 1 in 10 people)

Uncommon side effects (may affect up to 1 in 100 people) Rare side effects (may affect up to 1 in 1,000 people)

Very rare side effects (may affect up to 1 in 10,000 people, including isolated cases).

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

The rare side effects (may affect up to 1 in 1,000 people) are contact dermatitis, transient worsening of local signs at the application site, erythema at the application site, and

Reporting Side Effects

If you experience any side effects, consult your doctor or pharmacist or nurse, even if they are possible side effects not listed in this package leaflet. You can also report them directly through the national reporting system included in Appendix V*. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Ciclochem 10 mg/g Cream

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

Do not use this medication after the expiration date stated on the packaging after CAD. 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 unused medications at the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

• The active ingredient is ciclopirox olamine
• The other excipients are octyldodecanol, light liquid paraffin, stearyl alcohol, cetyl alcohol, myristyl alcohol, polysorbate 60, sorbitan monooleate, lactic acid, and purified water.

Appearance of the Product and Package Contents

Ciclochem 10 mg/g Cream is a practically white cream that is marketed in aluminum tubes with a polypropylene cap containing 30 g and 60 g of cream.

Marketing Authorization Holder and Manufacturer

Galenicum Derma, S.L.U. Ctra N-1, Km 36

28750 San Agustin del Guadalix (Madrid) Spain

Date of the Last Revision of this Package Leaflet:August 2024

Other Sources of Information

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/.