CICLOCHEM 10 MG/G CREAM

Patient Information Leaflet

Introduction

Package leaflet: Information for the patient

Ciclochem 10 mg/g cream

Ciclopirox olamine

Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only; do not give it to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist or nurse, even if these adverse effects are not listed in this leaflet. See section 4.

Package leaflet

1. What Ciclochem 10 mg/g cream is and what it is used for
2. What you need to know before using Ciclochem 10 mg/g cream
3. How to use Ciclochem 10 mg/g cream
4. Possible side effects
5. How to store Ciclochem 10 mg/g cream
6. Contents of the pack and other information

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

Ciclochem 10 mg/g cream contains an active substance called ciclopirox olamine, which belongs to a group of medicines known as "antifungals".

Ciclochem 10 mg/g cream is used for the topical treatment of superficial fungal infections of the skin and mucous membranes, such as dermatophytoses: Tinea pedis (athlete's foot), Tinea corporis (ringworm), Tinea cruris (Hebra's marginated eczema), candidiasis (moniliasis), pityriasis versicolor, and erythrasma.

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

2. What you need to know before using Ciclochem 10 mg/g cream

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

Warnings and precautions

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

Other medicines and Ciclochem 10 mg/g cream

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

Pregnancy, lactation and fertility

Due to the high penetration capacity of ciclopirox olamine and the limited data available on its use in pregnant women, administration of this medicinal product is not recommended in pregnant women or in women of childbearing potential who are not using contraception.

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

Driving and operating machinery

No effect on the ability to drive or operate machinery has been reported.

This medicine contains benzyl alcohol, cetyl alcohol, and stearyl alcohol.

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

This medicine contains 10 mg of benzyl alcohol in each 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 daily, in the morning and at night. The required duration of treatment varies, depending on the causative 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 additional weeks in order to prevent recurrences.

Patients with "Pityriasis versicolor" usually achieve clinical cure, with elimination of the causative agent, after two weeks of treatment.

After applying Ciclochem 10 mg/g cream, it is recommended to gently massage the affected area.

Clinical improvement is usually observed within the first week of treatment. If the patient shows no improvement after four weeks of application, the diagnosis should be reviewed.

Follow exactly the instructions for use provided in this leaflet or those indicated by your doctor, pharmacist, or nurse. In case of doubt, consult your doctor, pharmacist, or nurse.

Use in children and adolescents

May be administered to children over 6 years of age. Ciclochem 10 mg/g cream should only be given to children under 6 years of age in very special cases, after carefully evaluating the benefit-risk ratio.

4. Possible adverse effects

The following terms are used to describe how frequently adverse effects have been reported:

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

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

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

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

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 pruritus at the application site.

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor, pharmacist, or nurse, even if it is a possible adverse reaction not listed in this leaflet. You may also report them directly through the national reporting system detailed in Appendix V*. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of Ciclochem 10 mg/g cream

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the container and additional information

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

Appearance of the Product and Contents of the Container

Ciclochem 10 mg/g cream is an almost white cream available in aluminum tubes with a polypropylene cap containing 30 g and 60 g of cream.

Marketing Authorization Holder

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

28750 San Agustin del Guadalix (Madrid) Spain

Manufacturing Responsible

Ferrer Internacional, S.A.

Joan Buscallà, 1-9

San Cugat del Vallès (Barcelona) – 08173

Spain

SAG Manufacturing, S.L.U.

Ctra. N-1, Km 36

San Agustin del Guadalix, 28750 (Madrid)

Spain

Date of the most recent review of this leaflet: July 2025

Other sources of information

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.