Product Information for the Patient

Ciclochem 10 mg/g Cream

Ciclopirox olamine

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others even if they have similar symptoms to you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist or nurse, even if they are not mentioned in this leaflet. See section 4.

Table of Contents

1. What is Ciclochem 10 mg/g Cream 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. Storage of Ciclochem 10 mg/g Cream
6. Contents of the pack and additional information

Ciclochem 10 mg/g cream contains an active ingredient 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 skin and mucous membrane fungal infections such as dermatophytosis:Tinea pedis(athlete's foot),Tinea corporis(ringworm),Tinea cruris(jock itch), candidiasis (thrush), pityriasis versicolor, and erythrasma.

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

If you are allergic to ciclopirox olamina or to 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

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

Pregnancy, breastfeeding and fertility

Given the high penetration power of ciclopirox olamina and the limitation of data related to its use in pregnant women, this medication is not recommended for use in pregnant women or in women of childbearing age who are not using contraceptives.

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

Driving and operating machines

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

This medication contains benzyl alcohol, cetyl alcohol and stearic alcohol.

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

This medication contains 10 mg of benzyl alcohol in each gram of cream. Benzyl alcohol may provoke allergic reactions.

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 causative agent and the location of the lesion. Generally, symptoms disappear after the 1st week of treatment, but it is advisable to continue therapy for one or two weeks more to prevent recurrences.

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

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

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 reviewed.

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

Use in children and adolescents

Ciclochem 10 mg/g cream may be administered to children over 6 years old. Ciclochem 10 mg/g cream will only be administered to children under 6 years old in very special cases after careful evaluation of the benefit-risk ratio.

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

Adverse effects very common (may affect more than 1 in 10 people) Adverse effects common (may affect up to 1 in 10 people)

Adverse effects uncommon (may affect up to 1 in 100 people) Adverse effects rare (may affect up to 1 in 1,000 people)

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

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

Adverse effects rare (may affect up to 1 in 1,000 people) arecontact dermatitis, transient worsening of local signs at the application site, erythema at the application site, and pruritus at the application site

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist or nurse, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the national notification system included in theAppendix V*. 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 packaging after CAD. The expiration date is the last day of the month indicated.

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

Appearance of the product and contents of the packaging

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

Holder of the marketing authorization and responsible for manufacturing

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

28750 San Agustin del Guadalix (Madrid) Spain

Last review date of this leaflet: August 2024

Other sources of information

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