CICLOCHEM 15 mg/g SHAMPOO

Introduction

Package Leaflet: Information for the User

CICLOCHEM 15 mg/g Shampoo

Ciclopirox Olamine

Read the entire package leaflet carefully before starting to use the medicine, 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
• This medicine 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, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet:

1. What is Ciclochem and what is it used for
2. What you need to know before using Ciclochem
3. How to use Ciclochem
4. Possible side effects
5. Storage of Ciclochem
6. Contents of the pack and further information

1. What is Ciclochem and what is it used for

• Ciclochem contains the active ingredient ciclopirox olamine, which belongs to the group of medicines known as "antifungals".

• Ciclochem is used when the scalp is red, flaky, and itchy (a condition known as seborrheic dermatitis).

2. What you need to know before using Ciclochem

Do not use Ciclochem

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

If you are not sure, talk to your doctor or pharmacist before using Ciclochem.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Ciclochem.

Be careful with Ciclochem

• Ciclochem is for external use only.
• If you have gray, white, or chemically damaged hair (e.g., due to hair dyes), consult your doctor or pharmacist before using this shampoo, as Ciclochem may, in rare cases, affect your hair color.
• Ciclochem is not recommended for use in children under 12 years of age, as its safety and efficacy are unknown in this age group.

Avoid getting Ciclochem in your eyes. If this happens, it may cause irritation and stinging. If Ciclochem accidentally gets in your eyes, rinse the affected areawith water.

Using Ciclochem with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines, including those obtained without a prescription.

Pregnancy and breastfeedingDo not use this medicine if you are pregnantor breastfeeding

There is no information on the safety of Ciclochem in pregnant women.

If you are pregnant or plan to become pregnant, consult your doctor.

If you become pregnant during treatment with Ciclochem, inform your doctor.

Driving and using machines

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

Important information about some of the ingredients of Ciclochem

Ciclochem may cause skin irritation because it contains dipropylene glycol (in Fragrance AF 17050).

This medicine contains 105 mg/g of sodium lauryl sulfate. Sodium lauryl sulfate may cause local skin reactions (such as itching or burning sensation) or increase skin reactions caused by other medicines when applied to the same area.

3. How to use Ciclochem

• Follow the instructions for using Ciclochem exactly as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.
• Use Ciclochem two or three times a week, for 4 weeks, or for the time indicated by your doctor.
• Use Ciclochem only on the hair, scalp, and adjacent areas, if they are also affected.
• If you wish, you can wash your hair with a mild shampoo on the days when you do not need to use Ciclochem.

How to apply Ciclochem

1. Wet your hair.
2. Apply enough Ciclochem to cover your scalp and hair and adjacent areas, if they are also affected.
3. Masajee the scalp and adjacent areas, if necessary, with your fingertips.
4. Rinse the scalp and hair thoroughly.

Repeat steps 2 to 4. The shampoo should be in contact with the scalp for 3-5 minutes for the total applications.

Try to avoid getting the product in your eyes. If this happens, rinse with plenty of clean water.

If you accidentally ingest Ciclochem

It is not expected that the ingredients of Ciclochem will be harmful if ingested in small amounts. If Ciclochem accidentally gets in your mouth, rinse immediately with water.

If you accidentally ingest a large amount of Ciclochem, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

4. Possible side effects

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

Side effects may occur with a certain frequency. The frequencies are defined as:

• very common: may affect more than 1 in 10 people
• common: may affect up to 1 in 10 people
• rare: may affect up to 1 in 1,000 people

The following side effects have been observed with the use of Ciclochem:

Very common:

• skin irritation*
• itching*.

Common:

• rash*
• burning sensation on the skin
• redness at the application site*.

Rare:

• allergic reaction
• skin flaking*
• eczema (itchy rash on the skin)*
• hair loss*
• changes in hair color
• changes in hair texture (dry, dull, or lackluster hair).

Some of these effects (marked with *), may be symptoms of the disease being treated. Therefore, if you experience any of these effects for the first time after starting treatment with Ciclochem, or if they worsen, stop using the product and consult your doctor or pharmacist.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this package leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

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5. Storage of Ciclochem

• Keep this medicine out of the sight and reach of children.
• No special precautions for storage are required.
• Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.
• Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the SIGRE collection point (or any other medicine waste collection system) at your pharmacy. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of Ciclochem

The active ingredient is Ciclopirox Olamine. It contains 1.5 g per 100 g.

• The other ingredients are: Sodium lauryl sulfate 70%, Cocamidopropyl betaine, Disodium hydrogen phosphate dodecahydrate, Citric acid monohydrate, Hexylene glycol, Oleic alcohol, Polysorbate 80, Polyquaternium-10, Fragrance AF 17050 (contains dipropylene glycol), Sodium hydroxide, and Purified water.

Appearance of the product and pack contents

• Ciclochem is presented as a shampoo with a color between pale yellow and light orange in 100 ml bottles.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Galenicum Derma, S.L.U.

Ctra N-1, Km 36

28750 San Agustín del Guadalix (Madrid)

Spain

Manufacturer:

Aspen Bad Oldesloe GmbH

Industriestrasse 32-36

D-23843 Bad Oldesloe

Germany

or

Delpharm Bladel B.V.

Industrieweg 1

5531 Bladel (Netherlands)

Date of the last revision of this package leaflet: October 2024

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