Ciclochem 15 mg/g shampoo

Patient Information Leaflet

Introduction

Patient Information Leaflet

CICLOCHEM 15 mg/g shampoo

Ciclopirox Olamine

Please read this 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, please consult your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not share it with others, 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, even if the effects are not listed in this leaflet. See section 4.

Leaflet Contents:

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

1. What Ciclochem is and what it is used for

• Ciclochem contains an active substance called ciclopirox olamine, which belongs to a 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 to any of the other ingredients of this medicine (listed in section 6).

If you are unsure, speak with your doctor or pharmacist before using Ciclochem.

Warnings and precautions

Talk to your doctor or pharmacist before starting to use Ciclochem.

Take special care 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 hair color.
• The use of Ciclochem is not recommended in children under 12 years of age, as its safety and efficacy are unknown in this age group.

Avoid contact of Ciclochem with the eyes. If this occurs, it may cause stinging and irritation. If Ciclochem accidentally comes into contact with the eyes, rinse the affected area thoroughly with water.

Using Ciclochem with other medicines

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

Pregnancy and breastfeeding

Do not use this medicine if you are pregnant or breastfeeding.

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

If you are pregnant or planning 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 operate machinery have been reported.

Important information about some of the ingredients of Ciclochem

Ciclochem may cause skin irritation because it contains dipropylene glycol (contained 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 exactly the administration instructions for Ciclochem provided 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 duration prescribed by your doctor.
• Apply Ciclochem only to the hair, scalp, and adjacent areas, if they are also affected.
• If desired, you may wash your hair with a mild shampoo on the days when you do not use Ciclochem.

How to apply Ciclochem

1. Wet your hair.
2. Apply a sufficient amount of Ciclochem to cover your scalp, hair, and adjacent areas, if they are also affected.
3. Vigorously massage the scalp and adjacent areas, if necessary, using the fingertips.
4. Rinse the scalp and hair thoroughly.

Repeat steps 2 to 4. The shampoo should remain in contact with the scalp for a period of 3–5 minutes for each application.

Avoid contact with the eyes. If contact occurs, rinse thoroughly with plenty of clean water.

If Ciclochem is accidentally ingested

The ingredients in Ciclochem are not expected to be harmful if small amounts are ingested. If Ciclochem comes into contact with the mouth, rinse immediately with water.

If a large amount of Ciclochem is accidentally ingested, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number: 91 562 04 20, stating the medication and the quantity ingested.

4. Possible adverse effects

• Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.

Adverse effects may occur with varying 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 adverse 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 peeling*
• eczema (itchy skin rash)*
• hair loss*
• changes in hair color
• changes in hair texture (dry, matted, or dull hair).

Some of these effects (marked with *) may be symptoms of the condition being treated. Therefore, if you experience any of these effects for the first time after starting treatment with Ciclochem, or if skin irritation, redness, or itching worsens, discontinue use and consult your doctor or pharmacist.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ciclochem

• Keep this medicine out of the reach and sight of children.
• No special storage precautions are required.
• Do not use this medicine after the expiry date stated on the container after EXP. The expiry date refers to the last day of the month indicated.
• Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point (or any other medicine waste collection system) at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the package and other information

Composition of Ciclochem

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

• The other components are: Sodium lauryl ether sulfate 70%, Cocamidopropylbetaine, Sodium hydrogen phosphate dodecahydrate, Citric acid monohydrate, Hexylene glycol, Oleic alcohol, Polysorbate 80, Polyquaternium-10, Fragrance AF17050 (contains dipropylene glycol), Sodium hydroxide and Purified water.

Appearance of the product and contents of the pack

• Ciclochem is a shampoo with a color ranging from straw yellow to light orange, supplied 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:

Delpharm Bladel B.V.

Industrieweg 1

5531 Bladel (The Netherlands)

Date of the most recent revision of this leaflet: October 2024

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