Label: information for the user

CICLOCHEM 15 mg/g shampoo

Ciclopirox Olamina

Read this label carefully before starting to use the medication, as it contains important information for you.

• Keep this label, as you may need to read it again
• If you have any questions, consult your doctor or pharmacist
• This medication has been prescribed only for you, 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 any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

• Ciclochem contains an active ingredient called ciclopirox olamine, which belongs to a group of medications known as “antifungals”.

• Ciclochem is used when the scalp is inflamed, flaking, and itchy (which is known as seborrheic dermatitis).

No use Ciclochem

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

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

Warnings and precautions

Consult your doctor or pharmacist before starting to use Ciclochem.

Be especially careful with Ciclochem

• Ciclochem is only for external use.
• If you have gray, white, or chemically damaged hair (for example, from hair dye), consult your doctor or pharmacist before using this shampoo, as Ciclochem may, in rare cases, affect the color of your hair.
• 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 letting Ciclochem come into contact with your eyes. If this happens, it may cause burning and irritation. If Ciclochem accidentally comes into contact with your eyes,rinse the affected areawith water.

Using Ciclochem with other medications

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

Pregnancy and breastfeedingDo not use this medication if you arepregnantor inlactation

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 operating machinery

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

Important information about some of the components of Ciclochem

Ciclochem may cause skin irritation because it contains dipropylene glycol (contained inFragrance AF17050).

This medication 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 medications when applied to the same area.

• Follow exactly the administration instructions for Ciclochem 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.
• You may 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 a sufficient amount of Ciclochem to cover your scalp and hair and adjacent areas, if they are also affected.

3. Massage your scalp and adjacent areas, if necessary, with your fingertips.

4. Rinse your scalp and hair well.

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

Try to prevent the product from coming into contact with your eyes. If this occurs, rinse with plenty of clean water.

What to Do If You Accidentally Ingest Ciclochem

You should not expect the ingredients of Ciclochem to be harmful if ingested in small amounts. If Ciclochem accidentally comes into contact with your mouth, rinse immediately with water.

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

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

Adverse effects may occur with a certain frequency. Frequencies are defined as:

- very frequent: may affect more than 1 in 10 people

- frequent: 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 Frequent:

• skin irritation*
• itching*.

Frequent:

• eruption*
• sensation of burning in the skin
• redness at the application site*.

Rare:

• allergic reaction
• skin peeling*
• eczema (eruption with itching in the skin)*
• 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 disease being treated. Therefore, if you experience any of these effects for the first time after starting treatment with Ciclochem, or if the irritation, redness, or itching of the skin worsens, stop using the product and consult your doctor or pharmacist.

Reporting 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 prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use: https://www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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• Keep this medication out of the reach and sight of children.
• No special precautions are required for storage.
• Do not use this medication after the expiration date that appearson thecontainer after CAD. The expiration date is the last day of the month indicated.
• Medicines should not be disposed of through drains or in the trash. Dispose of containers and unused medicines at the SIGRE collection point(or any other medication waste collection system) at the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and unused medicines. By doing so, you will help protect the environment.

Ciclochem Composition

The active principle is Ciclopirox Olamina.Contains1.5 gper 100 g.

• The other components are: Laurileter sodium sulfate at 70%, Cocamidopropylbetaína, Sodium dodecahydrogenephosphate, Citric acid monohydrate, Cocoamidopropylamine, Hexylene glycol, Oleic alcohol, Polysorbate 80, Poliquaternium-10,Fragrance AF17050 (contains dipropylene glycol), Sodium hydroxide and Purified water.

Product appearance and packaging content

• Ciclochem is presented in the form of a shampoo of a color between beige and light orange in 100 ml bottles.

Holder of the marketing authorization and manufacturer.

Holder :

Galenicum Derma, S.L.U.

Ctra N-1, Km 36

28750 San Agustin de 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)

Last review date of this leaflet: June 2018

The detailed information of this medication is available on the website of the {Spanish Agency of Medicines and Medical Devices (AEMPS)} (http://www.aemps.gob.es/)