Label: information for the patient

Cicloseb 15 mg/g shampoo

Ciclopirox olamine

Read this label carefully before starting to use this 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, pharmacist, or nurse.
• This medication has been prescribed only for you, and you should not give it to others who have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this label. See section 4.

1. What is Cicloseb and how it is used

2. What you need to know before starting to use Cicloseb

3. How to use Cicloseb

4. Possible adverse effects

5. Storage of Cicloseb

6. Contents of the package and additional information

This medication contains an active ingredient called ciclopirox olamina, which belongs to a group of medications known as “antifungals”.

It is used for the treatment of seborrheic dermatitis (red, flaking, and itchy scalp).

Do not use Cicloseb:

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

Warnings and precautions

Consult your doctor or pharmacist before starting to use Cicloseb.

Be cautious:

-This medication is only for external use. Apply exclusively to the hair. Do not ingest.

-If you observe persistent skin irritation. In this case, treatment should be suspended.

-If you have gray, white, or chemically damaged hair (for example, from hair dyes), consult with your doctor or pharmacist before using this shampoo, as it may, in rare cases, affect the color of your hair.

Avoid contact between Cicloseb and your eyes.If this happens, it may cause burning and irritation.

If accidental contact with your eyes occurs,rinse the affected areawith plenty of water and contact an ophthalmologist if necessary.

Children

This product is not recommended for use in children under 12 years of age, as its safety and efficacy are unknown in this age group.

Use of Cicloseb with other medications

No data are available on drug interactions. However, given the low level of systemic absorption, it is unlikely that they will occur.

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

Pregnancy and breastfeeding

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

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medication. If you become pregnant during treatment with this shampoo, inform your doctor.

Consult your doctor or pharmacist before using any medication

Follow exactly the administration instructions for this medication indicated by your doctor or pharmacist.

Consult your doctor or pharmacist again if you are unsure.

Remember to use your medication.

Your doctor will inform you of the duration of your treatment with this shampoo. Do not discontinue treatment beforehand, as the medication will not be effective.

This shampoo should be used two or three times a week. The recommended treatment period is 4 weeks.

If you estimate that the shampoo's action is too strong or weak, inform your doctor or pharmacist.

Use this medication only on the hair, scalp, and adjacent areas, if they are also affected.

Instructions for application

-Apply a sufficient amount of shampoo to the wet hair to produce abundant foam.

-Massage the scalp and adjacent areas vigorously with the fingertips.

-Then, rinse the hair well and repeat the process.

-Leave the shampoo in contact with the scalp for 3-5 minutes.

You can wash your hair with a mild shampoo on the days when you do not need to use this medication.

As with all shampoos, avoid contact with the eyes, as it may cause itching and irritation. In case of accidental contact with the eyes, rinse with plenty of water.

What to do if you accidentally ingest Cicloseb 15 mg/g shampoo

It is not expected that the ingredients of this shampoo will be harmful if ingested in small amounts. If you accidentally come into contact with your mouth, rinse immediately with water.

In case of accidental ingestion, 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.

The adverse effects that may be observed with this shampoo are:

Very Frequent(may affect more than 1 in 10 people):

• skin irritation*
• itching*

Frequent(may affect up to 1 in 10 people):

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

Rare(may affect up to 1 in 1,000 people):

• allergic reaction
• skin peeling*
• eczema (eruption with itching on 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 or if the irritation, redness, or itching on 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 for Pharmacovigilance of Medicines for Human Use:www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

This medication does not require any special storage temperature. Store in the original packaging.

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.

Once the packaging is opened: storebelow <25ºCfor 8 weeks. Discard any remaining solution. Indicate the opening date in the designated box on the packaging.

Medications should not be disposed of through drains or in the trash. Deposit the packaging and unusedmedications at your local SIGREcollection point at your usual pharmacy. Ask your pharmacisthow to dispose of the packaging and unused medications. By doing so, you will help protect the environment

Composition of Cicloseb

The active ingredient is ciclopirox olamina. Each gram of shampoo contains 15 milligrams of ciclopirox olamina.

The other components (excipients) are: sodium lauryl sulfate, cocamidopropyl betaïne, disodium hydrogen phosphate, citric acid monohydrate (pH adjustment), hexylene glycol, oleic alcohol, poloxamer 80, polyquaternium 10, sodium hydroxide E 524 (pH adjustment), purified water, and fragrance.

Appearance of the product and content of the packaging

Cicloseb 15 mg/g shampoo is a colorless to yellowish viscous solution. Each package contains 100 ml of shampoo.

Holder of the marketing authorization and responsible for manufacturing:

Holder of the marketing authorization

Galenicum Derma, S.L.U.

Ctra. N-1, Km 36,

28750 San Agustin del Guadalix

Madrid – Spain

Responsible for manufacturing

Laboratorios Feltor

Polígono Industrial Molí de les Planes

c/ Roques Blanques 3-5

08470 Sant Celoni

Barcelona – Spain

Date of the last review of this leaflet: September 2017

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