Ciclopirox olamina isdin 15 mg/g champu

Label: information for the user

Ciclopirox olamina ISDIN 15 mg/g shampoo

Ciclopirox olamina

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 doubts, consult your doctor or pharmacist.
• This medication has been prescribed only to 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.

1. What is Ciclopirox Olamina Isdin and what is it used for

2. What you need to know before starting to use Ciclopirox Olamina Isdin

3. How to use Ciclopirox Olamina Isdin

4. Possible adverse effects

5. Storage of Ciclopirox Olamina Isdin

6. Contents of the package and additional information

This medication belongs to the group of external (topical) dermatological antifungals.

This medication is indicated for the treatment of seborrheic dermatitis of the scalp.

Ciclopirox olamina Isdin is intended for exclusive external use.

Like all shampoos, avoid contact with the eyes. In case of accidental contact with the eyes, rinse with plenty of water.

This product has not been tested in children.

Do not use Ciclopirox Olamina Isdin

If you are allergic to the active ingredient or to any of the other components of this medication (including those listed in section 6).

Warnings and precautions

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

If you have known sensitivity to the fragrance, avoid using this shampoo.

Consult your doctor or pharmacist before starting to use Ciclopirox Olamina Isdin.

Use of Ciclopirox Olamina Isdin with other medications

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

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

Pregnancy, breastfeeding, and fertility

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

Given the short contact time with the skin and the low level of systemic absorption, Ciclopirox Olamina Isdin may be used during pregnancy. Your doctor will evaluate the need to use this medication.

Ciclopirox Olamina Isdin may be used during breastfeeding.

Driving and operating machinery

Ciclopirox olamina ISDIN 15 mg/g shampoo does not affect the ability to drive or operate machinery.

Important information about some of the components of Ciclopirox:

This medication contains fragrance with the following allergens: limonene, geraniol, benzyl alcohol, citral, and linalool. These may cause allergic reactions.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again. Remember to use your medication.

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

If you estimate that the action of Ciclopirox Olamina Isdin is too strong or weak, inform your doctor or pharmacist.

Apply a sufficient amount of Ciclopirox Olamina Isdin to the hair when it is wet to produce abundant foam. Massage the scalp and adjacent areas vigorously with your fingertips. Then, rinse the hair well and repeat the process. Leave the shampoo in contact with the scalp for 3-5 minutes.

Ciclopirox Olamina Isdin should be used two or three times a week.

The recommended treatment period is 4 weeks.

Like all medications, Ciclopirox Olamina Isdin may cause adverse effects, although not everyone will experience them.

Ciclopirox Olamina Isdin could cause, in rare instances, skin irritation. If persistent irritation occurs, treatment should be discontinued.

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 Medicinal Products for Human Use: https://www.notificaRAM.es. 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.

No special storage conditions are required.

Once the container is opened, the shampoo must be used within an 8-week period.

Do not use this medication after the expiration date that appears on the box 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 containers and medications you no longer need at theSIGREcollection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Ciclopirox olamina ISDIN 15 mg/g shampoo

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

The other components are: sodium lauryl sulfate at 70%, cocamidopropyl betaaine, disodium dodecahydrogenephosphate, citric acid monohydrate, hexylene glycol, oleic alcohol, poloxamer 80, polyquaternium 10, sodium hydroxide, purified water, fragrance Rifskin 54193 (contains limonene, geraniol, benzyl alcohol, citral, and linalool).

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Appearance of the product and contents of the packaging

Ciclopirox olamina ISDIN 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

Isdin SA

Provençals 33

08019 Barcelona

Spain

Responsible for manufacturing

Laboratorios Feltor

Molí de les Planes Industrial Estate

C/ Roques Blanques 3-5

08470 Sant Celoni (Barcelona)

Spain

Last review date of this leaflet: September 2023

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