CICLOPIROX OLAMINE CAPITEC 15 mg/g SHAMPOO

Introduction

Package Leaflet: Information for the User

Ciclopirox Olamine CAPITEC 15 mg/g

Shampoo

Ciclopirox olamine

Read the package leaflet carefully before starting to use the medicine.

• Keep this package leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others, as it may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, consult your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet.

Contents of the package leaflet:

1. What Ciclopirox Olamine CAPITEC 15 mg/g Shampoo is and what it is used for.
2. Before using Ciclopirox Olamine CAPITEC 15 mg/g Shampoo.
3. How to use Ciclopirox Olamine CAPITEC 15 mg/g Shampoo.
4. Possible side effects.
5. Storage of Ciclopirox Olamine CAPITEC 15 mg/g Shampoo.
6. Further information.

1. What Ciclopirox Olamine Capitec 15 mg/g Shampoo is and what it is used for

This medicine belongs to the group of topical antifungal dermatological agents.

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

2. Before using Ciclopirox Olamine Capitec 15 mg/g Shampoo

Ciclopirox Olamine CAPITEC 15 mg/g Shampoo is intended exclusively for external use.

As with all shampoos, contact with the eyes should be avoided. 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 Olamine CAPITEC 15 mg/g Shampoo

In case of hypersensitivity to Ciclopirox Olamine or to any of the excipients.

Be cautious when using Ciclopirox Olamine CAPITEC 15 mg/g Shampoo:

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

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

Pregnancy

Given the short contact time with the skin and the low level of systemic absorption, Ciclopirox Olamine CAPITEC 15 mg/g Shampoo can be used during pregnancy. Your doctor will assess the need to use this medicine.

Consult your doctor or pharmacist before taking any medicine.

Breast-feeding

Ciclopirox Olamine CAPITEC 15 mg/g Shampoo can be used during breast-feeding.

Consult your doctor or pharmacist before taking any medicine.

Using other medicines

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

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.

3. How to use Ciclopirox Olamine Capitec 15 mg/g Shampoo

Follow these instructions unless your doctor has given you different instructions.

Remember to use your medicine.

Your doctor will indicate the duration of your treatment with Ciclopirox Olamine CAPITEC 15 mg/g Shampoo. Do not stop treatment before, as the medicine may not be effective.

If you think the effect of Ciclopirox Olamine CAPITEC 15 mg/g Shampoo is too strong or too weak, tell your doctor or pharmacist.

Apply a sufficient amount of Ciclopirox Olamine CAPITEC 15 mg/g Shampoo to damp hair to produce a rich lather. Massage the scalp and adjacent areas vigorously with your fingertips. Then, rinse your hair thoroughly and repeat the process. Leave the shampoo in contact with the scalp for 3-5 minutes.

Ciclopirox Olamine CAPITEC 15 mg/g Shampoo should be used two or three times a week.

The recommended treatment period is 4 weeks.

4. Possible side effects

Like all medicines, Ciclopirox Olamine CAPITEC 15 mg/g Shampoo can cause side effects.

Ciclopirox Olamine CAPITEC 15 mg/g Shampoo may rarely cause skin irritation. If persistent irritation occurs, treatment should be discontinued.

If you observe any other adverse reaction not described above, consult your doctor or pharmacist.

Tell your doctor or pharmacist about any unwanted effect, especially if it is not mentioned in this package leaflet.

5. Storage of Ciclopirox Olamine Capitec 15 mg/g Shampoo

Keep Ciclopirox Olamine CAPITEC 15 mg/g Shampoo out of the reach and sight of children.

No special precautions for storage are necessary.

Do not use Ciclopirox Olamine CAPITEC 15 mg/g Shampoo after the expiration date.

Once the package is opened, the shampoo should be used within 8 weeks.

6. Further information

Composition of Ciclopirox Olamine CAPITEC 15 mg/g Shampoo

The active ingredient is Ciclopirox Olamine. Each 100 g of shampoo contains 1.5 g of Ciclopirox Olamine.

The other components are: Sodium lauryl ether sulfate 70%, Cocamidopropyl betaine, Disodium phosphate dodecahydrate, Citric acid monohydrate, Monoethanolamine of coconut fatty acids, propoxylated, Hexylene glycol, Oleyl alcohol, Polysorbate 80, Polyquaternium 10, Sodium hydroxide, Purified water, Fragrance Rifskin 54193.

Appearance of the product and package contents

Ciclopirox Olamine CAPITEC 15 mg/g Shampoo is a colorless to yellowish viscous solution. Each package contains 100 ml of shampoo.

Marketing authorization holder and manufacturer:

Laboratorio Reig Jofré, SA

C/ Gran Capitán, 10

08970 Sant Joan Despí

Barcelona - Spain

This package leaflet was revised in April 2023