Ciclopirox olamine Capitec 15 mg/g shampoo

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Ciclopirox Olamine CAPITEC 15 mg/g

Shampoo

Ciclopirox olamine

Read the entire leaflet carefully before you start using this medicine.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you and should not be given to other people, even if they have the same symptoms, as it may harm them.
• If you consider any of the side effects you experience to be severe, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Leaflet contents:

1. What Ciclopirox Olamine CAPITEC 15 mg/g Shampoo is and what it is used for.
2. Before you use Ciclopirox Olamine CAPITEC 15 mg/g Shampoo.
3. How to use Ciclopirox Olamine CAPITEC 15 mg/g Shampoo.
4. Possible side effects.
5. How to store 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 medicinal product belongs to the group of topical dermatological antifungal agents.

This medicinal product 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 for external use only.

As with all shampoos, contact with the eyes should be avoided. In case of accidental eye contact, rinse thoroughly with plenty of water.

This product has not been tested in children.

Do not use Ciclopirox Olamine CAPITEC 15 mg/g Shampoo

If you are hypersensitive to ciclopirox olamine or to any of the excipients.

Take special care with Ciclopirox Olamine CAPITEC 15 mg/g Shampoo:

If you experience persistent skin irritation. In such cases, treatment should be discontinued.

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

Pregnancy

Due to the short duration of skin contact and the low level of systemic absorption, Ciclopirox Olamine CAPITEC 15 mg/g Shampoo may be used during pregnancy. Your doctor will assess the need for using this medication.

Consult your doctor or pharmacist before taking any medication.

Breast-feeding

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

Consult your doctor or pharmacist before taking any medication.

Use of other medicines

There are no data available on drug interactions. However, given the low level of systemic absorption, interactions are unlikely.

Inform 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 ones.

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 the treatment earlier, as the medicine would not be effective.

If you think that 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 wet hair to produce abundant foam. Vigorously massage the scalp and adjacent areas with the fingertips. Then rinse the 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 adverse effects

Like all medicines, Ciclopirox Olamine CAPITEC 15 mg/g Shampoo may have adverse effects.

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

If you notice any other adverse reactions not described above, consult your doctor or pharmacist.

Inform your doctor or pharmacist of any adverse effects, especially if they are not mentioned in this 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 storage precautions are required.

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

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

6. Additional Information

Composition of Ciclopirox Olamine CAPITEC 15 mg/g Shampoo

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

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

Appearance of the medicinal product and contents of the container

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

Marketing Authorization Holder and Manufacturer:

Laboratorio Reig Jofré, S.A.

C/ Gran Capitán, 10

08970 Sant Joan Despí

Barcelona - Spain

This leaflet was last reviewed in April 2023