CICLOPIROX OLAMINE ABAMED 15 mg/g SHAMPOO

Introduction

Leaflet: Information for the patient

Ciclopirox olamine Abamed 15 mg/g shampoo

Ciclopirox olamine

Read the entire leaflet carefully before starting to use this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.

• This medicine has been prescribed to you only, 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 side effects, consult your doctor, pharmacist, or nurse, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet:

1. What Ciclopirox olamine Abamed is and what it is used for.
2. What you need to know before starting to use Ciclopirox olamine Abamed
3. How to use Ciclopirox olamine Abamed
4. Possible side effects.
5. Storage of Ciclopirox olamine Abamed
6. Contents of the pack and additional information.

1. What Ciclopirox olamine Abamed is and what it is used for

This medicine contains an active ingredient called ciclopirox olamine, which belongs to the group of medicines known as "antifungals".

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

2. What you need to know before starting to use Ciclopirox olamine Abamed

Do not use Ciclopirox olamine Abamed:

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

Warnings and precautions

• Consult your doctor or pharmacist before starting to use Ciclopirox olamine Abamed.

Be cautious:

• This medicine is for external use only. Apply exclusively to the hair. Do not ingest.

• If you observe persistent skin irritation. In this case, treatment should be discontinued.
• If you have gray, white, or chemically damaged hair (e.g., due to hair dyes), consult your doctor or pharmacist before using this shampoo, as it may, in rare cases, affect the color of your hair.

Avoid contact with the eyes. If this happens, it may cause stinging and irritation.

If it accidentally comes into contact with the eyes, wash the affected areawith plenty of water and contact an ophthalmologist if necessary.

Children

The use of Ciclopirox olamine Abamed is not recommended in children under 12 years of age, as its safety and efficacy are unknown in this age group.

Using Ciclopirox olamine Abamed with other medicines

There is no data 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 recently used, or may need to use any other medicine.

Pregnancy and breastfeeding

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

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine. If you become pregnant during treatment with this shampoo, inform your doctor.

Consult your doctor or pharmacist before using any medicine.

3. How to use Ciclopirox olamine Abamed

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

Your doctor will indicate the duration of your treatment with this shampoo. Do not stop treatment before, as the medicine will not be effective.

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

If you think the effect of the shampoo is too strong or too weak, inform your doctor or pharmacist.

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

Application instructions

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

If you wish, you can wash your hair with a mild shampoo on the days when you do not need to use this medicine.

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

If you accidentally ingest Ciclopirox olamine Abamed

It is not expected that the ingredients of this Abamed shampoo will be harmful if ingested in small quantities. If it accidentally comes into contact with the mouth, rinse immediately with water.

In case of accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

The side effects that may occur with this shampoo are:

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

• skin irritation*
• itching*

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

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

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

• allergic reaction
• skin peeling*
• eczema (itchy rash on the skin)*
• hair loss*
• changes in hair color
• changes in hair texture (dry, dull, or lackluster 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 they worsen, stop using the product and consult your doctor or pharmacist.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System: www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Ciclopirox olamine Abamed

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

No special storage conditions are required. Store in the original packaging.

Do not use this medicine after the expiration date shown on the packaging after "EXP.". The expiration date is the last day of the month indicated.

Once the packaging is opened: store for 8 weeks. Discard any remaining solution. Indicate the opening date in the space provided on the packaging.

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medicines at the SIGRE collection point in your usual pharmacy. Ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Contents of the pack and additional information

Composition of Ciclopirox olamine Abamed

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

The other components (excipients) are: sodium lauryl ether sulfate, cocamidopropyl betaine, disodium hydrogen phosphate dodecahydrate, citric acid monohydrate (pH adjuster), hexylene glycol, oleic acid, polysorbate 80, polyquaternium 10, sodium hydroxide (pH adjuster), purified water, and fragrance.

Appearance of the product and contents of the pack

Ciclopirox olamine Abamed 15 mg/g shampoo is a viscous, colorless to yellowish solution. Each pack contains 100 ml of shampoo.

Marketing authorization holder and manufacturer:

Marketing authorization holder

Qualix Pharma, S.L.

c/ Botánica, 137-139

08908 L'Hospitalet de Llobregat

(Barcelona)

Spain

Manufacturer

Laboratorios Feltor

Polígono Industrial Molí de les Planes

c/ Roques Blanques 3-5

08470 Sant Celoni

(Barcelona)

Spain

Date of the last revision of this leaflet:May 2023

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) www.aemps.gob.es/