Ciclopirox olamine Abamed 15 mg/g shampoo

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

Ciclopirox olamine Abamed 15 mg/g shampoo

Ciclopirox olamine

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.

• If you have any questions, ask your doctor, pharmacist or nurse.

• This medicine has been prescribed for you only, and you should not give it to other people even if they have the same symptoms as you, because it may harm them.

  • If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of this leaflet:

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

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

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

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

2. What you need to know before using Ciclopirox olamine Abamed

Do not use Ciclopirox olamine Abamed:

• If you are allergic (hypersensitive) to ciclopirox olamine or to 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.

Take caution:

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

• If you experience persistent skin irritation, treatment should be discontinued.

• If you have gray, white, or chemically damaged hair (e.g., from hair dyes), consult your doctor or pharmacist before using this shampoo, as it may, in rare cases, affect your hair color.

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

If accidental contact with the eyes occurs, rinse the affected area thoroughly with 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 have not been established in this age group.

Use of Ciclopirox olamine Abamed with other medicines

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

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

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 are planning to become pregnant, consult your doctor or pharmacist before using this medicine. If you become pregnant while using this shampoo, inform your doctor.

Consult your doctor or pharmacist before using any medicine.

3. How to use Ciclopirox olamine Abamed

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in 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 the treatment earlier, 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 feel that 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.

Instructions for application

• Apply a sufficient amount of shampoo to wet hair to produce abundant lather.

• 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.

If desired, you may wash your hair with a mild shampoo on days when you are not required to use this medicine.

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

If Ciclopirox olamine Abamed is accidentally swallowed

The ingredients of this Abamed shampoo are not expected to be harmful if small amounts are ingested. If it accidentally comes into contact with the mouth, rinse immediately with water.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.

The adverse effects that could 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)*
• hair loss*
• changes in hair colour
• changes in hair texture (dry, matted or dull hair).

Some of these effects (marked with *) may be symptoms of the condition being treated. Therefore, if you experience any of these effects for the first time after starting treatment, or if skin irritation, redness or itching worsens, stop using the product and consult your doctor or pharmacist.

Reporting of 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 leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide 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 expiry date stated on the packaging after "EXP.:". The expiry date refers to the last day of the month indicated.

After opening the container: store for up to 8 weeks. Discard any remaining solution. Indicate the date of opening in the box provided for this purpose on the container.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE Point located at your usual pharmacy. Ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ciclopirox olamine Abamed

The active substance 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 adjustment), hexylene glycol, oleyl alcohol, polysorbate 80, polyquaternium 10, sodium hydroxide (pH adjustment), purified water, and fragrance.

Appearance of the product and contents of the pack

Ciclopirox olamine Abamed 15 mg/g shampoo is a viscous solution, colorless to slightly yellowish. Each container holds 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 most recent revision of this leaflet: May 2023

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) www.aemps.gob.es/