IONIL CHAMPU SHAMPOO

Introduction

Package Leaflet: Information for the User

Ionil Shampoo

Coal Tar / Salicylic Acid

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

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist.

• Keep this package leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.

• You should consult a doctor if it worsens or does not improve after 15 days.

Contents of the Package Leaflet

1. What Ionil Shampoo is and what it is used for
2. What you need to know before using Ionil Shampoo
3. How to use Ionil Shampoo
4. Possible side effects
5. Storage of Ionil Shampoo
6. Package Contents and Additional Information

1. What Ionil Shampoo is and what it is used for

It belongs to a group of medications called medicinal shampoos. Its active ingredients help reduce excessive scaling of the scalp.

It is indicated for the symptomatic relief of scaling disorders of the scalp, such as seborrheic dermatitis (eruption with inflammation and scaling), psoriasis (scaly red condition), dandruff, and itching.

Ionyl Shampoo is indicated for adults.

2. What you need to know before using Ionil Shampoo

Do not use Ionil Shampoo

• If you are allergic to coal tar or salicylic acid or any of the other components of this medication (listed in section 6).
• If you have psoriasis with inflammation, exudative eczema (releasing fluid), pustular psoriasis (with blisters), or erythrodermic (widespread redness) psoriasis extended and generalized throughout the body.
• If you have a history of photo-induced or photo-aggravated disease (such as photosensitive dermatosis, systemic lupus erythematosus).
• In children under 2 years of age.

Warnings and Precautions

Consult your doctor or pharmacist before starting to use Ionil Shampoo.

For topical use only, exclusively on the scalp.

• Avoid contact with mucous membranes.
• Coal tar may stain clothing and hair.
• If this medication comes into contact with the eyes accidentally, you should rinse your eyes with clean, lukewarm water.
• If you have wounds or infections on the scalp, you should consult your doctor before using this shampoo.
• This medication may cause sun-related allergic reactions if shampoo residue remains on the scalp. Therefore, it is recommended to rinse your hair thoroughly to completely remove the shampoo after washing. Additionally, you should be cautious when exposing the treated area to the sun (even if cloudy) or to ultraviolet lamps (UVA).

Children and Adolescents

This medication is contraindicated in children under 2 years of age and should not be used in minors under 18 years of age.

Other Medications and Ionil Shampoo

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

The simultaneous use of coal tar with photosensitizing medications (which produce an allergic reaction to sunlight; for example: tetracyclines, psoralens such as methoxsalen or trioxsalen, tretinoin) may produce additive photosensitizing effects.

The effects of other keratolytic products (which reduce the thickness of the outer layer of the skin) applied to the same area may be enhanced.

Pregnancy, Breastfeeding, and Fertility

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Treatment with Ionil Shampoo is not recommended if you are pregnant or breastfeeding.

Driving and Using Machines

Not applicable.

Ionyl Shampoo contains Benzalkonium Chloride

This medication contains 2 mg of benzalkonium chloride per gram of shampoo. Benzalkonium chloride may cause skin irritation.

Ionyl Shampoo contains Alcohol (Ethanol)

This medication contains 135 mg of alcohol (ethanol) per gram of shampoo. It may cause a burning sensation on damaged skin.

3. How to use Ionil Shampoo

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

It is recommended to apply Ionil Shampoo to the scalp 1 or 2 times a week, for 2 to 4 weeks.

• Apply Ionil Shampoo to wet hair.
• Gently massage and rinse.
• Repeat the operation, leaving the product on the hair for a few minutes before rinsing.
• Rinse thoroughly.

Use in Children and Adolescents

Do not use this shampoo in minors under 18 years of age (see section 2).

If you use more Ionil Shampoo than you should

Ionyl Shampoo is for topical use only, exclusively on the hair. Excessive application for prolonged periods does not lead to faster or better results and may cause intense irritation. If this occurs, treatment should be discontinued. The appearance of necrosis (severe damage) of healthy skin has been associated with abuse of salicylic acid.

In case of accidental ingestion, nausea and vomiting occur.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or go to a medical center, or call the Toxicology Information Service, Phone: 91 5620420, indicating the medication and the amount ingested.

If you forget to use Ionil Shampoo

Do not apply a double dose to make up for forgotten doses.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

In case of adverse reactions, treatment should be discontinued.

Hypersensitivity reactions, including contact dermatitis, have been reported.

Occasionally, redness, dryness, inflammation of the hair follicles (folliculitis), and skin irritation, acneiform eruption usually with prolonged use, burning sensation, and rarely photosensitivity (sun allergy) on the skin may occur; occasionally, generalized pustular psoriasis and infection may be induced by the use of coal tar.

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 package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Ionil Shampoo

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

No special storage conditions are required.

Do not use this medication after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Ionil Shampoo

• The active ingredients are Coal Tar and Salicylic Acid. Each ml of shampoo contains 42.5 mg of coal tar (4.25%) and 20 mg of salicylic acid (2%).
• The other components are: polysorbate 80, denatured alcohol, ethanol, lauryl ether macrogol, benzalkonium chloride, tetrasodium edetate tetrahydrate, anhydrous citric acid, and purified water.

Appearance of the Product and Package Contents

Clear amber-colored shampoo. Characteristic coal tar odor.

Ionyl Shampoo is available in bottles containing 200 ml of shampoo.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

LABORATOIRES BAILLEUL S.A.

10-12 Avenue Pasteur

L-2310 Luxembourg

LUXEMBOURG

Manufacturer

LABORATORIOS FELTOR, S.A.

Roques Blanques, 3-5

08470 SANT CELONI (Barcelona)

SPAIN

Date of the Last Revision of this Package Leaflet:

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