Ionil Shampoo

Patient Information Leaflet

Introduction

Patient Information Leaflet

Ionil shampoo

Coal tar / Salicylic acid

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

Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist.

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

• If you need advice or more information, consult your pharmacist.

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

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

Contents of this 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. How to store Ionil shampoo
6. Contents of the pack and further information

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

It belongs to a group of medicines known as medicated shampoos. Its active ingredients help reduce excessive scaling of the scalp.

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

Ionil shampoo is indicated for use in 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 to any of the other ingredients of this medicine (listed in section 6).
• If you have inflammatory psoriasis, exudative eczema (weeping lesions), generalized pustular psoriasis (with blisters), or erythrodermic psoriasis (widespread redness).
• If you have a history of photo-induced or photo-aggravated disorders (such as photosensitive dermatoses, systemic lupus erythematosus).
• In children under 2 years of age.

Warnings and precautions

Talk to your doctor or pharmacist before using Ionil shampoo.

For topical use only, specifically on the scalp.

• Avoid contact with mucous membranes.
• Coal tar may stain clothing and hair.
• If this medicine accidentally gets into the eyes, rinse them thoroughly with clean, lukewarm water.
• If you have wounds or infection on the scalp, consult your doctor before using this shampoo.
• This medicine may cause allergic reactions to sunlight if any residue remains on the scalp. Therefore, it is recommended to rinse the hair thoroughly to completely remove the shampoo after washing. In addition, caution should be taken when exposing the treated area to sunlight (even on cloudy days) or to ultraviolet (UV) lamps.

Children and adolescents

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

Other medicines and Ionil shampoo

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Concurrent use of coal tar with photosensitizing medicines (which cause an allergic reaction to sunlight; for example: tetracyclines, psoralens such as methoxsalen or trioxsalen, tretinoin) may result in additive photosensitizing effects.

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

Pregnancy, breastfeeding and fertility

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

Treatment with Ionil shampoo is not recommended during pregnancy or breastfeeding.

Driving and using machines

Not applicable.

Ionil shampoo contains benzalkonium chloride.

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

Ionil shampoo contains alcohol (ethanol)

This medicine 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 exactly the instructions for use provided in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

It is recommended to apply Ionil shampoo to the scalp once or twice a week for 2 to 4 weeks.

• Apply Ionil shampoo to wet hair.
• Gently massage and rinse.
• Repeat the procedure, 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 individuals under 18 years of age (see section 2).

If you use more Ionil shampoo than you should

Ionil shampoo is intended for topical use only, specifically on the hair. Excessive application over prolonged periods does not lead to faster or better results and may instead cause severe irritation. If this occurs, treatment should be discontinued. Cases of necrosis (significant damage) to healthy skin have been associated with abuse of salicylic acid.

In case of accidental ingestion, nausea and vomiting may occur.

In the event of overdose or accidental ingestion, immediately consult your doctor or pharmacist, go to a medical center, or call the Toxicology Information Service at Telephone: 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 missed doses.

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

4. Possible adverse effects

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

If adverse reactions occur, treatment should be discontinued.

Hypersensitivity reactions have been reported, including contact dermatitis.

Occasionally, redness, dryness, inflammation of the hair follicles (folliculitis), and skin irritation may occur; acneiform rash is usually observed with prolonged use, along with burning sensation and, rarely, photosensitivity (allergy to sunlight) of the skin. Occasionally, the use of coal tar may induce generalized pustular psoriasis and infection.

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 Medicinal Products: https://www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ionil Shampoo

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

No special storage conditions are required.

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.

Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused containers and medicines at the SIGRE Point at your pharmacy. If in doubt, 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 Ionil shampoo

• The active substances 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, macrogol lauryl ether, benzalkonium chloride, tetrasodium edetate tetrahydrate, anhydrous citric acid and purified water.

Nature and contents of the container

Clear amber-colored shampoo. Characteristic coal tar odour.

Ionil shampoo is available in bottles containing 200 ml of shampoo.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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 most recent revision of this leaflet:

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