Leaflet: information for the user

Ionil shampoo

Coal tar / Salicylic acid

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

Follow exactly the administration instructions contained 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 side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

It belongs to a group of medications called medicated shampoos. Its active ingredients help to reduce excessive scalp flaking.

It is indicated for the symptomatic relief of scalp desquamative alterations, such as seborrheic dermatitis (inflammatory eruption with flaking), psoriasis (red scaly condition), dandruff, and itch.

Ionil shampoo is indicated for adults.

Do not use Ionil shampoo

• If you are allergic to coal tar or salicylic acid or any of the other ingredients of this medicine (listed in section 6).
• If you have psoriasis with inflammation, exudative eczema (which secretes fluid), pustular psoriasis (with blisters) or erythrodermic (redness) extended and generalized over 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 old.

Warnings and precautions

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

Use on the scalp only.

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

Children and adolescents

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

Other medicines and Ionil shampoo

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

The simultaneous use of coal tar with photosensitizing medicines (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 in the same area may be potentiated.

Pregnancy, breastfeeding and fertility

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

The treatment with Ionil shampoo is not recommended if you are pregnant or breastfeeding.

Driving and use of machines

No.

Ionil shampoo contains benzalkonium chloride.

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

Ionil shampoo contains alcohol (ethanol)

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

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

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

• Apply Ionil shampoo on wet hair.
• Perform a gentle 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 old (see section 2).

If you use more Ionil shampoo than you should

Ionil shampoo is only for cutaneous use, exclusively on the hair. Excessive application for prolonged periods does not lead to faster or better results and may cause intense irritation instead. In case of occurrence, treatment should be interrupted. Severe skin damage 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 visit a medical center, or call the Toxicological Information Service, Phone: 91 5620420, indicating the medication and the amount ingested.

If you forgot to use Ionil shampoo

Do not apply a double dose to compensate for the missed doses.

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

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

If adverse reactions occur, treatment should be interrupted.

Reports have included hypersensitivity reactions, including contact dermatitis.

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

Reporting 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 prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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 that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Ionil shampoo

- The active principles 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 Lauril Ether, Benzalkonium Chloride, Tetrasodium EDTA Tetrahydrate, Citric Acid Anhydrous and Purified Water.

Appearance of the product and contents of the packaging

Clear amber-colored shampoo. Characteristic coal tar odor.

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

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Laboratoires Bailleul S.A.

10-12 Avenue Pasteur

L-2310 Luxembourg

LUXEMBOURG

Responsible for manufacturing

Laboratorios Feltor, S.A.

Roques Blanques, 3-5

08470 Sant Celdoni (Barcelona)

SPAIN

Last review date of this leaflet:

The detailed and updated information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.es