Product Information for the User

Benzac Wash 50 mg/g Gel

Benzoyl Peroxide

Read this entire product information carefully before starting to use this medication, as it contains important information for you.

Follow exactly the medication administration instructions contained in this product information or those provided by your doctor, pharmacist, or nurse.

• Keep this product information, as you may need to refer to it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this product information. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 30 days.

1.What is Benzac Wash Gel and what is it used for

2.What you need to know before starting to use Benzac Wash Gel

3.How to use Benzac Wash Gel

4.Possible Adverse Effects

5Storage of Benzac Wash Gel

6.Contents of the Package and Additional Information

Benzacwash gel is used for skin washing as a treatment for moderatecommon acne symptoms..

Benzoil peroxide acts as an antimicrobial agent and softens and exfoliates the outer skin layer.

Consult a doctor if symptoms worsen or do not improve after 30 days.

Do not useBenzacwash gel:

• If you are allergic to the active ingredient or any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to useBenzacwash gel.

• When starting treatment withBenzacwash gel, mild burning may appear on the first application and a few days later, moderate redness and skin peeling may occur. It is normal for skin peeling to occur during the first weeks of treatment; this effect is not harmful and usually disappears within 1 day or 2aftertemporarily stopping treatment.To prevent this possible effect, it is recommended to start applying the product to a small area, extending it to the affected area a few days later. If persistent irritation occurs, consult your doctor.
• Be cautious when applying to sensitive skin.
• Ensure thatBenzacwashgeldoes not enter the eyes, mouth, or nostrils, and other sensitive areas of the body. If this occurs, immediately wash the areas with plenty of warm water.
• Avoid excessive exposure to sunlight and UV lamps.
• Benzacwashgelshould not be used on damaged skin(areas with cuts, scratches, or eczema).
• Avoid allowingBenzacwashgelto come into contact with your hair or colored fabrics, as it may cause discoloration. Wash your hands carefully after using this medication.

Use ofBenzacwash gel with other medications

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

• Do not use otherkeratolyticor acne products (containing benzoyl peroxide, salicylates, or sulfur) at the same time asBenzacwashgel, as they may increase skin irritation.
• Avoid usingBenzacwashgelat the same time as other exfoliating or peeling products, preparations containing alcohol, soaps, or abrasive cleaners, cosmetics, and drying agents.

Pregnancy and breastfeeding and fertility

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

Benzacwashgelshould not be used during pregnancy.

If you become pregnant while usingBenzacwashgel, treatment should be discontinued and your doctor should be informed as soon as possible.

Avoid using this medication during breastfeeding unless your doctor has recommended it. If your doctor has recommended it during breastfeeding, do not applyBenzacwashgelto the breast to avoid exposure to the infant.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

Treatment withBenzacwashgeldoes not affect the ability to drive or operate machinery.

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

Apply 1 or 2 times a day on the affected areas. It is especially suitable for larger areas of the body (back and chest).

Instructions for the correct administration of Benzac wash gel

- Moisturize the skin of the area to be treated beforehand.

- Press the tube gently and place a small amount of gel on your hands.

- Wash the area to be treated with the gel for 1 to 5 minutes.

- Rinse thoroughly with water and dry gently and without rubbing.

- Wash your hands well after use.

Generally, improvement can be observed after 4-6 weeks of treatment. However, a longer use may be required.

If you estimate that the action of Benzac wash gel is too strong or too weak, inform your doctor or pharmacist.

If you suffer from persistent irritation when using Benzac wash gel, contact your doctor. You may be advised to apply a moisturizer, use the gel less frequently, stop using it for a short period of time, or stop using it altogether.

Benzoic peroxide can cause swelling and the appearance of blisters on the skin. If any of these symptoms occur, discontinue the medication.

Use in children and adolescents

BENZAC wash 50 mg/g gel is not recommended for newborns and children under 12 years of age due to the lack of information on its safety and efficacy.

If you use more Benzac wash gel than you should

This medication should not be ingested. It is only for external use.

If you use more Benzac wash gel than you should on your skin, your acne will not clear up faster and your skin may become irritated and red.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or go to a medical center, or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to use Benzac wash gel

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

If you interrupt the treatment with Benzac wash gel

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

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

Adverse reactions occur at the application site. They are usually reversible by reducing the frequency of application or interrupting treatment.

Benzac wash gel may cause the following adverse effects at the application site:

Very Common Adverse Effects(may affect more than 1 in 10 people)

- Dry skin

- Skin peeling

- Burning sensation on the skin

- Redness of the skin (erythema)

Common Adverse Effects(may affect up to 1 in 10 people)

- Skin irritation (irritant contact dermatitis)

- Pain in the skin

- Itching on the skin (pruritus)

Uncommon Adverse Effects(may affect up to 1 in 100 people)

- Allergic contact dermatitis

Adverse Effects of Unknown Frequency(cannot be known from the available information)

- Swelling of the face

- Allergic reactions including hypersensitivity at the application site and anaphylaxis

- Photosensitivity reaction

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

Do not store at a temperature above 25°C.

Do not use this medication after the expiration date that appears on the box, after CAD. The expiration date is thelast day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medicines. By doing so, you will help protect the environment.

Composition of Benzac wash gel:

The active ingredient is: benzoyl peroxide. Each gram of gel contains 50 mg of benzoyl peroxide.

The other components are: acrylate copolymer, glycerol, carbomer 940, C14- C16olefin sulfonate sodium, sodium hydroxide and purified water.

Appearance of the product and contents of the packaging:

Benzac wash gel is a white or off-white gel.

Benzac wash gel isavailable in containers containing 100 g.

Holder of the marketing authorization and responsible for manufacturing:

Holder of the marketing authorization:

Laboratorios Galderma, S.A.

Serrano Galvache, 56

28033 Madrid

Responsible for manufacturing:

Laboratoires Galderma

Z.I.- Montdésir

74540, Alby-sur-Chéran

France

Date of the last review of this leaflet:August 2018

“Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/ ”