BENZAC WASH 50 mg/g GEL

Introduction

Package Leaflet: Information for the User

Benzac Wash 50 mg/g Gel

Benzoic Acid Peroxide

Read the entire 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, pharmacist, or nurse.

• 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, pharmacist, or nurse, even if they are not listed in this package leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after 30 days.

Package Leaflet Contents:

1. What Benzac Wash Gel is and what it is used for
2. What you need to know before using Benzac Wash Gel
3. How to use Benzac Wash Gel
4. Possible side effects

5 Storage of Benzac Wash Gel

1. Package Contents and Additional Information

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

Benzac Wash Gel is used for skin washing as a treatment for symptoms of moderate common acne.

Benzoic acid peroxide acts as an antimicrobial agent and softens and scales the outermost layer of the skin.

You should consult a doctor if it worsens or does not improve after 30 days.

2. What you need to know before using Benzac Wash Gel

Do not useBenzac Wash 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 use Benzac Wash Gel.

• When starting treatment with Benzac Wash Gel, mild burning may appear on the first application and after a few days, moderate redness and skin scaling. It is normal for scaling to occur during the first weeks of treatment; this effect is not harmful and usually disappears within 1 or 2 days after temporarily interrupting treatment. To prevent this possible effect, it is recommended to start application on a small area, extending it to the affected area after a few days. If persistent irritation occurs, consult your doctor.
• Caution should be exercised when applying to sensitive skin.
• Make sure Benzac Wash Gel does not enter the eyes, mouth, or nasal orifices, and other sensitive areas of the body. If this happens, rinse the areas immediately with plenty of warm water.
• Avoid excessive exposure to sunlight and UV lamps.
• Benzac Wash Gel should not be used on damaged skin (areas with cuts, scratches, or eczema).
• Avoid getting Benzac Wash Gel in contact with your hair or colored fabrics, as it may discolor them, and wash your hands carefully after using this medication.

Using Benzac Wash Gel with other medications

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

• Do not use other keratolytic or acne products (containing benzoic acid peroxide, salicylates, or sulfur) at the same time as Benzac Wash Gel, as they may increase the appearance of skin irritation.
• Avoid using Benzac Wash Gel at the same time as other scaling or exfoliating products, preparations containing alcohol, soap, or abrasive cleaners, cosmetics, and drying agents.

Pregnancy, Breastfeeding, and Fertility

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

Benzac Wash Gel should not be used during pregnancy.

If you become pregnant while using Benzac Wash Gel, treatment should be discontinued and your doctor informed as soon as possible.

Avoid using this medication during breastfeeding, unless your doctor has indicated that you can use it. If your doctor has recommended it during breastfeeding, do not apply Benzac Wash Gel to the breast to avoid contact exposure of the infant.

Consult your doctor or pharmacist before using any medication.

Driving and Using Machines

Treatment with Benzac Wash Gel does not affect the ability to drive or use machinery.

3. How to use Benzac Wash Gel

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

Apply 1 or 2 times a day to 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

• Moisten the skin of the area to be treated beforehand.
• Gently press the tube 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 without rubbing.
• Wash your hands well after use.

Improvement can usually be observed after 4-6 weeks of treatment. However, longer use may be required.

If you think the effect of Benzac Wash Gel is too strong or too weak, tell your doctor or pharmacist.

If you experience persistent irritation when using Benzac Wash Gel, contact your doctor. You may be advised to apply a moisturizing product, use the gel less frequently, stop using it for a short period, or stop using it altogether.

Benzoic acid peroxide can cause swelling and blistering of the skin; if any of these symptoms occur, the medication should be discontinued.

Use in Children and Adolescents

BENZAC Wash 50 mg/g Gel is not recommended in 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 is not to be ingested. It is for external use only.

If you use more Benzac Wash Gel on the skin than you should, it will not cure your acne more quickly, 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 Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to use Benzac Wash Gel

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

If you interrupt treatment with Benzac Wash Gel

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

4. Possible Side Effects

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

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

Benzac Wash Gel may cause the following side effects at the site of application:

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

• Dryness of the skin
• Scaling of the skin
• Burning sensation on the skin
• Redness of the skin (erythema)

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

• Skin irritation (irritant contact dermatitis)
• Pain in the skin
• Itching of the skin (pruritus)

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

• Allergic contact dermatitis

Side Effects of Unknown Frequency(cannot be determined from available data)

• Facial swelling
• Allergic reactions including hypersensitivity at the site of application and anaphylaxis
• Photosensitivity reaction

Reporting Side Effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are 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 help provide more information on the safety of this medication.

5. Storage of Benzac Wash Gel

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

Do not store above 25°C.

Do not use this medication after the expiration date stated on the box, 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 your 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 Benzac Wash Gel:

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

The other components are: acrylate copolymer, glycerol, carbomer 940, C14-C16 olefin sulfonate sodium, sodium hydroxide, and purified water.

Appearance of the Product and Package Contents:

Benzac Wash Gel is a white or off-white gel.

Benzac Wash Gel is available in packages containing 100 g.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder:

Laboratorios Galderma, S.A.

Serrano Galvache, 56

28033 Madrid

Manufacturer:

Laboratoires Galderma

Z.I.- Montdésir

74540, Alby-sur-Chéran

France

Date of the Last Revision of this Package Leaflet:August 2018

“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.gob.es/”