Benzac Wash 50 mg/g gel
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Benzac wash 50 mg/g gel
Benzoyl peroxide
Read all of this leaflet carefully before you start using this medicine, as it contains important information for you.
Follow exactly the instructions for using this medicine as described in this leaflet or as directed by your doctor, pharmacist, or nurse.
- 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, pharmacist, or nurse, 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 30 days.
Contents of this leaflet:
- What Benzac wash gel is and what it is used for
- What you need to know before using Benzac wash gel
- How to use Benzac wash gel
- Possible side effects
- How to store Benzac wash gel
- Contents of the pack and other information
1. What Benzac wash is and what it is used for
Benzac wash gel is used for washing the skin as a treatment for symptoms of moderate vulgar acne.
Benzoyl peroxide acts as an antimicrobial agent and softens and peels the outermost layer of the skin.
You should consult a doctor if your condition worsens or does not improve after 30 days.
2. What you need to know before using Benzac wash gel
Do not use Benzac wash gel:
- if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before starting to use Benzac wash gel.
- When starting treatment with Benzac wash gel, mild stinging may occur upon first application, followed after a few days by moderate redness and skin peeling. It is normal to experience peeling during the first weeks of treatment; this effect is not harmful and usually disappears within 1 or 2 days after temporarily stopping treatment. To help prevent this possible effect, it is recommended to start application on a small area and gradually extend it to the affected area after a few days. If persistent irritation occurs, consult your doctor.
- Exercise caution when applying to sensitive skin.
- Make sure that Benzac wash gel does not come into contact with the eyes, mouth, nasal passages, or other sensitive areas of the body. If this occurs, rinse the affected areas immediately with plenty of lukewarm water.
- Avoid excessive exposure to sunlight and UV lamps.
- Benzac wash gel must not be used on damaged skin (areas with cuts, scratches, or eczema).
- Avoid contact of Benzac wash gel with your hair or colored fabrics, as it may cause bleaching. Wash your hands thoroughly after using this medicine.
Using Benzac wash gel with other medicines
Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.
- Do not use other keratolytic or acne products (containing benzoyl peroxide, salicylates, or sulfur) at the same time as Benzac wash gel, as they may increase the risk of skin irritation.
- Avoid using Benzac wash gel simultaneously with other peeling or exfoliating products, alcohol-containing preparations, abrasive soaps or cleansers, cosmetics, or drying agents.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Benzac wash gel must not be used during pregnancy.
If you become pregnant while using Benzac wash gel, treatment should be stopped and you should inform your doctor as soon as possible.
Avoid using this medicine during breastfeeding unless your doctor has advised you to do so. If your doctor has recommended its use during breastfeeding, do not apply Benzac wash gel to the breast area to avoid exposing the infant through contact.
Consult your doctor or pharmacist before using any medicine.
Driving and using machines
Treatment with Benzac wash gel does not affect the ability to drive or operate machinery.
3. How to use Benzac wash gel
Follow exactly the instructions for use of the medicine provided in this leaflet or as directed by your doctor, pharmacist, or nurse. If in doubt, consult your doctor, pharmacist, or nurse.
Apply once or twice daily to affected areas. It is especially suitable for larger body areas (back and chest).
Instructions for correct administration of Benzac wash gel
- Moisten the skin of the area to be treated beforehand.
- Gently squeeze the tube and place a small amount of gel onto the hands.
- Wash the affected area with the gel for 1 to 5 minutes.
- Rinse thoroughly with water and gently pat dry without rubbing.
- Wash hands thoroughly after use.
Improvement is usually observed after 4–6 weeks of treatment. However, longer-term use may be required.
If you think that the effect of Benzac wash gel is too strong or too weak, inform your doctor or pharmacist.
If you experience persistent irritation while 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 discontinue use altogether.
Benzoyl peroxide may cause swelling and blistering of the skin; if any of these symptoms occur, treatment must be discontinued.
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 lack of information on safety and efficacy.
If you use more Benzac wash gel than you should
This medicine must not be ingested. It is for external use only.
If you apply more Benzac wash gel than you should to the skin, your acne will not heal faster and your skin may become irritated and red.
In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, go to a medical center, or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.
If you forget to use Benzac wash gel
Do not apply a double dose to make up for missed doses.
If you stop using Benzac wash gel
If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse 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 by interrupting treatment.
Benzac wash gel may cause the following adverse effects at the site of application:
Very common adverse effects (may affect more than 1 in 10 people)
- Dryness of the skin
- Skin peeling (desquamation)
- Skin burning sensation
- Redness of the skin (erythema)
Common adverse effects (may affect up to 1 in 10 people)
- Skin irritation (irritant contact dermatitis)
- Skin pain
- Itching of the skin (pruritus)
Uncommon adverse effects (may affect up to 1 in 100 people)
- Allergic contact dermatitis
Adverse effects with unknown frequency (frequency cannot be estimated from the available information)
- Swelling of the face
- Allergic reactions including hypersensitivity at the site of application and anaphylaxis
- Photosensitivity reaction
Reporting of 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 leaflet. You may also report them directly through 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 Benzac wash gel
Keep this medicine out of the sight and reach of children.
Do not store above 25°C.
Do not use this medicine after the expiry date stated on the carton, following CAD. The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point in your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Benzac wash gel:
The active substance is: benzoyl peroxide. Each gram of gel contains 50 mg of benzoyl peroxide.
The other components are: acrylate copolymer, glycerol, carbomer 940, sodium C14-C16 olefin sulfonate, sodium hydroxide, and purified water.
Appearance of the product and contents of the pack:
Benzac wash gel is a white or almost white gel.
Benzac wash gel is available in packs containing 100 g.
Marketing Authorization Holder and Manufacturer:
Marketing Authorization Holder:
Laboratorios Galderma, S.A.
Serrano Galvache, 56
28033 Madrid
Spain
Manufacturer:
Laboratoires Galderma
Z.I.- Montdésir
74540 Alby-sur-Chéran
France
Date of the most recent review of this leaflet: August 2018
“Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/”