Peroxiben 50 mg/g gel
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Peroxiben 50 mg/g gel
Benzoyl peroxide
Read the entire 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 6 weeks.
Contents of the leaflet:
- What Peroxiben is and what it is used for
- What you need to know before using Peroxiben
- How to use Peroxiben
- Possible adverse effects
- How to store Peroxiben
- Contents of the pack and other information
1. What Peroxiben is and what it is used for
Benzoyl peroxide, the active substance in this medicine, has antimicrobial and sebostatic (sebum-regulating) activity, and is capable of inhibiting the growth of Cutibacterium acnes, the microorganism responsible for acne.
Peroxiben is indicated for the local symptomatic treatment of moderate vulgar acne in adults and adolescents aged 12 years and older.
You should consult a doctor if your condition worsens or does not improve after 6 weeks.
2. What you need to know before starting to use Peroxiben
Do not use Peroxiben
- if you are allergic to benzoyl peroxide or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before starting to use Peroxiben
- In case of very sensitive skin
- This medicine may cause skin irritation and some redness.
During the first application, you may experience mild stinging, redness, and skin peeling.
During the first weeks of treatment, peeling may suddenly increase in most patients. This usually decreases within one or two days if treatment is temporarily interrupted. To prevent this effect, it is recommended to start treatment on a small area and extend it to the affected area after a few days.
In case of mild irritation, applications should be spaced out.
If irritation persists or is severe, stop using Peroxiben and wash the skin carefully with water and soap. If irritation continues after stopping treatment, consult your doctor.
- Do not use Peroxiben on damaged or eczematous skin, or on cuts or abrasions due to the possible risk of absorption. Avoid contact with eyes, lips, mouth, nostrils, mucous membranes, or sensitive areas of the neck. In case of accidental contact, rinse immediately with water.
- The use of Peroxiben may cause discoloration of hair and certain dyed or colored fabrics.
Other medicines and Peroxiben
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Do not use Peroxiben together with other medicines or cosmetics that have peeling, irritating, or drying effects.
Peroxiben may be combined under medical supervision with other substances indicated for the treatment of seborrhea and acne.
Pregnancy and breastfeeding
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.
Peroxiben should only be administered to pregnant women when a medical evaluation determines that the benefit outweighs the potential risk, as the safety of benzoyl peroxide has not been established.
It is unknown whether Peroxiben is excreted in breast milk; therefore, it should be used with caution in breastfeeding women, and should not be applied to the breast to avoid transfer to the infant.
Driving and using machines
There is no evidence that Peroxiben may affect the ability to drive or operate machinery.
3. How to use Peroxiben
Follow exactly the instructions for administering this medicine provided in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Use in adults and adolescents aged 12 years and older
After washing the affected area with water and soap, apply a small amount of Peroxiben to the area using the fingertip, once or twice daily, depending on the severity of the condition and skin tolerance.
It is advisable to start treatment with Peroxiben 25 mg/g gel, switching to Peroxiben 50 mg/g gel or 100 mg/g gel after 3 or 4 weeks, or earlier if good tolerance to Peroxiben 25 mg/g gel is established.
Improvement is generally observed after 4–6 weeks of treatment. However, longer-term use may be required.
Use in children under 12 years of age
Do not use Peroxiben in children under 12 years of age without medical supervision.
If you use more Peroxiben than you should
If you have used more Peroxiben than recommended, consult your doctor or pharmacist immediately. If an overdose is applied topically, the skin may become excessively red and painful. In such cases, reduce the frequency of application until symptoms subside. If irritation persists, consult your doctor.
In case of accidental ingestion, do not induce vomiting. Rinse the mouth and seek immediate medical attention.
In cases of overdose or accidental ingestion, contact the Toxicology Information Service: Telephone: 915 620 420.
If you forget to use Peroxiben
If you miss a dose, apply the next dose as soon as possible and continue treatment as previously directed. Do not apply a double dose to make up for a missed dose.
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 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 discontinuing treatment.
Peroxiben 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 (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 of unknown frequency (frequency cannot be estimated from the available information)
- Swelling of the face
- Allergic reactions including hypersensitivity at the application site and anaphylaxis
- Photosensitivity reaction
If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.
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 can also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Peroxiben
Keep out of the sight and reach of children.
Store below 30 °C.
Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date is the last day of the month indicated.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.
6. Contents of the container and other information
Composition of Peroxiben
The active substance is benzoyl peroxide. Each gram of gel contains 50 mg of benzoyl peroxide.
The other components are glycerol (E-422), aloe vera gel, carbomer, acrylic copolymer, simethicone, sodium hydroxide (E-524), disodium edetate, sodium dioctyl sulfosuccinate, and purified water.
Appearance of the product and contents of the container
Peroxiben is presented as a white gel in a polyethylene tube with a polypropylene cap. Each tube contains 30 or 60 grams of gel.
Other presentations
Peroxiben 25 mg/g gel: tubes containing 30 g of gel.
Peroxiben 100 mg/g gel: tubes containing 30 or 60 g of gel.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Isdin S.A.
Provençals 33
08019 Barcelona
Spain
Manufacturer:
Antonio Puig S.A.
C/ Berlín 12
Polígono industrial Can Torella
08233 Vacarisses (Barcelona)
Spain
Date of the most recent review of this leaflet: August 2025
Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)