Leaflet: information for the user

Peroxiben 100 mg/g gel

Benzoic peroxide

Read this leaflet carefully because it contains important information for you.

This medicine can be purchased without a prescription. However, for the best results, it should be used properly.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If symptoms worsen or persist after 6 weeks, you should consult a doctor.
• If you consider any of the adverse effects you are experiencing to be severe or if you notice any adverse effect not mentioned in this leaflet, inform your doctor or pharmacist.

1. What Peroxiben is and what it is used forandwhat it is used for

2. Before using Peroxiben

3. How to use Peroxiben

4. Possible adverse effects

5. Storage of Peroxiben

6. Additional information

The benzoyl peroxide, active principle of this medication, has antimicrobial and sebostatic (regulator of fat) activity, and is able to stop the growth ofPropionibacterium acne,a microorganism that causes acne.

Peroxiben is indicated for the local symptomatic treatment of moderate vulgar acne in adults and adolescents from 12 years old.

Do not use Peroxiben

• If you are allergic (hypersensitive) to benzoyl peroxide or to any of the other components of Peroxiben.

Be extra cautious with Peroxiben

• On very sensitive skin
• This medication may cause skin irritation and certain redness.

You may experience mild burning, and certain redness and peeling of the skin during the first application.

During the first weeks of treatment, there may be a sudden increase in peeling in most patients. This usually decreases in one or two days if treatment is temporarily interrupted. To prevent this effect, it is recommended to start treatment on a small area, extending it to the affected area after a few days.

In case of mild irritation, applications should be spaced out.

If irritation persists or is intense, discontinue use of Peroxiben, and clean the skin thoroughly 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 risk of absorption. Avoid contact with the eyes, lips, mouth, nostrils, mucous membranes, or sensitive areas of the neck. In case of accidental contact, wash immediately with water.
• The use of Peroxiben may cause hair discoloration and discoloration of certain dyed or colored tissues.

Use of other medications

Inform your doctor or pharmacist if you are using, or have recently used, other medications, including those purchased without a prescription.

Do not use Peroxiben with other medications or cosmetics that have exfoliating, irritating, and drying effects.

Peroxiben may be combined under medical supervision with other substances indicated for the treatment of seborrhea and acne.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

Peroxiben should only be administered to pregnant women when a doctor's evaluation determines that the benefits outweigh the potential risks, as the safety of benzoyl peroxide has not been established.

The excretion of Peroxiben in breast milk is unknown, so 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 operating machinery

There is no indication that Peroxiben may affect the ability to drive or operate machinery.

Adults and adolescents 12 years and older

After washing the affected area with water and soap, apply a small amount of Peroxiben to the area with the tip of your fingers, one or two times a day, depending on the severity of the process and skin tolerance.

It is recommended 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, prolonged use may be required.

Children under 12 years

Do not use Peroxiben in children under 12 years without medical supervision.

Consult your doctor or pharmacist if you have any doubts.

If you use more Peroxiben than you should

If you have used more Peroxiben than you should, consult your doctor or pharmacist immediately. If you have used more Peroxiben than you should, the skin may become excessively red and painful. In this case, apply it more spaced out until this phase has passed. If irritation persists, consult your doctor.

In case of accidental ingestion, do not induce vomiting, wash your mouth, and seek medical assistance immediately.

In case of overdose or accidental ingestion, consult the Toxicological Information Service: Telephone 915 620 420.

If you forgot to usePeroxiben

If you forget to administer a dose, apply the next one as soon as possible and continue administration as before. Do not administer a double dose to compensate for the missed doses.

Like all medications, Peroxiben may produce adverse effects, although not all people will experience them.

It is very frequent (in more than 1 in 10 patients) for the patient to feel a mild burning sensation with the first application and for a moderate redness, dryness, and skin peeling to appear a few days later. During the first weeks of treatment, a sudden increase in peeling, redness, itching, and pruritus (itching) may occur in most patients; this is not harmful and usually disappears in one or two days if treatment is temporarily interrupted.

In rare cases (affecting 1 to 10 of every 10,000 patients), allergic dermatitis may be observed.

During the authorization period of this medication, the following adverse effects have been observed, whose frequency has not been established with precision. The patient may experience temporary facial inflammation, dermatitis, or rash. In these cases, treatment should be immediately discontinued and the doctor consulted. These reactions are of unknown frequency and are usually reversible.

If you consider that any of the adverse effects you are experiencing are severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Keep out of reach and sight of children.

No special storage conditions are required.

Do not use Peroxiben after the expiration date appearing on the packaging after the abbreviation “CAD”. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition of Peroxiben

The active ingredient is benzoyl peroxide. Each gram of gel contains 100 mg of benzoyl peroxide.

The other components are glycerol (E-422), aloe vera carbomer gel, acrylic copolymer, simethicone, sodium hydroxide (E-524), disodium edetate, dioctylsulfosuccinate sodium, and purified water.

Appearance of the product and contents of the package

Peroxiben is presented in the form of 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 with 30 g of gel.

Peroxiben 50 mg/g gel: tubes with 30 or 60 g of gel.

Holder of the marketing authorization and responsible for manufacturing

Holder:

Isdin S.A.

Provençals 33

08019 Barcelona, Spain

Responsible for manufacturing:

Antonio Puig S.A.

C/ Berlín 12

Polígono industrial Can Torella

08233 Vacarisses (Barcelona)

Spain

This prospectus was approved in June 2010