PEROXIBEN 100 mg/g GEL

Introduction

Package Leaflet: Information for the User

Peroxiben 100 mg/g gel

Benzoic peroxide

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

This medicine can be obtained without a prescription. Nevertheless, to obtain 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 that any of the side effects you are suffering from is serious or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Contents of the package leaflet:

1. What is Peroxiben and what is it used for
2. Before using Peroxiben
3. How to use Peroxiben
4. Possible side effects
5. Storage of Peroxiben
6. Additional information

1. What is PEROXIBEN and what is it used for

Benzoic peroxide, the active ingredient of this medicine, has antimicrobial and sebostatic activity (regulating fat), and is capable of stopping the growth of Propionibacterium acne,the microorganism that causes acne.

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

2. Before using PEROXIBEN

Do not use Peroxiben

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

Be careful with Peroxiben

• In case of very sensitive skin
• This medicine may cause skin irritation and some redness.

During the first application, you will probably notice mild burning, and some redness and skin peeling.

During the first weeks of treatment, skin peeling increases suddenly in most patients. Normally, it will decrease in one or two days if the treatment is temporarily interrupted. To prevent this effect, it is recommended to start the treatment in 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, stop using Peroxiben and carefully clean the skin 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 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 discoloration of hair and certain dyed or colored tissues.

Use of other medicines

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

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

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

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

Peroxiben should only be administered to pregnant women when a medical evaluation determines that the benefit outweighs the potential risk, since the safety of benzoic peroxide has not been established.

It is unknown whether Peroxiben is excreted in breast milk, so it should be administered with caution to breastfeeding women, and should not be applied to the breast to avoid transfer to the infant.

Driving and using machines

There is no indication that Peroxiben can affect the ability to drive or use machinery.

3. How to use PEROXIBEN

Adults and adolescents from 12 years of age

After washing the affected area with water and soap, apply a small amount of Peroxiben to the same area with the fingertips, one or two times a day, depending on the intensity of the process 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 in case of good tolerance to Peroxiben 25 mg/g gel.

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

Children under 12 years of age

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

Consult your doctor or pharmacist if you have doubts.

If you use more PEROXIBEN than you should

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

In case of accidental ingestion, do not induce vomiting, rinse your mouth, and seek immediate medical attention.

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

If you forget to use PEROXIBEN

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 make up for forgotten doses.

4. Possible side effects

Like all medicines, Peroxiben can cause side effects, although not everyone will experience them.

It is very common (in more than 1 in 10 patients) for the patient to feel a mild burning sensation with the first application, and for moderate redness, dryness, and skin peeling to appear after a few days. 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 in 10,000 patients), allergic dermatitis may be observed.

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

If you consider that any of the side effects you are suffering from is serious or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

5. Storage of PEROXIBEN

Keep out of the reach and sight of children.

No special storage conditions are required.

Do not use Peroxiben after the expiration date that appears on the packaging after the abbreviation "CAD". The expiration date is the last day of the month indicated.

Medicines should not be thrown away through wastewater or household waste. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Additional information

Composition of Peroxiben

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

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

Appearance of the product and packaging content

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.

Marketing authorization holder and manufacturer

Holder:

Isdin S.A.

Provençals 33

08019 Barcelona, Spain

Manufacturer:

Antonio Puig S.A.

C/ Berlín 12

Can Torella Industrial Park

08233 Vacarisses (Barcelona)

Spain

This leaflet was approved in June 2010