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Gel with antimicrobial and sebostatic activity indicated in adults and adolescents over 12 years old to treat acne vulgaris
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1. WHAT IS Peroxiben AND WHAT IT IS USED
This product contains benzoyl peroxide as the active ingredient. This compound has antimicrobial and sebostatic (regulatory fat) activity, and is able to stop the growth of Propionibacterium acne, acne causative organism.
Peroxiben is indicated for symptomatic local treatment of moderate acne vulgaris in adults and adolescents from 12 years old.
2. BEFORE YOU USE Peroxiben
Check with your doctor before using Peroxiben if you are allergic (hypersensitive) to benzoyl peroxide or to any of the other dePeroxiben components.
Special care with Peroxiben
· In case of very sensitive skin
· This medicine may cause skin irritation and some redness.
During the first application you'll probably notice mild burning, and some redness and peeling skin.
During the first weeks of treatment, peeling suddenly it increases in most patients. Normally it decreases in one or two days if treatment is interrupted temporarily. To prevent this effect it is recommended to start treatment in a small area, extending to the affected area a few days.
In case of slight irritation, should be spaced applications.
If irritation persists or is severe, stop using Peroxiben and carefully clean the skin with soap and water. If irritation persists after stopping treatment, consult your doctor.
· Do not use damaged or eczematous Peroxiben on skin or cuts or abrasions on the possible risk of absorption. Avoid contact with eyes, lips, mouth, nostrils, mucous membranes or sensitive areas of the neck. If accidental contact occurs, immediately wash.
· The use of Peroxiben can produce discoloration and certain hair dyed or colored fabric.
Using other medicines
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Do not use Peroxiben with other medicines or cosmetics with desquamative, irritant and drying effects.
Peroxiben under medical supervision can be combined with other substances indicated for the treatment of seborrhea and acne.
Pregnancy and lactation
Consult your doctor or pharmacist before taking any medicine.
Peroxiben should only be administered to pregnant women when an evaluation of the physician determines that the benefit outweighs the potential risk, because it has not been established safety benzoyl peroxide.
It is unknown whether Peroxiben is excreted in breast milk, so it should be administered cautiously to breastfeeding women and should not be applied to the chest to prevent transfer to the infant.
Driving and using machines
There is no indication that Peroxiben may affect ability to drive or operate machinery.
3. HOW TO USE Peroxiben
Adults and adolescents over 12 years old
After washing with soap and water, apply on it, with the fingertips, a small amount of Peroxiben once or twice a day, depending on the intensity of the process and skin tolerance.
It is advisable to start treatment with Peroxiben 25 mg / g gel, going to use Peroxiben 50 mg / g gel or 100 mg / g gel after 3 or 4 weeks or sooner if established a good tolerance
Peroxiben 25 mg / g gel.
You can generally observed improvement after 4-6 weeks of treatment. However, you could specify a longer use.
Children under 12 years old
Peroxiben not use in children under 12 years old without medical supervision.
Ask your doctor or pharmacist if you have doubts.
If you use more than you should Peroxiben
If you have used more Peroxiben than you should, immediately consult your doctor or pharmacist. If Peroxiben have used more than you should, the skin can become red and painful too. In that case it must be applied more spaced manner until this phase has passed. If irritation persists you should consult a doctor.
Accidental ingestion should not induce vomiting, wash your mouth and seek medical assistance immediately.
In case of overdose or accidental ingestion, consult the Toxicology Information Service: Phone: +34 915 620 420.
If you forget to Peroxiben
If you miss a dose, apply the following as soon as possible and continue administration as hitherto. Do not take a double dose to make up for missed doses.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Peroxiben can cause side effects, although not everybody gets them.
It is very common (in more than 1 in 10 patients) the patient feel a slight burning sensation with the first application and appear within a few days, a moderate redness, dryness and skin peeling. During the first weeks of treatment a sudden increase in peeling, redness, itching and pruritus (itching) in most patients may occur; this is not harmful and usually goes away in a day or two if treatment is temporarily interrupted.
In rare cases (affects 1 to 10 in 10,000 patients) can be observed allergic dermatitis.
During the period of authorization of this medicine have been observed following side effects, which often could not be established accurately. The patient may experience temporary facial swelling, rash or dermatitis. In these cases it should be discontinued immediately and seek medical treatment. These reactions are often unknown and usually reversible
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.
5. HOW TO STORE Peroxiben
Keep out of reach and sight of children. Store below 30 ° C.
Peroxiben Do not use after the expiry date stated on the label after the abbreviation "CAD". The expiry date is the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This way you will help to protect the environment.
6. FURTHER INFORMATION
The active ingredient is benzoyl peroxide. Each gram of gel contains 50 mg of benzoyl peroxide.
The other ingredients are glycerol (E-422), aloe vera gel carbomers, acrylic copolymer, simethicone, sodium hydroxide (E-524), edetate disodium, and purified water sodium dioctilsulfosuccionato
Looks like and contents of the pack
Peroxiben occurs as a white gel in a polyethylene tube with a polypropylene cap.
Authorization holder responsible for marketing and manufacturing
Isdin S.A. Provençals, 33
08019 Barcelona, Spain
Responsible for manufacturing:
Antonio Puig SA Pharmaceutical Laboratory Potosi 21
Source: Spanish Agency for Medicines and Health Products