Agua oxigenada foret 3 % solución cutánea y concentrado para solución bucal

Label: information for the user

Hydrogen Peroxide Foret 3%skin solution and concentrated solution for oral solution

Hydrogen Peroxide

Read this label carefully before starting to use this medication, as it contains important information for you.

• Keep this label, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

If symptoms worsen or persist after 5 days, you should consult your doctor.

Hydrogen peroxide is an antiseptic. It is indicated for superficial skin wounds and mouth rinses after dental extractions in adults and children over 12 years old.

You should consult a doctor if it worsens or does not improve after 5 days.

Do not use hydrogen peroxide Foret

• If you are allergic (hypersensitive) to hydrogen peroxide or any of the other components (see section 6).
• In closed body cavities or deep surgical wounds
• As a mouthwash in case of gum injuries

Children and adolescents

DO NOT use as a mouthwash in children under 12 years old. In adolescents, from 12 to 18 years old, it should be administered under the supervision of an adult.

Warnings and precautions

• Only for external use. DO NOT SWALLOW.
• Avoid contact with the eyes. If accidental contact with the eyes occurs, wash abundantly with water and consult an ophthalmologist if necessary.
• In some cases, especially with repeated use, mouthwashes may

produce irritation of the oral mucosa (tongue "velvety"), seesection 4.

Using hydrogen peroxide Foret with other medications

Inform your doctor or pharmacist if you are using, have used recently or

may need to use another medication.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machines

The influence of this medication on the ability to drive or operate machines is negligible or insignificant.

Follow exactly the administration instructions for this medication indicated by your doctor or pharmacist.

Consult your doctor or pharmacist again in case of doubt.

This medication is administered throughtopical applicationfor superficial skin wounds and throughoral routefor mouth rinses after dental extractions.

Dosage

-Forsuperficial skin wounds, apply directly to the wound or through a cotton ball or gauze.

-Fororal rinses after dental extractions, in adults and adolescents over 12 years old, dilute with the same amount of water.

Swish the mouth for 1 minute. It can be repeated up to a maximum of 4 times a day. Do not use in the case of gingival wounds (see section 2).

It should be used for a maximum of 5 days.

Children and adolescents, in the case of oral rinses after dental extractions

Do not administer to minors under 12 years old.

In adolescents (between 12 and 18 years old), it should be administered under the supervision of an adult.

If you use more Hydrogen Peroxide Foret than you should

Accidental ingestion may cause sore throat, gastrointestinal disturbances, and vomiting. Progressive oxygen advancement through the body may cause acute gastric distension and internal hemorrhage.

Large volume ingestion may cause gas embolism.

Information for healthcare professionals:

Treatment: administer abundant water to dilute the substance; symptomatic treatment is required

In case of overdose or accidental ingestion, go to a medical center or call the Toxicological Information Service. Phone: (91) 562 04 20 indicating the product and the amount ingested.

Like all medications, this medication may produce adverse effects, although not all people may experience them.

There have been reported cases of gas embolism, sometimes causing cardiac arrest, when hydrogen peroxide has been applied near closed body cavities or in deep surgical wounds.

Concentrated hydrogen peroxide solutions produce irritating burns on the skin and mucous membranes, resulting in a white scab. The pain disappears after approximately 1 hour.

Continuous use as a mouthwash may cause reversible hypertrophy (inflammation) of the tongue papillae.

Reporting 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 prospectus.

You can also report them directly through the Spanish System of Pharmacovigilance for Medicinal Products for Human Use:www.notificaram.esThrough the reporting of adverse effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Store at room temperature.

Do not dispose of medications through drains or in the trash. Dispose of containers and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and unused medications. By doing so, you will help protect the environment.

Composition of hydrogen peroxide Foret

The active principle is hydrogen peroxide. Each 100 ml of solution contains 3 g of

hydrogen peroxide (10 volumes).

Each ml of solution contains 0.03 mg of hydrogen peroxide

The other components (excipients) are: phosphoric acid.

Appearance of the product and contents of the packaging

Transparent and colorless solution.

It is presented in a high-density polyethylene bottle with a sealed cap and dropper that contains 250 ml, 500 ml or 1000 ml of solution.

Not all packaging sizes may be commercially available.

Marketing authorization holder

PEROXFARMA, S.A.

Calle Provenza 328

08037 Barcelona

Responsible for manufacturing

Laboratorios Reig Jofré

Gran Capità, 10

08970 Sant Joan Despí (Barcelona)

This leaflet was approved in January 2016

http://www.aemps.gob.es/

Detailed and updated information on this medication is available on the

website of the Spanish Agency of Medicines and Medical Devices (AEMPS)