Hydrogen peroxide Foret 3% cutaneous solution and oral concentrate solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Agua oxigenada Foret 3% cutaneous solution and oral concentrate solution

Hydrogen peroxide

Read all of this leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or 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.

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

1. What is Foret hydrogen peroxide and what is it used for

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 of age.

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

2. What you need to know before starting to use Foret hydrogen peroxide

Do not use Foret hydrogen peroxide

• 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 gingival injuries

Children and adolescents

DO NOT use as a mouthwash in children under 12 years of age. In adolescents aged 12 to 18 years, administration should be supervised by an adult.

Warnings and precautions

• For external use only. DO NOT SWALLOW.
• Avoid contact with the eyes. If accidental contact with the eyes occurs, rinse thoroughly with water and consult an ophthalmologist if necessary.
• In some cases, especially with repeated use in oral rinses, irritation of the oral mucosa (hairy tongue) may occur, see section 4.

Use of Foret hydrogen peroxide with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

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.

Driving and using machines

The effect of this medicine on the ability to drive or operate machinery is none or negligible.

3. How to use Foret hydrogen peroxide

Follow exactly the administration instructions for this medicine as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

This medicine is administered cutaneously in the case of superficial skin wounds and orally for mouth rinses following dental extractions.

Dosage

• For superficial skin wounds, apply directly to the wound or using cotton wool or gauze.

• For oral rinses after dental extractions, in adults and adolescents over 12 years of age, dilute with an equal amount of water. Rinse the mouth for 1 minute. This may be repeated up to a maximum of 4 times a day. It must not be used in the case of gingival wounds (see section 2).

It should be used for a maximum of 5 days.

Children and adolescents – for oral rinses after dental extractions:

It must not be administered to children under 12 years of age.

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

If you use more Foret hydrogen peroxide than you should

Accidental ingestion may cause sore throat, gastric disturbances, and vomiting. The progressive release of oxygen in the body may cause acute gastric distension and internal haemorrhage due to tissue damage.

Ingestion of large volumes may lead to 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 centre or call the Toxicology Information Service. Telephone: (91) 562 04 20, indicating the product and the amount ingested.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

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

Hydrogen peroxide in concentrated solutions causes irritating burns to the skin and mucous membranes, producing a white eschar (scab). Pain usually disappears after approximately 1 hour.

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

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 System for Pharmacovigilance of Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Foret hydrogen peroxide

Keep this medicine out of sight and reach of children.

Store at room temperature.

Medicines must not be disposed of via wastewater or in household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you are in doubt, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the container and additional information

Composition of Foret hydrogen peroxide

The active substance 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 container

Colourless, transparent solution.

It is supplied in a high-density polyethylene bottle with a tamper-evident cap and dropper, containing 250 ml, 500 ml or 1000 ml of solution.

Not all pack sizes may be marketed.

Marketing Authorization Holder

PEROXFARMA, S.A.
Provenza Street 328
08037 Barcelona

Manufacturer

Reig Jofré Laboratories
Gran Capità, 10
08970 Sant Joan Despí (Barcelona)

This patient information leaflet was approved in January 2016

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

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS)