AGUA OXIGENADA FORET 3% cutaneous solution and concentrate for oral solution

Introduction

Package Leaflet: Information for the User

Hydrogen Peroxide Foret 3%cutaneous solution and concentrate for oral solution

Hydrogen Peroxide

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

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

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

1. What is Hydrogen Peroxide Foret and what is it used for

Hydrogen peroxide is an antiseptic. It is indicated for superficial skin wounds and mouthwashes 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.

2. What you need to know before using Hydrogen Peroxide Foret

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 wounds

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 adult supervision.

Warnings and Precautions

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

It can produce irritation of the oral mucosa (hairy tongue), see section 4.

Using Hydrogen Peroxide Foret with other medications

Tell your doctor or pharmacist if you are using, have recently used, or may need to use another medication.

Pregnancy and Breastfeeding

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

Driving and Using Machines

The influence of this medication on the ability to drive or use machines is nil or insignificant.

3. How to use Hydrogen Peroxide Foret

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

This medication is administered topically in the case of superficial skin wounds and orally in the case of mouthwashes after dental extractions.

Dosage

- In superficial skin wounds, apply directly to the wound or using a cotton swab or gauze

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

Rinse the mouth for 1 minute. It can be repeated up to a maximum of 4 times a day. It should not be used in the case of gum wounds (see section 2).

It should be used for a maximum of 5 days.

Children and Adolescents, in the case of mouthwashes after dental extractions

It should not be administered to children under 12 years old.

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

If you use more Hydrogen Peroxide Foret than you should

Accidental ingestion can cause throat pain, gastric disorders, and vomiting. The progressive advance of oxygen through the body can cause lesions due to acute stomach distension and internal bleeding.

The ingestion of large volumes can cause a gas embolism.

Information for the healthcare professional:

Treatment: administer plenty of water to dilute the substance; symptomatic treatment is required.

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

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

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

Hydrogen peroxide in concentrated solutions produces irritating burns on the skin and mucous membranes, producing a white eschar (scab). The pain disappears after about 1 hour.

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

Reporting Side Effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this package leaflet.

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

5. Storage of Hydrogen Peroxide Foret

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

Store at room temperature.

Medications should not be disposed of through wastewater or household waste. Deposit the containers and medications you no longer need at the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Hydrogen Peroxide Foret

The active ingredient 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 Package Contents

Transparent and colorless solution.

It comes 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 package sizes may be marketed.

Marketing Authorization Holder

PEROXFARMA, S.A.

Provenza Street, 328

08037 Barcelona

Manufacturer

Laboratorios Reig Jofré

Gran Capità, 10

08970 Sant Joan Despí (Barcelona)

This package 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 for Medicines and Health Products (AEMPS).