OXIMEN 3% CUTANEOUS SOLUTION AND CONCENTRATE FOR ORAL SOLUTION

Introduction

Package Leaflet: Information for the User

Oximen 3% skin solution and concentrate for oral 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, you may need to read it again. If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
• If your symptoms worsen or persist after 5 days, you should consult your doctor.

1. What is Oximen 3% 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 of age.

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

2. What you need to know before you start using Oximen 3%

Do not useOximen 3%

• 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 of age. In adolescents, from 12 to 18 years, it should be administered under the supervision of an adult.

Warnings and precautions

• For external use only. 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, oral rinses can cause irritation of the oral mucosa (hairy tongue), see section 4.

UsingOximen 3%with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

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 medicine.

Driving and using machines

The influence of this medicine on the ability to drive or use machines is negligible or nonexistent.

3. How to use Oximen 3%

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

This medicine 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, 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.

Do not use 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

Do not administer in children under 12 years of age.

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

If you use moreOximen 3%than you should

Accidental ingestion may 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 hemorrhage.

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. Telephone: (91) 562 04 20 indicating the product and the amount ingested.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

There have been reports of gas embolism, sometimes causing cardiac arrest, when hydrogen peroxide has been applied near closed body cavities or in 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 of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet.

You can also report them directly through the Spanish Medicines and Health Products Agency (AEMPS) website: www.notificaram.es By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Oximen 3%

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

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition ofOximen 3%

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 g of hydrogen peroxide

The other components (excipients) are: phosphoric acid.

Appearance of the product and pack contents

Clear 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 pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorio Reig Jofré, S.A.

C/ Gran Capitán, 10

08970 Sant Joan Despí (Barcelona)

Spain

Manufacturer

Pharmex Advanced Laboratories, SL

Ctra. A-431 Km. 19

Almodóvar del Río, 14720 – Córdoba

Spain

or

Laboratorio Reig Jofré, S.A.

C/ Gran Capitán, 10

08970 Sant Joan Despí (Barcelona)

Spain

This leaflet was approved inJuly/2016

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/