Label: information for the user

Oximen 3% topical 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 read it again.
  If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• 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 persistafter 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 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 injuries

Children and adolescents

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

Warnings and precautions

- Forexternal 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, mouthwashes may cause irritation of the oral mucosa (tongue "velvety" appearance), seesection 4.

Use ofOximen 3%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 as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

This medication is administered bytopical routein the case of superficial skin wounds and byoral routein the case of mouth rinses after dental extractions

Dosage

-Insuperficial skin wounds, apply directly to the wound or using a cotton ball or gauze

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

Swish the mouth around 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 gingival wounds (see section 2).

It should be used for a maximum of 5 days.

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

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

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

If you use moreOximen 3%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

Toxicology Information Service. Phone: (91) 562 04 20 indicating the productand the amount ingested.

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

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

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

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 for Pharmacovigilance of Medicinal Products for Human Use:www.notificaram.esReporting adverse effects can help provide more information about the safety of this medication.

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

No special storage conditions are required.

Do not dispose of medications through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition ofOximen 3%

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 g 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.

Holder of the marketing authorization and Responsible for the manufacture

Holder of the marketing authorization

Laboratorio Reig Jofré, S.A.

C/ Gran Capitán, 10

08970 Sant Joan Despí (Barcelona)

Spain

Responsible for the manufacture

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 has been approved inJuly/2016

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/