Oximen 3% cutaneous solution and concentrate for oral solution

Patient Information Leaflet

Introduction

Patient Information Leaflet

Oximen 3% cutaneous solution and oral solution concentrate

Hydrogen peroxide

Read this entire leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet as you may need to read it again. If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if these adverse effects are not listed in this leaflet. See section 4. >
• If symptoms worsen or persist after 5 days, you should consult your doctor.

1. What Oximen 3% is and what it is used for

Hydrogen peroxide is an antiseptic. It is indicated for superficial skin wounds and mouth rinses following dental extractions, in adults and children over 12 years of age.

You should consult a doctor if symptoms worsen or do not improve after 5 days.

2. What you need to know before starting Oximen 3%

Do not use Oximen 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 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 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 (e.g., "hairy tongue") may occur; see section 4.

Use of Oximen 3% with other medicines

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicine.

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 use machines is none or negligible.

3. How to use Oximen 3%

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 for superficial skin wounds and orally for mouth rinses after 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 should not be used for 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

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 the supervision of an adult.

If you use more Oximen 3% than you should

Accidental ingestion may cause sore throat, gastric disturbances, and vomiting.

Progressive accumulation of oxygen in the body may cause acute gastric distension lesions and internal bleeding.

Ingestion of large volumes 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. 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.

Concentrated hydrogen peroxide solutions cause irritating burns to the skin and mucous membranes, resulting in 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 Pharmacovigilance System for Human Medicines: www.notificaram.es By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Oximen 3%

Keep this medicine out of sight and reach of children.

Special storage conditions are not required.

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

6. Contents of the container and other information

Composition of Oximen 3%

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 g of hydrogen peroxide.

The other components (excipients) are: phosphoric acid.

Appearance of the medicine and contents of the container

Clear, colourless solution.

It is presented in a high-density polyethylene bottle with a sealed cap and dropper, containing 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 in July/2016

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