HYDROGEN PEROXIDE CUVE 30 mg/ml CUTANEOUS SOLUTION AND CONCENTRATE FOR ORAL SOLUTION

Introduction

Leaflet:information for the user

Hydrogen Peroxide CUVE 30 mg/ml cutaneous solution and concentrate for oral solution

Hydrogen peroxide

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

Follow the administration instructions for the medication contained in this leaflet or as indicated by your doctor or pharmacist exactly.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after 5 days.

Contents of the leaflet

1. What is Hydrogen Peroxide CUVE and what is it used for
2. What you need to know before starting to use Hydrogen Peroxide CUVE
3. How to use Hydrogen Peroxide CUVE
4. Possible side effects

5 Conservation of Hydrogen Peroxide CUVE

1. Package contents and additional information

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

Hydrogen peroxide is an antiseptic. It is indicated for:

• Superficial skin wounds in adults, adolescents, and children 2 years of age and older.
• Mouthwashes after dental extractions, in adults and adolescents (12 to less than 18 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 starting to use Hydrogen Peroxide CUVE

Do not use Hydrogen Peroxide CUVE

• If you are allergic to hydrogen peroxide or any of the other components of this medication (listed in section 6).
• In closed body cavities or deep surgical wounds.

Warnings and precautions

-For external use only. Do not ingest.

-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 rinses can cause irritation of the oral mucosa (hairy tongue), see section 4.

Children and adolescents

Do not administer this medication as a disinfectant for superficial skin wounds in children under 2 years of age.

Do not administer this medication as a mouthwash in children under 12 years of age.

In children 12 years of age and older, Hydrogen Peroxide CUVE as a mouthwash should be used under adult supervision due to the risk of accidental ingestion.

Other medications and Hydrogen Peroxide CUVE

Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other 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 CUVE

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

Adults,adolescents, and children 2 years of age and older

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

Adults and adolescents

-For mouthwashes after dental extractions, in adults and adolescents, dilute with an equal 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 gingival wounds (see section 2).

It should be used for a maximum of 5 days

In adolescents, it should be used under adult supervision due to the risk of accidental ingestion.

If you use more Hydrogen Peroxide CUVE 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.

Ingestion of large volumes can cause a gas embolism.

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 in deep surgical wounds.

Hydrogen peroxide in concentrated solutions causes irritating burns on the skin and mucous membranes, producing a white scab (eschar). 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 leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: www.notificaram.es By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Hydrogen Peroxide CUVE

Keep this medication out of sight and reach of children.

No special storage conditions are required

Do not use Hydrogen Peroxide CUVE after the expiration date shown on the packaging, after CAD.

Medications should not be thrown away in drains or trash. Deposit the packaging and unused medications at the SIGRE point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Hydrogen Peroxide CUVE 30 mg/ml

• The active ingredient is hydrogen peroxide. Each 100 ml of solution contains 3 g of hydrogen peroxide.
• The other components are: concentrated phosphoric acid, phenacetin, 96º ethanol (c.s.p. to solubilize phenacetin), sequion (sodium salt of DTPMP), and purified water.

Appearance of the product and package contents

Clear and colorless solution.

It is presented in a polyethylene bottle with a cap and seal that contains 250 ml, 500 ml, or 1000 ml of solution.

Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

PHARMEX ADVANCED LABORATORIES, S.L.

Ctra. A-431 Km. 19

14720 Almodóvar del Río (Córdoba)

Spain

Date of the last revision of this leaflet:

April 2018

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