Agua oxigenada Cuve 30 mg/ml cutaneous solution and concentrate for oral solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

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

Hydrogen peroxide

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

Follow exactly the instructions for use provided in this leaflet or as directed by your doctor or pharmacist.

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

Contents of the leaflet

1. What Hydrogen peroxide CUVE is and what it is used for
2. What you need to know before using Hydrogen peroxide CUVE
3. How to use Hydrogen peroxide CUVE
4. Possible side effects
5. How to store Hydrogen peroxide CUVE
6. Contents of the pack and other information

1. What Agua Oxigenada CUVE is and what it is used for

Hydrogen peroxide is an antiseptic. It is indicated for:

• Superficial skin wounds in adults, adolescents, and children aged 2 years and older.
• Mouth rinses following dental extractions in adults and adolescents (aged 12 to less than 18 years).

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

2. What you need to know before using Agua oxigenada CUVE

Do not use Agua oxigenada CUVE

• If you are allergic to hydrogen peroxide or to any of the other ingredients of this medicine (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 occurs, rinse thoroughly with water and consult an ophthalmologist if necessary.

• In some cases, especially with repeated use, oral rinses may cause irritation of the oral mucosa (hairy tongue), see section 4.

Children and adolescents

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

Do not administer this medicine as a mouth rinse in children under 12 years of age.

In children aged 12 years and older, Agua oxigenada CUVE used as a mouth rinse should be supervised by an adult due to the risk of accidental ingestion.

Other medicines and Agua oxigenada CUVE

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might 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 operate machinery is none or negligible.

3. How to use Agua oxigenada CUVE

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 in the case of superficial skin wounds and orally for mouth rinses after dental extractions.

Posology

Adults, adolescents, and children aged 2 years and older

• For superficial skin wounds, apply directly to the wound or using cotton wool or gauze.

Adults and adolescents

• For mouth rinses after dental extractions, in adults and adolescents, 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 in the case of gingival wounds (see section 2).

It should be used for a maximum of 5 days.

In adolescents, use must be supervised by an adult due to the risk of accidental ingestion.

If you use more Agua oxigenada CUVE than you should

Accidental ingestion may cause sore throat, gastric disturbances, and vomiting. Progressive oxygen release in the body may lead to acute gastric distension and internal bleeding.

Ingestion of large volumes may cause gas embolism.

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 one 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 via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaram.es By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Hydrogen Peroxide CUVE

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

No special storage conditions are required.

Do not use Hydrogen Peroxide CUVE after the expiry date stated on the container, after EXP.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the package and other information

Composition of Agua oxigenada CUVE 30 mg/ml

• The active substance is hydrogen peroxide. Each 100 ml of solution contains 3 g of hydrogen peroxide.
• The other components are: concentrated phosphoric acid, phenacetin, 96º ethyl alcohol (q.s. to dissolve phenacetin), sequion (sodium salt of DTPMP), and purified water.

Appearance of the product and contents of the container

Clear, colourless solution.

It is presented in polyethylene bottles with a tamper-evident cap containing 250 ml, 500 ml or 1000 ml of solution.

Not all container 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 most recent review of this leaflet:

April 2018

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