Prospecto:Information for the User

Hydrogen Peroxide CUVE 30 mg/ml Skin Solution and Concentrate for Oral Solution

Hydrogen Peroxide

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

Follow exactly the medication administration instructions contained in this prospectus or those indicated by your doctor or pharmacist.

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

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

2.What you need to know before starting to use Hydrogen Peroxide CUVE

3.How to use Hydrogen Peroxide CUVE

4.Possible adverse effects

5Storage of Hydrogen Peroxide CUVE

6.Contents of the package and additional information

Hydrogen peroxide is an antiseptic. It is indicated for :

• Superficial skin wounds inadults, adolescents, andchildren aged 2 yearsandolder.
• Mouthwashes after dental extractions, in adults and adolescents (12 years of age and under 18 years of age).

Consult a doctor if it worsens or does not improve after 5 days.

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, wash abundantly with water and consult an ophthalmologist if necessary.

-In some cases, especially with repeated use, mouthwash may cause irritation of the oral mucosa (tongue "velvety" appearance), see section 4.

Children and adolescents

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

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

For 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 used recently, or may need to use any other 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 machinery

The influence of this medication on the ability to drive or operate machinery 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

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

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

Adults and adolescents

-Inmouth rinses after dental extractions, in adults and adolescents, dilute with the same amount of water.

Rinse your mouth for 1 minute. You can repeat up to a maximum of 4 times a day. Do not use 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 the supervision of an adultdue to the risk of accidental ingestion.

If you use more Hydrogen Peroxide CUVE 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 bleeding.

Large volume ingestion may cause gas embolism.

Incaseofoverdoseoraccidental ingestion,seekmedical attentionorcallthe Toxicological Information Service. Phone: (91) 562 04 20 indicating the product and the amount ingested.

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

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

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

Continued 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.es By reporting adverse effects, you can contribute to providing 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 use Hydrogen Peroxide CUVE after the expiration date shown on the packaging, after CAD.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at theSIGREcollection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment

Composition of Hydrogen Peroxide CUVE 30 mg/ml

• The active ingredient is hydrogen peroxide. Each 100 ml of solution contains3 gof hydrogen peroxide.
• The other components are:concentrated phosphoric acid, phenacetin, 96º (c.s.p.) ethanol to dissolve phenacetin, sequestrant (sodium salt of DTPMP) and purified water.

Appearance of the product and contents of the packaging

Transparent and colorless solution.

It is presented in a polyethylene bottlepresentedin polyethylene bottles and stopper withplug 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 manufacturing

PHARMEX ADVANCED LABORATORIES, S.L.

Ctra. A-431 Km. 19

14720 Almodóvar del Río (Córdoba)

Spain

Last review date of this leaflet:

April 2018

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