NORMOSEPT 10 mg/ml CUTANEOUS SPRAY SOLUTION

Introduction

Package Leaflet: Information for the Patient

Normosept 10 mg/ml Cutaneous Spray Solution

chlorhexidine digluconate

Read the entire package leaflet carefullybefore starting to use thismedication, as it contains important informationfor you.

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

• Keep this package 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 side effects not listed in this package leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after 2 days.

Package Leaflet Contents

1. What Normosept is and what it is used for
2. What you need to know before starting to use Normosept
3. How to use Normosept
4. Possible side effects
5. Storage of Normosept
6. Package Contents and Additional Information

1. What Normosept is and what it is used for

Normosept is a cutaneous antiseptic whose active ingredient is chlorhexidine digluconate. Chlorhexidine is an antiseptic applied to the skin.

Normosept is indicated as an antiseptic for small superficial wounds such as minor burns, scratches, cuts, and abrasions in adults, adolescents, children, and babies from 2 months of age or older.

2. What you need to know before starting to use Normosept

Do not use Normosept:

• If you are allergic (hypersensitive) to chlorhexidine digluconate or any of the other components of this medication (listed in section 6).
• In the ears, especially if the eardrum is damaged.

Warnings and Precautions

Consult your doctor or pharmacist before starting to use Normosept.

• This medication is for external use on the skin only. Do not ingest.
• Do not spray on the eyes, ears, or inside the mouth or other mucous membranes. In case of accidental contact with eyes or ears, rinse immediately with plenty of water.
• Avoid contact with the brain, meninges (membranes surrounding the brain and spinal cord), and middle ear.
• Normosept should not come into contact with the eyes due to the risk of visual damage. If it comes into contact with the eyes, wash immediately and abundantly with water. In cases of irritation, redness, or pain in the eyes, or visual disturbances, consult a doctor immediately.
• Severe cases of persistent corneal injury (injury to the surface of the eye) that may require a corneal transplant have been reported when similar products have accidentally come into contact with the eyes during surgical interventions, in patients under general anesthesia (induced deep sleep).
• It should not be used in the case of deep and extensive wounds without consulting a doctor.
• It should not be applied repeatedly, nor used on large surfaces, with occlusive dressing (non-permeable), on damaged skin, and on mucous membranes.
• It should not be used for the asepsis of puncture or injection areas, nor for the disinfection of surgical equipment.
• Do not use excessive amounts, and do not allow the solution to accumulate in skin folds or under the patient or drip onto sheets or other materials in direct contact with the patient.

Children

• Consult with your doctor before using in children under 30 months. The use in children from 2 months to under 30 months will be done exclusively under medical supervision for safety reasons.
• Chlorhexidine should not be used in children under 2 months of age for safety reasons.

Using Normosept withother medications

• Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.
• The use of several antiseptics at the same time or successively should be avoided.

• It should not be used in combination or after the application of anionic soaps, acids, heavy metal salts, and iodine. If the wound is cleaned with any of these products, the skin should be rinsed well after cleaning.

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.

There are no known risks associated with the use of Normosept during pregnancy or breastfeeding. It is unknown whether chlorhexidine digluconate or any of its metabolites are excreted in breast milk. No effects are expected during pregnancy, in newborns, or in breastfed infants, as systemic exposure to chlorhexidine is negligible. Normosept can be used during pregnancy or breastfeeding. Breastfeeding women should avoid using it on their breasts.

Driving and Using Machines

The influence of this medication on the ability to drive and use machines is nil or insignificant.

3. How to Use Normosept

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

This medication should be used on your skin.

The recommended dose is the amount of product sufficient to cover the entire surface of the wound 1 or 2 times a day, until the first signs of healing appear.

The duration of treatment depends on the type and course of the wound, and according to experience, it is approximately 1 to 2 weeks.

You should consult a doctor if the wound worsens or does not improve within 2 days after treatment.

The spray is ready for use. It is recommended to clean and dry the wound before applying this medication. Spray Normosept directly onto the affected area, at a distance of approximately 10 cm from your skin. You can also spray the medication onto a gauze and clean the damaged skin area. After application, let it act and dry.

Once the medication is applied, the antimicrobial effect is achieved in 1 minute.

If you use more Normosept than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

4. Possible Side Effects

Like all medications, Normosept can cause side effects, although not everyone will experience them.

Stop using Normosept and inform your doctor immediately if you have a severe allergic reaction. The frequency of this side effect is unknown (cannot be estimated from available data). If you notice any of the following, contact your doctor immediately:

• Sudden wheezing or difficulty breathing.
• Fainting.
• Swelling of the face.
• Swelling of the mouth, tongue, or throat that may be red and painful and/or cause difficulty swallowing.
• Chest pain.
• Red spots on the skin.

These may be signs of an allergic reaction.

Other possible side effects, for which the frequency is unknown:

Unknown frequency:

• Chemical burns in neonates.
• Skin allergic disorders such as dermatitis (skin inflammation), pruritus (itching), erythema (skin redness), eczema, rash, urticaria (hives), skin irritation, and blisters.
• Corneal injury (injury to the surface of the eye) and permanent eye injury, including permanent visual impairment (after accidental eye exposure during surgical interventions in the head, face, and neck) in patients under general anesthesia (induced deep sleep).

Reporting Side Effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this package 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. Storage of Normosept

Keep this medication out of sight and reach of children.

No special storage conditions are required.

Do not use this medication after the expiration date shown on the box after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need 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 Normosept

• The active ingredient is chlorhexidine digluconate. Each ml contains 10 mg of chlorhexidine digluconate.
• The other components (excipients) are: nonoxinol 9, isopropyl alcohol, and purified water.

Appearance of the Product and Package Contents

Normosept is a clear and colorless solution.

It is presented in a polyethylene terephthalate (PET) bottle, equipped with a spray valve, containing 25 ml.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (Spain)

Date of the Last Revision of this Package Leaflet:August 2025

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