NORMOSEPT 10 mg/ml CUTANEOUS SOLUTION

Introduction

Patient Information Leaflet

Normosept 10 mg/ml cutaneous solution

chlorhexidine digluconate

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

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

• 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 Normosept is and what it is used for
2. What you need to know before using 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

It is a medicine for cutaneous use that contains chlorhexidine as the active ingredient. Chlorhexidine is an antiseptic applied to the skin.

It is indicated as an antiseptic for wounds and minor burns on the skin and as an antiseptic for the navel in newborns.

If symptoms worsen after 5 days, consult your doctor.

2. What you need to know before using Normosept

Do not use Normosept:

• If you are allergic (hypersensitive) to chlorhexidine or any of the other components of this medicine (listed in section 6).

Do not use in eyes or ears, or inside the mouth or other mucous membranes.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Normosept.

• This medicine is for external use on the skin only. Do not ingest.

• In case of accidental contact with ears, wash immediately with plenty of water.
• 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 (deep sleep induced without pain).

• Do not use in case of deep and extensive wounds without consulting a doctor.
• Do not apply repeatedly, nor use on large surfaces, with occlusive dressing (non-permeable), on damaged skin, and on mucous membranes.
• Clothes that have come into contact with this medicine should not be washed with bleach or other hypochlorites, as a brownish discoloration may occur on the tissues, but with domestic detergents based on sodium perborate.
• Do not use for asepsis of puncture or injection areas, nor for disinfection of surgical equipment.
• Use with caution in neonates, especially in premature babies. Normosept can cause chemical burns on the skin.
• Consult your doctor before using in children under 30 months.

Using Normosept with other medicines

• Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medicine.
• The use of several antiseptics at the same time or successively should be avoided, except with other cationic compounds.
• Do not use in combination or after applying anionic soaps (soaps), acids, heavy metal salts, and iodine, so 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 medicine.

Driving and using machines

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

3. How to use Normosept

Follow the administration instructions for the medicine contained in this leaflet or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

Use undiluted.

It is recommended to clean and dry the wound before applying Normosept. Apply to the affected area, or on a gauze, one or two times a day. Do not perform more than two daily applications of the product.

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 medicine and the amount ingested.

4. Possible side effects

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

Skin allergic reactions may occur.

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

• 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 (deep sleep induced without pain).

If you think any of the side effects you are experiencing is serious, or if you notice any side effects not mentioned in this leaflet, inform your doctor or pharmacist.

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 leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Normosept

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

Store in the original packaging, protected from light.

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

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines in the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. 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 30 ml polyethylene bottle.

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 leaflet:June 2024

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