NORMOSEPT 10 MG/ML CUTANEOUS SOLUTION

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Normosept 10 mg/ml cutaneous solution

chlorhexidine digluconate

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

Follow exactly the instructions for administration of 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 adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

• You should consult a doctor if you worsen or do not improve after 5 days.

Leaflet contents:

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 adverse effects
5. Storage of Normosept
6. Contents of the pack and other information

1. What Normosept is and what it is used for

It is a topical medication containing chlorhexidine as the active substance. Chlorhexidine is an antiseptic applied to the skin.

It is indicated as an antiseptic for minor wounds and burns of the skin, and as an antiseptic for the umbilicus 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 to any of the other components of this medicine (listed in section 6).

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

Warnings and precautions

Consult your doctor or pharmacist before starting to use Normosept.

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

• In case of accidental contact with ears, rinse immediately with plenty of water.

• Normosept must not come into contact with the eyes due to the risk of visual injury. If contact occurs, wash immediately and thoroughly with abundant water. In cases of eye irritation, redness, pain, or visual disturbances, consult a doctor immediately.

Severe cases of persistent corneal injury (damage to the surface of the eye) have been reported, which could eventually require a corneal transplant, when similar products have accidentally come into contact with the eyes during surgical procedures in patients under general anesthesia (induced painless deep sleep).

• Do not use in case of deep or extensive wounds without consulting a doctor.
• Must not be applied repeatedly or used over large areas, under occlusive dressings (non-breathable), on damaged skin, or on mucous membranes.
• Clothing that has been in contact with this medicine should not be washed with bleach or other hypochlorites, as this may cause a brownish discoloration of fabrics. Instead, wash with domestic detergents based on sodium perborate.
• Should not be used for antisepsis of puncture or injection sites, nor for disinfection of surgical instruments.
• Use with caution in neonates, especially in premature infants. Normosept may cause chemical burns on the skin.
• Consult your doctor before use in children under 30 months of age.

Use of Normosept with other medicines

• Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
• The simultaneous or sequential use of multiple antiseptics should be avoided, except with other cationic compounds.
• Must not be used in combination with, or after application of, anionic soaps (soaps), acids, heavy metal salts, or iodine. The skin should therefore be thoroughly rinsed after cleansing.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

The effect of Normosept on the ability to drive and operate machinery is none or negligible.

3. How to use Normosept

Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Use undiluted.

It is recommended to clean and dry the wound before applying Normosept. Apply to the affected area, or onto a gauze dressing, once or twice daily. Do not apply the product more than twice a day.

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 at telephone number: 91 562 04 20, indicating the medication and the amount ingested.

4. Possible adverse effects

Like all medicines, Normosept may cause adverse effects, although not everyone experiences them.

Allergic skin reactions may occur.

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

• Corneal injury (damage to the surface of the eye) and permanent eye damage, including permanent visual impairment (following accidental ocular exposure during surgical procedures on the head, face, and neck) in patients under general anesthesia (induced painless deep sleep).

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through 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 Normosept

Keep this medicine out of sight and reach of children.

Store in the original packaging, protected from light.

Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of the month indicated.

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

6. Contents of the pack and other information

Composition of Normosept

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

Nature of the product and pack contents

Normosept is a clear, colorless solution.

It is supplied in a polyethylene bottle containing 30 ml.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.
Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (Spain)

Date of the most recent revision of this leaflet: June 2024

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