Package Insert: Information for the Patient

Normosept 10 mg/ml Topical Solution

Chlorhexidine Digluconate

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

Follow exactly the administration instructions for the medication contained in this package insert or those indicated by your doctor, pharmacist, or nurse.

• Keep this package insert, as you may need to refer to it again.

• For advice on use or for more information, consult your pharmacist.
• Consult your doctor or pharmacist if you experience any adverse effects, even if they are not listed in this package insert. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 5 days.

1. What is Normosept and what it is used for

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

3. How to use Normosept

4. Possible adverse effects

5. Storage of Normosept

6. Contents of the pack and additional information

It is a topical medication that contains chlorhexidine as the active ingredient. Chlorhexidine is an antiseptic applied to the skin.

It is indicated as a wound and minor skin burn antiseptic and as umbilical cord antiseptic in newborns.

If symptoms worsen after 5 days, consult your doctor.

No use Normosept:

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

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

Warnings and precautions

Consult your doctor or pharmacist before starting to use Normosept.

- This medication is exclusively for external use on the skin. 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 injury. 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) have been reported, which could require a corneal transplant when similar products have accidentally entered contact with the eyes during surgical interventions, in patients under general anesthesia (deep, painless sleep).

- Do not use in case of deep and extensive wounds without consulting a doctor.

- Do not apply repeatedly, or use on large surfaces, with occlusive dressing (non-breathable), on injured skin and in mucous membranes.

- Clothing that has been in contact with this medication should not be washed with bleach or other hypochlorites, as a brownish discoloration of the tissues would occur, but with domestic detergents based on sodium perborate.

- Do not use for the asepsis of puncture or injection areas, or for the disinfection of surgical material.

- Use with caution in newborns, especially in premature children. Normosept can cause chemical burns on the skin.

- Consult with the doctor before using in children under 30 months.

Use of Normosept with other medications

• Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.
• Avoid the use of multiple antiseptics at the same time or in succession, except with other cationic compounds.
• Do not use in combination or after the application of anionic soaps (soaps), acids, heavy metal salts, and iodine, so the skin should be thoroughly rinsed after cleaning.

Pregnancy and breastfeeding

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

Driving and operating machines

The influence of Normosept on the ability to drive and operate machines is negligible or insignificant.

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

Use without dilution.

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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

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

Allergic reactions in the skin may occur.

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

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

If you consider any of the adverse effects you are experiencing to be severe or if you notice any adverse effects not mentioned in this prospectus, inform your doctor or pharmacist.

Reporting 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 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.

Store in the original packaging protected from light.

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

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Normosept

• The active principle 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 content of the container

Normosept is a transparent and colorless solution.

It is presented in a polyethylene bottle containing 30 ml.

Holder of the marketing authorization and responsible for manufacturing

LABORATORIOS NORMON, S.A.

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

Date of the last review of this leaflet:June 2024

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