Normosept 10 mg/ml solution for cutaneous spray
Spain
Table of Contents
Patient Information Leaflet
Introduction
Package leaflet: Information for the patient
Normosept 10 mg/ml cutaneous spray 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 use provided in this leaflet or those given by your doctor, pharmacist, or nurse.
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Keep this leaflet, as you may need to read it again.
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If you need advice or further information, consult your pharmacist.
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If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
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You should consult a doctor if your condition worsens or if you do not improve after 2 days.
Contents of the leaflet
- What Normosept is and what it is used for
- What you need to know before using Normosept
- How to use Normosept
- Possible adverse effects
- How to store Normosept
- Contents of the pack and other information
1. What Normosept is and what it is used for
Normosept is a cutaneous antiseptic whose active substance is chlorhexidine digluconate. Chlorhexidine is an antiseptic applied to the skin.
Normosept is indicated as an antiseptic for minor superficial wounds such as mild burns, scratches, cuts, and abrasions in adults, adolescents, children, and babies from 2 months of age and older.
2. What you need to know before using Normosept
Do not use Normosept:
- If you are allergic (hypersensitive) to chlorhexidine digluconate or to any of the other ingredients of this medicine (listed in section 6).
- In the ears, especially if the eardrum is damaged.
Warnings and precautions
Consult your doctor or pharmacist before using Normosept.
- This medicine is for external use on the skin only. Do not ingest.
- Do not spray near the eyes, ears, inside the mouth, or on other mucous membranes. In case of accidental contact with eyes or ears, rinse immediately with plenty of water.
- Avoid contact with the brain, meninges (the membranes surrounding the brain and spinal cord), and the middle ear.
- Normosept must not come into contact with the eyes due to the risk of visual injury. If contact occurs, rinse immediately and thoroughly with water. In case of eye irritation, redness, pain, or visual disturbances, consult a doctor immediately.
- Serious cases of persistent corneal injury (damage to the surface of the eye) have been reported, which may even require corneal transplantation, when similar products have accidentally come into contact with the eyes during surgical procedures in patients under general anesthesia (induced painless deep sleep).
- Should not be used for deep or extensive wounds without consulting a doctor.
- Should not be applied repeatedly, nor used over large skin areas, under occlusive dressings (non-breathable), on damaged skin, or on mucous membranes.
- Must not be used for antisepsis of puncture or injection sites, nor for disinfection of surgical instruments.
- Do not use excessive amounts and do not allow the solution to accumulate in skin folds, under the patient, or drip onto sheets or other materials in direct contact with the patient.
Children
- Consult a doctor before use in children under 30 months of age. Use in children from 2 months up to under 30 months should be performed exclusively under medical supervision for safety reasons.
- Chlorhexidine should not be used in children under 2 months of age for safety reasons.
Use of Normosept with other medicines
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Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.
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The simultaneous or consecutive use of multiple antiseptics should be avoided.
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Must not be used in combination with, or after application of, anionic soaps, acids, heavy metal salts, or iodine. If the wound is cleaned with any of these products, the skin should be thoroughly rinsed after cleaning.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
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 or in newborns or breastfed infants, as systemic exposure to chlorhexidine is negligible. Normosept may be used during pregnancy or breastfeeding. Breastfeeding women should avoid using it on the breasts.
Driving and using machines
The effect of this medicine on the ability to drive and use machines 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, ask your doctor or pharmacist.
This medicine is for topical use on your skin.
The recommended dose is a sufficient amount of product to cover the entire wound surface, applied 1 or 2 times daily, until the first signs of healing appear.
The duration of treatment depends on the type and progression of the wound; experience indicates it is approximately 1 to 2 weeks.
Consult your doctor if the wound worsens or does not improve within 2 days of starting treatment.
The spray is ready to use. It is recommended to clean and dry the wound before applying this medicine. Spray Normosept directly onto the affected area from a distance of approximately 10 cm from your skin. Alternatively, you may spray the medicine onto a gauze pad and use it to clean the damaged skin area. After application, allow it to act and dry.
After application, antimicrobial effect is achieved within 1 minute.
If you use more Normosept than you should
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number: 91 562 04 20, stating the medicine and the amount ingested.
4. Possible adverse effects
Like all medicines, Normosept may cause adverse effects, although not everyone experiences them.
Stop using Normosept and contact your doctor immediately if you experience a severe allergic reaction. The frequency of this adverse 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, which may appear 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 adverse effects, for which frequency is unknown:
Frequency not known:
- Chemical burns in neonates.
- Allergic skin disorders such as dermatitis (inflammation of the skin), pruritus (itching), erythema (redness of the skin), eczema, rash, urticaria (hives), skin irritation, and blisters.
- Corneal injury (damage to the surface of the eye) and permanent eye injury, 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).
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 via the Spanish Pharmacovigilance System for Human Medicines: 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 the sight and reach of children.
No special storage conditions are required.
Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date is the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. 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: nonoxynol 9, isopropyl alcohol and purified water.
Appearance of the product and contents of the container
Normosept is a clear, colourless solution.
It is supplied in a polyethylene terephthalate (PET) bottle fitted with a spray pump, containing 25 ml.
Marketing Authorization Holder and Manufacturer
LABORATORIOS NORMON, S.A.
Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (Spain)
Date of the latest review of this leaflet: August 2025
Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/