Septeal Antiseptic Solution

Introducing Septeal Solution for Topical Application

Septeal solution for topical application is an antiseptic. This disinfectant will therefore fight the proliferation of microorganisms.

It is indicated for:

Antisepsis of surgical or traumatic wounds,
Adjunctive treatment of certain skin infections,
Disinfection of healthy skin before medical procedures or minor surgery.

Composition of Septeal Antiseptic Solution

The active ingredient in Septeal is chlorhexidine digluconate, while its excipients are: 95 percent v/v ethyl alcohol, purified water. It should therefore not be used if you are allergic to any of these.

Using Septeal Solution

Septeal should be used neat by rubbing it onto the skin with a compress twice a day. It does not need to be rinsed off. It cannot be used to disinfect equipment or the surgical site and should not be mixed with other antiseptics.

Contraindications for Septeal Disinfectant

The use of Septeal is subject to several contraindications:

Pregnant and breastfeeding women: Its use is not recommended except on medical advice, due to a possible risk of toxicity.
Premature babies and infants: Contraindicated in premature babies and infants under two weeks of age; it should be used with caution in newborns and infants.
Sensitive areas: Do not apply to the eyes, ears, or mucous membranes.
Deep wounds: Do not use on head wounds or deep wounds on the arms or legs, to avoid contact with the brain or nerves.

You can then apply a spray bandage to protect the wound from bacteria and water.

Possible side effects

Local reactions: burning sensation, stinging, dry skin
Allergic reactions: rash, itching, swelling
Rarely: severe allergic reaction or persistent corneal damage (in case of accidental eye exposure).

In case of contact with eyes, rinse immediately and thoroughly with clean water and consult a doctor.

Precautions for use: Pierre Fabre Septeal
The use of Septeal cutaneous solution requires certain precautions to avoid any risk of toxicity or adverse effects:

Presence of alcohol: Keep the bottle away from any open flame or hot surface to avoid any risk of flammability.
Contact with eyes and mucous membranes: Septeal should not come into contact with the eyes or mucous membranes, nor be applied to the inner ears. In case of accidental eye exposure, careful and immediate rinsing is essential to limit the risk of persistent corneal damage. Use in children: Contraindicated in premature babies and infants under 2 weeks of age. Use with caution in newborns and infants due to an increased risk of significant absorption.
Pregnancy and breastfeeding: Use only on medical advice (potential risk of toxicity).
Excessive quantities: Do not apply overly thick diapers or occlusive dressings, which would promote skin absorption and increase the risk of toxicity.
Allergic reactions: Stop treatment immediately if a burning sensation, irritation, or severe allergic reaction occurs.
Combination with other products: Do not mix Septeal with other antiseptic agents (risk of loss of efficacy or adverse reactions).

Practical tip: Note the date the bottle was opened. As with any antiseptic medication, prolonged storage after opening may reduce its effectiveness and increase risks.

Capacity: 250 ml








LEAFLET
ANSM - Updated on: 07/10/2024
Name of the medicinal product
SEPTEAL, solution for topical application
Chlorhexidine digluconate
Box
Please read all of this leaflet carefully before using this medicine because it contains important information for you.
You must always use this medicine exactly as provided in this leaflet or by your pharmacist or nurse.
Keep this leaflet; you may need to read it again.
Ask your pharmacist for advice or information.
If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
You must talk to your doctor if you do not feel better or if you feel worse.
What is in this leaflet? 1. What is SEPTEAL, solution for topical application, and what is it used for?
2. What you need to know before using SEPTEAL, solution for topical application?
3. How to use SEPTEAL, solution for topical application?
4. What are the possible side effects?
5. How to store SEPTEAL, solution for topical application?
6. Contents of the pack and other information.
1. WHAT IS SEPTEAL, solution for topical application, AND WHAT IS IT USED FOR?
Pharmacotherapeutic group: ANTISEPTICS AND DISINFECTANTS – Biguanides and amidines. ATC code: D08AC02.
This medication contains chlorhexidine, which is an antiseptic (it fights the proliferation of microbes).
Antiseptic agents are not sterilizing: they temporarily reduce the number of microorganisms. It is indicated for premature babies, newborns, infants, children, adolescents, and adults for:
· Antisepsis of surgical or traumatic wounds.
· Certain skin conditions, primarily bacterial or susceptible to secondary infection.
· Antisepsis of healthy skin before minor surgery.
You should consult your doctor if you do not feel any improvement or if you feel worse.

2. WHAT YOU NEED TO KNOW BEFORE USING SEPTEAL, solution for topical application?
Never use SEPTEAL, solution for topical application:
· If you are allergic to chlorhexidine or any of the other ingredients of this medicine, listed in section 6. Do not apply to the eyes or ears (in particular, this product should not penetrate the ear canal in case of a perforated eardrum) or come into contact with mucous membranes. Do not apply to head wounds, as this product should not come into contact with the brain.
Do not apply to deep wounds on an arm or leg, as the product should not come into contact with a nerve.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using SEPTEAL.
Special warnings
This medication is for external use only.
It should not be used for surgical site antisepsis or for disinfecting small surgical equipment.
There is a risk of developing an allergy to chlorhexidine: risk of local allergic reactions (chlorhexidine sensitization) or severe generalized allergic reactions (such as difficulty breathing, facial swelling, or severe rash) that may be life-threatening if not immediately medically treated. In case of an allergic reaction to chlorhexidine, stop using the medication immediately and consult a doctor.
SEPTEAL should not come into contact with the eyes due to the risk of vision impairment. If it comes into contact with the eyes, rinse immediately and thoroughly with water. If eye irritation, redness, or pain, or visual disturbances occur, seek prompt medical advice.
Serious cases of persistent corneal damage (damage to the surface of the eye) that may require a corneal transplant have been reported when similar products accidentally come into contact with the eyes. Although the transfer of this drug into the systemic circulation is very low, special caution is required because the risk of transfer cannot be ruled out in the event of repeated applications, use on a large area of ??skin, under an occlusive dressing, on damaged skin (particularly burned skin), mucous membranes, or on the skin of premature babies or infants (due to the surface area/weight ratio and the occlusion effect of diapers in the diaper area).
Precautions for Use
Talk to your doctor or pharmacist before using SEPTEAL.
Do not use excessive amounts and do not allow the solution to accumulate in skin folds or under the patient, or drip onto sheets and other materials in direct contact with the patient.
Children
Never leave within reach of children.
Use with caution in newborns, especially those born before 32 weeks of gestation and during the first two (2) weeks of life. SEPTEAL may cause chemical burns to the skin.
Other medications and SEPTEAL, topical solution
Avoid the simultaneous or successive use of different antiseptics with this antiseptic or cleansing agents (risk of incompatibility or ineffectiveness). Prior use of soap should be followed by careful rinsing.
Combination with other antiseptics should be avoided as their effects may be negated.
Do not use at the same time as ordinary soap.
Inform your doctor, pharmacist, or nurse if you are using, have recently used, or might use any other medication.
SEPTEAL, topical solution with food and drink
Not applicable.
Pregnancy and breastfeeding
As a precautionary measure, it is preferable to avoid the use of SEPTEAL during pregnancy and breastfeeding.
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, ask your doctor or pharmacist for advice before using this medicine. Driving and using machines
Not applicable.
SEPTEAL, solution for topical application, contains 241 mg of alcohol (ethanol) per ml. This may cause a burning sensation on damaged skin.
In newborns (premature and full-term), high concentrations of alcohol (ethanol) may cause severe local reactions and systemic toxicity due to significant absorption through immature skin (particularly under occlusion).
3. HOW TO USE SEPTEAL, solution for topical application?

Precaution
Flammable product.
Keep away from heat, hot surfaces, sparks, open flames, and other ignition sources.
Do not smoke when using or handling the bottle.

Always use this medicine exactly as your doctor, pharmacist, or nurse has told you. Check with your doctor, pharmacist, or nurse if you are unsure. Use undiluted twice a day by rubbing onto the skin without rinsing.
Never swallow.
The bottle should not be closed with a cork.
If you use more SEPTEAL, solution for topical application than you should
Not applicable.
If you forget to use SEPTEAL, solution for topical application
Not applicable.
If you stop using SEPTEAL, solution for topical application
If you are disinfecting a wound or lesion, stopping treatment too soon may cause the wound or lesion to become infected.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.
4. POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects are of unknown frequency (frequency cannot be estimated from the available data):
· Local or generalized allergy, anaphylactic shock (very serious and immediate allergy).
· Eye irritation in case of accidental exposure.
· Corneal damage (damage to the surface of the eye), and permanent eye damage including permanent visual impairment following accidental eye exposure.
· Eczema (contact dermatitis).
· Idiosyncratic drug reaction (an unusual reaction of the body to the drug).
· Chemical burns in newborns.
Reporting of side effects
If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system: French National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centers - Website: https://signalement.social-sante.gouv.fr/.
By reporting side effects, you can help provide more information on the safety of this medicine.
5. HOW TO STORE SEPTEAL, solution for topical application?
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date indicated on the outer packaging. The expiry date refers to the last day of that month.
Flammable product. Keep away from heat, hot surfaces, sparks, open flames, and other ignition sources. Do not smoke.
No special storage conditions are required.
Once opened, the solution can be stored for 6 months. Do not dispose of any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What SEPTEAL, solution for topical application contains
· The active ingredient is:
Chlorhexidine digluconate................................................................................................. 0.5 g
Quantity corresponding to 2.5 ml of 20 percent aqueous solution
Per 100 ml
· The other ingredients are:
Ethyl alcohol 96 percent* v/v, purified water.
*See section 2 "SEPTEAL contains".
What SEPTEAL, solution for topical application looks like and contents of the outer packaging
This medicine is presented as a clear, colorless solution for topical application. 60 ml, 125 ml (with spray), 250 ml, 500 ml, or 1000 ml bottles.
Not all pack sizes may be marketed.
Marketing Authorization Holder
PIERRE FABRE MEDICAMENT
LES CAUQUILLOUS
81500 LAVAUR
Marketing Authorization Holder
PIERRE FABRE MEDICAMENT
PARC INDUSTRIEL DE LA CHARTREUSE
81100 CASTRES
Manufacturer
PIERRE FABRE MEDICAMENT PRODUCTION
RUE DU LYCEE
ZONE INDUSTRIELLE DE CUIRY
45500 GIEN
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
This leaflet was last revised:
[To be completed later by the holder]
Others
Not applicable.
Detailed information on this medicine is available on the ANSM (France) website.