Leaflet: information for the user

Bactiseptic Pharma 20 mg/ml + 0,70 ml/ml topical solution

chlorhexidine digluconate / isopropyl alcohol

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

Follow exactly the administration instructions for the medicine contained in this leaflet or those indicated by your doctor 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 any side effects, consult your doctor or nurse, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve.

1. What is Bactiseptic Pharma and what it is used for

2. What you need to know before starting to use Bactiseptic Pharma

3. How to use Bactiseptic Pharma

4. Possible side effects

5. Storage of Bactiseptic Pharma

6. Contents of the pack and additional information

Bactiseptic Pharma is a medication whose active principles are chlorhexidine digluconate and isopropyl alcohol.

It is indicated as a skin antiseptic before performing invasive medical procedures, such as injections, insertion of intravascular catheters, minor and major surgeryin adults and children.

No use Bactiseptic Pharma

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

Warnings and precautions

Consult your doctor or nurse before starting to use Bactiseptic Pharma.

Bactiseptic Pharma is only for external use.

Bactiseptic Pharma should not be used:

• Near the eyes or sensitive areas (mucous membranes), as it may cause irritation, pain, redness, vision problems, chemical burns, and eye injuries. In case of contact with the eyes or mucous membranes of the body's entryways, the affected area should be washed immediately with plenty of water.
• On open wounds.
• On the inner part of the ear (middle ear).
• In direct contact with neural tissue (e.g., the brain and spinal cord).
• Textiles that have been in contact with Bactiseptic Pharma should not be washed with bleach or other hypochlorites, as this would cause a brownish discoloration, but with domestic detergents based on sodium perborate.

• Bactiseptic Pharma should not come into contact with the eyes due to the risk of visual injuries. If it comes into contact with the eyes, wash immediately and abundantly with water. In case of eye irritation, redness, or pain, or visual disturbances, consult a doctor immediately.

Severe cases of persistent corneal injury (surface of the eye injury) that could 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, painless sleep).

Use with caution in newborns, especially in premature babies.Bactiseptic Pharmamay cause chemical burns on the skin.

Avoid prolonged contact with the skin.

Soaked materials, such as surgical fields or textiles, should be removed before use. Do not let the solution stagnate.

Bactiseptic Pharmamay, in rare cases, cause severe allergic reactions, leading to a decrease in blood pressure and even loss of consciousness. The first symptoms of a severe allergic reaction may be skin rash or asthma. If you notice these symptoms, stop usingBactiseptic Pharmaand contact your doctor as soon as possible (see section 4: "Possible side effects").

When the solution is applied too vigorously on fragile or sensitive skin, or after repeated use, it may cause a local skin reaction with redness of the skin, inflammation, itching, dry skin, and/or peeling, and localized pain in the administration area. In the event of the first sign of local skin reaction, discontinue the administration of Bactiseptic Pharma.

Thesolutionis flammable.Cases of fires in the operating room have been reported, resulting in severe burns to the patient.

The risk of fire is high when using a source of ignition (electrosurgical units, lasers, fiber optic light sources, high-speed drills/burs...) in combination with the use of a combustion source (such as cloths, towels...) and the use of an oxidizer (oxygen, air, nitrous oxide...).

To reduce the risk of fire:

•Do not use electrocauterization procedures or other ignition sources until the skin is completely dry.

•Remove any soaked materials, gauze, or gowns before starting the procedure.

•Do not use excessive amounts and avoid allowing the solution to accumulate in skin folds, under the patient, or to soak the sheets or other materials in direct contact with the patient.

•When applying occlusive dressings to areas previously exposed to Bactiseptic Pharma, special care should be taken to ensure there is no excess product before applying the dressing.

•Reduce oxygen supply or any other oxidizer to the minimum necessary. Procedures performed in the head, neck, and upper chest (above T5) and the use of an ignition source near an oxidizer put the patient at risk of suffering a surgical fire.

Children

Bactiseptic Pharma should be used with caution in newborns, especially in premature babies.

Bactiseptic Pharma should only be used under medical prescription in children under 30 months.

Other medications and Bactiseptic Pharma

Inform your doctor or nurse if you have recently received a vaccine or an injection for a skin test (epicutaneous tests for detecting allergies).

It should not be used in combination or after the application of anionic agents (including surfactants) and bleach with hypochlorite, so the skin should be thoroughly cleaned after cleaning.

Pregnancy, breastfeeding, and fertility

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

Driving and operating machinery

Bactiseptic Pharma does not affect the ability to drive or operate machinery.

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

Your doctor or nurse will decide the amount to apply based on the medical procedure and the area to be covered.

Apply the product directly onto the skin, in sufficient quantity to cover the selected area for each procedure, without leaving any gaps, for a minimum of 30 seconds. Wait for the product to dry completely before performing any puncture or insertion on the skin, to ensure that the solution penetrates into the first layers of cells of the epidermis. Each ml of Bactiseptic Pharma allows covering a maximum area of 100 cm2(10 cm x 10 cm).

If you use more Bactiseptic Pharma 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, this medication may produce adverse effects, although not all people may experience them.

Very rare (less than 1 in 10,000 people):allergic reactions or skin irritation, including: erythema, eruption (for example, erythematous, papular, or maculopapular), pruritus, and blisters or vesicles at the site of administration have been reported.

Adverse effects of unknown frequency(cannot be estimated from available data):

- dermatitis, eczema, urticaria, skin irritation, chemical burns in neonates, hypersensitivity reactions, and anaphylactic shock during anesthesia, eye irritation, pain, hyperemia, vision problems, eye injuries.

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

Stop using Bactiseptic Pharma and seek immediate medical attention if you experience any of the following reactions: swelling of the face, lips, tongue, or throat; red, itchy skin rash; wheezing or difficulty breathing; feeling of faintness and dizziness; strange metallic taste in the mouth; collapse. You may be having an allergic reaction.

If you develop a skin rash or your skin becomes red, itchy, dry, or inflamed in the area where you have used the product for skin washing, consult your doctor or pharmacist.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or nurse, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Flammable. Avoid exposure of the bottle and its contents to open flames during use, storage, and disposal of the product.

Do not store at a temperature above 30°C..

Avoid exposure of the bottle and its contents to open flames during use, storage, and disposal of the product.

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

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

Dispose of 1 month after the first opening.

Medicines should not be thrown away through drains or in the trash. If in doubt, ask your pharmacist how to dispose of the containers and medicines that you no longer need. By doing so, you will help protect the environment.

Composition of Bactiseptic Pharma

-The active principles are chlorhexidine digluconate and isopropyl alcohol. Each ml contains 20 mg of chlorhexidine digluconate and 0.70 ml of isopropyl alcohol.

-The other components (excipients) are: anhydrous citric acid (E330) and purified water.

Appearance of Bactiseptic Pharma and contents of the packaging

Bactiseptic Pharma is a homogeneous and transparent solution that is presented in high-density polyethylene bottles containing 50 ml, 125 ml, or 250 ml. It is presented in:

-Clinical packaging of 36 bottles of 50 ml.

-Clinical packaging of 36 bottles of 125 ml.

-Clinical packaging of 15 bottles of 250 ml.

Some packaging sizes may only be commercially available.

Marketing Authorization Holder

Vesismin S.L.U.

Carrer Aribau 230-240, 6th floor, L-O

08006 Barcelona

Spain

Responsible for Manufacturing

Laboratorios Reig Jofre, S.A.

Gran Capitán, 10

08970 Sant Joan Despi (Barcelona)

Last review date of this leaflet:July 2024

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