Leaflet: information for the user

Bactiseptic Pharma Orange 20 mg/ml + 0.70 ml/ml topical solution

chlorhexidine digluconate /isopropyl alcohol

Read this leaflet carefully before starting to use 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 adverse 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 Orange and what it is used for

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

3. How to use Bactiseptic Pharma Orange

4. Possible adverse effects

5. Storage of Bactiseptic Pharma Orange

6. Contents of the pack and additional information

Bactiseptic PharmaOrangeis a medication whose active ingredients arechlorhexidine digluconate and isopropyl alcohol.

It is indicatedas a skin antisepticbefore performing invasive medical procedures, such as injections, insertion of intravascular catheters, minor and major surgery in adults and children.

No useBactiseptic PharmaOrange

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 Orange.

Bactiseptic Pharma Orange is only for external use.

Bactiseptic Pharma Orange 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 entry points, 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 Orange 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 Orange 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 may 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 Pharma Orangemay cause chemical burns on the skin.

Avoid prolonged contact with the skin.

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

Bactiseptic Pharma Orange may, 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 Pharma Orangeand contact your doctor as soon as possible (see section 4: "Possible side effects").

When the solution is applied too vigorously to very 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 administration of Bactiseptic Pharma Orange.

Thesolutionis flammable. Cases of surgical fires have been reported that resulted 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 combustible source (cloths, towels...) and the use of an oxidizer (oxygen, air, nitrous oxide...).

To reduce the risk of fire:

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

•Remove any saturated 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 Orange, 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 Orange should be used with caution in newborns, especially in premature babies.

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

Other medications and Bactiseptic Pharma Orange

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

Do not use in combination or after applying 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 Orange 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 chosen 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 the first layers of cells of the epidermis. Each ml of Bactiseptic Pharma Orange allows covering a maximum area of 100 cm2(10 cm x 10 cm).

If you use more Bactiseptic Pharma Orange 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 will 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 Orange 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 of 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 down the drains or in the trash. If in doubt, ask your pharmacist how to dispose of the containers and medicines that you no longer need. In this way, you will help protect the environment.

Composition of Bactiseptic Pharma Orange

• The other components (excipients) are: glycerol (E422), polisorbate 80, anhydrous citric acid (E330), curcumin (E100), Allura AC Red (E129) and purified water

Appearance of Bactiseptic Pharma Orange and contents of the packaging

Bactiseptic Pharma Orange is a transparent orange-red solution that is presented in high-density polyethylene bottles with high-density polyethylene caps, containing 50 ml, 250 or 500 ml. It is presented in:

Only some sizes of packaging may 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 Despí (Barcelona)

Last review date of this leaflet: April 2024

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