BACTISEPTIC PHARMA 20 mg/mL + 0.70 mL/mL CUTANEOUS SOLUTION

Introduction

Leaflet: information for the user

Bactiseptic Pharma 20 mg/ml + 0.70 ml/ml cutaneous solution

chlorhexidine digluconate / isopropyl alcohol

Read the entire leaflet carefully before starting to use this medicine, as it contains important information for you.

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

Contents of the leaflet

1. What is Bactiseptic Pharma and what is it 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. Package contents and additional information

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

Bactiseptic Pharma is a medicine whose active ingredients 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 surgery in adults and children.

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

Do not use Bactiseptic Pharma

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

Warnings and precautions

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

Bactiseptic Pharma is for external use only.

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, the affected area should be rinsed 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., brain and spinal cord).
• Textile materials that have come into contact with Bactiseptic Pharma should not be washed with bleach or other hypochlorites, as this may cause a brown discoloration; instead, they should be washed with domestic detergents based on sodium perborate.

• Bactiseptic Pharma should not come into contact with the eyes due to the risk of visual impairment. If it comes into contact with the eyes, rinse immediately and abundantly with water. In case 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) 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 sleep induced without pain).

Use with caution in neonates, especially in premature babies. Bactiseptic Pharma can cause chemical burns to the skin.

Avoid prolonged contact with the skin.

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

Bactiseptic Pharma 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 using Bactiseptic Pharma and 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, a local skin reaction may occur with redness of the skin, inflammation, itching, dry skin, and/or peeling and localized pain in the administration area. If you experience the first sign of a local skin reaction, you should interrupt the administration of Bactiseptic Pharma.

The solution is flammable. Cases of fire in the operating room have been reported, resulting in severe burns to the patient.

The risk of fire is high when using an ignition source (electrosurgical units, lasers, fiber optic light sources, high-speed drills/burs...) in combination with a combustion source (such as cloths, towels...) and an oxidizing agent (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, gauzes, or gowns before starting the intervention.
• Do not use excessive amounts and avoid accumulating the solution in skin folds, under the patient, or soaking sheets or other materials in direct contact with the patient.
• When applying an occlusive dressing to areas previously exposed to Bactiseptic Pharma, be careful not to leave excess product before applying the dressing.
• Reduce the oxygen supply or any other oxidizing agent to the minimum necessary. Those procedures performed on the head, neck, and upper chest (above T5) and the use of an ignition source near an oxidizing agent put the patient at risk of suffering a surgical fire.

Children

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

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

Other medicines and Bactiseptic Pharma

Tell your doctor or nurse if you have recently been administered 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 bleaches with hypochlorite; therefore, the skin should be rinsed well after cleaning.

Pregnancy, breastfeeding, and fertility

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

Driving and using machines

Bactiseptic Pharma does not alter the ability to drive or operate machines.

3. How to use Bactiseptic Pharma

Follow exactly the administration instructions of the medicine contained in this leaflet or as 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 to the skin, in sufficient quantity to cover the chosen area for each procedure, without leaving spaces, 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 epidermal cells. 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 Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone may experience them.

Very rare (less than 1 in 10,000 people): allergic reactions or skin irritation, including: erythema, rash (e.g., erythematous, papular, or maculopapular), pruritus, and blisters or vesicles in the administration area, have been reported.

Frequency not known (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 (after accidental eye exposure during surgical interventions in the head, face, and neck) in patients under general anesthesia (deep sleep induced without pain).

Stop using Bactiseptic Pharma and seek medical attention immediately 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 fainting 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 used the product for skin washing, consult your doctor or pharmacist.

Reporting side effects

If you experience any side effects, consult your doctor or nurse, even if they are possible side effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Bactiseptic Pharma

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

Do not store above 30°C.

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

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

Do not use this medicine after the expiration date stated on the label after CAD. The expiration date is the last day of the month indicated.

Discard 1 month after the first opening.

Medicines should not be disposed of via wastewater or household waste. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Bactiseptic Pharma

• The active ingredients 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 package contents

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

• Clinical packages of 36 bottles of 50 ml.
• Clinical packages of 36 bottles of 125 ml.
• Clinical packages of 15 bottles of 250 ml.

Only some package sizes may be marketed.

Marketing authorization holder

Vesismin S.L.U.

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

08006 Barcelona

Spain

Manufacturer

Laboratorios Reig Jofre, S.A.

Gran Capitán, 10

08970 Sant Joan Despi (Barcelona)

Date of the last revision of this leaflet:July 2024

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/