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

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

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

chlorhexidine digluconate / isopropyl alcohol

Read this 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 or nurse.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, consult your pharmacist.
• If you experience any 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 you worsen or do not improve.

Contents of the leaflet

1. What Bactiseptic Pharma is and what it is used for
2. What you need to know before using Bactiseptic Pharma
3. How to use Bactiseptic Pharma
4. Possible adverse effects
5. How to store Bactiseptic Pharma
6. Contents of the pack and other information

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

Bactiseptic Pharma is a medicine containing as active substances chlorhexidine digluconate and isopropyl alcohol.

It is indicated as a skin antiseptic prior to invasive medical procedures such as injections, insertion of intravascular catheters, and minor or major surgery in adults and children.

2. What you need to know before using Bactiseptic Pharma

Do not use Bactiseptic Pharma

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

Warnings and precautions

Talk to your doctor or nurse before using Bactiseptic Pharma.

Bactiseptic Pharma is for external use only.

Bactiseptic Pharma must 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 body entry mucous membranes, the affected area should be immediately washed with abundant water.

• On open wounds.

• Inside the ear (middle ear).

• In direct contact with neural tissue (e.g., brain and spinal cord).

• Textile materials that have been in contact with Bactiseptic Pharma must not be washed with bleach or other hypochlorites, as this would cause a brownish discoloration. Instead, wash them with domestic detergents based on sodium perborate.

• Bactiseptic Pharma must not come into contact with the eyes due to the risk of visual injury. If contact occurs, immediately and thoroughly rinse the eyes with water. In case of eye irritation, redness, pain, or visual disturbances, consult a doctor immediately.

Severe cases of persistent corneal injury (damage to the eye surface) have been reported, which may require corneal transplantation, when similar products accidentally came into contact with the eyes during surgical procedures in patients under general anesthesia (induced painless deep sleep).

Use with caution in neonates, especially in premature infants. Bactiseptic Pharma may cause chemical burns on the skin.

Avoid prolonged contact with the skin.

Saturated materials such as surgical drapes or textiles should be removed before use. Do not allow the solution to pool.

Bactiseptic Pharma may, in rare cases, cause severe allergic reactions leading to a drop in blood pressure and even loss of consciousness. Early signs of a severe allergic reaction may include 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 on very fragile or sensitive skin, or after repeated use, local skin reactions may occur, such as redness, swelling, itching, dry and/or scaly skin, and localized pain at the application site. If any sign of local skin reaction appears, discontinue use of Bactiseptic Pharma immediately.

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

The risk of fire is high when an ignition source (electrosurgical units, lasers, fiber-optic light sources, high-speed drills/burs) is used in combination with a combustible material (such as cloths, towels) and an oxidizing agent (oxygen, air, nitrous oxide, etc.).

To reduce the risk of fire:

• Do not use electrocautery or other ignition sources until the skin is completely dry.
• Remove any soaked materials, gauze, or drapes before starting the procedure.
• Do not use excessive amounts and avoid accumulation of the solution in skin folds, under the patient, or soaking sheets and other materials in direct contact with the patient.
• When applying an occlusive dressing to areas previously exposed to Bactiseptic Pharma, take special care to ensure there is no excess product before applying the dressing.
• Reduce the supply of oxygen or any other oxidizing agent to the minimum necessary. Procedures performed on the head, neck, and upper chest (above T5), combined with the use of an ignition source near an oxidizing agent, place the patient at risk of surgical fire.

Children

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

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

Other medicines and Bactiseptic Pharma

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

It must not be used in combination with, or after application of, anionic agents (including surfactants) and hypochlorite-based bleaching agents; therefore, the skin should be thoroughly rinsed after cleansing.

Pregnancy, breastfeeding, and fertility

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

Driving and using machines

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

3. How to use Bactiseptic Pharma

Follow exactly the instructions for administering this medicine as described in this leaflet or as indicated by your doctor or nurse. If in doubt, consult your doctor or pharmacist.

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

Apply the product directly to the skin, using a sufficient amount to completely cover the area designated for each procedure without leaving any gaps, for at least 30 seconds. Wait for the product to dry completely before performing any skin puncture or insertion, to ensure the solution penetrates the outermost layers of epidermal cells. Each mL of Bactiseptic Pharma is sufficient to cover 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

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

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 anaesthesia, eye irritation, pain, hyperemia, vision problems, eye injuries.
• corneal injury (damage to the surface of the eye) and permanent eye damage, including permanent visual impairment (following accidental ocular exposure during surgical procedures on the head, face and neck) in patients under general anaesthesia (induced painless deep sleep).

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 rash; wheezing or difficulty breathing; feeling faint or dizzy; unusual 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 at the area where you applied the product for skin washing, consult your doctor or pharmacist.

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor 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 Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide 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 expiry date stated on the label after EXP. The expiry date is the last day of the month indicated.

Discard 1 month after first opening.

Medicines must not be disposed of via wastewater or household waste. If you are unsure how to dispose of unused medicines or their packaging, please consult your pharmacist. This will help protect the environment.

6. Contents of the pack and other information

Composition of Bactiseptic Pharma

• The active substances 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 pack

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

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

Only some pack 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 Despí (Barcelona)

Date of the most recent review of this leaflet: July 2024

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