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

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Bactiseptic Pharma Orange 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.

Always 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 more information, consult your pharmacist.
• If you experience any adverse reactions, consult your doctor or nurse, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if your condition worsens or does not improve.

Contents of the leaflet

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

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

Bactiseptic Pharma Orange is a medicine containing the 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 and major surgery in adults and children.

2. What you need to know before using Bactiseptic Pharma Orange

Do not use Bactiseptic Pharma Orange

If you are allergic (hypersensitive) to chlorhexidine digluconate, isopropyl alcohol, or 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 Orange.

Bactiseptic Pharma Orange is for external use only.

Bactiseptic Pharma Orange must not be used:

• Near the eyes or on 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 plenty of 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 Orange must not be washed with bleach or other hypochlorites, as this will 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 with water. In case of eye irritation, redness, pain, or visual disturbances, consult a doctor immediately.

Severe, persistent corneal injury (damage to the surface of the eye) has been reported, which in some cases 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 Orange may cause chemical burns on the skin.

Avoid prolonged contact with the skin.

Saturated materials such as surgical drapes or textiles must be removed promptly. Do not allow the solution to pool.

Bactiseptic Pharma Orange 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 experience these symptoms, stop using Bactiseptic Pharma Orange 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, a local skin reaction may occur, including redness, inflammation, itching, dry and/or flaking skin, and localized pain at the site of application. At the first sign of a local skin reaction, discontinue use of Bactiseptic Pharma Orange.

The solution is flammable. Fires in the operating room 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 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 accumulation of the solution in skin folds, under the patient, or soaking into sheets or other materials in direct contact with the patient.
• When applying an occlusive dressing to areas previously exposed to Bactiseptic Pharma Orange, 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 Orange should be used with caution in neonates, especially in premature infants.

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

Other medicines and Bactiseptic Pharma Orange

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

It should not be used in combination with, or after, anionic agents (including surfactants) or hypochlorite-based bleaches. The skin should be thoroughly rinsed after cleaning.

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 Orange does not affect the ability to drive or operate machinery.

3. How to use Bactiseptic Pharma Orange

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

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

Apply the product directly to the skin, using a sufficient quantity to cover the selected area 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 Orange can cover 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 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 will experience 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 application.

Adverse effects with 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 (injury 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 Orange 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 where you have 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 can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: 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 Orange

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, consult your pharmacist. This will help protect the environment.

6. Contents of the container and other information

Composition of Bactiseptic PharmaOrange

• 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: glycerol (E422), polysorbate 80, anhydrous citric acid (E330), curcumin (E100), Allura red AC (E129), and purified water.

Appearance of Bactiseptic PharmaOrange and contents of the container

Bactiseptic PharmaOrange is a red-orange colored transparent solution supplied in high-density polyethylene bottles with high-density polyethylene caps, containing 50 ml, 250 ml, or 500 ml. It is available in:

• Clinical packs of 36 bottles of 50 ml.
• Clinical packs of 15 bottles of 250 ml.
• Clinical packs of 15 bottles of 500 ml.

Only certain 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: April 2024

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/