Aquaseptic Pharma Orange 20 mg/ml cutaneous solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Aquaseptic Pharma Orange 20 mg/ml cutaneous solution

chlorhexidine digluconate

Read the 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 more information, consult your pharmacist.
• If you experience any adverse effects, consult your doctor or nurse, even if they are adverse effects not listed in this leaflet. See section 4.
• You should consult a doctor if you worsen or do not improve.

Contents of this leaflet

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

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

Aquaseptic Pharma Orange is a medicine whose active substance is chlorhexidine digluconate.

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 Aquaseptic Pharma Orange

Do not use Aquaseptic Pharma Orange

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

Warnings and precautions

Talk to your doctor or nurse before using Aquaseptic Pharma Orange.

Aquaseptic Pharma Orange is for external use only.

Aquaseptic 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 injuries to the eyes. In case of contact with 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 Aquaseptic Pharma Orange must not be washed with bleach or other hypochlorites, as this will result in a brownish discoloration. Instead, wash them with household detergents based on sodium perborate.
• Aquaseptic Pharma Orange 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. If eye irritation, redness, pain, or visual disturbances occur, consult a doctor immediately.

Severe cases of persistent corneal injury (damage to the surface of the eye) have been reported, which may require corneal transplantation, when similar products have accidentally come 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. Aquaseptic Pharma Orange may cause chemical burns on the skin.

Avoid prolonged contact with the skin.

Saturated materials, such as surgical drapes or textile materials, must be removed before use. Do not allow the solution to pool or stagnate.

Aquaseptic 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 Aquaseptic 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, swelling, itching, dry and/or scaly skin, and localized pain at the site of application. At the first sign of a local skin reaction, discontinue use of Aquaseptic Pharma Orange.

Children

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

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

Other medicines and Aquaseptic Pharma Orange

Do not use in combination with, or after applying, anionic agents (including surfactants) or hypochlorite-based bleaching agents. The skin must 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

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

3. How to use Aquaseptic Pharma Orange

Follow exactly the instructions for use provided in this leaflet or those given by your doctor or nurse. If in doubt, consult your doctor or nurse.

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, in sufficient quantity to cover the area selected for each procedure without leaving any gaps, for a minimum of 30 seconds. Wait for the product to dry completely before performing any skin puncture or insertion, to ensure that the solution penetrates into the outermost layers of epidermal cells. Each mL of Aquaseptic Pharma Orange allows coverage of a maximum area of 100 cm² (10 cm x 10 cm).

If you use more Aquaseptic 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 medication and the amount ingested.

4. Possible adverse effects

Like all medicines, this medicine can 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.
• 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 Aquaseptic 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 in the area where you applied the skin cleansing product, consult your doctor or pharmacist.

Reporting of adverse effects

If you experience any 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 Aquaseptic Pharma Orange

No special storage conditions are required.

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 refers to the last day of the month indicated.

Discard 1 month after first opening.

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

6. Contents of the pack and other information

Composition of Aquaseptic PharmaOrange

• The active substance is chlorhexidine digluconate. Each ml contains 20 mg of chlorhexidine digluconate.
• The other components (excipients) are: glycerol (E422), polysorbate 80, guar gum galactomannan, isopropyl alcohol, anhydrous citric acid (E330), curcumin (E100), Allura Red AC (E129), and purified water.

Appearance of Aquaseptic PharmaOrange and contents of the pack

Aquaseptic PharmaOrange is a transparent red-orange solution supplied in high-density polyethylene bottles containing 50 ml.

It is available in clinical packs of 36 bottles of 50 ml.

Marketing Authorization Holder

Vesismin S.L.U.

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

08006 Barcelona

Spain

Manufacturer

Laboratorio Reig Jofre, S.A.

Gran Capitán, 10

08970 Sant Joan Despí (Barcelona)

Date of the most recent revision of this leaflet: June 2024

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