AQUASEPTIC PHARMA 20 mg/ml CUTANEOUS SOLUTION

Introduction

Package Leaflet: Information for the User

Aquaseptic Pharma 20 mg/ml Cutaneous Solution

Chlorhexidine digluconate

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

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or nurse.

• Keep this package 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 package leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve.

Contents of the Package Leaflet

1. What Aquaseptic Pharma is and what it is used for.
2. What you need to know before starting to use Aquaseptic Pharma.
3. How to use Aquaseptic Pharma.
4. Possible side effects.
5. Storage of Aquaseptic Pharma.
6. Package Contents and Additional Information.

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

Aquaseptic Pharma is a medication whose active ingredient is chlorhexidine digluconate.

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 Aquaseptic Pharma

Do not use Aquaseptic Pharma

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

Warnings and Precautions

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

Aquaseptic Pharma is for external use only.

Aquaseptic 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 damage. 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 Aquaseptic Pharma should not be washed with bleach or other hypochlorites, as this would cause a brown discoloration, but with domestic detergents based on sodium perborate.
• Aquaseptic Pharma should not come into contact with the eyes due to the risk of visual damage. 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 premature infants. Aquaseptic Pharma can cause chemical burns to the skin.

Avoid prolonged contact with the skin.

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

Aquaseptic 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 Aquaseptic 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 and/or flaky skin, and localized pain in the administration area. Upon the first sign of a local skin reaction, administration of Aquaseptic Pharma should be interrupted.

Children

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

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

Other Medications and Aquaseptic Pharma

It should not be used in combination or after the application of anionic agents (including surfactants) and bleaches with hypochlorite, so 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 medication.

Driving and Using Machines

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

3. How to Use Aquaseptic Pharma

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or nurse. In case of doubt, ask your doctor or nurse.

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 Aquaseptic Pharma allows covering a maximum area of 100 cm2 (10 cm x 10 cm).

If you use more Aquaseptic 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 medication and the amount ingested.

4. Possible Side Effects

Like all medications, this medication can cause side 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 in the administration area.

Side 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.
• corneal injury (injury to the surface of the eye) and permanent eye damage, including permanent visual impairment (after accidental ocular exposure during surgical interventions in the head, face, and neck) in patients under general anesthesia (deep sleep induced without pain).

Stop using Aquaseptic Pharma 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 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 type of side effect, consult your doctor or nurse, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Medication Pharmacovigilance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Aquaseptic Pharma

No special storage conditions are required.

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

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

Discard 1 month after the first opening.

Medications should not be thrown away through the sewers or in the trash. In case of doubt, ask your pharmacist how to dispose of the packaging and medications that are no longer needed. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Aquaseptic Pharma

• The active ingredient is chlorhexidine digluconate. Each ml contains 20 mg of chlorhexidine digluconate.
• The other components (excipients) are: anhydrous citric acid (E330), polysorbate 80, and purified water.

Appearance of Aquaseptic Pharma and Package Contents

Aquaseptic Pharma is a homogeneous and transparent solution presented in high-density polyethylene bottles containing 50 ml.

It is presented in clinical packages 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

Spain

Date of the Last Revision of this Package Leaflet: June 2024

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