Leaflet: information for the user

Aquaseptic Pharma 20 mg/ml topical solution

chlorhexidine digluconate

Read this leaflet carefully before you start using this medicine because it contains important information for you

Follow exactly the administration instructions for the medicine contained in this leaflet or those 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 any side effects, consult your doctor or nurse, even if they are not listed in this leaflet. See section 4.

-You should consult a doctor if it worsens or does not improve.

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.Contents of the pack and additional information

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.

No 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 only for external use.

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 injuries. In case of contact with the eyes or mucous membranes of the body's entryways, the affected area should be immediately washed with plenty of water.

-On open wounds.

-On the inner part of the ear (middle ear).

-In direct contact with neural tissue (for example, the brain and spinal cord).

-Textiles that have been in contact with Aquaseptic Pharma should not be washed with bleach or other hypochlorites, as this would cause a brownish 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 injuries. If it comes into contact with the eyes, wash immediately and abundantly with water. In case of eye irritation, redness, or pain, or visual disturbances, consult a doctor immediately.

Severe cases of persistent corneal injury (surface eye injury) that could require a corneal transplant have been reported when similar products have accidentally entered contact with the eyes during surgical interventions, in patients under general anesthesia (deep, painless sleep).

Use with caution in newborns, especially in premature babies.Aquaseptic Pharmamay cause chemical burns on the skin.

Avoid prolonged contact with the skin.

Soaked materials, such as surgical fields or textiles, should be removed before use. Do not let the solution 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, it may cause a local skin reaction with skin redness, inflammation, itching, dry skin, and/or peeling, and localized pain in the administration area. In the event of the first sign of local skin reaction, discontinue the administration of Aquaseptic Pharma.

Children

Aquaseptic Pharma should be used with caution in newborns, especially in premature babies.

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 with or after the application of anionic agents (including surfactants) and bleaching agents with hypochlorite, so the skin should be thoroughly cleaned after cleaning.

Pregnancy, breastfeeding, and fertility

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

Driving and operating machinery

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

Follow exactly the administration instructions of the medication contained in this leaflet or those indicated by your doctor or nurse. If in 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 onto the skin, in sufficient quantity to cover the selected area for each procedure, without leaving any gaps, 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 into the first layers of cells of the epidermis. 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

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

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 anesthesia.

- corneal injury (injury to the surface of the eye) and permanent eye injury, including permanent visual impairment (following accidental ocular exposure during surgical interventions in the head, face, and neck) in patients under general anesthesia (induced painless deep sleep).

Stop using Aquaseptic Pharma and seek immediate medical attention if you experience any of the following reactions: facial swelling, 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 Adverse Effects

If you experience any type of adverse effect, consult your doctor or nurse, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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 that appears on the label after CAD. The expiration date is the last day of the month indicated.

Dispose of 1 month after the first opening.

Medicines should not be thrown down the drain or in the trash. If in doubt, ask your pharmacist how to dispose of the packaging and medications that you no longer need. In this way, you will help protect the environment.

Composition of Aquaseptic Pharma

Appearance of Aquaseptic Pharma and content of the container

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

It is presented in clinical containers of 36 bottles of 50 ml.

Holder of the marketing authorization

Vesismin S.L.U.

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

08006 Barcelona

Spain

Responsible for manufacturing

Laboratorio Reig Jofre, S.A.

Gran Capitán, 10

08970 Sant Joan Despí – Barcelona

Spain

Last review date of this leaflet: June 2024

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