Aquaseptic Pharma 20 mg/ml cutaneous solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Aquaseptic Pharma 20 mg/ml cutaneous solution

chlorhexidine digluconate

Read all of this 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 side effects, consult your doctor or nurse, even if they are side effects not listed in this leaflet. See section 4.
• You should consult a doctor if you get worse or do not improve.

Contents of this leaflet

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

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

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

It is indicated as a skin antiseptic prior to performing 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 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 medicine (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 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 copious amounts 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 Aquaseptic Pharma must not be washed with bleach or other hypochlorites, as this will cause a brownish discoloration; instead, they should be washed with domestic detergents based on sodium perborate.
• Aquaseptic Pharma must not come into contact with the eyes due to the risk of visual damage. If contact occurs, immediately and thoroughly rinse the eyes with water. In case of eye irritation, redness or pain, or visual disturbances, 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 (pain-free induced deep sleep).

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

Avoid prolonged contact with the skin.

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

Aquaseptic 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 Aquaseptic 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, a local skin reaction may occur, including redness, inflammation, itching, dry and/or scaly skin, and localized pain at the site of application. At the first sign of a local skin reaction, discontinue the use of Aquaseptic Pharma.

Children

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

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

Other medicines and Aquaseptic Pharma

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 use of machines

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

3. How to use Aquaseptic Pharma

Follow exactly the instructions for administering the medicine 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 decide the amount to apply depending on the medical procedure and the area to be covered.

Apply the product directly onto the skin, using a sufficient quantity to cover the area designated for each procedure without leaving any gaps, for at least 30 seconds. Allow the product to dry completely before performing any skin puncture or insertion to ensure that the solution penetrates the outermost layers of epidermal cells. Each ml of Aquaseptic Pharma can cover 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 at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

4. Possible adverse effects

Like all medicines, this medicine can 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 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 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 have used the skin wash 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 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 Aquaseptic Pharma

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 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 and their packaging, please consult your pharmacist. This will help protect the environment.

6. Contents of the container and other information

Composition of Aquaseptic Pharma

• The active substance 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 contents of the container

Aquaseptic Pharma is a homogeneous, transparent 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 responsible for production

Laboratorio Reig Jofre, S.A.

Gran Capitán, 10

08970 Sant Joan Despí – Barcelona

Spain

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

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