Linitul Antiséptico 10 mg/ml solution for cutaneous spray

Patient Information Leaflet

Introduction

Patient Information Leaflet

Linitul Antiseptic 10 mg/ml cutaneous spray solution

Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.

Always follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist.

• 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 pharmacist, even if they are side effects not listed in this leaflet. See section 4.
• You should consult your doctor if your condition worsens or if you do not improve after 5 days.

Contents of this leaflet

1. What Linitul Antiseptic 10 mg/ml is and what it is used for
2. What you need to know before using Linitul Antiseptic 10 mg/ml
3. How to use Linitul Antiseptic 10 mg/ml
4. Possible side effects
5. How to store Linitul Antiseptic 10 mg/ml
6. Contents of the pack and other information

1. What Linitul Antiseptic 10 mg/ml is and what it is used for

Linitul Antiseptic 10 mg/ml is a topical medication whose active substance is chlorhexidine digluconate. Chlorhexidine digluconate is an antiseptic applied to the skin.

It is indicated as an antiseptic for wounds and minor skin burns, and as an antiseptic for the umbilicus in newborns.

You should consult a doctor if your condition worsens or does not improve after 5 days.

2. What you need to know before starting to use Linitul Antiseptic 10 mg/ml

Do not use Linitul Antiseptic 10 mg/ml

• If you are allergic to chlorhexidine digluconate or to any of the other components of this medicine (listed in section 6).
• Do not use in eyes, ears, inside the mouth, or on other mucous membranes.

Warnings and precautions

Consult your doctor or pharmacist before starting to use this medicine.

• This medicine is for external use on the skin only. Do not swallow.
• In case of accidental contact with ears, rinse immediately with plenty of water.
• Linitul Antiseptic 10 mg/ml must not come into contact with the eyes due to the risk of visual injury. If contact occurs, rinse immediately and thoroughly with plenty of 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 could eventually require a corneal transplant, when similar products have accidentally come into contact with the eyes during surgical procedures in patients under general anesthesia (induced painless deep sleep).

• Do not use in case of deep or extensive wounds without first consulting a doctor.
• Must not be applied repeatedly, nor used over large surface areas, under occlusive dressings (non-breathable), on damaged skin, or on mucous membranes.
• Must not be used for antisepsis of puncture or injection sites, or for disinfection of surgical instruments.

Children

• Use with caution in neonates, especially in premature infants. This medicine may cause chemical burns on the skin.
• Consult your doctor before use in children under 30 months of age.

Use of Linitul Antiseptic 10 mg/ml with other medicines

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.

• The simultaneous or sequential use of other antiseptics should be avoided.
• Must not be used in combination with, or after application of, anionic soaps (soaps), acids, heavy metal salts, or iodine; therefore, the skin should be thoroughly rinsed after cleaning.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

It is unknown whether chlorhexidine or any of its metabolites are excreted in human breast milk. The potential risk of systemic effects should be considered.

Driving and using machines

The effect of this medicine on the ability to drive or operate machinery is negligible or none.

3. How to use Linitul Antiséptico 10 mg/ml

Follow exactly the administration instructions contained in this leaflet or those provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Do not dilute this medicine. It is recommended to clean and dry the wound before applying this medicine. Apply to the affected area, or onto a gauze dressing, once or twice daily. Do not apply the product more than twice a day.

If you use more Linitul Antiséptico 10 mg/ml than you should

In case of overdose or accidental ingestion, contact 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.

Information for healthcare professionals

In case of accidental ingestion, perform gastric lavage and provide protection for the gastrointestinal mucosa.

Cases of hemolysis following chlorhexidine ingestion have been reported. In case of hemolysis, blood transfusion may be required.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

The following adverse effects may occur (frequency not known: cannot be estimated from available data):

• Allergic skin reactions.
• Chemical burns in neonates.
• 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 anesthesia (induced painless deep sleep).

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: http://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Linitul Antisepsis 10 mg/ml

This medicine does not require any special storage conditions.

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

Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month indicated.

Discard the container 6 months after first opening, even if it is not empty. It should not be kept for later use.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point in your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and unused medicines. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Linitul Antiseptic 10 mg/ml

• The active substance is chlorhexidine digluconate. Each ml contains 10 mg of chlorhexidine digluconate.
• The other component (excipient) is purified water.

Additional information

• Clothing that has been in contact with this medicinal product should not be washed with bleach or other hypochlorites, as this would cause a brownish discoloration of the fabrics. Instead, use domestic detergents based on sodium perborate.

Appearance of the product and contents of the container

A clear, colourless or slightly yellowish solution supplied in high-density polyethylene bottles fitted with a spray pump, in 25 ml and 100 ml sizes, and clinical packs of 20 bottles of 100 ml and 250 ml.

Marketing Authorization Holder and Manufacturer

Holder:

ALFASIGMA ESPAÑA, S.L.

C/ Aribau 195, 4º

08021 Barcelona, Spain

Manufacturer:

LAINCO, S.A.

Avda. Bizet, 8-12

08191 RUBÍ - Barcelona (Spain)

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

Up-to-date and detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es