Linitul antiseptico 10 mg/ml s… leaflet – Spain

How to use Linitul antiseptico 10 mg/ml solucion para pulverizacion cutanea

Introduction

Leaflet: information for the user

Linitul Antiseptic 10 mg/ml skin spray solution

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 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 not listed in this leaflet. See section 4.
You should consult your doctor if you get worse or do not improve after 5 days.

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

Linitul Antiséptico10 mg/ml is a topical medication whose active ingredient is chlorhexidine digluconate.

It is indicated as a wound and minor skin burn antiseptic and as umbilical cord antiseptic in newborns.

Consult a doctor if it worsens or does not improve after 5 days.

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

No use Linitul Antiséptico 10 mg/ml

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

Warnings and Precautions

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

This medication is exclusively for external use on the skin. Do not ingest.
In case of accidental contact with ears, wash immediately with plenty of water.
Linitul Antiséptico 10 mg/ml should not come into contact with the eyes due to the risk of visual injury. 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 (injury to the surface of the eye) have been reported, which may require a corneal transplant when similar products have accidentally entered the eyes during surgical procedures, in patients under general anesthesia (deep, painless sleep).

Do not use in case of deep and extensive wounds without consulting a doctor.
Do not apply repeatedly, or use on large surfaces, with occlusive dressing (non-breathable), on injured skin, and in mucous membranes.
Do not use for the asepsis of puncture or injection sites, or for the disinfection of surgical equipment.

Children

Use with caution in newborns, especially in premature children. This medication may cause chemical burns on the skin.
Consult with your doctor before using in children under 30 months.

Use of Linitul Antiséptico 10 mg/ml with other medications

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

Simultaneous or successive use of other disinfectants should be avoided.
Do not use in combination with or after the application of anionic soaps (soaps), acids, heavy metal salts, and iodine, so the skin should be thoroughly rinsed after cleaning.

Pregnancy and breastfeeding

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

The excretion of chlorhexidine or any of its metabolites in breast milk is unknown. The possible risk of systemic effects should be taken into account.

Driving and operating machinery

The influence of this medication on the ability to drive or operate machinery is negligible or insignificant.

3. How to Use Linitul Antiséptico 10 mg/ml

Follow exactly the administration instructions of the medication contained in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

Do not dilute this medication. It is recommended to clean and dry the wound before applying this medication. Apply to the affected area, or on a gauze, one or two times a day. Do not perform more than two daily applications of the product.

If you use more Linitul Antiséptico 10 mg/ml 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.

Information for the healthcare professional

In case of accidental ingestion, proceed with gastric lavage and protection of the digestive mucosa.

Cases of hemolysis have been described after ingestion of chlorhexidine. In case of hemolysis, blood transfusion may be necessary.

4. Possible Adverse Effects

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

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

Allergic reactions in the skin.
Chemical burns in newborns.
Corneal injury (injury to the surface of the eye) and permanent eye injury, including permanent visual deterioration (following accidental ocular exposure during surgical procedures on the head, face, and neck) in patients under general anesthesia (induced painless deep sleep).

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Usehttp://www.notificaram.es.By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Preservation of Antiseptic Linitul 10 mg/ml

This medication does not require special preservation conditions.

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

Do not use this medication after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

Dispose of the packaging after 6 months of its first opening, even if it is not empty. Do not store for future use.

Medicines should not be thrown down the drains or in the trash. Deposit the packaging and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

6. Contents of the packaging and additional information

Composition of Linitul Antiséptico 10 mg/ml

The active ingredient 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 medication should not be washed with bleach or other hypochlorites, as this would cause a brownish discoloration of the fabric, but rather with domestic detergents based on sodium perborate.

Appearance of the product and contents of the packaging

Transparent, colorless, or slightly yellowish solution presented in high-density polyethylene bottles, equipped with 25 ml and 100 ml spray pumps, and clinical containers of 20 bottles of 100 ml and 250 ml.

Holder of the marketing authorization and responsible manufacturer

Holder:

ALFASIGMA ESPAÑA, S.L.

Avda. Diagonal 490

08006 Barcelona

Responsible manufacturer:

LAINCO, S.A.

Avda. Bizet, 8-12

08191 RUBÍ - Barcelona (Spain)

Date of the last review of this leaflet: October 2024

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