LINITUL ANTISEPTIC 10 mg/ml CUTANEOUS SPRAY SOLUTION

Introduction

Leaflet: Information for the user

Linitul Antiseptic 10 mg/ml solution for cutaneous spraying

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

Follow the administration instructions of the medication contained in this leaflet or as 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 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 it worsens or does not improve after 5 days.

Contents of the leaflet

1. What Linitul Antiseptic 10 mg/ml is and what it is used for
2. What you need to know before starting to use Linitul Antiseptic 10 mg/ml
3. How to use Linitul Antiseptic 10 mg/ml
4. Possible side effects
5. Storage of Linitul Antiseptic 10 mg/ml
6. Package contents and additional information

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

Linitul Antiseptic 10 mg/ml is a medication for cutaneous use whose active ingredient is chlorhexidine digluconate. Chlorhexidine digluconate is an antiseptic applied to the skin.

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

You should 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

Do not use Linitul Antiseptic 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 inside 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 the ears, rinse immediately with plenty of water.
• Linitul Antiseptic 10 mg/ml should not come into contact with the eyes due to the risk of visual damage. If it comes into contact with the eyes, wash 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 induced sleep).

• Do not use in case of deep and extensive wounds without consulting a doctor.
• Do not apply repeatedly, nor use on large surfaces, with occlusive dressing (non-permeable), on damaged skin, and on mucous membranes.
• Do not use for the asepsis of puncture or injection areas, nor for the disinfection of surgical equipment.

Children

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

Use of Linitul Antiseptic 10 mg/ml with other medications

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

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

Pregnancy and breastfeeding

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

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

Driving and using machines

The influence of this medication on the ability to drive or use machines is null or insignificant.

3. How to use Linitul Antiseptic 10 mg/ml

Follow the administration instructions of the medication contained in this leaflet or as indicated by your doctor or pharmacist. In case of 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 make more than two daily applications of the product.

If you use more Linitul Antiseptic 10 mg/ml 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.

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 side effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

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

• Allergic reactions on the skin.
• Chemical burns in neonates.
• Corneal injury (injury to the surface of the eye) and permanent eye injury, including permanent visual impairment (after accidental eye exposure during surgical interventions in the head, face, and neck) in patients under general anesthesia (deep induced sleep).

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use http://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Linitul Antiseptic 10 mg/ml

This medication does not require special storage conditions.

Keep this medication out of 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.

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

Medications should not be thrown away through the sewers or in the trash. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Angileptol mint flavor

Each tablet contains:

• The active ingredients:

Chlorhexidine dihydrochloride, 5 mg

Benzocaine, 4 mg

Enoxolone, 3 mg

• The other components (excipients) are: sorbitol (E420), acesulfame potassium (E950), magnesium stearate, and mint flavor

Appearance of the product and package contents

Angileptol is a lozenge, white, round, and with the Greek letter σ on one of its faces.

It is presented in packages containing 15 and 30 lozenges.

Other presentations

Angileptol Mint-eucalyptus flavor

Angileptol Honey-lemon flavor

Marketing authorization holder

Alfasigma España S.L.

C/ Aribau 195, 4º

08021 Barcelona, Spain

Manufacturer

Pharmaloop, S.L

Polígono Industrial Azque C/Bolivia, 15

28806 Alcalá de Henares (Madrid), SPAIN

or

Alfasigma, S.p.A.

Via Pontina, Km 30,400

00071 Pomezia (Rome), ITALY

Date of the last revision of this leaflet:September 2021

Other sources of information

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