LINITUL 0.185 mg/1.678 mg Dressing

2. What you need to know before starting to use Linitul Healing

Do not use Linitul Healing

• If you are allergic to Peru balsam, castor oil, or any of the other components of this medication (included in section 6).
• If you suffer from inflammatory dermatosis (superficial skin inflammation, with redness, moisture, fluid retention, scales, itching, etc.).
• On recent arterial blood clots (produced in an artery).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Linitul Healing Dressing.

• Do not use this medication on skin with acne or oil.
• You should consult your doctor if you have a disease with a lack of hemoglobin (such as in some anemias) or zinc, and in case of delayed healing of your injury.

Children and adolescents

Linitul Healing Dressing should not be applied to children because there is no data on its use in them.

Other medications and Linitul Healing

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

No interaction studies have been conducted.

Peru balsam may present cross-reactions with Tolu balsam and some essential oils used as flavorings in sensitive individuals.

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.

Before using Linitul Healing Dressing during pregnancy or breastfeeding, the potential benefits should be weighed against the possible risks.

Driving and using machines

Linitul Healing Dressing does not affect your ability to drive or operate machinery.

3. How to use Linitul Healing

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.

The recommended dose is:

-Adults

Use the Linitul Healing Dressing presentation suitable for the size of the affected area.

The dressing is applied covering the affected area, ensuring that the skin is clean and dry, and proceeding to renew it every 12 or 24 hours, and it can be kept for a longer time if the treatment requires it.

If after 15 days of treatment the lesions worsen or do not improve, the clinical condition should be reevaluated.

Instructions for use

Topical use (on the skin).

Linitul Healing should be used immediately after opening the envelope or box. Do not reuse once used.

To apply Linitul Healing Dressing, preferably use tweezers previously disinfected with alcohol.

1. Make sure the skin is clean and dry.
2. Remove the Linitul Healing dressing from its packaging and place it on the affected area. In the single-dose presentations of Linitul Healing (5.5x8, 9x15, and 15x25), open the envelope by pulling the tabs to the end and slide the dressing, dragging it over the aluminum to collect the impregnation mass, which would otherwise remain on the aluminum walls. In the case of Linitul Healing 8.5x10, the polystyrene box will be carefully closed after use. Unfold the dressing if its size requires it (presentations 9x15 and 15x25).
3. Apply the dressing with the tweezers, so that it covers the affected area.
4. Cover the dressing with a protective bandage.

Use in children and adolescents

There is no data available on its use in children.

If you use more Linitul Healing than you should

It is unlikely that an overdose will occur with normal use.

However, in case of accidental ingestion, it may cause nausea, vomiting, colic, and severe diarrhea.

In case of accidental ingestion, consult your doctor or pharmacist immediately or go to a medical center, or call the Toxicology Information Service, Telephone 91 562 04 20, indicating the product and the amount ingested.

If you forget to use Linitul Healing

Do not use a double dose to make up for forgotten doses.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

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

With a frequency not exactly known, the following may occur: allergic reactions such as contact dermatitis and a sensation of itching at the application site.

Reporting side effects

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

5. Storage of Linitul Healing

Keep this medication out of sight and reach of children.

Do not store at a temperature above 30°C. Keep away from heat.

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.

Medications should not be thrown away in drains or trash. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. 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 Spain S.L.

C/ Aribau 195, 4th floor

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