Linitul Cicatrizing Impregnated Dressing

Patient Information Leaflet

Introduction

Patient Information Leaflet

Linitul Cicatrizante Impregnated Dressing

Peruvian balsam / castor oil

Read this entire 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 as directed by your doctor or pharmacist.

• Keep this leaflet, as you may need to refer to it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 15 days.

Contents of this leaflet

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

1. What Linitul Cicatrizante Dressing is and what it is used for

It belongs to a group of medicines called medicated dressings, and contains an ointment base that is used as a healing agent, acting by stimulating blood flow and reducing drying in the affected area.

Linitul Cicatrizante is indicated in adults to promote the healing of wounds, minor burns, pressure ulcers (decubitus ulcers), and varicose ulcers.

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

Do not use Linitul Cicatrizante

• If you are allergic to Peru balsam, castor oil, or any of the other components of this medicine (listed in section 6).
• If you have inflammatory dermatosis (superficial skin inflammation, with redness, moisture, fluid retention, scaling, itching, etc.).
• On recent arterial blood clots (occurring in an artery).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Linitul Cicatrizante Apósito.

• This medicine should not be used on acne-prone or oily skin.
• You should consult your doctor if you suffer from any disease involving hemoglobin deficiency (such as certain anemias) or zinc deficiency, or if you have delayed wound healing.

Children and adolescents

Linitul Cicatrizante Apósito should not be applied to children, as there are no data available on its use in this population.

Other medicines and Linitul Cicatrizante

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

No interaction studies have been conducted.

Peru balsam may cause cross-reactions in sensitive individuals with Tolu balsam and certain essential oils used as flavoring agents.

Pregnancy and breastfeeding

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

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

Driving and using machines

Linitul Cicatrizante Apósito does not affect your ability to drive or operate machinery.

3. How to use Linitul Cicatrizante

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

The recommended dose is:

-Adults

Use the Linitul Cicatrizante Impregnated Dressing presentation appropriate for the size of the affected area.

Apply the dressing to cover the affected area, ensuring that the skin is clean and dry, and renew it every 12 or 24 hours. It may be left in place for a longer period if required by the treatment.

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

Instructions for use

Cutaneous use (on the skin).

Linitul Cicatrizante should be used immediately after opening the pouch or box. It must not be reused once used.

To apply Linitul Cicatrizante Dressing, use preferably alcohol-disinfected forceps.

1. Ensure the skin is clean and dry.
2. Remove the Linitul Cicatrizante dressing from its packaging and place it over the affected area. For single-dose presentations of Linitul Cicatrizante (5.5x8, 9x15, and 15x25), open the pouch by pulling the tabs fully apart and slide the dressing, dragging it across the aluminum to collect the impregnating mass, which would otherwise remain on the aluminum walls. In the case of Linitul Cicatrizante 8.5x10, the polystyrene box should be carefully closed after use. Unfold the dressing if its size requires it (presentations 9x15 and 15x25).
3. Apply the dressing with forceps 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 Cicatrizante than you should

Overdose is unlikely with normal use.

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

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

If you forget to use Linitul Cicatrizante

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

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

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

Adverse effects with unknown exact frequency may include: allergic reactions such as contact dermatitis and burning sensation at the application site.

Reporting of adverse effects

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

5. Storage of Linitul Cicatrizante

Keep this medicine out of sight and reach of children.

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

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.

Medicines should not be disposed of via wastewater drains or household waste. Unused containers and medicines should be returned to the SIGRE Point at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the package and other information

Composition of Linitul Cicatrizante Impregnated Dressing

• The active substances are: Peru balsam and castor oil. Each gram of the mixture (oleaginous mass) contains the soluble fraction of 18.5 mg of Peru balsam and 167.8 mg of castor oil.
• The other components (excipients) are: soft white paraffin, liquid paraffin, beeswax, solid paraffin, and gauze.

Appearance of the product and contents of the packaging (presentations)

Linitul Cicatrizante Impregnated Dressing is presented as impregnated dressings. These are flexible, yellowish-white greasy dressings (products used to protect a wound) made of polyester gauze, containing an oily mixture.

Presentations:

• Unit-dose sachets:

Linitul Cicatrizante Impregnated Dressing, 10 unit-dose sachets with 5.5x8 cm dressing.

Linitul Cicatrizante Impregnated Dressing, 20 unit-dose sachets with 9x15 cm dressing.

Linitul Cicatrizante Impregnated Dressing, 20 unit-dose sachets with 15x25 cm dressing.

• Other presentation:

Linitul Cicatrizante Impregnated Dressing, 20 dressings of 8.5x10 cm.

Other presentations of Linitul Cicatrizante

Linitul Cicatrizante Ointment, 30-gram tube.

Marketing Authorization Holder and Manufacturer

Holder

Alfasigma España, S.L.

C/ Aribau 195, 4º

08021 Barcelona, Spain

Manufacturer

Alfasigma España, S.L.

Naus 301-304 Polig. Ind. Baix Ebre.

Campredo, Tortosa (Tarragona), Spain

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

Other sources of information

Detailed and up-to-date 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/.