Label: Information for the User

Linitul Healing Apósito Impregnated

Peruvian balm / castor oil

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

Follow exactly the medication administration instructions contained in this label or those indicated by your doctor or pharmacist.

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

1. What isLinitul Healingand for what it is used

2. What you need to know before starting to useLinitul Healing

3. How to useLinitul Healing

4. Possible adverse effects

5. Storage ofLinitul Healing

6. Contents of the package and additional information

It belongs to a group of medications called medicated dressings, and contains a greasy mass that is used as a wound healer, 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.

Do not use Linitul Cicatrizante

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

Warnings and precautions

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

• Do not use this medication on skin with acne or oiliness.
• Consult your doctor if you have any disease with low hemoglobin (such as some anemias) or zinc and in case of delayed healing of your wound.

Children and adolescents

Linitul Cicatrizante Apósito should not be applied in children because there are no data on its use in them.

Other medications and Linitul Cicatrizante

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

No interactions studies have been performed.

Peru balsam may present cross-reactions in sensitive individuals with Peru balsam, tolu balsam, and some essential oils used as fragrances.

Pregnancy and breastfeeding

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

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

Driving and operating machinery

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

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.

The recommended dose is:

-Adults

The appropriate Linitul Cicatrizante Apósito impregnated presentation will be used according to the size of the affected area.

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

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

Usage Instructions

Cutaneous use (on the skin).

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

To apply Linitul Cicatrizante Apósito, preferably use pre-sterilized pinches with alcohol.

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

Use in children and adolescents

No data is available for its use in children.

If you use more Linitul Cicatrizante 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, cramps, and severe diarrhea.

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

If you forgot to use Linitul Cicatrizante

Do not use a double dose to compensate for the missed doses.

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

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

Adverse effects of unknown frequency may include: allergic reactions such as contact dermatitis and a stinging sensation at the site of application.

Reporting 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 prospectus. You can also report them directly through the Spanish System of Pharmacovigilance for human use medications, https://www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

Do not store at a temperature above 86°F (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.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition of Linitul Cicatrizante Apósito impregnado

• The active principles are: Peru balsam and castor oil. Each gram of the mixture (greasy mass) contains the soluble fraction of 18.5 mg of Peru balsam and 167.8 mg of castor oil.
• The other components (excipients) are: petrolatum, liquid petrolatum, beeswax, solid paraffin, and wool.

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

Linitul Cicatrizante apósito impregnado is presented in the form of impregnated dressings. They are dressings (products used to protect a wound) of polyester wool, flexible, containing a greasy mixture of yellowish white color.

Presentations:

- Single-dose presentations:

Linitul Cicatrizante Apósito impregnado, 10 single-dose packs with dressing of 5.5x8 cm.

Linitul Cicatrizante Apósito impregnado, 20 single-dose packs with dressing of 9x15 cm.

Linitul Cicatrizante Apósito impregnado, 20 single-dose packs with dressing of 15x25 cm.

- Other presentation:

Linitul Cicatrizante Apósito impregnado, 20 dressings of 8.5x10 cm.

Other presentations of Linitul Cicatrizante

Linitul Cicatrizante Ointment, 30-gram tube.

Holder of the authorization for commercialization and responsible for the manufacturing

Holder

Alfasigma España, S.L.

Avda.Diagonal, 490

08006 Barcelona

Responsible for the manufacturing

Alfasigma España, S.L.

Naus 301-304 Polig. Ind. Baix Ebre.

Campredo,Tortosa (Tarragona) Spain

Date of the last review of this prospectus: October 2024

Other sources of information

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