Prospect: information for the user

Linitul Healing Ointment

Peruvian balm / castor oil

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

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

• Keep this prospect, as you may need to read 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 prospect. See section 4.
• You should consult a doctor if it worsens or does not improve after 15 days.

1. What is Linitul Healing Ointment and for what it is used

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

3. How to use Linitul Healing Ointment

4. Possible adverse effects

5. Storage of Linitul Healing Ointment

6. Contents of the package and additional information

It belongs to a group of medications used as wound healers, and it acts by stimulating blood flow and reducing dehydration in the affected area.

Linitul Cicatrizante is indicated in adults to promote wound healing, 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.).
• Recent arterial blood clots (produced in an artery).

Warnings and precautions

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

• Do not use this medication on oily or acne-prone skin.
• Do not apply to the eyes.
• Consult your doctor if you have any disease with low hemoglobin (such as some anemias) or zinc deficiency, and in case of delayed wound healing.

Children and adolescents

Linitul Cicatrizante Ointment should not be applied to children because there is 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 conducted.

Peru balsam may cause 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 or plan to become pregnant, consult your doctor or pharmacist before using this medication.

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

Driving and operating machinery

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

Follow exactly the medication administration instructions 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:

Apply a thin layer of ointment to the affected area at least 2 times a day, and repeat as needed.

Skin use (on the skin).

After applying the ointment, the area can be covered with a protective dressing. The area should be gently washed with a cleaning solution (such as saline solution) when the ointment is renewed. Repeat the procedure as needed.

Use in children and adolescents

No data is available for its use in children.

If you use more Linitul Cicatrizante than you should

A overdose is unlikely to 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 Toxicological Information Service, Phone 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 everyone may experience them.

The exact frequency of the following adverse effects is unknown: allergic reactions such as contact dermatitis and a stinging sensation at the application site.

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 leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Human 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).

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 the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Linitul Cicatrizante

• The active principles: Peru balsam and castor oil. Each gram of ointment contains the soluble fraction of 20 mg of Peru balsam and 150 mg of castor oil.
• The other components (excipients) are: petrolatum, liquid petrolatum, dimeticone, beeswax, and solid paraffin.

Appearance of the product and content of the packaging

Linitul Cicatrizante Ointment e is a white translucent ointment.

It is presented in an aluminum tube containing 30 g of ointment.

- Other presentations of Linitul:

Linitul Cicatrizante Impregnated Dressing, 10 single-dose packs with dressings of 5.5x8 cm

Linitul Cicatrizante Impregnated Dressing, 20 dressings of 8.5 x 10 cm

Linitul Cicatrizante Impregnated Dressing, 20 single-dose packs with dressings of 9x15 cm

Linitul Cicatrizante Impregnated Dressing, 20 single-dose packs with dressings of 15x25 cm.

Holder of the marketing authorization and responsible for manufacturing

Holder

Alfasigma España, S.L.

Avda. Diagonal, 490

08006 Barcelona

Responsible for manufacturing

Alfasigma España, S.L.

Naus 301-304 Polig. Ind. Baix Ebre.

Campredo, Tortosa (Tarragona) Spain

Last review date of this leaflet: October 2024

Other sources of information

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