LINITUL CICATRIZANTE POMADA - Healing Liniment Ointment

Introduction

Package Leaflet: Information for the User

Linitul Healing Ointment

Peru balsam / castor oil

Read the entire package 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 package leaflet or as indicated by your doctor or pharmacist.

• Keep this package 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 package leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after 15 days.

Contents of the Package Leaflet

1. What Linitul Healing Ointment is and what it is used for
2. What you need to know before starting to use Linitul Healing Ointment
3. How to use Linitul Healing Ointment
4. Possible side effects
5. Storage of Linitul Healing Ointment
6. Package Contents and Additional Information

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

It belongs to a group of medications used as healing agents, and it acts by stimulating blood flow and reducing desiccation in the affected area.

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

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

Do not use Linitul Healing Ointment

• If you are allergic to Peru balsam, castor oil, or any of the other components of this medication (listed 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 Ointment.

• Do not use this medication on skin with acne or oil.
• Do not apply to the eyes.
• You should consult a 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 lesion.

Children and Adolescents

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

Other Medications and Linitul Healing Ointment

Tell 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 in sensitive individuals with balsam of Tolu and with some essential oils used as flavorings.

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 Ointment during pregnancy or breastfeeding, the potential benefits should be weighed against the possible risks.

Driving and Using Machines

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

3. How to use Linitul Healing Ointment

Follow the administration instructions of the medication contained in this package leaflet or as 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.

Topical use (on the skin).

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

Use in Children and Adolescents

There is no data on its use in children.

If you use more Linitul Healing Ointment 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, Phone 91 562 04 20, indicating the product and the amount ingested.

If you forget to use Linitul Healing Ointment

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 an unknown frequency, 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 not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance 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 Ointment

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

Do not store at a temperature above 30°C.

Do not use this medication after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. 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 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 sucking tablet, white, round, and with the Greek letter σ on one of the faces.

It is presented in packages containing 15 and 30 sucking tablets.

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 Package 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