PASTA LASSAR IMBA OINTMENT

Introduction

Package Leaflet: Information for the User

Pasta Lassar Imba Ointment

Zinc Oxide

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

Follow the administration instructions for 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 not listed in this package leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after 7 days.

Contents of the Package Leaflet

1. What Pasta Lassar Imba Ointment is and what it is used for
2. What you need to know before using Pasta Lassar Imba Ointment
3. How to use Pasta Lassar Imba Ointment
4. Possible side effects
5. Storage of Pasta Lassar Imba Ointment
6. Package contents and additional information

1. What Pasta Lassar Imba Ointment is and what it is used for

It is an ointment that contains zinc oxide as the active ingredient for use on the skin; it belongs to the medications called emollients and protectants. Zinc oxide is a skin protector that acts as a barrier between the skin and irritants.

Pasta Lassar Imba is indicated for: Prevention and treatment of diaper area dermatitis and prevention of chafing and irritation in other areas of friction with clothing or other skin areas.

Protection and relief of mild skin irritations: Mild excoriations (abrasions) and chafing.

2. What you need to know before using Pasta Lassar Imba Ointment

Do not use Pasta Lassar Imba

• if you are allergic to zinc oxide or any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Pasta Lassar Imba.

• Avoid contact of the medication with the eyes, ears, and other mucous membranes, such as the nose and mouth.
• Do not use the product if the area of skin to be treated has wounds that secrete fluid.

Children

Pasta Lassar Imba can be applied to children. The usual precautions are required in babies and children.

Other medications and Pasta Lassar Imba

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

It is recommended not to apply other products at the same time as this medication on the same area.

Pregnancy, breastfeeding, and fertility

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.

In necessary cases, Pasta Lassar Imba can be used during pregnancy or breastfeeding if necessary, and the benefits outweigh the potential risks.

Driving and using machines

Pasta Lassar Imba does not affect your ability to drive or operate machinery.

Pasta Lassar Imba Ointment contains lanolin

This medication may cause local skin reactions (such as contact dermatitis) because it contains lanolin.

3. How to use Pasta Lassar Imba Ointment

Follow the administration instructions for 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:

Topical use (on the skin).

• In diaper area dermatitis: Once the area to be protected or treated is clean and dry, apply the ointment 2 to 3 times a day over the area, usually after a diaper change.

The application of Pasta Lassar should be done in general after bathing and, if necessary, at other times, usually coinciding with diaper changes, covering the area to be treated with a thin layer using the fingertips.

• In other cases, apply the ointment to the affected area as needed, 2 to 3 times a day in general.

If symptoms do not improve within 7 days or worsen, you should consult a doctor.

Use in children

Apply as described.

If you use more Pasta Lassar Imba than you should

No risk of intoxication is expected if the product is used as recommended.

Prolonged use of this medication may cause irritation. In case of application of an excessive amount of product and skin irritation occurs, wash the affected area with plenty of water and mild soap.

In case of accidental ingestion of large amounts of the medication, symptomatic treatment should be applied. It may cause allergic reactions in patients with wheat allergy.

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 Pasta Lassar Imba

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

If you have any other questions 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.

The frequencies of adverse reactions are defined as:

• Common: may affect up to 1 in 10 people.
• Rare: may affect up to 1 in 1000 people.

The following adverse reactions have been reported:

• Common is the appearance of local skin reactions, such as local irritation, itching, or burning.
• Rarely, granulomatous lesions (inflammatory) may appear.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Pasta Lassar Imba Ointment

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

Keep the tube perfectly closed.

Do not store at a temperature above 25°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. If in doubt, 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 Pasta Lassar Imba Ointment

• The active ingredient is Zinc Oxide. Each gram of ointment contains 250 mg of zinc oxide (25%).
• The other components (excipients) are: wheat starch, lanolin, and refined almond oil.

Appearance of the product and package contents

Pasta Lassar Imba is a semi-solid, greasy, homogeneous ointment, ivory in color, and characteristic of lanolin in smell.

Each package contains a tube with 50 g.

Marketing authorization holder and manufacturer

PHARMEX ADVANCED LABORATORIES, S.L.

Ctra. A-431 Km.19

14720 Almodóvar del Río (Córdoba), Spain

Date of the last revision of this package leaflet:February 2017.

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/.