Lassar paste Imba ointment

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Pasta Lassar Imba ointment

Zinc Oxide

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 those given by your doctor or pharmacist.

• Keep this leaflet, as you may need to read 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 effects not listed in this leaflet. See section 4.
• You should consult a doctor if your condition worsens or if you do not get better after 7 days.

Contents of the 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 adverse effects
5. How to store Pasta Lassar Imba ointment
6. Contents of the pack and other information

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

It is an ointment containing zinc oxide as the active ingredient for topical use, belonging to a group of medicines known as emollients and protectants. Zinc oxide is a skin protectant that acts as a barrier between the skin and irritants.

Pasta Lassar Imba is indicated for: Prevention and treatment of diaper dermatitis and prevention of chafing and irritations in other areas of skin 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 Lassar Paste Imba ointment

Do not use Lassar Paste Imba

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

Warnings and precautions

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

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

Children

Lassar Paste Imba may be applied to children. Usual precautions should be taken in infants and children.

Other medicines and Lassar Paste Imba

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

It is recommended not to apply other products simultaneously with this medicine to the same area.

Pregnancy, breastfeeding, and fertility

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

Lassar Paste Imba may be used during pregnancy or breastfeeding when necessary and when the benefits outweigh the potential risks.

Driving and using machines

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

Lassar Paste Imba Ointment contains lanolin

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

3. How to use Imba Lassar Paste ointment

Follow exactly the instructions for use provided in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

The recommended dose is:

For topical use (on the skin).

• In diaper dermatitis: After cleaning and drying the area to be protected or treated, apply the ointment 2 to 3 times daily to the affected area, usually after each diaper change.

Imba Lassar Paste should generally be applied after bathing and, if necessary, at other times, usually coinciding with diaper changes, covering the affected area with a thin layer using the fingertips.

• In all other cases, apply the ointment to the affected area as needed, generally 2 to 3 times daily.

If symptoms do not improve within 7 days or worsen, you must consult your doctor.

Use in children

Apply as described above.

If you use more Imba Lassar Paste than you should

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

Prolonged use of this medicine may cause irritation. If an excessive amount of product is applied and skin irritation occurs, wash the affected area thoroughly with plenty of water and mild soap.

In case of accidental ingestion of large quantities of the medicine, symptomatic treatment should be administered. Allergic reactions may occur in patients allergic to wheat.

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

If you forget to use Imba Lassar Paste

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 can cause adverse effects, although not everyone will experience them.

The frequencies of adverse reactions are defined as follows:

• Frequent: may affect up to 1 in 10 people.
• Rare: may affect up to 1 in 1,000 people.

The following adverse reactions have been reported:

• Local skin reactions such as local irritation, itching, or burning sensation are frequent.
• Granulomatous (inflammatory) lesions may rarely occur.

Reporting of adverse effects

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

5. Storage of Pasta Lassar Imba ointment

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

Keep the tube tightly closed.

Do not store above 25°C.

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 must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Pasta Lassar Imba ointment

• The active substance 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 contents of the container

Pasta Lassar Imba is a semi-solid, greasy, homogeneous ointment of ivory colour and with a characteristic lanolin odour.

Each package contains one 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 most recent revision of this leaflet: February 2017.

Detailed 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/.