Label: Information for the User

Lassar Imba Ointment

Zinc Oxide

Read this label carefully before using this medicine, as it contains important information for you.

Follow exactly the administration instructions contained in this label or those given 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 any 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 7 days.

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.

Lassar's Paste Imba is indicated for: Prevention and treatment of diaper dermatitis and prevention of friction and irritation in other areas of skin contact with clothing or other areas of the skin.

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

Do not use Lassar's Paste Imba

• if you are allergic to zinc oxide or 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's Paste Imba.

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

Children

Lassar's Paste Imba may be applied to children. The usual precautions are required in babies and children.

Other medicines and Lassar's Paste Imba

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

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

Pregnancy, breastfeeding and fertility

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

In necessary cases, Lassar's Paste Imba may be used during pregnancy or breastfeeding if necessary, and the benefits outweigh the potential risks.

Driving and operating machines

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

Lassar's Paste Imba Ointment contains lanolin

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

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:

Cutaneous use (on the skin).

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

The application of Lassar Imba should be made in general after bathing and, if necessary, 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 in 7 days or worsen, consult a doctor.

Use in children

Apply as described.

If you use more Lassar Imba than you should

No overdose is expected if the product is used as recommended.

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

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

In case of accidental ingestion, consult a 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 Lassar Imba

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 may experience them.

The frequencies of adverse reactions are defined as:

- Frequent: may affect up to 1 in 10 people.

- Rare: may affect up to 1 in 1000 people.

The following adverse reactions have been reported:

- It is frequent for local skin reactions to appear, such as local irritation, itching, or stinging.

- Rarely, granulomatous lesions (inflammatory) may appear.

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: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.

Keep the tube perfectly closed.

Do not store at a temperature above 25°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.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Lassar Imba Ointment

• The active principle 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 packaging

Lassar Imba Ointment is a semi-solid, greasy, homogeneous, ivory-colored product with a characteristic lanolin odor.

Each package contains a 50 g tube.

Holder of the marketing authorization and responsible for manufacturing

PHARMEX ADVANCED LABORATORIES, S.L.

Ctra. A-431 Km.19

14720 Almodóvar del Río (Córdoba)Spain

Date of the last review of this leaflet:February 2017.

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