ANTICONGESTIVA CUSI (LASSAR PASTE) - Decongestant Paste

Introduction

Package Leaflet: Information for the User

Anticongestiva Cusí (Pasta Lassar) Skin Paste

Zinc oxide / cornstarch

Read the entire 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.
• You should consult a doctor if your symptoms worsen or do not improve after 7 days.

Contents of the Package Leaflet:

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

1. What Anticongestiva Cusí is and what it is used for

It belongs to the group of emollient and protective medications that contain zinc. It combines the protective action of zinc oxide and cornstarch; the first absorbs moisture and has a mild astringent (healing) and moderate antisepic (anti-infectious) effect.

Anticongestiva Cusí is indicated for the protection and temporary relief of mild irritative skin conditions, such as:

Burns, irritations, and superficial erosions of the skin caused by: minor or superficial burns, sun erythema, intertrigo (inflammation of skin folds).

Anticongestiva Cusí is indicated for adults and children.

2. What you need to know before starting to use Anticongestiva Cusí

Do not use Anticongestiva Cusí

• if you are allergic to zinc oxide, cornstarch, or any of the other components of this medication (listed in section 6).
• if you have an infection in the area to be treated.

Warnings and Precautions

Consult your doctor or pharmacist before starting to use Anticongestiva Cusí.

• Avoid contact of the medication with the eyes, ears, and other mucous membranes.
• The product should not be used for a prolonged period or on large areas of the skin.

Children

Anticongestiva Cusí can be applied to children under 2 years of age.

Using Anticongestiva Cusí with other medications

Tell your doctor or pharmacist if you are using or may need to use any other medication.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Anticongestiva Cusí should not be used during pregnancy or breastfeeding, unless it is clearly necessary, considering the benefits versus the risks.

Anticongestiva Cusí should not be applied to the breasts if you are breastfeeding a baby.

Driving and Using Machines

This preparation does not affect the ability to drive or use machinery.

Anticongestiva Cusí contains lanolin.

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

3. How to use Anticongestiva Cusí

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor. If in doubt, ask your doctor or pharmacist.

The recommended dose is:

• Adults and children:

Generally, a thin layer of paste will be applied 1 or 2 times a day.

For skin use.

Puncture the tube mouth using the punch incorporated into the cap at the top.

Clean and dry the area to be treated well. Then apply the paste directly to the area, covering it with a gauze in cases where it is necessary.

If symptoms do not improve within 7 days or worsen during treatment, consult a doctor.

If you use more Anticongestiva Cusí than you should

Due to the characteristics of this preparation, intended for skin use, intoxication phenomena are not expected with the use of the product at the recommended doses.

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

If you forget to use Anticongestiva Cusí

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, Anticongestiva Cusí can cause side effects, although not everyone experiences them.

The following side effects may occur, with an unknown frequency:

Allergic manifestations, local irritation, itching, or burning. In these cases, treatment should be discontinued and the affected area washed with water.

Granulomatous lesions (inflammatory) may appear.

Others: dryness of the skin and, with prolonged use, increased residue of the lesion, with increased discomfort.

If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet.

5. Storage of Anticongestiva Cusí

Store below 25°C.

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

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 thrown away in drains or trash. 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 Anticongestiva Cusí

• The active ingredients are zinc oxide and cornstarch. Each gram of paste contains

250 mg of zinc oxide (25%) and 250 mg of cornstarch (25%).

• The other components (excipients) are lanolin (wool fat), petroleum jelly, and

liquid petroleum jelly.

Appearance of the Product and Package Contents

Anticongestiva Cusí is a skin paste (for skin use) and is presented in a package containing 45 g of paste.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona), Spain

[email protected]

Manufacturer

Laboratoris Feltor, S.A.U.

Polígono Industrial Molí de les Planes

Roques Blanques, 3-5

08470 Sant Celoni (Barcelona), Spain

Date of the Last Revision of this Package Leaflet:October 2012

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/