Label: information for the user

Anticongestiva Cusí (Lassar's Paste) Cutaneous paste

Zinc oxide / cornstarch

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

Follow exactly the medication administration instructions contained in this label or those indicated 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.
• You should consult a doctor if your condition worsens or does not improve after 7 days.

It belongs to the group of emollient and protective medications that contain zinc. It combines the protective action of zinc oxide and starch; the former absorbs moisture and has a mild astringent (healing) and moderate antiseptic (anti-infective) effect.

Anticongestiva Cusí is indicated for the protection and temporary relief of mild skin irritations, including the following:

Minor burns, superficial burns, sunburn, intertrigo (inflammation of skin folds).

Anticongestiva Cusí is indicated for adults and children.

Do not use Anticongestiva Cusí

• if you are allergic to zinc oxide, cornstarch, or any of the other ingredients 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.

- Do not use the product for a prolonged period or on large areas of the skin.

Children

Anticongestiva Cusí may be applied to children under 2 years old.

Use of Anticongestiva Cusí with other medications

Inform 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 is not recommended during pregnancy or breastfeeding, except if clearly necessary, taking into account the benefits versus the risks.

Do not apply Anticongestiva Cusí to the breasts if breastfeeding a baby.

Driving and operating machinery

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

Anticongestiva Cusícontains lanolin.

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

Follow exactly the medication administration instructions contained in this prospectus or those indicated by your doctor. In case of 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.

Cutaneous use.

Perforate the tube mouth, using for this purpose the pin that comes incorporated with the cap on its upper part.

Clean and dry the area to be treated well. Then apply the paste directly on the area, covering it with a gauze when necessary.

If symptoms do not improve in 7 days or worsen during treatment, consult the doctor.

If you use more Anticongestiva Cusíthan you should

Due to the characteristics of this preparation, intended for cutaneous use, it is not expected to have intoxication phenomena 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 Toxicological Information Service, phone: 91 562 04 20, or go to a medical center, indicating the medication and the amount ingested.

If you forgot to use Anticongestiva Cusí

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, Anticongestiva Cusí may produce adverse effects, although not all people will experience them.

The following adverse effects may occur, with frequency unknown exactly:

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

Granulomatous (inflammatory) lesions may appear.

Others: dry skin and, with prolonged use, increased scarring, with increased discomfort.

If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus.

Store below 25°C.

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

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 Anticongestiva Cusí

- The active principles 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), White petrolatum and

Liquid petrolatum.

Appearance of the product and content of the packaging

Anticongestiva Cusí is a topical paste (for use on the skin) and is presented in a packaging that contains45 gof paste.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

STADA Laboratory, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)
Spain

[email protected]

Responsible for manufacturing

Feltor Laboratories, S.A.U.

Molí de les Planes Industrial Estate

Roques Blanques, 3-5

08470 Sant Celoni (Barcelona)

Spain

Last review date of this leaflet:October 2012

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