This medicine belongs to a group of medicines called sympathomimetics. It is a nasal decongestant medicine that contains oxymetazoline as an active ingredient. Oxymetazoline administered through the nose produces constriction of blood vessels locally, decongesting the nasal mucosa.

It is indicated for the local and temporary relief of nasal congestion in adults and children from 6 years of age.

You must talk to a doctor if you do not feel better or if you feel worse after 3 days of treatment.

Do not use Utabon Adults

• if you are allergic to oxymetazoline, other nasal decongestants or any of the other ingredients of this medicine (listed in section 6).
• if you have recently had an operation on your head (if you have undergone a cranial, transnasal or transoral surgery).

Warnings and cautions

Talk to your doctor or pharmacist before using Utabon Adult if:

• You are being treated with antidepressant medications, phenothiazine (tranquilizer), or methyldopa (to lower blood pressure).
• You have suffered or are suffering from, even if it only happened once, any of the following illnesses or symptoms:

• If you have high blood sugar levels (diabetes mellitus)
• If you have high blood pressure (hypertension)
• If you have a disease of the heart or circulatory system
• If you have any prostate disease with difficulty urinating (prostatic hypertrophy)
• If you have any thyroid disease (hyperthyroidism)

• If you have ever suffered from insomnia or vertigo when you have been treated with other sympathomimetic medicines, such as, for example, some of those used to treat heart disease, hypotension (low blood pressure) or to treat asthma.

In rare cases, oxymetazoline, due to its temporary effects and prolonged use, can increase nasal congestion instead of reducing it; This is known as the rebound effect.

Insomnia can rarely occur after using the medicine. If this happens to you, avoid using it in the late afternoon or evening.

Do not exceed the recommended dose in section 3. How to use Utabon Adults.

To avoid contagion, the medicine should not be used by more than one person and the applicator should always be cleaned after each use with a clean, damp cloth.

Children

Do not use in children under 6 years without consulting a doctor. Children can be especially prone to the appearance of adverse effects of this medicine.

Interaction of Utabon Adults with other medications

Please inform your doctor or pharmacist if you are using or have recently used any other medicines, even those obtained without a prescription.

This medicine should not be used by people who are taking or have taken during the last 2 weeks: medicines used to treat depression (tricyclic antidepressants or monoamine oxidase inhibitors (MAOIs)), or with a medicine to lower blood pressure called methyldopa .

It should also not be used in case of being treated with phenothiazine (tranquilizer) or with medications to treat asthma.

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, or think you might be pregnant or are planning to become pregnant, consult your doctor or pharmacist before using any medicine.

This medicine should not be used during pregnancy or while breastfeeding.

Driving and using machines

Although this medicine is not expected to affect the ability to drive or use machines, if you experience drowsiness or dizziness, do not drive or operate dangerous machinery.

Utabon Adults contains benzalkonium chloride

This medicine can cause inflammation of the nasal mucosa, especially with long-term treatments, because it contains benzalkonium chloride. If such a reaction (persistent nasal congestion) is suspected, a nasal medicine that does not contain this excipient should be used whenever possible.

Follow exactly the instructions for administration of the medicine contained in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

The normal dose is:

Adults and children over 6 years: one application in each nostril, once a day. If necessary, another application can be made every 12 hours. Do not use more than 2 times in 24 hours.

Use in children

This medicine should not be used in children younger than 6 years old.

Children can be especially prone to the appearance of adverse effects of this medicine.

Over 65 years

Consult your doctor or pharmacist as older people are more sensitive to the adverse effects of this medicine.

How to use

This medicine is used nasal.

Instructions for the correct administration of the medication

Before applying this medicine, you need to remove the existing nasal fluids by blowing your nose well.

Make an application in each nostril keeping the head straight. Inhale deeply while squeezing the bottle quickly and firmly. It can also be administered in the form of drops, tilting the head back for a few minutes so that the medicine spreads into the nose.

To avoid contagion, after each use and before closing the container, the end of the applicator should be cleaned with a clean, damp cloth. In addition, each container should be used only by one person.

If it worsens or if it does not improve after 3 days of treatment, stop the treatment and consult your doctor.

If you use more Utabon Adult than you should

By applying excessive or very continuous doses you may notice: headache, tremors, insomnia, excessive sweating, palpitations, tachycardia, increased blood pressure or sleep disturbances.

In case of overdose or accidental ingestion, immediately consult your doctor or pharmacist, or call the Toxicology Information Service, telephone 915 620 420, indicating the medicine and the amount ingested.

Like all medicines, Utabon Adults can cause side effects, although not everyone gets them.

During the period of use of oxymetazoline the following side effects have been observed, the frequency of which has not been able to be accurately established:

The most common side effects are:

Stinging at the application site, dryness, itching of the nasal mucosa or sneezing.

Side effects that may occur in rare cases are:

Anxiety, restlessness, insomnia, hallucinations, tremors, and sleep disorders in children. Tachycardia, palpitations, increased blood pressure, headache, nausea, rash (redness of the skin).

Excessive or continued use of this medicine can lead to nasal congestion.

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

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

Store below 25 ° C.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Deposit the containers and medicines that you do not need at the SIGRE Point of the pharmacy. If in doubt, ask your pharmacist how to dispose of unneeded medicine and containers. This way you will help to protect the environment.

Composition of Utabon

• The active substance is: oxymetazoline hydrochloride. Each ml contains 0.5 mg of oxymetazoline hydrochloride (35 micrograms per 0.07 ml pump).

• The other ingredients (excipients) are: benzalkonium chloride, anhydrous disodium hydrogen phosphate, sodium dihydrogen phosphate dihydrate, glycine (E-640), sorbitol (E-420) and purified water.

What the product looks like and contents of the pack

Utabon is a clear, colorless solution. It is presented in a container with a dosing pump containing 15 ml of solution.

Holder of the marketing authorization and responsible for manufacturing

Marketing authorization holder:

Uriach Consumer Healthcare, SL

Av. Camí Reial 51-57

08184 Palau-solità i Plegamans

(Barcelona, Spain)

Responsible for manufacturing:

ITALFARMACO, SA

San Rafael, 3

28108 - Alcobendas

(Spain)

Date of the last revision of this leaflet: December 2012

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