UTABON ADULTS 0.5 mg/ml NASAL SPRAY SOLUTION

Introduction

Package Leaflet: Information for the User

Utabon Adults 0.5 mg/ml Nasal Spray Solution

Oxymetazoline Hydrochloride

Read this package leaflet carefully before starting to use this medicine, as it contains important information for you.

Follow the administration instructions for the medicine 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 condition worsens or does not improve after 3 days of treatment.

Contents of the Package Leaflet:

1. What Utabon Adults is and what it is used for
2. What you need to know before taking Utabon Adults
3. How to take Utabon Adults
4. Possible side effects
5. Storage of Utabon Adults
6. Package Contents and Additional Information

1. What Utabon Adults is and what it is used for

This medicine belongs to the group of medicines called sympathomimetics. It is a nasal decongestant that contains oxymetazoline as the active ingredient. Oxymetazoline, when administered nasally, produces local vasoconstriction, 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 should consult a doctor if your condition worsens or does not improve after 3 days of treatment.

2. What you need to know before taking Utabon Adults

Do not use Utabon Adults

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

Warnings and Precautions

Consult your doctor or pharmacist before starting to use Utabon Adults if:

• You are being treated with antidepressant medications, phenothiazine (a tranquilizer), or methyldopa (for lowering blood pressure).
• You have had or currently have any of the following diseases or symptoms:

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

• If you have ever experienced insomnia or dizziness when treated with other sympathomimetic medications, such as those used to treat heart diseases, hypotension (low blood pressure), or asthma.

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

Insomnia may rarely occur after using the medicine. If this happens, 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 be cleaned after each use with a clean, damp cloth.

Children

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

Interaction of Utabon Adults with other medicines

Inform your doctor or pharmacist if you are using or have recently used other medicines, including those purchased without a prescription.

This medicine should not be used by people who are taking or have taken in 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 treatment with phenothiazine (a tranquilizer) or with medicines to treat asthma.

Pregnancy and Breastfeeding

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

This medicine should not be used during pregnancy or breastfeeding.

Driving and Using Machines

Although it is not expected that this medicine will affect your ability to drive or use machines, if you notice drowsiness or dizziness, do not drive or operate hazardous machinery.

Utabon Adults contains Benzalkonium Chloride

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

3. How to use Utabon Adults

Follow the administration instructions for the medicine contained in this package leaflet or as indicated by your doctor or pharmacist. In case of 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 under 6 years of age.

Children may be especially prone to the 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 nasally.

Instructions for the correct administration of the medicine

Before applying this medicine, eliminate any existing nasal fluids by blowing your nose well.

Make one application in each nostril, keeping your head straight. Inhale deeply while quickly and firmly pressing the container. It can also be administered as drops, tilting your head back for a few minutes to allow the medicine to spread inside the nose.

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

If your condition worsens or does not improve after 3 days of treatment, discontinue treatment and consult your doctor.

If you use more Utabon Adults than you should

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

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

4. Possible side effects

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

During the period of use of oxymetazoline, the following side effects have been observed, whose frequency cannot be established with precision:

The most common side effects are:

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

Rare side effects that may occur are:

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

The excessive or continued use of this medicine may lead to nasal congestion.

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

5. Storage of Utabon Adults

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

Store below 25°C.

Do not use this medicine after the expiration date stated on the container after CAD. The expiration date is the last day of the month indicated.

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

6. Package Contents and Additional Information

Composition of Utabon

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

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

Appearance of the Product and Package Contents

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

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Uriach Consumer Healthcare, S.L.

Av. Generalitat 163-167

08174 Sant Cugat del Vallès

(Barcelona - Spain)

Manufacturer:

ITALFARMACO, S.A.

San Rafael, 3

28108 – Alcobendas

(Spain)

Date of the last revision of this package leaflet: December 2012

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