UTABON NIÑOS 0.25 mg/ml NASAL DROPS IN SOLUTION

Introduction

Leaflet: Information for the user

Utabon Children 0.25 mg/ml nasal drops in solution

Oxymetazoline hydrochloride

Read this leaflet carefully before starting to use this medicine, because it

contains important information for you.

Follow exactly the administration instructions of the medicine contained in this leaflet or as indicated by your doctor or pharmacist.

• Keep this 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 leaflet.
• You should consult a doctor if it worsens or does not improve after 3 days of treatment.

Contents of the leaflet:

1. What is Utabon Children and what is it used for
2. What you need to know before starting to use Utabon Children
3. How to use Utabon Children
4. Possible side effects
5. Storage of Utabon Children
6. Package contents and additional information

1. What is Utabon Children and what is it 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 through the nose, produces local constriction of blood vessels, decongesting the nasal mucosa.

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

You should consult a doctor if it worsens or does not improve after 3 days of treatment.

2. What you need to know before starting to use Utabon Children

Do not use Utabon Children:

• 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 an operation on the head (if you have undergone any cranial, transnasal, or transoral surgical intervention).

Warnings and precautions

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

• You are being treated with antidepressant medications, phenothiazine (tranquilizer), or methyldopa (to lower 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 suffered from 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, due to its temporary effects and prolonged use, can increase nasal congestion instead of decreasing it; this is known as rebound effect.

Insomnia can 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 Children.

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

Children

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

Children may be especially prone to the appearance of side effects of this medicine.

Interaction of Utabon Children 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 (tranquilizer) or with medicines to treat asthma.

Pregnancy and lactation

If you are pregnant or breastfeeding, or think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using a 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 Children 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 Children

Follow exactly the administration instructions of the medicine contained in this leaflet or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

The normal dose is:

Children over 6 years old:one application of 2 drops in each nostril, once a day. One drop is equivalent to approximately 0.023 ml. 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 old.

Children may be especially prone to the appearance of side effects of this medicine.

Over 65 years old

Although this is a medicine for children, older people who want to use it should consult their doctor or pharmacist, as they are more sensitive to the side effects of this medicine.

How to use

This medicine is used nasally.

Instructions for the correct administration of the medicine

Before applying this medicine, existing nasal fluids should be eliminated by blowing your nose well.

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

Apply two drops in each nostril, inhaling deeply and keeping your head back.

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

If you use more Utabon Children 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 Children 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 has not been established with precision:

The most common side effects are:

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

Rare side effects that can occur are:

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

The 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 not listed in this leaflet.

5. Storage of Utabon Children

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

Store below 25°C.

Do not use this medicine after the expiration date that appears on the package after CAD. The expiration date is the last day of the month indicated.

Medicines should not be thrown away through the sewers or in the trash. Deposit the packages and medicines you no longer need in the SIGRE point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packages and medicines you no longer need. This way, you 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 and colorless solution. It comes in a package 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 leaflet: December 2012

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