Package Insert: Information for the User

Utabon Children 0.25 mg/ml Nasal Drops in Solution

Oxymetazoline Hydrochloride

Read this entire package insert carefully before starting to use this medication, because

it contains important information for you.

Follow exactly the medication administration instructions contained in this package insert or those indicated by your doctor or pharmacist.

• Keep this package insert, 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 package insert.
• You should consult a doctor if your condition worsens or does not improve after 3 days of treatment.

This medication belongs to a group of medications called sympathomimetics. It is a nasal decongestant medication that contains oxymetazoline as the active ingredient. Oxymetazoline administered through the nose produces local vasoconstriction, thereby decongesting the nasal mucosa.

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

Consult a doctor if symptoms worsen or do not improve after 3 days of treatment.

No use Utabon Niños:

• If you are allergic to oxymetazoline, other nasal decongestants, or any of the other components of this medication (listed in section 6).
• If you have recently undergone surgery on your 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 Niños if:

• You are being treated with antidepressant medications, phenothiazine (tranquilizer), or methyldopa (to lower blood pressure).
• You have experienced or are experiencing any of the following diseases or symptoms, even if it only occurred once:

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

• If you have ever experienced insomnia or dizziness when taking other sympathomimetic medications, such as those used to treat heart disease, low blood pressure, or asthma.

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

Rarely, insomnia may occur after using the medication. If this happens, avoid using it in the late afternoon or at night.

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

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

Children

Do not use in children under 6 years old. Children may be especially prone to adverse effects of this medication

Utabon Niños Interactions with Other Medications

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

This medication should not be used by people taking or having taken during the last two weeks: medications used to treat depression (tricyclic antidepressants or monoamine oxidase inhibitors (MAOIs)), or a medication to lower blood pressure called methyldopa.

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

Pregnancy and Breastfeeding

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

This medication should not be used during pregnancy or breastfeeding.

Driving and Operating Machines

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

Utabon Niños Contains Benzalkonium Chloride

This medication may cause nasal mucosa inflammation, especially with long-term treatments, because it contains benzalkonium chloride. If such a reaction is suspected (persistent nasal congestion), a nasal medication without this excipient should be used whenever possible.

Follow exactly the medication administration instructions contained in this leaflet or those 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 nasal opening, once a day. One drop is approximately equal to 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 medication should not be used in children under 6 years old.

Children may be especially prone to the appearance of adverse effects of this medication.

Over 65 years old

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

How to use

This medication is used by nasal route.

Instructions for correct medication administration

Before applying this medication, you must eliminate existing nasal fluids, blowing your nose well.

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

Apply 2 drops in each nasal opening, inhaling deeply and keeping the head back.

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

If you use more Utabon Niños than you should

By excessive or very frequent dose application, 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 Toxicological Information Service, phone 915 620 420, indicating the medication and the amount ingested.

Like all medications, Utabon Niños may produce adverse effects, although not everyone will experience them.

During the period of use of oxymetazoline, the following adverse effects have been observed, whose frequency has not been established with precision:

The adverse effects that have occurred most frequently are:

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

The adverse 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, exanthema (skin redness).

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

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

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

Store below 25°C.

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.

Medicines 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 of 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 Utabon

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

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

Appearance of the product and contents of the packaging

Utabon is a transparent and colorless solution. It is presented in a packaging with a dosing pump that contains 15 ml of solution.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Uriach Consumer Healthcare, S.L.

Av.Generalitat 163-167

08174 Sant Cugat del Vallès

(Barcelona - Spain)

Responsible for manufacturing:

ITALFARMACO, S.A.

San Rafael, 3

28108 – Alcobendas

(Spain)

Last review date of this leaflet: December 2012

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