Leaflet: information for the user

Utabon 0.5 mg/ml nasal spray with pump dosifier

Oxymetazoline hydrochloride

Read this leaflet carefully before you start using this medicine because it contains important information for you.

Follow exactly the administration instructions contained in this leaflet or those given 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 any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.
• You should consult a doctor if your symptoms worsen or do not improve after 3 days of treatment.

This medication belongs to the group of medications known as 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 adults and children aged 6 years and above.

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

Do not use Utabon

• 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

Inform your doctor or pharmacist before starting to use Utabon 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 they 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, hypotension (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.

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

Children

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

Utabon interaction with other medications

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

This medication should not be used by people taking or having taken during the last 2 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 or plan to become pregnant, consult your doctor or pharmacist before using a medication.

This medication should not be used during pregnancy or breastfeeding.

Driving and operating machinery

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

Utabon 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 that does not contain 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:

Adults and children over 6 years old: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 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

Consult your doctor or pharmacist since older people 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 the first use, press several times the dosifier, directing it to a safe place, until the first pulverization occurs.

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

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

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

If you use more Utabon 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 can produce adverse effects, although not all people 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 site of application, dryness, nasal mucosa itching or sneezing.

The adverse effects that may occur in rare occasions 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 30°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.

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 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/.