Utabon 0.5 mg/ml nasal spray solution with metered-dose pump
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Utabon 0.5 mg/ml nasal spray solution with metered-dose pump
Oxymetazoline hydrochloride
Read all of this leaflet carefully before you start using this medicine, as it contains important information for you.
Follow exactly the instructions for use provided 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 adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.
- You must consult a doctor if your condition worsens or if you do not improve after 3 days of treatment.
Leaflet Contents:
- What Utabon is and what it is used for
- What you need to know before using Utabon
- How to use Utabon
- Possible adverse effects
- How to store Utabon
- Contents of the pack and other information
1. What Utabon is and what it is used for
This medicine belongs to the group of drugs known as sympathomimetics. It is a nasal decongestant containing oxymetazoline as the active substance. Oxymetazoline, when administered through the nose, produces local constriction of blood vessels, 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 older.
You should consult a doctor if symptoms worsen or do not improve after 3 days of treatment.
2. What you need to know before using Utabon
Do not use Utabon
- if you are allergic to oxymetazoline, to other nasal decongestants, or to any of the other ingredients of this medicine (listed in section 6).
- if you have recently undergone head surgery (if you have had cranial, transnasal, or transoral surgery).
Warnings and precautions
Tell your doctor or pharmacist before starting to use Utabon if:
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You are being treated with antidepressant medicines, phenothiazines (tranquilizers), or methyldopa (used to lower blood pressure).
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You have had or currently have, even if only once, any of the following conditions or symptoms:
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If you have high blood sugar levels (diabetes mellitus)
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If you have high blood pressure (hypertension)
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If you have any heart or circulatory system disease
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If you have prostate disease with difficulty urinating (prostatic hypertrophy)
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If you have any thyroid disease (hyperthyroidism)
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If you have ever experienced insomnia or dizziness while taking other sympathomimetic medicines, such as those used to treat heart conditions, hypotension (low blood pressure), or asthma.
In rare cases, oxymetazoline, due to its temporary effects and prolonged use, may increase nasal congestion rather than reduce it; this is known as rebound congestion.
Rarely, insomnia may occur after using the medicine. If this happens, avoid using it late in the afternoon or at night.
Do not exceed the recommended dose stated in section 3, How to use Utabon.
To prevent spreading infections, the medicine must 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 of age without consulting a doctor. Children may be especially prone to adverse effects from this medicine.
Interaction of Utabon with other medicines
Inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.
This medicine must not be used by people who are taking or have taken within the last 2 weeks: medicines used to treat depression (tricyclic antidepressants or monoamine oxidase inhibitors [MAOIs]), or the blood pressure-lowering medicine called methyldopa.
It should also not be used if you are being treated with phenothiazines (tranquilizers) or medicines used to treat asthma.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
This medicine should not be used during pregnancy or while breastfeeding.
Driving and using machines
Although this medicine is not expected to affect your ability to drive or operate machinery, if you experience drowsiness or dizziness, do not drive or operate dangerous machinery.
Utabon contains benzalkonium chloride
This medicine may cause inflammation of the nasal mucosa, especially with prolonged treatment, because it contains benzalkonium chloride. If such a reaction is suspected (persistent nasal congestion), a nasal medicine not containing this excipient should be used whenever possible.
3. How to use Utabon
Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The usual dose is:
Adults and children over 6 years of age: one spray into each nostril once daily. If necessary, a second spray may be administered every 12 hours. Do not use more than twice in 24 hours.
Use in children
This medicine must not be used in children under 6 years of age.
Children may be especially prone to adverse effects from this medicine.
Patients over 65 years of age
Consult your doctor or pharmacist, as elderly individuals are more sensitive to the adverse effects of this medicine.
How to use
This medicine is for nasal use.
Instructions for correct administration of the medicine
Before first use, press the pump several times, directing it towards a safe place, until the first spray is released.
1. Remove the protective cap from the bottle. |
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Before applying this medicine, you should remove any existing nasal secretions by thoroughly blowing your nose.
To prevent contagion, after each use and before closing the container, clean the applicator tip with a clean, damp cloth. In addition, each container should be used by only one person.
If your condition worsens or does not improve after 3 days of treatment, stop the treatment and consult your doctor.
If you use more Utabon than you should
With excessive or prolonged doses, you may experience: 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 at telephone number 915 620 420, indicating the medicine and the amount ingested.
4. Possible adverse effects
Like all medicines, Utabon may produce adverse effects, although not everyone experiences them.
During the period of use of oxymetazoline, the following adverse effects have been observed, although their frequency cannot be precisely established:
The most frequently occurring adverse effects are:
Burning sensation at the application site, dryness, itching of the nasal mucosa, or sneezing.
Adverse effects that may occur rarely are:
Anxiety, restlessness, insomnia, hallucinations, tremors, and sleep disorders in children. Tachycardia, palpitations, increased blood pressure, headache, nausea, rash (skin redness).
Excessive or prolonged use of this medicine may lead to nasal congestion.
If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.
5. Storage of Utabon
Keep this medicine out of sight and reach of children.
Store below 30°C.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.
Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of medicines and their containers. This will help protect the environment.
6. Contents of the pack and other information
Composition of Utabon
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The active substance is: oxymetazoline hydrochloride. Each ml contains 0.5 mg of oxymetazoline hydrochloride (35 micrograms per spray of 0.07 ml).
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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 contents of the pack
Utabon is a clear, colourless solution. It is supplied in a container with a metering pump containing 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 most recent review of this leaflet: December 2012
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.