Utabon Niños 0.25 mg/ml nasal drops in solution
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Utabon Niños 0.25 mg/ml nasal drops, solution
Oxymetazoline hydrochloride
Read the entire leaflet carefully before you start using this medicine, because
it contains important information for you.
Follow exactly the administration instructions 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 should consult a doctor if your condition worsens or if you do not improve after 3 days of treatment.
Leaflet contents:
- What Utabon Niños is and what it is used for
- What you need to know before using Utabon Niños
- How to use Utabon Niños
- Possible adverse effects
- How to store Utabon Niños
- Contents of the pack and other information
1. What Utabon Niños is and what it is used for
This medicine belongs to the group of medicines called sympathomimetics. It is a nasal decongestant containing oxymetazoline as the active substance. Oxymetazoline administered through the nose produces local constriction of blood vessels, thereby decongesting the nasal mucosa.
It is indicated for local and temporary relief of nasal congestion in 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 Niños
Do not use Utabon Niños:
- if you are allergic to oxymetazoline, to other nasal decongestants, or to any of the other components 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
Consult your doctor or pharmacist before using Utabon Niños if:
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You are being treated with antidepressant medications, 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 being treated with 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 effect.
Insomnia may rarely occur after using the medicine. If this occurs, avoid using it late in the afternoon or at night.
Do not exceed the recommended dose indicated in section 3. How to use Utabon Niños.
To prevent infection, the medicine should not be used by more than one person, and the dropper tip should always be cleaned after each use with a clean, damp cloth.
Children
Do not use in children under 6 years of age. Children may be especially prone to adverse effects from this medicine.
Interaction of Utabon Niños with other medicines
Inform your doctor or pharmacist if you are using or have recently used 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: medications used to treat depression (tricyclic antidepressants or monoamine oxidase inhibitors [MAOIs]), or the antihypertensive drug methyldopa.
It should also not be used if you are being treated with phenothiazines (tranquilizers) or medications for asthma.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, 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 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 Niños contains benzalkonium chloride
This medicine may cause inflammation of the nasal mucosa, especially with long-term use, 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 Niños
Follow exactly the instructions for administering the medicine provided in this leaflet or those given by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.
The usual dose is:
Children over 6 years of age: one application of 2 drops into each nostril, once daily. One drop corresponds to approximately 0.023 ml. If necessary, another application may be given every 12 hours. Do not use more than twice within 24 hours.
Use in children
This medicine must not be used in children under 6 years of age.
Children may be especially prone to experiencing adverse effects from this medicine.
Patients over 65 years of age
Although this is a medicine intended for children, elderly individuals who wish to use it should consult their doctor or pharmacist, as they may be 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 applying this medicine, clear any existing nasal secretions by thoroughly blowing your nose.
To prevent infection, after each use and before closing the container, clean the dropper tip with a clean, damp cloth. In addition, each container should be used by only one person.
Apply 2 drops into each nostril, inhaling deeply while keeping your head tilted backward.
If symptoms worsen or do not improve after 3 days of treatment, discontinue treatment and consult your doctor.
If you use more Utabon Niños than you should
With excessive or prolonged dosing, you may experience: headache, tremors, insomnia, excessive sweating, palpitations, tachycardia, increased blood pressure, or sleep disturbances.
In case of overdose or accidental ingestion, contact 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 Niños can cause adverse effects, although not everyone experiences them.
During the period of use of oxymetazoline, the following adverse effects have been observed, although their frequency could not be established with certainty:
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 disturbances in children. Tachycardia, palpitations, increased blood pressure, headache, nausea, exanthema (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 Niños
Keep this medicine out of sight and reach of children.
Store below 25°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 must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and packaging you no longer need. 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 0.07 ml spray).
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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 Authorisation Holder and Manufacturer
Marketing Authorisation 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 medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.