Utabon Children 0.25 Mg/Ml Nasal Drops 1 Bottle

1. What is Utabon Kids and what it is used for

This medicine belongs to the group of medicines called sympathomimetics. It's a

nasal decongestant drug containing oxymetazoline as an active substance. Oxymetazoline

administered by the nose causes constriction of blood vessels locally, decongesting the

nasal mucosa.

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

You should see a doctor if it gets worse or if it does not improve after 3 days of treatment.

2. What you need to know before you start using Utabon Kids

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 had a head operation (if you have had any interventions

cranial, transnasal or transoral surgical).

Warnings and precautions

Talk to your doctor or pharmacist before using Utabon Children if:

- You are being treated with antidepressant medications, phenothiazine (tranquilizer), or methyldopa (for

lower blood pressure).

- You have suffered or suffered, even if it would only have happened to you once, any of the following

diseases or symptoms:

o If you have high blood sugar levels (diabetes mellitus)

o If you have high blood pressure (high blood pressure)

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o If you have heart or circulatory system disease

o If you have prostate disease with difficulty urinating (prostate hypertrophy)

o If you have thyroid disease (hyperthyroidism)

- If you have ever had insomnia or vertigo when you have been being treated with other medicines

sympathomimetics, such as, among others, some of those used to treat

hypotension (low blood pressure) or to treat asthma.

In rare cases oximetazoline, because its effects are temporary and its prolonged use, it can

increase nasal congestion rather than decrease it; this is known as the rebound effect.

Insomnia can rarely occur after using the medicine. If this happens to you avoid

use it late in the afternoon or evening.

Do not exceed the recommended dose in paragraph 3. How to use Utabon Kids.

To prevent contagion, the medicine should not be used by more than one person and the end of the dropper

should always be cleaned after each use with a clean, damp cloth.

Children

It should not be used in children under 6 years of age. Children may be especially prone to the onset of

side effects of this medicine

Interaction of Utabon Children with other medicines

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines,

even those purchased without a prescription.

This medicine should not be used by people who are taking or have taken it during the 2

recent weeks: medicines used to treat depression (tricyclic antidepressants or inhibitors

monoamine oxidase (IMAO)), or with a blood pressure medication called methyldopa.

It should also not be used if being treated with phenothiazine (tranquilizer) or

medicines to treat asthma.

Pregnancy and lactation

If you are pregnant or breast-feeding, or think you may be pregnant or intend to

becoming pregnant, talk to your doctor or pharmacist before using a medicine.

This medicine should not be used during pregnancy or during lactation.

Driving and using machines

Although it is not expected that this medicine will affect the ability to drive or use machines, if

drowsiness or dizziness, do not drive or operate hazardous machinery.

Utabon Children contains benzalkonium chloride

This medicine can cause inflammation of the nasal mucosa, especially with long-term treatments

duration, because it contains benzalkonium chloride. If such a reaction is suspected (nasal congestion

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whenever possible, a nasal medicine that does not contain this

Excipient.

3. How to use Utabon Kids

Always take the medicine exactly as contained in this leaflet or the

indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

The normal dose is:

Children over 6 years old: an application of 2 drops in each nostril, once a day. A drop

equivalent to approximately 0.023 ml. If necessary, another application can be performed 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 of age.

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

Over 65

Although it is a children's drug, older people who want to use it should

consult your 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 proper administration of the medicine

Before applying this medicine, you should remove existing nasal fluids, sounding good

Nose.

To avoid contagion, after each use and before closing the container, the end of the dropper should be cleaned

with a clean, damp cloth. In addition, each pack should be used only by one person.

Apply two drops to each nostril, vacuuming deeply and holding your head back.

If it gets worse or if it does not improve after 3 days of treatment, stop the treatment and consult your

Doctor.

If you use more Utabon Kids than you should

By applying excessive or very continuous doses you may notice: headache, tremors, insomnia,

excessive sweating, palpitations, tachycardia, increased blood pressure or sleep disturbances.

In case of overdose or accidental ingestion, talk to your doctor or pharmacist immediately, or call

Toxicological Information Service, phone 915 620 420, indicating the drug and the amount

Ingested.

4. Possible side effects

Like all medicines, Utabon Children can cause side effects, although not all

people suffer from them.

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During the period of use of oxymetazoline, the following side effects have been observed

frequency could not be established accurately:

The most common side effects are:

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

Side effects that may occur rarely include:

Anxiety, restlessness, insomnia, hallucinations, tremors and sleep disorders in children. Tachycardia

palpitations, increased blood pressure, headache, nausea, exanthemum (redness of the

skin).

Excessive or continued use of this medicine may result in nasal congestion.

If you experience side effects, talk to your doctor or pharmacist, even if these are

side effects not listed in this leaflet.

5. Conservation of Utabon Children

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

Store below 25oC.

Do not use this medicine after the expiry date which is stated on the carton after EXP.

The expiration date is the last day of the specified month.

Medicines should not be flushed down drains or into trash. Deposit containers and containers

medicines you don't need at the SIGRE Point of the pharmacy. If in doubt, ask your

how to get rid of medicines you don't need. In this way

will help protect the environment.

6. Packaging contents and additional information

Composition of Utabon Children

- The active substance is: oxymetazoline hydrochloride. Each ml contains 0.25 mg oxymetazoline

Hydrochloride.

- The other ingredients (excipients) are: benzalkonium chloride, anhydrous disodium hydrogen phosphate,

sodium dihydrogen phosphate dihydrate, glycine (E-640), sorbitol (E-420) and purified water.

Product appearance and packaging content

Utabon Children is a clear and colourless solution. It comes in the form of nasal drops in solution,

each pack contains 15 ml of solution.

Marketing authorisation holder and manufacturing manager

Marketing authorisation holder:

URIACH-AQUILEA OTC, S.L.

Av. Camí Reial 51-57

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08184 Palau-solita i Plegamans

(Barcelona -Spain)

Responsible for manufacturing:

ITALFARMACO, S.A.

San Rafael, 3

28108 - Alcobendas

(Spain)