PROSPECTO : INFORMATION FOR THE USER

RhinovínKids 0.5 mg/ml Nasal Drops in Solution

Xilometazolina hydrochloride

Read this prospectus carefully because it contains important information for youThis medication can be purchased without a prescription. Nevertheless, for the best results, it must be used properly.

• Keep this prospectus, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If symptoms worsen or persist after 3 days, you must consult a doctor.
• If you consider that any of the adverse effects you are experiencing is severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

1. What is RhinovínKidsand for what it is used

2. Before using RhinovínKids

3. How to use RhinovínKids

4. Possible adverse effects

5 Conservation of RhinovínKids

6. Additional information

This medication belongs to a group of medications known as Sympathomimetics. It is a nasal decongestant medication.

It contains xylometazoline as the active ingredient. Xylometazoline, administered as nasal drops, causes local vasoconstriction, thereby decongesting the nasal mucosa.

Rhinovín is indicated for the local and temporary relief of nasal congestion.

No use RhinovínKids:

• If you are allergic (hypersensitive) to xylometazoline, other nasal decongestants, or any of the other components (excipients) of the medication
• If you have recently undergone surgery on the head. (If you have undergone any cranial, transnasal, or transoral surgical intervention.

Tenga especial cuidado con Rhinovín Kids:

Tenga especial cuidado con Rhinovín y consulte a su médico antes de utilizar este medicamento si:

- Está en tratamiento con medicamentos antidepresivostri o tetracíclicos, fenotiazina (tranquilizante), o metildopa (para bajar la tensión arterial).

- Ha padecido o padece, aunque solo le hubiera ocurrido una vez, cualquiera de las siguientes enfermedades o síntomas:

• Si tiene niveles de azúcar en sangre elevados (diabetes mellitus)
• Si tiene la tensión arterial alta (hipertensión arterial)
• Si tiene alguna enfermedad del corazón o del aparato circulatorio(por ejemplo, síndrome de QT largo);

• Si tiene alguna enfermedad de la próstata con dificultad al orinar (hipertrofia prostática)
• Si tiene alguna enfermedad del tiroides (hipertiroidismo)

- Si alguna vez ha padecido insomnio o vértigo cuando ha estado en tratamiento con otros medicamentos simpaticomiméticos, como por ejemplo pueden ser, entre otros, alguno de los utilizados para tratar enfermedades del corazón, hipotensión (tensión arterial baja) o para tratar el asma .

- En casos raros la xilometazolina, debido a que sus efectos son temporales y a su uso prolongado, puede aumentar la congestión nasal en lugar de disminuirla; esto se conoce como efecto rebote.

- Raramente se puede producir insomnio después de utilizar el medicamento. Si esto le ocurriera evite utilizarlo a última hora de la tarde o por la noche.

No exceder la dosis recomendada en el apartado 3 COMO USAR Rhinovín.

Para evitar contagios, el medicamento no se debe utilizar por más de una persona y el aplicador debe limpiarse siempre después de cada uso con un paño limpio y húmedo.

Uso de otros medicamentos

Informe a su médico o farmacéutico si está utilizando o ha utilizado recientemente otros medicamentos - incluso los adquiridos sin receta.

Este medicamento no debe ser utilizado por personas que estén tomando o hayan tomado durante las dos últimas semanas: medicamentos utilizados para tratar la depresión (antidepresivos tri o tetracíclicos o inhibidores de la momoaminooxidasa (IMAO)), o con un medicamento para bajar la tensión arterial llamado metildopa .

Tampoco se debe utilizaren caso de estar en tratamiento con fenotiazina (tranquilizante) o con medicamentos para tratar el asma.

Uso en niños:

Rhinovín Kids no debe emplearse en niños menores de 6 años, sin la recomendación del médico. Los niños pueden ser más propensos a la aparición de los efectos adversos de este medicamento.

Uso en mayores de 65 años:

Consulte a su médico o farmacéutico ya que las personas mayores son más sensibles a los efectos de este medicamento.

Embarazo y lactancia

Consulte a su médico o farmacéutico antes de usar cualquier medicamento.

Este medicamento no se debe usar durante el embarazo ni durante la lactancia.

Conducción y uso de máquinas

Aunque no son de esperar problemas en este sentido, si mientras está usando este medicamento nota somnolencia o mareos, no conduzca ni maneje herramientas ó máquinas peligrosas.

Información importante sobre algunos de los componentes de Rhinovín Kids:

Este medicamento puede producir inflamación de la mucosa nasal, especialmente con tratamientos de larga duración, porque contiene cloruro de benzalconio. Si se sospecha tal

reacción (congestión nasal persistente), siempre que sea posible, se debería utilizar un medicamento de uso nasal que no contenga este excipiente.

Follow these instructions unless your doctor has given you different instructions. Consult your doctor or pharmacist if you have any doubts.

Children over 6 years old:

1 or 2 drops of the solution in each nostril (as needed); 1 application per day, if necessary, a second application can be repeated (every 10 to 12 hours). Do not exceed 2 applications in 24 hours.

This medication is used by nasal route.

Usage Instructions :

1. Before applying, you must remove existing nasal secretions, blowing your nose well.
2. Place your head slightly back or tilt your head if you are lying down
3. Apply the drops in each nostril and keep your head slightly tilted back to facilitate the distribution of the drops throughout the nose.
4. To prevent contagion, after each use and before closing the container, the applicator tip must be cleaned with a clean and damp cloth. In addition, each container must be used only by one person.
5. After using the medication, replace the cap immediately.

To minimize the risk of transmission of infections, the medication should not be used by more than one person, and it must be cleaned always after each use, as indicated in the previous paragraph.

If symptoms worsen or persist after 3 days of treatment, discontinue treatment and consult your doctor.

If you use more Rhinovín Kids 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 Toxicology Information Service, Phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to use Rhinovín Kids:

Do not use a double dose to compensate for a missed dose.

If necessary, use it as indicated in the section 3. HOW TO USE Rhinovín

Like all medications, Rhinovín may produce adverse effects, although not all people may experience them.

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

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 have occurred with low frequency are:

Nasal bleeding.

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).

Like other nasal decongestants, excessive or continued use of Rhinovín may lead to nasal congestion due to rebound effect.

If you consider that any of the adverse effects you experience are severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Keep out of the reach and sight of children.

Store below 30°C.

Do not use Rhinovín Kids after the expiration date shown on the packaging. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through the drains or in the trash. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

Rhinovín Composition

• The active ingredient is xylometazoline hydrochloride. Each milliliter of this solution contains 1mg of xylometazoline and each spray contains 138 micrograms of xylometazoline hydrochloride.
• The other components (excipients) are dihydrogen phosphate of sodium dihydrate, dodecahydrate of disodium phosphate, disodium edetate, benzalkonium chloride, sorbitol (E420), hypromellose, sodium chloride, and purified water.

Product Appearance and Packaging Contents

Rhinovín is a nasal spray solution presented in a nasal sprayer with 10 ml.

Marketing Authorization Holder

Haleon Spain, S.A.
Parque Tecnológico de Madrid, Calle de Severo Ochoa 2
28760 Tres Cantos, Madrid - Spain

Responsible for Manufacturing

Novartis Consumer Health GmbH

Zielstattstrasse 40

81379 Munich

Germany

GlaxoSmithKline Consumer Healthcare GmbH & Co.KG

Barthstraße 4

80339 Munich

Germany

Haleon Germany GmbH

Barthstraße 4

80339 Munich

Germany

This leaflet was approved in January 2024.