RHINOVIN KIDS 0.5 mg/ml NASAL DROPS IN SOLUTION

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

RhinovínKids 0.5 mg/ml Nasal Drops in Solution

Xylometazoline Hydrochloride

Read this leaflet carefully because it contains important information for you. This medicine can be obtained without a prescription. Nevertheless, to get the best results, it should be used properly.

• Keep this leaflet, 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 should consult a doctor.
• If you consider that any of the adverse effects you are suffering from is serious or if you notice any adverse effect not mentioned in this leaflet, inform your doctor or pharmacist.

Contents of the package leaflet:

1. What Rhinovín Kids is and what it is used for
2. Before using Rhinovín Kids
3. How to use Rhinovín Kids
4. Possible side effects

5 Conservation of Rhinovín Kids

1. Additional information

1. What RHINOVÍN KIDS is and what it is used for

This medicine belongs to the group of medicines called Sympathomimetics. It is a nasal decongestant medicine.

It contains xylometazoline as the active ingredient. Xylometazoline, administered in the form of drops in the nose, produces a constriction of blood vessels at the local level, decongesting the nasal mucosa.

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

2. BEFORE USING RHINOVÍN KIDS

Do not use RhinovínKids:

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

Be careful with Rhinovín Kids:

Be careful with Rhinovín and consult your doctor before using this medicine if:

• You are being treated with tricyclic or tetracyclic antidepressant medications, phenothiazine (tranquilizer), or methyldopa (to lower blood pressure).
• You have had or have, even if it only happened once, any of the following diseases or symptoms:
  • If you have high blood sugar levels (diabetes mellitus)
  • If you have high blood pressure (arterial hypertension)
  • If you have any heart or circulatory system disease (e.g., long QT syndrome);

• If you have any prostate disease with difficulty urinating (prostatic hyperplasia)
• If you have any thyroid disease (hyperthyroidism)

• If you have ever suffered from insomnia or dizziness when treated with other sympathomimetic medications, such as those used to treat heart diseases, hypotension (low blood pressure), or asthma.
• In rare cases, xylometazoline, due to its temporary effects and prolonged use, can increase nasal congestion instead of decreasing it; this is known as rebound effect.
• Rarely, insomnia can occur after using the medicine. If this happens to you, avoid using it in the late afternoon or evening.

Do not exceed the recommended dose in section 3 HOW TO USE Rhinovín.

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

Use of other medicines

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

This medicine should not be used by people who are taking or have taken during the last two weeks: medicines used to treat depression (tricyclic or tetracyclic antidepressants or monoamine oxidase inhibitors (MAOIs)), or with a medicine to lower blood pressure called methyldopa.

It should also not be used in case of treatment with phenothiazine (tranquilizer) or with medicines to treat asthma.

Use in children:

Rhinovín Kids should not be used in children under 6 years old without the doctor's recommendation. Children may be more prone to the adverse effects of this medicine.

Use in people over 65 years old:

Consult your doctor or pharmacist, as older people are more sensitive to the effects of this medicine.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

This medicine should not be used during pregnancy or breastfeeding.

Driving and using machines

Although no problems are expected in this regard, if you notice drowsiness or dizziness while using this medicine, do not drive or operate hazardous tools or machines.

Important information about some of the components of Rhinovín Kids:

This medicine can cause inflammation of the nasal mucosa, especially with long-term treatments, because it contains benzalkonium chloride. If such a reaction is suspected (persistent nasal congestion), whenever possible, a nasal medicine that does not contain this excipient should be used.

3. HOW TO USE RHINOVÍN KIDS

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

Children over 6 years old:

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

This medicine is used nasally.

Instructions for use:

1. Before application, existing nasal fluids should be eliminated by 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 avoid contagion, after each use and before closing the container, the applicator tip should be cleaned with a clean and damp cloth. Also, each container should be used only by one person.
5. After using the medicine, immediately replace the cap.

To minimize the risk of infection transmission, the medicine should not be used by more than one person, and it should 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:

Due to excessive or very continuous 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 medicine and the amount ingested.

If you forget to use Rhinovín Kids:

Do not use a double dose to make up for a forgotten dose.

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

4. Possible side effects

Like all medicines, Rhinovín can cause side effects, although not everyone gets them.

During the period of use of xylometazoline, the following side effects have been observed, whose frequency cannot be established with precision:

The most common side effects are:

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

Uncommon side effects are:

Nasal bleeding.

Rare side effects 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 continuous use of Rhinovín can lead to nasal congestion due to rebound effect.

If you consider that any of the side effects you are suffering from is serious or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

5. Conservation of RHINOVÍN KIDS

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 container. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the containers and medicines you no longer need. This will help protect the environment.

6. ADDITIONAL INFORMATION

Composition of Rhinovín

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

Appearance of the product and container contents

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

Marketing authorization holder

Haleon Spain, S.A. Paseo de la Castellana, 259D, 32nd floor - 28046 - Madrid - Spain

Manufacturer

Novartis Consumer Health GmbH

Zielstattstrasse 40

81379 Munich

Germany

Haleon Germany GmbH

Barthstraße 4

80339 Munich

Germany

This leaflet was approved in January 2024.