RhinoVín Kids 0.5 mg/ml nasal drops in solution

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

RhinovínKids 0.5 mg/ml Nasal drops solution

Xylometazoline hydrochloride

Read the entire leaflet carefully because it contains important information for you. This medicine can be purchased without a prescription. However, to achieve the best results, it must be used correctly.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, consult your pharmacist.
• If symptoms worsen or persist beyond 3 days, you should consult a doctor.
• If you consider any of the side effects you experience to be severe, or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Leaflet contents:

1. What Rhinovín Kids is and what it is used for
2. Before you use Rhinovín Kids
3. How to use Rhinovín Kids
4. Possible side effects
5. How to store Rhinovín Kids
6. Further 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.

It contains xylometazoline as the active substance. Xylometazoline, administered as drops into the nose, produces local constriction of blood vessels, thereby decongesting the nasal mucosa.

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

2. BEFORE USING RHINOVÍN KIDS

Do not use Rhinovín Kids:

• 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 head surgery (if you have had cranial, transnasal, or transoral surgery).

Take special care with Rhinovín Kids:

Take special care with Rhinovín and consult your doctor before using this medicine if:

• you are being treated with tricyclic or tetracyclic antidepressants, phenothiazines (tranquilizers), or methyldopa (to lower blood pressure)

• you have ever had, or currently have—even if only once—any of the following conditions 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 (for example, long QT syndrome)

• if you have prostate disease with difficulty urinating (prostatic hypertrophy)

• if you have any thyroid disease (hyperthyroidism)

• if you have ever experienced insomnia or dizziness while being treated with other sympathomimetic drugs, such as those used to treat heart conditions, hypotension (low blood pressure), or asthma

• in rare cases, xylometazoline, 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 happens, avoid using it late in the afternoon or at night

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

To prevent transmission of 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.

Use with other medicines

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

This medicine must not be used by people who are taking, or have taken within the last two weeks, medicines used to treat depression (tricyclic or tetracyclic 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 medicines used to treat asthma.

Use in children:

Rhinovín Kids must not be used in children under 6 years of age without medical recommendation. Children may be more prone to experiencing adverse effects from this medicine.

Use in people aged 65 and over:

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

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

This medicine must not be used during pregnancy or breastfeeding.

Driving and using machines

Although problems in this regard are not expected, if you experience drowsiness or dizziness while using this medicine, do not drive or operate dangerous tools or machinery.

Important information about some components of Rhinovín Kids:

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

3. How to use RHINOVÍN KIDS

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

Children over 6 years of age:

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

This medicine is for nasal use.

Instructions for use:

1. Before application, clear existing nasal fluids by blowing your nose thoroughly.
2. Tilt your head slightly backward, or turn your head to the side if lying down.
3. Apply the drops into each nostril and keep your head slightly tilted backward to facilitate distribution of the drops throughout the nasal passages.
4. To prevent infection, after each use and before closing the container, clean the tip of the applicator with a clean, damp cloth. In addition, each container must be used by only one person.
5. After using the medicine, immediately replace the cap.

To minimize the risk of spreading infections, this medicine must not be shared among different individuals, and must always be cleaned after each use as indicated in the paragraph above.

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

If you use more Rhinovín Kids 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 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 missed dose.

If necessary, resume use as indicated in section 3. HOW TO USE RHINOVÍN KIDS.

4. Possible adverse effects

Like all medicines, Rhinovín can produce adverse effects, although not everyone experiences them.

During the period of use of xylometazoline, the following adverse effects have been observed, although their frequency could not be accurately determined:

The most frequently occurring adverse effects are:

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

The adverse effects that have occurred less frequently are:

Nasal bleeding.

The adverse effects that may occur rarely 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 prolonged use of Rhinovín may lead to rebound congestion.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effect not listed in this leaflet, inform your doctor or pharmacist.

5. Storage of RHINOVÍN KIDS

Keep out of the reach and sight of children.

Store below 30°C.

Do not use Rhinovín Kids after the expiry date shown on the packaging. The expiry 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 medicines and packaging that you no longer need. This will help protect the environment.

6. ADDITIONAL INFORMATION

Composition of Rhinovín

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

Appearance of the product and contents of the pack

Rhinovín is a solution supplied in a 10 ml nasal spray pump.

Marketing Authorization Holder

Haleon Spain, S.A.
Paseo de la Castellana, 259D, planta 32 - 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.