Rhinovín 1 mg/ml solution for nasal spray

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Rhinovín 1 mg/ml nasal spray solution

Xylometazoline hydrochloride

Read all of this 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 effects not listed in this leaflet, inform your doctor or pharmacist.

Contents of the leaflet:

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

1. What RHINOVÍN is and what it is used for

This medicine belongs to a group of medicines called sympathomimetics.

It is a nasal decongestant medicine.

It contains xylometazoline as the active substance. Xylometazoline, administered as a nasal spray, 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

Do not use Rhinovín:

• 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 surgical procedures).

Take special care with Rhinovín

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 (used to lower blood pressure).

• you have 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 (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 described in section 3 HOW TO USE Otrivin.

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

Use of 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 should 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 Infantil should not be used in children under 6 years of age without medical recommendation. Children may be more susceptible to adverse effects of this medicine.

Use in people over 65 years of age:

Consult your doctor or pharmacist, as elderly individuals 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 operating machinery

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 of the components of Rhinovín:

This medicine may cause inflammation of the nasal mucosa, especially with prolonged treatment, because it contains benzalkonium chloride. If such a reaction is suspected (persistent nasal congestion), a nasal medicine without this excipient should be used whenever possible.

3. HOW TO USE RHINOVÍN

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

Adults and children aged 12 years and over:

The usual dose is: 1 spray into each nostril per application. Apply once daily; if necessary, a second application may be repeated (every 10 to 12 hours). Do not exceed 2 applications within 24 hours.

This medicine is for nasal use.

The metered spray pump ensures good distribution of the solution over the surface of the nasal mucosa by delivering a fine mist.

Before first use

Prime the pump by actuating it 5 times. Once primed, the pump will remain normally charged throughout the daily treatment period.

If no spray is expelled during full actuation, or if the medicine has not been used for more than 7 days, the pump must be re-primed with 2 actuations.

If a full spray dose is not delivered, do not repeat the dose.

Instructions for use:

Remove the cap.

Take care not to spray into the eyes.

1. Blow your nose.
2. Hold the bottle vertically with your thumb on the actuation button.
3. To avoid dripping, remain upright and insert the spray nozzle into one nostril.
4. Press the button to spray and gently inhale through the nose at the same time.

Repeat this process (steps 2 to 4) in the other nostril.

1. After each use, clean and dry the nozzle.
2. Replace the protective cap until you hear a "click".

To avoid possible spread of infection, the spray should only be used by one person.

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

If you use more Rhinovín 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:

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.

4. Possible adverse effects

Like all medicines, Rhinovín may cause adverse effects, although not everyone will experience them.

During the period of use of xylometazoline, the following adverse effects have been observed, the frequency of which has not been accurately established:

The most frequently occurring adverse effects are:

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

The less frequently occurring adverse effects are:

Nasal bleeding.

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).

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

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

5. Storage of RHINOVÍN

Keep out of the reach and sight of children.

Store below 30°C.

Do not use Rhinovín after the expiry date shown on the container. The expiry date is the last day of the month indicated. This date applies even if the container has been opened.

Medicines must not be disposed of via wastewater drains or household waste. Ask your pharmacist how to dispose of medicines and containers 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, dodecahydrated disodium phosphate, disodium edetate, benzalkonium chloride, sorbitol (E420), hypromellose, sodium chloride and purified water.

Appearance of the medicinal product and contents of the container

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

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 last approved in January 2024.