PROSPECTO : INFORMATION FOR THE USER

Rhinovín1 mg/ml nasal spray solution

Xilometazolina hidrocloruro

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 Rhinovín and for what it is used

2. Before using Rhinovín

3. How to use Rhinovín

4. Possible adverse effects

5 Conservation of Rhinovín

6. Additional information

This medication belongs to the group of medications known as Sympathomimetics.

It is a nasal decongestant medication

It contains xylometazoline as the active ingredient. Xylometazoline, administered in the form of a nasal spray, produces a local constriction of blood vessels, thereby decongesting the nasal mucosa.

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

Do not use Rhinovín:

• 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.

Be especially careful with Rhinovín

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

- You are being treated with antidepressant medications tri or tetracyclic, phenothiazine (tranquilizer), or methyldopa (to lower blood pressure).

- You have suffered or suffer, although only once, any of the following diseases 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 any prostate disease with difficulty urinating (prostatic hypertrophy)
• If you have any thyroid disease (hyperthyroidism)

- If you have ever suffered insomnia or vertigo when treated with other sympathomimetic medications, such as those used to treat heart disease, hypotension (low blood pressure), or asthma, .

- In rare cases, xylometazoline, due to its temporary effects and prolonged use, may increase nasal congestion instead of reducing it; this is known as rebound effect.

- Rarely, insomnia may occur after using the medication. If this happens, avoid using it in the late afternoon or at night.

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

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

Use of other medications

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

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

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

Use in children:

Rhinovín Infantil 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 medication.

Use in people over 65 years old:

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

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

This medication should not be used during pregnancy or breastfeeding.

Driving and operating machines

Although problems are not expected, if you experience drowsiness or dizziness while using this medication, do not drive or operate hazardous machinery.

Important information about some of the components of Rhinovín:

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

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

Adults and children 12 years and older:

The usual dose is: 1 spray in each nostril per application. 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 spray.

The dosing pump ensures a good distribution of the solution on the nasal mucosa surface through the fine nebulization.

Before using for the first time

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

If the spray does not expel during the complete actuation, or if the medication has not been used for more than 7 days, it will be necessary to re-prime the pump with 2 actuations.

If the full spray dose is not administered, the dose should not be repeated.

Usage instructions:

Remove the cap.

Be careful not to spray into the eyes.

1. Blow your nose..
2. Hold the bottle vertically with your thumb on the actuator button.
3. To avoid dripping, remain upright and insert the nozzle into one nostril.
4. Press the button to spray and inhale gently 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 again until you hear a "click".

To avoid possible infection dissemination, 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:

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 Toxicological Information Service, Telephone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to use Rhinovín :

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

If necessary, use it again 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 precision:

The adverse effects that have occurred most frequently are:

Burning sensation at the application site, 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 prolonged use of Rhinovín may lead to nasal congestion due to rebound effect.

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.

Keep out of reach and sight of children.

Store below 30°C.

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

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of packaging and medicines that you no longer need. By doing so, you 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 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 Manufacturer

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 inJanuary 2024.