RESPIBIEN FRESHMINT 0.5 mg/ml NASAL SPRAY SOLUTION

Introduction

Package Leaflet: Information for the User

respibien freshmint 0.5 mg/ml nasal spray solution

oxymetazoline, hydrochloride

Read the entire package leaflet carefully before starting to use this medication, as it contains important information for you.

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist.

• Keep this package leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.
• You should consult a doctor if your symptoms worsen or do not improve after 3 days.

Contents of the Package Leaflet

1. What respibien freshmint is and what it is used for.
2. What you need to know before starting to use respibien freshmint.
3. How to use respibien freshmint.
4. Possible side effects.
5. Storage of respibien freshmint.
6. Package contents and additional information.

1. What respibien freshmint is and what it is used for

This medication belongs to the group of medications called sympathomimetics. It is a nasal decongestant medication that contains oxymetazoline as the active ingredient. Oxymetazoline, when administered nasally, produces local constriction of blood vessels, decongesting the nasal mucosa.

It is indicated for the local and temporary relief of nasal congestion in adults, adolescents, and children over 6 years of age. You should consult a doctor if your symptoms worsen or do not improve after 3 days of treatment.

2. What you need to know before starting to use respibien freshmint

Do not use respibien freshmint

• If you are allergic to oxymetazoline, other nasal decongestants, or any of the other components of this medication (listed in section 6).
• If you are taking monoamine oxidase inhibitors (MAOIs, used to treat Parkinson's disease and depression). MAOIs can increase the hypertensive effects of oxymetazoline.
• If you have narrow-angle glaucoma.
• If you have recently undergone head surgery (if you have had any cranial, transnasal, or transoral surgical intervention).
• If you have inflammation of the skin and mucosa of the nasal vestibule and crusts in the nose (dry rhinitis).
• If you have acute heart disease or cardiac asthma.
• If you have ever experienced insomnia or vertigo while being treated with other sympathomimetic medications, such as those used to treat heart disease, hypotension (low blood pressure), or asthma.
• In children under 6 years of age.

Warnings and precautions

Consult your doctor or pharmacist before starting to use respibien freshmint if:

• you have had or currently have any of the following diseases or symptoms:

• high blood sugar levels (diabetes mellitus),
• high blood pressure (arterial hypertension),
• any heart or circulatory disease,
• any prostate disease with difficulty urinating (prostatic hypertrophy),
• any thyroid disease (hyperthyroidism).

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

Rarely, insomnia can occur after using the medication. 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 respibien freshmint.

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

Children

Do not use in children under 6 years of age.

Children may be especially prone to the adverse effects of this medication.

Other medications and respibien freshmint

Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.

This medication should not be used by people who are taking or have taken during the last 2 weeks: medications used to treat depression (tricyclic antidepressants, maprotiline, or monoamine oxidase inhibitors [MAOIs]), or with a medication to lower blood pressure called methyldopa.

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

This medication should not be used during pregnancy or breastfeeding.

Driving and using machines

Although no problems are expected, if you notice drowsiness, do not drive or use hazardous tools or machines.

respibien freshmint contains benzalkonium chloride.

This medication contains 0.2 mg of benzalkonium chloride per ml (each 0.13 ml spray contains 26 micrograms).

Benzalkonium chloride can cause irritation or inflammation inside the nose, especially when used for extended treatment periods.

3. How to use respibien freshmint

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

The recommended dose is:

Adults, adolescents, and children over 6 years of age

1 spray in each nostril, every 12 hours if necessary, in the morning and at night

Do not exceed 2 applications in 24 hours.

Do not repeat at intervals of less than 12 hours.

Consult your doctor if symptoms worsen or do not improve after 3 days of treatment.

Use in children under 6 years of age

This medication cannot be used in children under 6 years of age (see section 2. Do not use respibien freshmint).

Elderly patients (over 65 years of age)

Consult your doctor or pharmacist, as elderly patients are more sensitive to the adverse effects of this medication.

How to use

This medication is used nasally.

Before applying this medication, eliminate any existing nasal fluids by blowing your nose well.

If it is the first time you are using this product or have not used it for a long time, you need to prime the spray pump. To do this, holding the container away from your body, press the spray pump several times until a finely sprayed liquid comes out.

To avoid contagion, after each use and before closing the container, clean the tip of the applicator with a clean, damp cloth. Additionally, each container should only be used by 1 person.

The treatment duration should not exceed 7 days unless your doctor prescribes it.

If you use more respibien freshmint than you should

By applying excessive doses or very continuous doses, or if you accidentally swallow the product, you may notice: headache, tremors, insomnia, excessive sweating, palpitations, tachycardia, increased blood pressure, or sleep disturbances.

In children, these effects can include: hallucinations, excitability, hives, nausea and vomiting, hysteria, drowsiness or lethargy, abnormal gait, facial edema.

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 forget to use respibien freshmint

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

If necessary, use it again as indicated in section 3. How to use respibien freshmint.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

During the use of oxymetazoline, 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, sneezing, and irritation of the nose, mouth, and throat.

Rare side effects can include:

Anxiety, restlessness, insomnia, hallucinations, tremors, fatigue, irritability, and sleep disorders in children. Tachycardia, palpitations, increased blood pressure. Headache, nausea, rash (skin redness), inflammation of the nasal mucosa, and visual disturbances.

Excessive or continuous use of this medication can lead to rebound nasal congestion.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of respibien freshmint

Keep this medication out of sight and reach of children.

This medication does not require special storage conditions.

Do not use this medication after the expiration date shown on the container after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the containers and medications you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of respibien freshmint

• The active ingredient is oxymetazoline hydrochloride. Each ml contains 0.5 mg of oxymetazoline hydrochloride (65 micrograms per 0.13 ml spray).
• The other components are: benzalkonium chloride, glycine (E-640), povidone (E-1201), non-crystallizable liquid sorbitol (E-420), peppermint flavor (aromatizing components and glycerol triacetate (E-1518)), aloe vera, eucalyptol, and purified water.

Appearance of the product and package contents

respibien freshmint is a slightly whitish or transparent solution with a mentholated aroma.

It is presented in blue polyethylene terephthalate containers, equipped with a dosing pump and a cap that ensures its proper preservation. Each container contains 15 ml of nasal spray solution.

Marketing authorization holder and manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Date of the last revision of this package leaflet:April 2023

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/