RespiBien FreshMint 0.5 mg/ml solution for nasal spray

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

respibien freshmint 0.5 mg/ml solution for nasal spray

oxymetazoline hydrochloride

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist.

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

Leaflet contents

1. What respibien freshmint is and what it is used for.
2. What you need to know before using respibien freshmint.
3. How to use respibien freshmint.
4. Possible adverse effects.
5. How to store respibien freshmint.
6. Contents of the pack and other information.

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

This medicine belongs to the group of drugs known as sympathomimetics. It is a nasal decongestant containing oxymetazoline as the active substance. When administered through the nose, oxymetazoline produces local constriction of blood vessels, thereby 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 symptoms worsen or do not improve after 3 days of treatment.

2. What you need to know before using respibien freshmint

Do not use respibien freshmint

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

Warnings and precautions

Consult your doctor or pharmacist before using respibien freshmint if:

• You have had or currently have, even if only once, any of the following conditions or symptoms:

• High blood sugar levels (diabetes mellitus),

• High blood pressure (hypertension),

• Any heart or circulatory system disease,

• Prostate disease with difficulty urinating (prostatic hypertrophy),

• Any thyroid disease (hyperthyroidism).

In rare cases, oxymetazoline, due to its temporary effects and prolonged use, may increase nasal congestion rather than reduce it; this is known as rebound effect.

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

Do not exceed the dose recommended in section 3. How to use respibien freshmint.

To prevent infections, the medicine should not be used by more than one person, and the applicator should always 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 experiencing adverse effects from this medicine.

Other medicines and respibien freshmint

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

This medicine must not be used by people who are taking or have taken within the last 2 weeks: medicines used to treat depression (tricyclic antidepressants, maprotiline, or monoamine oxidase inhibitors [MAOIs]), or the antihypertensive medicine methyldopa.

It should also not be used if you are being treated with phenothiazines (tranquilizers) or medicines for asthma.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

This medicine should not be used during pregnancy or breastfeeding.

Driving and using machines

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

respibien freshmint contains benzalkonium chloride.

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

Benzalkonium chloride may cause irritation or inflammation inside the nose, especially when used for long periods of treatment.

3. How to use respibien freshmint

Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

The recommended dose is:

Adults, adolescents and children over 6 years of age

1 spray into 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 shorter 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 medicine must not 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 medicine.

How to use

This medicine is for nasal use.

Before administering the medicine, clear any existing nasal secretions by thoroughly blowing your nose.

If this is the first time you are using the product or if you have not used it for a long time, it is necessary to prime the spray. To do this, hold the container away from your body and press the spray several times until a fine mist is released.

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.

The duration of treatment should not exceed 7 days unless otherwise prescribed by your doctor.

If you use more respibien freshmint than you should

With excessive or prolonged dosing, or if the product is accidentally swallowed, you may experience: headache, tremors, insomnia, excessive sweating, palpitations, tachycardia, increased blood pressure, or sleep disturbances.

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service at telephone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to use respibien freshmint

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

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

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may produce adverse effects, although not everyone will experience them.

During the period of oxymetazoline use, 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 application site, dryness, sneezing, and irritation of the nose, mouth, and throat.

Adverse effects that may occur rarely are:

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

Excessive or prolonged use of this medicine may lead to rebound nasal congestion.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of respibien freshmint

Keep this medicine out of the sight and reach of children.

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point in your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Respibien Freshmint

• The active substance 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 flavour (flavouring agents and glyceryl triacetate (E-1518)), aloe vera, eucalyptol, and purified water.

Appearance of the product and contents of the pack

Respibien Freshmint is a slightly whitish or transparent solution with a menthol scent.

It is supplied in blue polyethylene terephthalate bottles equipped with a metering pump and a cap to ensure proper preservation. Each bottle 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 most recent review of this leaflet: April 2023

Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/