Package Insert: Information for the User

respibien freshmint 0.5 mg/ml nasal spray solution

oxymetazoline hydrochloride

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

Follow exactly the administration instructions contained in this package insert or those provided by your doctor or pharmacist.

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

This medication belongs to the group of medications known as sympathomimetics. It is a nasal decongestant medication that contains oxymetazoline as the active ingredient. Oxymetazoline administered through the nose, produces local vasoconstriction, 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. Consult a doctor if symptoms worsen or do not improve after 3 days of treatment.

No 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 (MAO inhibitors, used to treat Parkinson's disease and depression). MAO inhibitors may increase the hypertensive effects of oxymetazoline.
• If you have narrow-angle glaucoma.
• If you have recently undergone surgery on the head (if you have undergone any cranial, transnasal, or transoral surgery).
• If you have inflammation of the skin and mucous membrane 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 dizziness when taking 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 experienced or have any of the following diseases or symptoms:

• High blood sugar levels (diabetes mellitus),
• High blood pressure (hypertension),
• Any heart disease or circulatory disease,
• Any 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 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 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 with a clean, damp cloth after each use.

Children

Do not use in children under 6 years of age.

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

Other Medications and respibien freshmint

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

This medication should not be used by people taking or having 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 while being treated with phenothiazine (tranquilizer) or medications to treat asthma.

Pregnancy and Breastfeeding

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

This medication should not be used during pregnancy or breastfeeding.

Driving and Operating Machines

Although problems are not expected, if you experience drowsiness, do not drive or use hazardous tools or machines.

respibien freshmint contains benzalkonium chloride.

This medication contains 0.2 mg of benzalkonium chloride in each 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.

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

The recommended dose is:

Adults, adolescents, and children over 6 years old

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 old

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

Patients over 65 years old

Consult your doctor or pharmacist as patients over 65 years old are more sensitive to the adverse effects of this medication.

How to use

This medication is used nasally.

Before applying this medication, you must remove existing nasal secretions, blowing your nose well.

If it is the first time you use this product or have not used it for a long time, it is necessary to prime the sprayer. To do this, holding the container away from your body, press the sprayer several times until a finely powdered liquid comes out.

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

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

If you use more respibien freshmint than you should

By excessive or very frequent dose application, 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 may include: hallucinations, excitability, urticaria, nausea, and vomiting, hysteria, somnolence, or numbness, abnormal gait, facial edema.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to use respibien freshmint

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

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

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

Like all medications, this medication may produce adverse effects, although not all people may experience them.

During the period of use of oxymetazoline, the following adverse effects have been observed, whose frequency has not been established with exactness.

The adverse effects that have occurred most frequently are:

Burning sensation at the application site, dryness, sneezing, and irritation of the nose, mouth, and throat.

The adverse effects that may occur in rare occasions are:

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

The excessive or continued use of this medication may lead to rebound nasal congestion.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is about possible adverse effects that do not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

This medication does not require special storage conditions.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of respibien freshmint

Appearance of the product and contents of the packaging

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

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

Holder of the marketing authorization and responsible for manufacturing

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Areta Industrial Estate

31620 Huarte (Navarra) - Spain

Date of the last review of this leaflet:April 2023

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