Label: information for the user

Respibien 0.5 mg/mL nasal spray solution

oxymetazoline hydrochloride

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

Follow exactly the medication administration instructions contained in this label or those indicated by your doctor or pharmacist.

• Keep this label, 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 label.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 and children over 6 years old.

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

No use respibien

• If you are allergic to oxymetazoline hydrochloride, 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.
• If you are under 6 years old.

Warnings and precautions

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

• You have had or have any of the following diseases or symptoms, even if they only occurred once:

• 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 at night.

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

To prevent 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 old.

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

Other medications and respibien

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 two weeks: medications used to treat depression (tricyclic antidepressants, maprotiline, or monoamine oxidase inhibitors [MAOIs]), or 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 lactation

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 machinery

Although problems are not expected, if you feel drowsy, do not drive or use hazardous tools or machinery.

respibien contains benzalkonium chloride.

This medication contains 0.2 mg of benzalkonium chloride in each ml.

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

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

The recommended dose is:

Adults and children over6years

1 spray in each nostril no more than 2 times in 24 hours.

Use in children under 6 years

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

Elderly patients (over 65 years)

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 by nasal route.

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.

If it worsens or does not improve after 3 days of treatment, interrupt the treatment and consult your doctor.

If you usemore respibien than you should

By application of excessive or very frequent 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 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 userespibien

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

If necessary,return to using it as indicated insection3.How to use respibien.

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

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

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

The adverse effects that may occur in rare cases 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 a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for 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. 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

• The other components are: benzalkonium chloride, glycine (E-640), povidone (E-1201), non-crystallizable liquid sorbitol (E-420) and purified water.

Appearance of the product and contents of the packaging

respibien is a colourless or slightly yellowish solution.

It is presented in high-density polyethylene bottles, white, provided with a dosing pump and a screw cap that ensures its correct 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:August 2019

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