RESPIBIEN 0.5 mg/ml NASAL SPRAY SOLUTION

Introduction

Leaflet: Information for the User

respibien 0.5 mg/ml nasal spray solution

oxymetazoline, hydrochloride

Read the entire 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 leaflet or as indicated 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 side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after 3 days.

Contents of the Leaflet

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

1. What respibien 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 and children over 6 years of age.

You should consult a doctor if it worsens or does not improve after 3 days of treatment.

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

Do not 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 (MAOIs, used to treat Parkinson's disease and depression). MAOIs may 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 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 hyperplasia),
• any thyroid disease (hyperthyroidism).

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

Insomnia may rarely 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.

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 adverse effects of this medication.

Other medications and respibien

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 in 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 not be used in case of treatment with phenothiazine (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 feel drowsy, do not drive or use hazardous tools or machines.

respibien contains benzalkonium chloride.

This medication contains 0.2 mg of benzalkonium chloride per ml.

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

3. How to use respibien

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

The recommended dose is:

Adults and children over 6 years

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 of age (see section 2. Do not use respibien).

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 nasally.

Before applying this medication, existing nasal fluids should be eliminated 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, it is necessary to charge the sprayer. To do this, holding the container away from your body, press the sprayer several times until a finely sprayed liquid comes out.

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

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

If you use more respibien than you should

Due to excessive or continuous dosing, 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, 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

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.

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 certainty.

The most common side effects are:

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

Rare side effects that may occur are:

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 prolonged use of this medication may 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 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

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 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 pharmacy's SIGRE point. Ask your pharmacist how to dispose of the containers and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of respibien

• 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-crystallizing liquid sorbitol (E-420), and purified water.

Appearance of the product and package contents

respibien is a colorless or slightly yellowish solution.

It is presented in high-density polyethylene bottles, white, with a dosing pump and a screw cap that ensures its proper conservation.

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 leaflet:August 2019

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