Label: information for the user

Respir 0.5mg/ml nasal spray solution

oxymetazolinehydrochloride

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

• Follow exactly the administration instructions contained in this label or those indicated by your doctor, pharmacist, or nurse.
• Keep this label, as you may need to refer to it again.
• For advice or more information, consult your pharmacist.
• Report any adverse effects to your doctor, pharmacist, or nurse, 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.

1.What is Respir and how is it used

2.What you need to knowbeforestarting touse Respir

3.How to use Respir

4.Possible adverse effects

5.Storage of Respir

6.Contents of the package and additional information

This medication belongs to a group of medications known as sympathomimetics. It is a nasal decongestant medication that contains oxymetazoline as the active ingredient. Oxymetazolineadministered through the nose, produces local vasoconstriction, thereby decongesting the nasal mucosa.

It is indicated for symptomatic relief of nasal congestion in adults, adolescents, and children aged 6 years and above.

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

No use Respir

• If you are allergic to oxymetazoline, other nasal decongestants, or any of the other ingredients in this medication (listed in section 6),
• If you have ever experienced insomnia or dizziness when taking other sympathomimetic medications, such as those used to treat heart disease, low blood pressure, or asthma,
• 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 (elevated eye pressure),
• If you have recently undergone surgery on the head (if you have undergone any cranial, transnasal, or transoral surgical intervention),
• If you have inflammation of the skin and mucous membranes of the nasal vestibule (front and lower part of the nasal cavities) and crusts in the nose (dry rhinitis),
• If you have acute heart disease or cardiac asthma,
• If you have severe hypertension
• in children under 6 years of age.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before using this medication if:

• You have ever experienced or are experiencing any of the following diseases or symptoms:

• High blood sugar levels (diabetes mellitus),
• High blood pressure (hypertension),
• Any heart disease or circulatory system 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 Respir.Respir.

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 Respir

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
• A medication to lower blood pressure called methyldopa.

It should also not be used in people being treated with phenothiazine (tranquilizer) or medications to treat asthma.

This medication should not be used in conjunction with other vasoconstrictors.

Pregnancy and lactation

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

Consult your doctor before using this medication to evaluate the benefit against the potential risk.

Driving and operating machinery

The influence of Respir on the ability to drive and operate machinery is negligible or insignificant.

Respir containsbenzalkonium chloride and propylene glycol

This medication contains 0.2 mg of benzalkonium chloride in each milliliter. Each 0.10 ml spray contains 20 micrograms of benzalkonium chloride. Benzalkonium chloride may cause irritation or inflammation inside the nose, especially when used for a long treatment period.

This medication contains 100 mg of propylene glycol in each milliliter. Each 0.10 ml spray contains 10 mg of propylene glycol.

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

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.

Do not exceed the recommended daily dose.

Use in children under 6 years old

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

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 by nasal route.

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

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

Shake before use.

Nebulizer bottle: with the head in an upright position, place the atomizer opening in the nasal fossa without completely obstructing it. During each application, slightly incline the head forward and inhale quickly while pressing the bottle.

Bottle with pump sprayer:

Shake well before use. Remove the protective cap.

Before the first use, press the pump several times until a complete spray is produced.

To spray, hold the bottle between the palm and the index and middle fingers. Without tilting the head, insert the nozzle into the nasal fossa.

Press the edge completely with a firm and uniform movement and spray the recommended number of sprays in each nostril. Keep the bottle in a vertical position

See illustrative drawings:

You must consult your doctor if symptoms worsen or do not improve after 3 days of treatment.

If you use more Respir than you should

Due to excessive or very frequent doses, or if you accidentally swallow the product, the following symptoms may occur:headache, tremors, insomnia, excessive sweating, palpitations, tachycardia, increased blood pressure or sleep disturbances.

In children, these effects may include: convulsions and coma, hallucinations, decreased heart rate, transient suspension of breathing, increased blood pressure that later becomes decreased blood pressure, excitability, urticaria, nausea and vomiting, hysteria, drowsiness 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: 91.5620420, indicating the medication and the amount ingested.

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

Like all medications, Respir may produce adverse effects, although not all people will experience them.

During the period of oxymetazoline use, the following adverse effects have been observed, although their frequency has not been established with precision.

The most frequent adverse effect is a sensation of local dryness in the nasal mucosa.

Rare adverse effects are itching and burning sensations in the local area.

Adverse effects that may occur in rare instances are:

Allergic reaction, nervousness, agitation, anxiety, dizziness or disorientation, difficulty sleeping, drowsiness, tremors, headache, hallucinations (particularly in children), blurred vision, tachycardia, palpitations, increased blood pressure, reactive hyperemia (accumulation of blood in an organ due to obstruction of the veins), nasal burning, sneezing, increased nasal secretion, increased nasal congestion, dry nose, dry mouth, nasal irritation, throat irritation, rebound congestion, nausea, rash, convulsions (particularly in children), and weakness.

Reporting Adverse Effects:

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance for Human Use Medications: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.

No special storage conditions are required.

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

Medicines should not be disposed of through drains or in the trash. Dispose of the containers and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and unused medications. By doing so, you will help protect the environment.

Composition of Respir

-The active ingredient is oximetazoline hydrochloride.Each ml of nasal spray solution contains 0.5 mg of oximetazoline hydrochloride

-The other components (excipients) are sodium monobasic phosphate, disodium edetate, propylene glycol (E-1520), benzalkonium chloride, sodium hydroxide or hydrochloric acid for pH adjustment and purified water.

Appearance of the product and contents of the packaging

Respir is a transparent and colourless solution.

Respir is presented in:

Polyethylene nebulizer bottle of 10 ml.

Polyethylene bottles with a spray pump of 10 and 20 ml.

Only some sizes of packaging may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Bayer Hispania, S.L.

Avda. Baix Llobregat, Nº 3 – 5

08970 Sant Joan Despí, Barcelona

Spain

Responsible for manufacturing:

Berlimed S.A.

C/ Francisco Alonso nº 7

Polígono Industrial Santa Rosa (Alcalá de Henares)

28806 Madrid

Spain

or

Schering-Plough Labo N.V.

Industriepark, 30

B-2220 Heist-op-den-Berg

Belgium

Date of the last review of this leaflet:October2024

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