Respir 0.5 mg/ml nasal spray solution
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Respir 0.5 mg/ml nasal spray solution
oxymetazoline hydrochloride
Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.
- Always follow exactly the instructions for administering this medicine as described in this leaflet or as given by your doctor, pharmacist, or nurse.
- 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, pharmacist, or nurse, 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:
- What Respir is and what it is used for
- What you need to know before using Respir
- How to use Respir
- Possible adverse effects
- How to store Respir
- Contents of the pack and other information
1. What Respir is and what it is used for
This medicine belongs to a group of medicines 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 symptomatic relief of nasal congestion in adults, adolescents, and children from 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 Respir
Do not use Respir
- 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 have ever experienced insomnia or dizziness while being treated with other sympathomimetic medicines, such as those used, among others, for treating heart diseases, hypotension (low blood pressure), or asthma,
- 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 (increased eye pressure),
- if you have recently undergone head surgery (if you have had cranial, transnasal, or transoral surgery),
- if you have inflammation of the skin and mucosa of the nasal vestibule (anterior and lower part of the nasal cavities) and nasal crusts (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 medicine 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),
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any heart or circulatory disease,
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prostate disease with difficulty urinating (prostatic hypertrophy),
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any thyroid disease (hyperthyroidism).
In rare cases, oxymetazoline may increase nasal congestion instead of relieving it, due to its temporary effects and prolonged use. This is known as rebound effect.
Insomnia may rarely occur after using this medicine. If this happens, avoid using it late in the afternoon or at night.
Do not exceed the recommended dose stated in section 3. How to use Respir.
To prevent infections, this medicine must not be shared among 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 susceptible to adverse effects of this medicine.
Other medicines and Respir
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
- a blood pressure-lowering medicine called methyldopa.
It should also not be used if you are being treated with phenothiazine (a tranquilizer) or medicines for treating asthma.
This medicine must not be used together with other vasoconstrictors.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Consult your doctor before using this medicine so they can assess the benefit versus potential risk.
Driving and operating machinery
The effect of Respir on the ability to drive and operate machinery is none or negligible.
Respir contains benzalkonium chloride and propylene glycol
This medicine contains 0.2 mg of benzalkonium chloride per 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 during long-term treatment.
This medicine contains 100 mg of propylene glycol per milliliter. Each 0.10 ml spray contains 10 mg of propylene glycol.
3. How to use Respir
Follow exactly the instructions for administering this medicine as stated in this leaflet or as directed by your doctor, pharmacist, or nurse. If in doubt, consult your doctor, pharmacist, or nurse.
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 doses in 24 hours.
Do not repeat administration at intervals shorter 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 of age
This medicine must not be used in children under 6 years of age (see section 2 Do not use Respir).
Elderly patients (over 65 years of age)
Consult your doctor or pharmacist, as elderly patients may be more sensitive to the adverse effects of this medicine.
How to use
This medicine is for nasal use.
Before administration, clear any nasal secretions by thoroughly blowing your nose.
To prevent infection, after each use and before closing the container, clean the applicator tip with a clean, damp cloth. In addition, each container must be used by only one person.
Shake well before use.
Nebulizer bottle: with the head in an upright position, place the opening of the atomizer into the nostril without completely blocking it. During each administration, tilt the head slightly forward and inhale quickly while pressing the bottle.
Bottle with spray pump:
Shake well before use. Remove the protective cap.
Before first use, press the pump several times until the first complete spray is released.
To spray, hold the bottle between the palm and the index and thumb fingers. Without tilting the head, insert the nozzle into the nostril.
Press the rim firmly and evenly in one complete motion, and spray the recommended number of sprays into each nostril. Keep the bottle in an upright position.
See illustrative drawings:
Consult your doctor if symptoms worsen or do not improve after 3 days of treatment.
If you use more Respir than you should
Excessive or prolonged dosing, or accidental ingestion of the product, may cause the following symptoms: headache, tremors, insomnia, excessive sweating, palpitations, tachycardia, increased blood pressure, or sleep disturbances.
In children, these effects may include: seizures and coma, hallucinations, decreased heart rate, transient cessation of breathing, increased blood pressure followed by a drop in blood pressure, excitability, urticaria, nausea and vomiting, hysteria, drowsiness or lethargy, abnormal gait, facial edema.
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone: 91.5620420, indicating the medicine and the amount ingested.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, Respir may cause adverse effects, although not everyone experiences them.
The following adverse effects have been observed during the period of use of oxymetazoline, although their frequency cannot be precisely determined.
The most frequently occurring adverse effect is local dryness sensation in the nasal mucosa.
Uncommon adverse effects are local stinging and burning.
Adverse effects that may occur rarely include:
Allergic reaction, nervousness, agitation, anxiety, dizziness or lightheadedness, 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, nasal dryness, dry mouth, nasal irritation, throat irritation, rebound congestion, nausea, rash, seizures (particularly in children), and weakness.
Reporting of 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 leaflet. You may also report them directly through the Spanish System of Pharmacovigilance 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 Respir
Keep this medicine out of sight and reach of children.
No special storage conditions are required.
Do not use this medicine after the expiry date stated on the bottle after EXP. The expiry date is the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Unused medicines and waste materials, including packaging, should be handed in at the SIGRE point at your pharmacy. If you are unsure, please consult your pharmacist on how to dispose of medicines and packaging you no longer need. This will help protect the environment.
6. Contents of the container and additional information
Composition of Respir
- The active substance is oxymetazoline hydrochloride. Each ml of nasal spray solution contains 0.5 mg of oxymetazoline hydrochloride.
- The other components (excipients) are monosodium 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 container
Respir is a clear, colourless solution.
Respir is available in:
- 10 ml polyethylene spray bottle.
- 10 ml and 20 ml polyethylene bottles with spray pump.
Please note that only certain pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Bayer Hispania, S.L.
Avda. Baix Llobregat, Nº 3 – 5
08970 Sant Joan Despí, Barcelona
Spain
Manufacturer:
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 most recent revision of this leaflet: October 2024
Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/