Normonasal 0.5 mg/ml solution for nasal spray
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
normonasal 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.
Follow exactly the instructions for use provided in this leaflet or as directed 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 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.
Contents of the leaflet
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What normonasal is and what it is used for
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What you need to know before using normonasal
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How to use normonasal
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Possible adverse effects
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How to store normonasal
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Contents of the pack and other information
1. What normonasal is and what it is used for
This medicine belongs to a group of medicines called sympathomimetics. It is a nasal decongestant containing oxymetazoline as the active substance.
Oxymetazoline, when administered through the nose, produces local constriction of blood vessels, thereby 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 symptoms worsen or do not improve after 3 days of treatment.
2. What you need to know before using normonasal
Do not use normonasal
- If you are allergic to oxymetazoline, to other nasal decongestants, or to any of the other ingredients of this medicine (listed in section 6).
- If you have recently undergone head surgery (if you have had cranial, transnasal, or transoral surgery).
Warnings and precautions
Consult your doctor or pharmacist before using normonasal if:
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You are being treated with antidepressant medicines, phenothiazines (tranquilizers), or methyldopa (used to lower blood pressure).
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You have had or currently have, even if only once, any of the following conditions or symptoms:
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If you have high blood sugar levels (diabetes mellitus)
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If you have high blood pressure (hypertension)
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If you have any heart or circulatory system disease
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If you have prostate disease with difficulty in urination (prostatic hypertrophy)
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If you have thyroid disease (hyperthyroidism)
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If you have ever experienced insomnia or dizziness while being treated with other sympathomimetic medicines, such as those used to treat heart conditions, hypotension (low blood pressure), or asthma.
In rare cases, oxymetazoline, due to its temporary effects and prolonged use, may increase nasal congestion rather than reduce it; this is known as rebound effect.
Insomnia may rarely occur after using the medicine. If this happens, avoid using it late in the afternoon or at night.
Do not exceed the recommended dose described in section 3, How to use normonasal.
To prevent infections, the medicine should not be used by more than one person, and the applicator must 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 prone to adverse effects from this medicine.
Using normonasal with other medicines
Tell 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 or monoamine oxidase inhibitors (MAOIs)), or the blood pressure-lowering medicine called methyldopa.
It should also not be used if you are being treated with phenothiazines (tranquilizers) or medicines used to treat asthma.
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.
This medicine should not be used during pregnancy or breastfeeding.
Driving and using machines
Although problems in this regard are unlikely, if you experience drowsiness or dizziness, do not drive or operate dangerous tools or machinery.
Normonasal contains benzalkonium chloride
This medicine contains 0.216 mg of benzalkonium chloride per ml.
Benzalkonium chloride may cause irritation or inflammation inside the nose, especially when used for long-term treatment.
3. How to use normonasal
Follow exactly the instructions for administering this medicine provided in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The recommended dose is:
Adults and children aged 6–12 years
2–3 sprays into each nostril, no more than 2 times in 24 hours.
Use in children
Children under 6 years: This medicine must not be used in children under 6 years of age.
Patients over 65 years
Consult your doctor or pharmacist, as elderly individuals are more sensitive to the adverse effects of this medicine.
How to use
This medicine is administered by nasal route.
If this product is being used for the first time or has not been used for a long time, the spray must first be primed. To do this, hold the container away from the body and press the spray pump several times until a fine mist is released.
Before administering the medicine, clear any existing nasal secretions by blowing your nose thoroughly.
Press the spray pump quickly and firmly, into each nostril, while keeping your head upright and inhaling deeply as you press the spray.
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.
If your symptoms worsen or do not improve after 3 days of treatment, discontinue treatment and consult your doctor.
If you use more normonasal than you should
With excessive or prolonged dosing, you may experience: headache, tremors, insomnia, excessive sweating, palpitations, tachycardia, increased blood pressure, or sleep disturbances.
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.
4. Possible adverse effects
Like all medicines, Normonasal can cause adverse effects, although not everyone experiences them.
During the period of use of oxymetazoline, the following adverse effects have been observed, although their frequency could not be precisely established:
The most frequently occurring adverse effects are:
Burning sensation at the application site, dryness, itching of the nasal mucosa, or sneezing.
The adverse effects that may occur rarely are:
Anxiety, restlessness, insomnia, hallucinations, tremors, and sleep disturbances in children.
Tachycardia, palpitations, increased blood pressure, headache, nausea, exanthema (skin redness).
Excessive or prolonged use of this medicine may lead to nasal congestion.
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 Pharmacovigilance System for Human Medicines (Website: www.notificaRAM.es).
By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Normonasal
Keep this medicine out of the sight and reach of children.
Special storage conditions are not required.
Do not use this medicine after the expiry date stated on the packaging after
EXP. The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater drains or household waste.
Dispose of unused medicines and their containers at the SIGRE Point located at the pharmacy.
If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging.
This will help protect the environment.
6. Contents of the pack and other information
Composition of Normonasal
The active substance is oxymetazoline. Each ml contains 0.5 mg of oxymetazoline as the active ingredient.
The other components (excipients) are benzalkonium chloride, monobasic sodium phosphate anhydrous, sodium chloride, dibasic sodium phosphate, eucalyptol, menthol and purified water.
Nature of the product and pack contents
Normonasal is a colourless, transparent solution for nasal spray.
It is supplied in polyethylene bottles with a metering pump containing 15 ml of solution.
Marketing Authorization Holder and Manufacturer:
LABORATORIOS NORMON, S.A.
Ronda de Valdecarrizo, 6
28760-Tres Cantos-Madrid (SPAIN)
Date of the most recent review of this leaflet: October 2013
Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/