NORMONASAL 0.5 mg/ml NASAL SPRAY SOLUTION

Introduction

Package Leaflet: Information for the User

normonasal 0.5 mg/ml nasal spray solution

Oxymetazoline, hydrochloride

Read the entire package 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 package leaflet exactly

or as indicated by your doctor or pharmacist.

• Keep this package 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, pharmacist, or nurse, even if they are not listed in this package leaflet. See section 4.
• You should consult a doctor if your symptoms worsen or do not improve after 3 days.

Package Leaflet Contents

1. What normonasal is and what it is used for
2. What you need to know before using normonasal
3. How to use normonasal
4. Possible side effects
5. Storage of normonasal

1. Package Contents and Additional Information

1. What normonasal is and what it is used for

This medication belongs to the group of medications known as sympathomimetics. It is a nasal decongestant medication that contains oxymetazoline as the active ingredient. The

oxymetazoline administered through the nose produces constriction of blood vessels at the local level, 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 your 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, other nasal decongestants, or any of the other components of this medication (listed in section 6).
• If you have recently undergone surgery on the head (if you have had any cranial, transnasal, or transoral surgical intervention).

Warnings and Precautions

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

• You are being treated with antidepressant medications, phenothiazine (a tranquilizer), or methyldopa (to lower blood pressure).
• You have had or currently have any of the following diseases or symptoms:

• If you have high blood sugar levels (diabetes mellitus)
• If you have high blood pressure (arterial hypertension)
• If you have any heart or circulatory system disease
• If you have any prostate disease with difficulty urinating (prostatic hypertrophy)

prostatic hypertrophy

• If you have any thyroid disease (hyperthyroidism)

• If you have ever experienced insomnia or vertigo while being treated with other sympathomimetic medications, such as those used to treat heart diseases, hypotension (low blood pressure), or asthma.

Due to its temporary effects and prolonged use, oxymetazoline can rarely increase nasal congestion instead of reducing it; this is known as rebound effect.

Insomnia can rarely occur after using the medication. If this happens to you, avoid using it in the late afternoon or evening.

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

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 experiencing side effects from this medication.

Using normonasal with other medications

Tell 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 or monoamine oxidase inhibitors (MAOIs)), or a medication to lower blood pressure called methyldopa.

It should also not be used in case of treatment with phenothiazine (a tranquilizer) or medications to treat asthma.

Pregnancy and Breastfeeding

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

This medication should not be used during pregnancy or breastfeeding.

Driving and Using Machines

Although no problems are expected, if you experience drowsiness or dizziness, do not drive or operate hazardous tools or machines.

Normonasal contains benzalkonium chloride

This medication contains 0.216 mg of benzalkonium chloride per ml.

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

3. How to use normonasal

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

The recommended dose is:

Adults and children 6-12 years

2-3 sprays in each nostril, no more than 2 times in 24 hours.

Use in children

Children under 6 years: This medication should not be used in children under 6 years of age.

Over 65 years

Consult your doctor or pharmacist, as older people are more sensitive to the side effects of this medication.

How to use

This medication is used nasally.

If it is the first time using this product or it has not been used for a long time, it is necessary to prime the spray pump. To do this, holding the container away from the body, press the spray pump several times until a fine spray is released.

Before applying this medication, eliminate any existing nasal fluids by blowing your nose well.

Perform the spray quickly and firmly in each nostril, keeping your head upright and inhaling deeply while pressing the spray pump.

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

Due to excessive or continuous dosing, you may experience: headache, tremors, insomnia, excessive sweating, palpitations, tachycardia, increased blood pressure, or sleep disturbances.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91.5620420, indicating the medication and the amount ingested.

4. Possible side effects

Like all medications, normonasal can cause side effects, although not everyone experiences them.

During the use of oxymetazoline, the following side effects have been observed, although their frequency cannot be established with precision:

The most common side effects are:

Irritation at the application site, dryness, itching of the nasal mucosa, or sneezing.

Rare side effects that can occur are:

Anxiety, restlessness, insomnia, hallucinations, tremors, and sleep disorders in children.

Tachycardia, palpitations, increased blood pressure. Headache, nausea, exanthema (skin redness).

Excessive or prolonged use of this medication can lead to nasal congestion.

Reporting side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use (Website: www.notificaRAM.es).

By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of normonasal

Keep this medication out of sight and reach of children.

No special storage conditions are required.

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 SIGRE point in your pharmacy. If in doubt, 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 normonasal

The active ingredient is oxymetazoline. Each ml contains 0.5 mg of oxymetazoline as the active ingredient.

The other components (excipients) are benzalkonium chloride, sodium phosphate monobasic anhydrous, sodium chloride, sodium phosphate dibasic, eucalyptol, menthol, and purified water.

Appearance of the product and package contents

Normonasal is a colorless and transparent nasal spray solution.

It is presented in polyethylene bottles with a dosing 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 last revision of this package leaflet:October 2013

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