NASOLINA 0.5 mg/ml NASAL PRODUCT

Contents of the leaflet

1. Introduction
2. Oxymetazoline Hydrochloride
3. What Nasolina is and what it is used for
4. What you need to know before taking Nasolina
5. How to use Nasolina
6. Possible Side Effects
7. Storage of Nasolina
8. Package Contents and Additional Information Composition of Nasolina

Introduction

Package Leaflet: Information for the User

Nasolina 0.57 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 or as indicated by your doctor, pharmacist, or nurse.
• 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 side effects 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.

Contents of the Package Leaflet:

1. What Nasolina is and what it is used for
2. What you need to know before taking Nasolina
3. How to use Nasolina
4. Possible side effects
5. Storage of Nasolina
6. Package Contents and Additional Information

1. What Nasolina is and what it is used for

It is a nasal decongestant medication that contains oxymetazoline as the active ingredient.

Oxymetazoline, when administered through the nose, produces a local constriction of blood vessels, which reduces nasal congestion.

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 your symptoms worsen or do not improve after 3 days of treatment.

2. What you need to know before taking Nasolina

Do not use Nasolina

• 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 ever suffered from insomnia or dizziness when treated with other sympathomimetic medications, such as those used to treat heart disease, hypotension (low blood pressure), or asthma,
• 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 (increased eye pressure),
• 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 (anterior and lower part of the nasal cavities) and crusts in the nose (dry rhinitis),
• if you suffer from acute heart disease or cardiac asthma,
• if you suffer from 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 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
• increased eye pressure (glaucoma)
• 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 Nasolina

Using the same package by more than one person can lead to infections.

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 Nasolina

Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.

It is essential that you inform your doctor if you are taking or have taken in the last two weeks:

• medications used to treat depression (monoamine oxidase inhibitor antidepressants, maprotiline, or tricyclic antidepressants)
• a medication to lower blood pressure (methyldopa).

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

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

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.

Consult your doctor before using this medication to assess the benefits versus the potential risk.

Driving and Using Machines

The influence of this medication on the ability to drive and use machines is nil or insignificant.

Nasolina contains Benzyl Alcohol

This medication contains 1.04 mg of benzyl alcohol per spray. Benzyl alcohol may cause allergic reactions and moderate local irritation.

3. How to use Nasolina

Follow the administration instructions for the medication contained in this package leaflet or as 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:

Apply one spray in each nostril, 2 times a day, as needed, once in the morning and once at night.

Do not exceed 2 applications in 24 hours.

Do not repeat applications 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 dose.

Use in children under 6 years

This medication cannot be used in children under 6 years of age (see section 2. Do not use Nasolina).

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 Nasolina

This medication is used nasally.

Before application, blow your nose well to eliminate existing nasal fluids.

At the time of application, the product must be below 25°C to maintain it in solution form, which will gelify once applied to the nasal cavities.

Before the first use, the unit must be filled by pressing the pump several times until the first complete spray is produced.

To spray, hold the bottle between the palm and the index and thumb fingers.

Without tilting your head, insert the nozzle into the nostril. Press with a firm and uniform movement and perform one spray in each nostril. Keep the bottle in a vertical position.

Each person should use their own package to avoid infections.

To avoid contamination, clean the applicator tip with a clean, damp cloth, and close the package immediately after use.

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

If you use more Nasolina than you should

In case of excessive dose application or very continuous use, or if you accidentally swallow the product, headaches, tremors, insomnia, excessive sweating, sleep disturbances, palpitations, tachycardia, and increased blood pressure may occur.

In children, these effects may include: convulsions and coma, hallucinations, decreased heart rate, temporary suspension of breathing, increased blood pressure that later becomes a decrease in blood pressure, excitability, urticaria, nausea, and vomiting, nervousness, somnolence or drowsiness, 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 5620420, indicating the medication and the amount ingested.

If you forget to use Nasolina

Do not use a double dose to make up for the forgotten dose.

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

4. Possible Side Effects

Like all medications, Nasolina can cause side effects, although not everyone will experience them.

The following side effects have been observed, whose frequency cannot be established with precision.

The most common side effects are: dryness in the nasal mucosa, sneezing, irritation of the nose, mouth, and throat, itching at the application site

Rare side effects that may occur are: allergic reaction, nervousness, agitation, anxiety, dizziness or drowsiness, sleep problems, somnolence, tremors, headache, hallucinations (particularly in children), blurred vision, tachycardia, palpitations, increased blood pressure, reactive hyperemia (blood accumulation in an organ due to vein obstruction), nasal burning, increased nasal secretion, dry mouth, nausea, rash, convulsions (particularly in children), and weakness.

Reporting Side Effects:

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this package 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 Nasolina

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 indicated on the package 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 packages and medications you no longer need at the pharmacy's SIGRE point. In case of doubt, ask your pharmacist how to dispose of the packages and medications you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information Composition of Nasolina

The active ingredient is oxymetazoline hydrochloride.

Each ml of nasal spray solution contains 0.57 mg of oxymetazoline hydrochloride (equivalent to 0.5 mg of oxymetazoline).

The other components (excipients) are 1.04 mg of benzyl alcohol, anhydrous glycerin, gelano CL-GA gum, eucalyptus essence, menthol, glycine, and purified water.

Appearance of the Product and Package Contents

Nasolina is a nasal spray solution that, due to the increase in temperature, in contact with the nasal mucosa, transforms into a gel.

Each bottle contains 20 ml of solution.

Marketing Authorization Holder and Manufacturer

Laboratorios Salvat, S.A.

C/. Gall 30-36, 08950 Esplugues de Llobregat, Barcelona,

Spain.

Date of the Last Revision of this Package Leaflet: May 2025

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/