Nasolina 0.57 mg/ml solution for nasal spray

Patient Information Leaflet

Introduction

Patient Information Leaflet

Nasolina 0.57 mg/ml

nasal spray solution

Oxymetazoline hydrochloride

Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.

• Follow exactly the instructions for administration of the medicine provided in this leaflet or as directed 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 adverse 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:

1. What Nasolina is and what it is used for
2. What you need to know before using Nasolina
3. How to use Nasolina
4. Possible adverse 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 medicine containing oxymetazoline as the active substance.

Oxymetazoline, administered through the nose, produces local constriction of blood vessels, thereby reducing nasal congestion.

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

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 Nasolina

Do not use Nasolina

• 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 conditions, 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

Talk to 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)
• any heart or circulatory system disease
• increased eye pressure (glaucoma)
• prostate disease with difficulty urinating (prostatic hypertrophy)
• thyroid disease (hyperthyroidism)

In rare cases, oxymetazoline may increase nasal congestion rather than relieve it, due to its temporary effects and prolonged use. 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 in section 3. How to use Nasolina.

Using the same container by more than one person may lead to transmission of infections.

Children

Do not use in children under 6 years of age.

Children may be especially prone to experiencing adverse effects from this medicine.

Other medicines and Nasolina

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

It is important that you inform your doctor if you are taking or have taken within the past two weeks:

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

This medicine 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 might 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 the potential risk.

Driving and using machines

The effect of this medicine on the ability to drive and use machines is none or negligible.

Nasolina contains benzyl alcohol

This medicine 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 exactly the instructions for administering this medicine as described 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 :

Administer one single spray into each nostril, up to 2 times daily—once in the morning and once at night.

Do not exceed 2 applications in 24 hours.

Do not repeat applications 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 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 Nasolina).

Elderly patients (over 65 years of age)

Consult your doctor or pharmacist, as elderly patients are more sensitive to the adverse effects of this medicine.

How to use Nasolina

This medicine is for nasal use only.

Before administration, blow your nose thoroughly to clear existing nasal secretions.

At the time of administration, the product should be below 25°C to maintain it in solution form, which will gelify once applied into the nasal passages.

Before first use, prime the pump by pressing it 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 your head, insert the nozzle into the nostril. Press firmly and evenly with a single motion to deliver one spray into each nostril. Keep the bottle in an upright position.

Each person should use their own container to avoid transmission of infection.

To prevent contamination, clean the tip of the applicator with a clean, damp cloth and close the container immediately after use.

Consult your doctor if your condition worsens or does not improve after 3 days of treatment.

If you use more Nasolina than you should

With excessive or prolonged dosing, or if the product is accidentally swallowed, symptoms such as headache, tremors, insomnia, excessive sweating, sleep disturbances, palpitations, tachycardia, and increased blood pressure may occur.

In children, these effects may include: seizures and coma, hallucinations, decreased heart rate, transient cessation of breathing, increased blood pressure followed by a subsequent drop in blood pressure, excitability, urticaria, nausea and vomiting, nervousness, drowsiness or lethargy, abnormal gait, and facial edema.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 5620420, stating the name of the medicine and the amount ingested.

If you forget to use Nasolina

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

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Nasolina may produce adverse effects, although not everyone experiences them.

The following adverse effects have been observed, although their frequency cannot be precisely determined.

The most frequent adverse effects are: dryness of the nasal mucosa, sneezing, irritation of the nose, mouth and throat, stinging at the site of application.

Adverse effects that may occur occasionally include: allergic reaction, nervousness, agitation, anxiety, dizziness or lightheadedness, sleep disturbances, 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, increased nasal discharge, dry mouth, 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 involves possible adverse effects not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System 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 Nasolina

Keep this medicine out of the sight and reach of children.

No special storage conditions are 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 or household waste. Dispose of empty containers and unused medicines at a pharmacy’s SIGRE collection point. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This way, you will help protect the environment.

6. Contents of the pack and other information Composition of Nasolina

The active substance 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 gum CL-GA, eucalyptus flavor, menthol, glycine, and purified water.

Appearance of the product and contents of the container

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

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 most recent revision of this leaflet: May 2025

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