Rhinospray Eucalyptus 1.18 mg/ml solution for nasal spray

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Rhinospray Eucalyptus 1.18 mg/ml nasal spray solution

Tramazoline 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 or pharmacist, 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 of treatment.

Contents of the leaflet

1. What Rhinospray Eucalyptus is and what it is used for
2. What you need to know before using Rhinospray Eucalyptus
3. How to use Rhinospray Eucalyptus
4. Possible adverse effects
5. How to store Rhinospray Eucalyptus
6. Contents of the pack and other information

1. What Rhinospray Eucalyptus is and what it is used for

Rhinospray Eucalyptus is a nasal decongestant medicine containing tramazoline hydrochloride as the active substance. When administered into the nose, it produces local constriction of blood vessels, thereby decongesting the nasal mucosa.

This medicine is indicated for the local and temporary relief of nasal congestion in adults 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 Rhinospray Eucalyptus.

Do not use Rhinospray Eucalyptus

• if you are allergic to tramazoline hydrochloride, to other adrenergic decongestants, or to any of the other ingredients of this medicine (listed in section 6).
• if you have eye disease with increased pressure, dryness of the nasal mucosa with crust formation (dry rhinitis), or if you have undergone cranial surgery through the nasal cavity.
• if you have recently undergone head surgery (if you have had cranial, transnasal, or transoral surgery).
• Children under 6 years of age must not use this medicine.

Warnings and precautions

Talk to your doctor or pharmacist before using Rhinospray Eucalyptus:

• If you have high blood pressure, heart disease, thyroid disorders, diabetes, prostate problems, porphyrin metabolism disorders, or pheochromocytoma (a tumor of the adrenal glands).
• If you are being treated with medicines for depression or medicines for blood pressure disorders.
• Prolonged use of nasal decongestants may cause chronic inflammation and atrophy of the nasal mucous membrane, leading to nasal blockage. If you have chronic nasal obstruction, consult your doctor and do not continue using the product on your own.
• When the effect of the medicine decreases, rebound inflammation of the nasal mucosa may occur.
• Avoid contact with the eyes to prevent irritation.
• If the medicine causes insomnia, avoid using it late in the afternoon or at night.

Children

Do not administer to children under 6 years of age. Children may be especially prone to adverse effects from this medicine.

Use in people aged 65 years and older

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

Other medicines and Rhinospray Eucalyptus

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Concurrent use of Rhinospray Eucalyptus with certain antidepressants (MAO inhibitors or tricyclic antidepressants) or with medicines used to treat low blood pressure (vasopressor agents) may cause an increase in blood pressure.

Concurrent use with tricyclic antidepressants may also cause disturbances in heart rhythm (arrhythmias). Interaction with antihypertensives (medicines used to lower high blood pressure) may lead to cardiovascular disturbances.

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 must not be used during pregnancy or breastfeeding.

Driving and using machines

Do not drive or operate machinery if you experience hallucinations, drowsiness, sedation, fatigue, or dizziness.

Rhinospray Eucalyptus contains benzalkonium chloride

This medicine contains 0.202 mg of benzalkonium chloride per ml.

Benzalkonium chloride may cause irritation or inflammation inside the nose, especially when used during long-term treatment.

3. How to use Rhinospray Eucalyptus

Follow exactly the administration instructions for this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is:

Adults and children aged 6 years and older: 1 to 2 sprays into each nostril as needed, up to 3 times a day if necessary.

Use in children

Do not administer this medicine to children under 6 years of age.

This medicine is administered via the nasal route.

Before each spray, observe the following instructions:

1. Remove the protective cap.

2. Before using for the first time, prime the spray pump by pressing it several times until a uniform spray is obtained (see figure 1). From this point on, the spray pump is ready for immediate use. Clear the nose before inserting the spray nozzle into the nostril.

1. Administer the spray by pressing the spray pump once (see figure 2). Repeat this process in the other nostril. During spraying, gently inhale through the nose. If a second spray is required, repeat the procedure.

1. Replace the protective cap after administration is complete.

After each use, clean the spray nozzle with a clean, damp cloth before closing the container.

To minimize the risk of transmitting infections, this medicine must not be used by more than one person.

If symptoms worsen, persist for more than 3 days, or new symptoms appear, consult your doctor.

If you use more Rhinospray Eucalyptus than you should

In case of overdose or accidental ingestion, phases of stimulation and depression of the central nervous system may occur (anxiety, agitation, hallucinations, and convulsions; decreased body temperature, lethargy, drowsiness, and coma, respectively). Other symptoms may include pupil dilation and constriction, sweating, fever, pallor, bluish discoloration of the lips, and cardiovascular, respiratory, and psychological disturbances.

Especially in children, poisoning may result in increased blood pressure followed by a drop in blood pressure, increased heart rate, anxiety, hallucinations, and convulsions, followed by decreased body temperature, lethargy, drowsiness, shock, decreased heart rate, and coma.

If you have used more Rhinospray Eucalyptus than you should, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number 915 620 420, indicating the medicine and the amount administered.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

Frequent (may affect more than 1 in 10 people)

• nasal discomfort

Uncommon (may affect up to 1 in 100 people)

• restlessness
• headache
• palpitations
• nasal congestion, nasal dryness, nasal discharge, sneezing
• nausea

Rare (may affect up to 1 in 1000 people)

• dizziness, taste disturbance
• nosebleed

Frequency not known

• hypersensitivity (allergy)
• hallucinations, insomnia
• drowsiness, sedation
• heart rhythm disturbance
• skin rash, itching, skin swelling
• mucosal swelling, fatigue
• increased blood pressure

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via 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 Rhinospray Eucaliptus

No special storage conditions are required.

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

Do not use this medicine after the expiry date stated on the packaging, after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at a SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Rhinospray Eucaliptus

• The active substance is tramazoline hydrochloride. Each ml of solution contains 1.18 mg tramazoline hydrochloride, equivalent to 83 micrograms per 0.07 ml spray.
• The other components (excipients) are eucalyptol, menthol, camphor, benzalkonium chloride, glycerol, citric acid monohydrate, sodium hydroxide, hypromellose, povidone, magnesium sulfate, magnesium chloride, calcium chloride, sodium bicarbonate, sodium chloride and purified water.

Appearance of the product and contents of the pack

Rhinospray Eucaliptus is a clear, slightly yellowish solution with eucalyptus odour for nasal spray.

It is presented in a glass container holding 10 ml of solution and comes with a metering valve.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Opella Healthcare Spain, S.L.

C/ Rosselló i Porcel, 21

08016 Barcelona,

Spain

Manufacturer:

Istituto de Angeli, S.r.l.

Località Prulli 103/C

50066 Reggello (Florence) – Italy

Date of the most recent review of this leaflet: November 2025

You can access detailed information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the leaflet and packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/56731/P_56731.html

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/.