RHINOSPRAY EUCALIPTUS 1.18 mg/ml NASAL SPRAY SOLUTION

Introduction

Package Leaflet: Information for the Patient

Rhinospray Eucalyptus 1.18 mg/ml Nasal Spray Solution

Tramazoline Hydrochloride

Read this package leaflet carefully before you start using this medicine, because it contains important information for you.

Follow exactly the administration instructions of the medicine contained in this package leaflet or as indicated by your doctor or pharmacist.

• Keep this package leaflet, 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 or pharmacist, even if it is a side effect not listed in this package leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after 3 days of treatment.

Contents of the Package Leaflet

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

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

It is a nasal decongestant medicine that contains tramazoline hydrochloride as the active ingredient, which, when administered in the nose, produces a local constriction of blood vessels, decongesting the nasal mucosa.

This medicine is indicated for the local and temporary relief of nasal congestion in adults and children from 6 years of age.

You should consult a doctor if it worsens or does not improve after 3 days of treatment.

2. What you need to know before you start using Rhinospray Eucalyptus

Do not use Rhinospray Eucalyptus

• if you are allergic to tramazoline hydrochloride, other adrenergic decongestants, or any of the other components of this medicine (listed in section 6).
• if you have an 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 undergone any cranial, transnasal, or transoral surgical intervention).
• Children under 6 years of age must not use this medicine.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Rhinospray Eucalyptus:

• If you have high blood pressure, heart disease, thyroid disorders, diabetes, prostate problems, porphyria metabolism disorder, and pheochromocytoma (tumor of the adrenal glands).
• If you are being treated with medicines for depression and medicines for the treatment of blood pressure disorders.
• The continued use of nasal decongestant medicines can cause chronic inflammation and atrophy of the nasal mucous membrane, and therefore nasal blockage. If you have chronic nasal obstruction, you should consult your doctor and not continue using the product on your own initiative.
• When the effect of the medicine decreases, a rebound inflammation of the nasal mucosa may appear.
• You should avoid contact with the eyes to avoid irritation.
• If it causes insomnia, avoid using the medicine in the late afternoon or evening.

Children

Do not administer to children under 6 years of age. Children may be especially prone to the appearance of side effects of this medicine.

Use in people over 65 years of age

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

Other medicines and Rhinospray Eucalyptus

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

The simultaneous use of Rhinospray Eucalyptus with certain medicines for treating depression (IMAO or tricyclic antidepressants) or with medicines used to treat low blood pressure (vasopressor medicines) may cause an increase in blood pressure.

The simultaneous use with tricyclic antidepressants may also cause the appearance of heart rhythm disorders (arrhythmias). The interaction with antihypertensive medicines (medicines used to lower high blood pressure) may cause cardiovascular disorders.

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 medicine.

This medicine must not be used during pregnancy or breastfeeding.

Driving and using machines

Do not drive or use machines if you notice 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 of this medicine as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is:

Adults and children from 6 years of age: 1 to 2 sprays in 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 nasally.

Before each spray, consider the following instructions:

1. Remove the protective cap.

1. Before proceeding to the first spray, actuate the microdosifier several times until a uniform spray is achieved (see figure 1). From here, the microdosifier is always ready for immediate application. Clean the nose before introducing the spray nozzle into the nostril.

1. The spray is performed by actuating the microdosifier once (see figure 2). This process is repeated in the other nostril. During the spray, a gentle inspiration should be made through the nose. If a second spray is necessary, repeat the procedure.

1. Place the protective cap once the administration is finished.

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

To minimize the risk of infection transmission, the medicine should not be used by more than one person.

If it worsens, symptoms persist, or new ones appear after 3 days of treatment, you should consult a 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 appear (anxiety, agitation, hallucinations, and convulsions; decrease in body temperature, lethargy, drowsiness, and coma, respectively). Also, dilation and contraction of the pupils, sweating, fever, paleness, blue discoloration of the lips, and disorders of cardiovascular function, respiratory disorders, and psychological alterations may occur.

Especially in children, an overdose can result in an increase in blood pressure followed by a decrease in blood pressure, increased heart rate, anxiety, hallucinations, and convulsions, followed by a decrease in body temperature, lethargy, drowsiness, shock, decreased heart rate, and coma.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Common (may affect up to 1 in 10 people)

• nasal discomfort

Uncommon (may affect up to 1 in 100 people)

• restlessness
• headache
• palpitations
• nasal swelling, nasal dryness, nasal secretion, sneezing
• nausea

Rare (may affect up to 1 in 1000 people)

• dizziness, alteration of taste
• nasal bleeding

Frequency not known

• hypersensitivity (allergy)
• hallucinations, insomnia
• drowsiness, sedation
• heart rhythm disorders
• skin rashes, itching, skin swelling
• mucosal swelling, fatigue
• increase in blood pressure.

Reporting of side effects:

If you experience any side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Rhinospray Eucalyptus

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 container, 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 the container and any unused medicine in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the container and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of Rhinospray Eucalyptus

• The active ingredient is tramazoline hydrochloride. Each ml of solution contains 1.18 mg tramazoline hydrochloride, equivalent to 83 micrograms per spray of 0.07 ml.
• 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 Eucalyptus is a clear, slightly yellowish solution with a eucalyptus odor for nasal spray.

It is presented in a glass container containing 10 ml of solution and is provided with a dosing valve.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Opella Healthcare Spain, S.L.

C/ Rosselló i Porcel, 21

08016 – Barcelona

Spain

Sanofi Group

Manufacturer:

Istituto de Angeli, S.r.l.

Località Prulli 103/ C

50066 Reggello (Florence) – Italy

Date of the last revision of this package leaflet:September 2022

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

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