Prospect: information for the patient

Rhinospray Eucaliptus 1.18 mg/ml nasal spray solution

Tramazoline hydrochloride

Read this prospect carefully before starting to use this medicine, as it contains important information for you.

Follow exactly the administration instructions of the medicine contained in this prospect or those indicated by your doctor or pharmacist.

• Keep this prospect, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 3 days of treatment.

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

2. What you need to know before starting to use Rhinospray Eucaliptus

3. How to use Rhinospray Eucaliptus

4. Possible adverse effects

5. Storage of Rhinospray Eucaliptus

6. Contents of the package and additional information

It is a nasal decongestant medication that contains tramazoline hydrochloride as the active ingredient and when administered in the nose, it causes a constriction of the blood vessels at the local level, decongesting the nasal mucosa.

This medication is indicated for the local and temporary relief of nasal congestion in adults and children aged 6 years and above.

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

Do not use Rhinospray Eucaliptus

• If you are allergic to tramazoline hydrochloride, other adrenergic decongestants, or any of the other components of this medication (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 a head operation (if you have undergone any cranial, transnasal, or transoral surgery).
• Children under 6 years old cannot use this medication.

Warnings and precautions

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

• If you have high blood pressure, heart disease, thyroid disorders, diabetes, prostate problems, porphyrin metabolism disorders, and phaeochromocytoma (adrenal gland tumor).
• If you are being treated with depression medications and blood pressure medications.
• The continued use of nasal congestion medications can cause chronic inflammation and atrophy of the nasal mucosa membrane and therefore nasal blockage. If you have chronic nasal obstruction, consult your doctor and do not continue using the product on your own initiative.
• When the medication effect decreases, rebound inflammation of the nasal mucosa may appear.
• Avoid contact with the eyes to prevent irritation.
• If it causes insomnia, avoid using the medication in the late afternoon or at night.

Children

Do not administer to children under 6 years old. Children may be especially prone to the appearance of adverse effects of this medication.

Use in people over 65 years old

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

Other medications and Rhinospray Eucaliptus

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

The simultaneous use of Rhinospray Eucaliptus with some depression medications (IMAO or tricyclic antidepressants) or with medications used to treat low blood pressure (vasopressor medications) 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 anti-hypertensive medications (medications 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 intend to become pregnant, consult your doctor or pharmacist before using this medication.

This medication should not be used during pregnancy or breastfeeding.

Driving and operating machinery

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

Rhinospray Eucaliptus contains benzalkonium chloride

This medication contains 0.202 mg of benzalkonium chloride in each ml.

Benzalkonium chloride may cause irritation or inflammation inside the nose, especially when used for a long treatment period.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is:

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

Use in children

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

This medication is administered via the nose.

Before each spray, please follow the following instructions:

1. Remove the protective cap.

2.Before proceeding to thefirst sprayactuate the microdoser several times to achieve a uniform spray (see figure 1). From here on, the microdoser is always ready for immediate application. Clean the nose before introducing the spray head into the nostril.

3.The spray is performed by actuating the microdoser once (see figure 2). This process is repeated in the other nostril. During the spray, a light inspiration through the nose should be made. In the case of needing a second spray, repeat the procedure.

4.Place the protective cap once the administration is complete.

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

To minimize the risk of transmission of infections, the medication should not be used by more than 1 person.

If symptoms worsen, persist, or new ones appear after 3 days of treatment, you should consult the doctor.

If you use more Rhinospray Eucaliptus than you should

In case of overdose or accidental ingestion, phases of stimulation and depression of the central nervous system (anxiety, agitation, hallucinations, and convulsions; decrease in body temperature, lethargy, somnolence, and coma, respectively) may appear. Also, dilatation and contraction of the pupils, sweating, fever, pallor, blue discoloration of the lips, and cardiovascular, respiratory, and psychological disorders may occur.

Especially in children, an overdose may result in an increase in blood pressure followed by a decrease, an increase in heart rate, anxiety, hallucinations, and convulsions, followed by a decrease in temperature, lethargy, somnolence, shock, decrease in heart rate, and coma.

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

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Frequent(may affect more than 1 in 10 people)

• nasal discomfort

Possibly Frequent(may affect up to 1 in 100 people)

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

Rare(may affect up to 1 in 1000 people)

• dizziness, alteration of taste
• nasal bleeding

Unknown Frequency

• hypersensitivity (allergy)
• hallucinations, insomnia
• drowsiness, sedation
• alteration of heart rhythm
• skin rash, itching, skin swelling
• swelling of mucous membranes, fatigue
• increased blood pressure.

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es.Reporting adverse effects can help provide more information about the safety of this medication.

No special conservation conditions are required.

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

Do not use this medication after the expiration date that appears on the packaging, after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Composition of Rhinospray Eucalyptus

• The active principle 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 packaging

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 comes with a dosing valve.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Opella Healthcare Spain, S.L.

C/ Rosselló i Porcel, 21

08016 – Barcelona

Spain

Sanofi Group

Responsible for manufacturing:

Istituto de Angeli, S.r.l.

Località Prulli 103/ C

50066 Reggello (Florence) – Italy

Last review date of this leaflet: September 2022

You can access detailed information about this medicine by scanning with your smartphone the QR code included in the leaflet and packaging. You can also access this information on 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 Medical Devices (AEMPS) http://www.aemps.gob.es/.