Prospect: information for the patient

Rhinospray 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 and for what it is used

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

3. How to use Rhinospray

4. Possible adverse effects

5. Storage of Rhinospray

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, causes a local constriction of blood vessels, thereby 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.

Consult a doctor if symptoms worsen or do not improve after 3 days of treatment.

Do not use Rhinospray

• 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:

• 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 evening.

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

The simultaneous use of Rhinospray with some medications for treating depression (MAO 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 antihypertensive medications (medications used to reduce high blood pressure) may cause cardiovascular disorders.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be 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 contains benzalkonium chloride

This medication contains 0.20 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 for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The Rhinospray containers can be used not only as sprayers but also as droppers.

The recommended dose is:

Adults and children 6 years of age and older: 2-3 drops or 1-2 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 application, please take the following instructions into account:

1. Blow your nose before using the product.
2. To apply as a spray: The bottle must be used with the applicator inside the nostril and upwards, performing 1 single and energetic pressure on the walls of the bottle and at the same time, breathe deeply while keeping the other nostril closed. Remove the bottle from the nasal fossa without stopping pressing the walls of the same. This process is repeated in the other nostril. In the case of needing to perform a second spray, repeat the procedure.

To apply in the form of drops: The bottle must be tilted downwards, placing the applicator near the nostril and exerting pressure on the walls of the bottle until the necessary drops come out. This process is repeated in the other nostril.

After each use, clean the end of the applicator with a clean and moist 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 after3 daysof treatment, you must consult the doctor.

If you use more Rhinospray 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, dilation 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 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 everyone 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, altered sense of taste
• nasal bleeding

Unknown Frequency

• hypersensitivity (allergy)
• hallucinations, insomnia
• drowsiness, sedation
• alteration of heart rhythm
• skin eruptions, 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. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

This product does not require special conditions for conservation.

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

• The active ingredient is tramazoline hydrochloride. Each ml of solution contains 1.18 mg of tramazoline hydrochloride.
• The other components (excipients) are sorbitol solution, benzalkonium chloride, citric acid monohydrate, disodium phosphate, sodium chloride, and purified water.

Appearance of the product and contents of the packaging

Rhinospray is a clear, colorless, and slightly perceptible odor solution for nasal spray or nasal drops.

It is presented in a plastic container containing 12 ml of solution.

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 the QR code included in the leaflet with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/39574/ P_39574.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/