RHINOSPRAY 1.18 mg/ml NASAL SPRAY SOLUTION

Introduction

Leaflet: Information for the Patient

Rhinospray 1.18 mg/ml Nasal Spray Solution

Tramazoline Hydrochloride

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

Follow the administration instructions for this medicine exactly as indicated 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 side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if your symptoms worsen or do not improve after 3 days of treatment.

Contents of the Leaflet

1. What Rhinospray is and what it is used for
2. What you need to know before using Rhinospray
3. How to use Rhinospray
4. Possible side effects
5. Storage of Rhinospray
6. Package contents and additional information

1. What Rhinospray is and what it is used for

It is a nasal decongestant medicine that contains tramazoline hydrochloride as the active ingredient, which, when administered into 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 your symptoms worsen or do not improve after 3 days of treatment.

2. What you need to know before using Rhinospray

Do not use Rhinospray

• 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:

• If you have high blood pressure, heart disease, thyroid disorders, diabetes, prostate problems, porphyria metabolism disorders, and pheochromocytoma (tumor of the adrenal glands).
• If you are being treated with medicines for depression and medicines for the treatment of high blood pressure.
• 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 prevent 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

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

The simultaneous use of Rhinospray 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 contains benzalkonium chloride

This medicine contains 0.20 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

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

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

The recommended dose is:

Adults and children from 6 years of age: 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 medicine to children under 6 years of age.

This medicine is administered nasally.

Before each application, consider the following instructions:

1. Blow your nose before using the product.
2. To apply as a spray: The bottle should be used with the applicator inside the nostril and upwards, making a single and energetic pressure on the bottle walls and at the same time, inhaling deeply while keeping the other nostril closed. Remove the bottle from the nasal cavity without stopping the pressure on the bottle walls. This process is repeated in the other nostril. If a second spray is necessary, repeat the procedure.

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

After each use, clean the applicator tip 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 your symptoms worsen, persist, or new ones appear after 3 daysof treatment, you should consult a 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, drowsiness, and coma, respectively) may appear. Dilatation and contraction of the pupils, sweating, fever, paleness, blue discoloration of the lips, and cardiovascular, respiratory, and psychological disorders may also occur.

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

If you have used more Rhinospray 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 everyone will experience them.

Frequent (may affect more than 1 in 10 people)

• nose discomfort

Uncommon (may affect up to 1 in 100 people)

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

Rare (may affect up to 1 in 1,000 people)

• dizziness, alteration of taste
• nasal bleeding

Frequency not known

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

Reporting side effects:

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this 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 contribute to providing more information on the safety of this medicine.

5. Storage of Rhinospray

No special storage conditions are required.

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

Do not use this medicine after the expiration date stated on the container, after CAD. The expiration date is the last day of the month indicated.

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

6. Package contents and additional information

Rhinospray composition

• 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 package contents

Rhinospray is a clear, colorless solution with a barely perceptible odor for nasal spray or nasal drops.

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

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 leaflet:September 2022

You can access detailed information about this medicine by scanning the QR code included in the leaflet with your mobile phone (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 Health Products (AEMPS) http://www.aemps.gob.es/