Rhinospray Antialergico 1.18 mg/ml + 5.05 mg/ml solution for nasal spray

Package Leaflet: Information for the User

Introduction

Package leaflet: information for the user

Rhinospray antiallergic 1.18 mg/ml + 5.05 mg/ml nasal spray solution

tramazoline hydrochloride/chlorphenamine maleate

Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.

Always follow exactly the instructions for use provided in this leaflet or those given 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 antiallergic is and what it is used for
2. What you need to know before using Rhinospray antiallergic
3. How to use Rhinospray antiallergic
4. Possible adverse effects
5. How to store Rhinospray antiallergic
6. Contents of the pack and other information

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

It is a nasal decongestant medicine containing tramazoline and chlorpheniramine as active substances. Tramazoline, administered in the nose, produces local constriction of blood vessels, thereby decongesting the nasal mucosa. Chlorpheniramine is an antihistamine that relieves nasal discharge.

This medicine is indicated for the local and temporary relief of nasal congestion and discharge in allergic rhinitis in adults and children aged 6 years and older.

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

2. What you need to know before using Rhinospray antiallergic

Do not use Rhinospray antiallergic

• if you are allergic to tramazoline, chlorpheniramine, other adrenergic decongestants, or any of the other ingredients of this medicine (listed in section 6).
• if you have dry nasal mucosa with crust formation (dry rhinitis).
• if you have heart failure.
• if you have high blood pressure (hypertension).
• if you have an eye disease with increased pressure (glaucoma or high intraocular pressure).
• if you have thyroid disorders (hyperthyroidism).
• if you have prostate problems (prostatic hypertrophy).
• if you have undergone cranial surgery through the nasal cavity.
• if you have recently had head surgery (if you have undergone cranial, transnasal, or transoral surgery).
• if you have experienced asthma attacks when using medicines containing chlorpheniramine or other medicines used for allergies (antihistamines).
• if you are asthmatic and have experienced bronchopulmonary problems when using medicines for allergies (antihistamines).
• in children under 6 years of age.
• if you are pregnant or breastfeeding.

Warnings and precautions

Consult your doctor or pharmacist before using Rhinospray antiallergic:

• If you have high blood pressure, heart disease, diabetes mellitus, porphyrin metabolism disorders, or pheochromocytoma (a tumor of the adrenal glands).
• If you are taking medicines for depression or medicines for blood pressure disorders.
• It is not recommended to use this medicine for more than 3 days. If symptoms do not resolve within 3 days, consult a doctor.
• Prolonged use of nasal decongestants may cause chronic inflammation and atrophy of the nasal mucous membrane, leading to nasal blockage. If you experience chronic nasal obstruction, consult your doctor and do not continue using the medicine on your own.
• When the effect of the medicine decreases, rebound inflammation of the nasal mucosa may occur.
• Repeated long-term use may be harmful, as it may lead to sensitization phenomena. In such cases, treatment should be discontinued or medical advice sought.
• Administer carefully to avoid eye irritation.
• Elderly patients should consult their doctor or pharmacist due to the risk of urinary retention. They may be more likely to experience dizziness, sedation, confusion, and hypotension; they are especially susceptible to the anticholinergic effects of antihistamines, such as dry mouth and urinary retention.
• If the medicine causes insomnia, avoid using it late in the afternoon or at night.
• Do not exceed the recommended dose.

Children

Do not use in children under 6 years of age.

Children may be particularly prone to adverse effects of this medicine.

Elderly patients

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

Other medicines and Rhinospray antiallergic

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

This medicine must not be used together with medicines for depression or within two weeks after their administration. Concurrent use of this medicine with certain antidepressants (MAOIs or tricyclic antidepressants) or vasopressor agents may cause increased blood pressure.

Concurrent use with tricyclic antidepressants may also lead to disturbances in heart rhythm (arrhythmias).

Concomitant use of monoamine oxidase inhibitors (MAOIs) and tricyclic antidepressants is not recommended, as they may prolong and intensify the anticholinergic and central nervous system depressant effects of this medicine.

Concurrent use of this medicine with alcohol and other medicines such as tranquilizers or those used to treat insomnia or anxiety (central nervous system depressants) may enhance the sedative effects of this medicine.

Concomitant use with phenytoin is not recommended, as it may reduce phenytoin elimination.

Interaction with antihypertensives (medicines used to lower high blood pressure) may cause cardiovascular disturbances.

Pregnancy, breastfeeding, and fertility

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 use of machines

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

Rhinospray antiallergic contains benzalkonium chloride

This medicine contains 0.2 mg of benzalkonium chloride per ml.

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

3. How to use Rhinospray antialérgico

Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Recommended dose:

Adults and adolescents aged 14 years and over: 1 spray into each nostril every 8–12 hours, up to 3 times a day if necessary. If needed, a second spray into each nostril may be administered in adults. Do not use more than 3 times per day.

Use in children

Children aged 6 to 14 years: 1 spray into each nostril once daily. If necessary, an additional spray may be administered after 12 hours. Do not use more than 2 times per day.

Children under 6 years:

Do not use this medicine in children under 6 years of age.

Instructions for use

Before each application, the following instructions should be observed:

This medicine is administered by nasal route.

To obtain proper spray mist, the bottle must be kept in an upright position during use.

1. Remove the protective cap.

2. Blow your nose thoroughly before using Rhinospray antialérgico.

3. With your head in a normal position, insert the spray nozzle into one nostril and press down quickly and firmly on the container to release one or two sprays.

4. When the spray is released, inhale deeply through the nose with your mouth closed, gently pressing the other nostril closed with your index finger, to help distribute the sprayed solution over the surface of the nasal mucosa.

5. Then repeat the application in the other nostril.

The empty space above the liquid is necessary for the container to function properly as a spray. It is recommended to clean the nasal adapter after use and replace the protective cap.

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

Maximum duration of treatment is 3 days. If symptoms worsen or persist beyond 3 days of treatment, discontinue use and consult your doctor.

If you use more Rhinospray antialérgico than you should

If you have used more Rhinospray antialérgico than recommended, consult your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number 915 620 420, indicating the medicine and the amount taken.

Especially in children, overdose may result in increased blood pressure and rapid heartbeat, followed by a drop in body temperature and blood pressure, shock, and decreased heart rate.

In cases of overdose or accidental ingestion, phases of central nervous system and cardiovascular system stimulation and depression may occur.

Especially in children, poisoning may lead to central nervous system effects such as seizures and coma, decreased heart rate, and respiratory depression. Symptoms of central nervous system stimulation include anxiety, nervousness, hallucinations, and seizures. Symptoms of central nervous system depression include decreased body temperature, lethargy, drowsiness, and coma.

Other possible symptoms include pupil dilation and constriction, sweating, fever, pallor, bluish discoloration of the lips, cardiovascular dysfunction, respiratory disorders, and psychological disturbances.

Due to the presence of chlorpheniramine, the following symptoms may also occur: hallucinations, excitement, ataxia, lack of coordination, acidosis, seizures, fixed and dilated pupils, facial flushing, sinus tachycardia, urinary retention, dry mouth, and fever.

If you forget to use Rhinospray antialérgico

Do not use a double dose to make up for a missed dose.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

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

Frequent (may affect more than 1 in 10 people)

• nasal dryness

Uncommon (may affect up to 1 in 100 people)

• headache, dizziness
• palpitations
• burning sensation in the nose, sneezing
• nausea

Rare (may affect up to 1 in 1000 people)

• hypersensitivity (allergy)
• epistaxis (nosebleed), nasal edema

Frequency not known (cannot be estimated from available data)

• hallucinations, insomnia, restlessness
• somnolence, sedation, taste disturbances
• heart rhythm abnormalities, increased heart rate
• nasal discharge
• skin rashes, 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 can also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Rhinospray antiallergic

Keep this medicine out of sight and reach of children.

This medicine does not require any special storage conditions.

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

Medicines should not be disposed of via wastewater or household waste. Dispose of medicine containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly 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 antiallergic

The active substances are tramazoline hydrochloride and chlorpheniramine maleate.

Each ml of solution contains 1.18 mg of tramazoline hydrochloride and 5.05 mg of chlorpheniramine maleate.

The delivered dose range per spray is 30 - 50 µl, equivalent to 35 μg - 60 μg of tramazoline hydrochloride and 151 μg - 253 μg of chlorpheniramine maleate.

The other components (excipients) are: benzalkonium chloride, liquid sorbitol (E-420), anhydrous citric acid, disodium phosphate dihydrate, sodium chloride and purified water.

Appearance of the product and contents of the pack

Rhinospray antiallergic is a clear, colourless solution for nasal spray.

It is supplied in a polyethylene container containing 12 ml of solution.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Opella Healthcare Spain, S.L.

C/ Roselló 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

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/