Prospect: information for the user

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

tramazoline hydrochloride/clorphenamine maleate

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

Follow exactly the medication administration instructions 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 antiallergic and for what it is used

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

3.How to use Rhinospray antiallergic

4.Possible adverse effects

5Storage of Rhinospray antiallergic

6.Contents of the package and additional information

It is a nasal decongestant medication that contains tramazoline and chlorphenamine as active principles. Tramazoline, administered in the nose, produces a constriction of the blood vessels at the local level, decongesting the nasal mucosa, and chlorphenamine, an antihistamine that relieves nasal secretion.

This medication is indicated forthe local and temporary relief of nasal congestion and secretion in allergic rhinitis 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 antialérgico

• if you are allergic to tramazoline, chlorphenamine, other adrenergic decongestants, or any of the other components of this medication (listed in section 6).
• if you have dryness of the nasal mucosa with crust formation (dry nose).
• if you have heart failure
• if you have high blood pressure
• 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 had cranial surgery through the nasal cavity
• if you have recently undergone a head operation (if you have undergone any cranial, transnasal, or transoral surgical intervention).
• if you have had asthma attacks when using a medication with chlorphenamine or other allergy medications (antihistamines).
• if you are asthmatic and when using allergy medications (antihistamines), they have caused respiratory problems.
• in children under 6 years old.
• if you are pregnant or breastfeeding.

Warnings and precautions

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

• if you have high blood pressure, heart disease, diabetes mellitus, porphyria metabolism disorder, and phaeochromocytoma (adrenal gland tumor).
• if you are being treated with depression medications and blood pressure medications.
• Do not use this medication for more than 3 days. If symptoms do not disappear in 3 days, consult a doctor.
• 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 medication on your own initiative.
• When the medication effect decreases, rebound inflammation of the nasal mucosa may appear.
• Repeating use for long periods of time may be harmful, as it may lead to sensitization phenomena. In this case, treatment should be suspended or a doctor consulted.
• Administer with caution to avoid eye irritation.
• Older 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 it causes insomnia, avoid using the medication in the late afternoon or evening.
• Do not exceed the recommended dose.

Children

Do not use in children under 6 years old.

Children may be especially prone to the appearance of adverse effects of this medication.

Older patients

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

Other medications and Rhinospray antialérgico

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

This medication should not be used concurrently with depression medications or within two weeks of their administration. The simultaneous use of this medication with some depression medications (MAO or tricyclic antidepressants) or vasopressors may cause an increase in blood pressure.

The simultaneous use with tricyclic antidepressants may also cause the appearance of heart rhythm disturbances (arrhythmias).

The simultaneous use of monoamine oxidase inhibitors (MAO) and tricyclic antidepressants is not recommended, as it may prolong and intensify the anticholinergic and central nervous system depressant effects of this medication.

The simultaneous use of this medication with alcohol and other medications such as tranquilizers and those used for insomnia or anxiety (central nervous system depressants) may potentiate the sedative effects of this medication.

Do not take concurrently with phenytoin, as it may cause a decrease in phenytoin elimination.

The interaction with antihypertensive medications (used to reduce high blood pressure) may cause cardiovascular alterations.

Pregnancy, lactation, and fertility

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 antialérgico contains benzalkonium chloride

This medication contains 0.2 mg of benzalkonium chloride per 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 the medication contained in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

The recommended dose is:

Adults and adolescents 14 years and older:1 spray in each nostril, every 8-12 hours, up to 3 times a day if necessaryIn case of need, in adults, a second spray in each nostril could be administered.Do not use more than 3 times a day.

Use in children

Children 6 to 14 years::1 spray in each nostril,once a day. In case of need, another spray can be performed at 12 hours. Do not use more than 2 times a day.

Children under 6 years::

Do not use this medication in children under 6 years.

Usage instructions

Before each application, the following instructions must be taken into account:

This medication is administered via the nose.

To obtain the nebulizations in spray, the bottle must be kept in a vertical position while in use.

1. Remove the protective cap.

1. Blow your nose well before using Rhinospray antialérgico.

1. With your head in a normal position, introduce the adapter of the sprayer into the nasal fossa and exert a quick and strong pressure on the container to spray one or two times.

1. When the spray is released, breathe deeply with your mouth closed, pressing gently on the other nasal fossa with your index finger, to facilitate the distribution of the sprayed solution over the surface of the nasal mucous membrane.

1. Then repeat the application in the other nasal fossa.

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

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

The maximum duration of treatment is 3 days. If symptoms worsen or persist after 3 days of treatment, discontinue treatment and consult your doctor.

If you use more Rhinospray antialérgico than you should

If you have usedmore Rhinospray antialérgicothan 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.

Especially in children, an overdose can result in an increase in blood pressure and rapid heart palpitations, followed by a drop in temperature and blood pressure, shock, and decreased heart rate.

In case of overdose or accidental ingestion, phases of stimulation and depression of the central nervous system and cardiovascular system may appear.

Especially in children, an overdose can result in effects on the central nervous system such as convulsions and coma, decreased heart rate, and respiratory depression. The symptoms of stimulation of the central nervous system are anxiety, nervousness, hallucinations, and convulsions. The symptoms of depression of the central nervous system are a drop in temperature, lethargy, somnolence, and coma.

Alsomay appear dilatation and contraction of the pupils, sweating, fever, pallor, blue discoloration of the lips, cardiovascular and respiratory disorders, and psychological alterations.

Due to the content of chlorphenamine, the following symptoms may occur: hallucinations, excitement, ataxia, discoordination, acetosis, convulsions, dilated and fixed pupils, facial flushing, sinus tachycardia, urinary retention, dry mouth, and fever.

If you forgot to use Rhinospray antialérgico

Do not use a double dose to compensate for the missed doses.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

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 dryness

Infrequent (may affect up to 1 in 100 people)

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

Rare (may affect up to 1 in 1000 people)

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

Unknown frequency (cannot be estimated from available data)

• hallucinations, insomnia, restlessness
• drowsiness, sedation, taste alterations
• heart rhythm alteration, increased heart rate
• nasal secretion
• skin eruptions, itching, and swelling
• mucosal swelling, 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 Medicines for Human Use: https://www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

This medication does not require special storage conditions.

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 medicines you no longer need at the SIGRE point of your pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

Composition ofRhinospray antialérgico

The active principles are tramazoline hydrochloride and chlorphenamine maleate.

Each ml of solution contains1.18 mg of tramazoline hydrochloride and 5.05 mg of chlorphenamine maleate.

The dose range released in each spray is 30 - 50μl, equivalent to35 μg - 60 μgof tramazoline hydrochlorideand to 151 μg - 253 μg of chlorphenamine maleate.

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

Appearance of the product and contents of the packaging

Rhinospray antialérgico is a clear and colorless nasal spray solution.

It is presented in a polyethylene 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/ Roselló 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

Date of the last review of this prospectus: April 2023

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/