Package Insert: Information for the User

Disneumon pernasal 5 mg/ml nasal spray solution

fenilefrina hidrocloruro

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

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed to you alone, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package insert. See section 4.

The active ingredient of Disneumon pernasal is phenylephrine hydrochloride; which belongs to the group of medications known as nasal decongestants.

Phenylephrine administered nasally has an intense, rapid, and prolonged local vasoconstrictive action that produces nasal decongestion.

It is indicated for the symptomatic treatment of nasal congestion and secretion due to common cold or allergic processes, sinusitis, or other alterations of the upper respiratory tract in adults and children over 12 years old.

If symptoms persist for more than three days or worsen, consult your doctor.

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

No use Disneumon pernasal

• If you are allergic to phenylephrine or any of the other components of this medication (listed in section 6).

If you have hypertension or peripheral vascular disease (poor circulation), heart disease, diabetes, hyperthyroidism, Raynaud's syndrome, or benign prostatic hyperplasia.

If you are being treated with depression medications (monoamine oxidase inhibitors (MAOIs) or tricyclic antidepressants) or have been treated with them in the past two weeks.

If you have recently undergone surgery on the head (if you have undergone any cranial, transnasal, or transoral surgery).

If you have an eye disease with increased pressure (angle-closure glaucoma) or dryness of the nasal mucosa with the formation of crusts (dry rhinitis).

Children under 6 years old should not use this medication.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Disneumon pernasal.

Consult your doctor before using this medication if:

• You have high blood sugar levels (diabetes).
• You have high blood pressure (hypertension).
• You suffer from heart disease, including chronic heart disease, peripheral vascular insufficiency, cardiac arrhythmias, tachycardia (elevated heart rate), bradycardia (low heart rate), partial heart block, angina pectoris;
• You have a vascular disease, such as arteriosclerosis (hardening and thickening of blood vessel walls);
• You suffer from poor blood circulation in the brain;
• You have a prostate disease with difficulty urinating (benign prostatic hyperplasia).
• You have a thyroid disease (hyperthyroidism).
• You have Raynaud's syndrome.
• You are taking depression or asthma medications (adrenergic bronchodilators).
• You suffer from angle-closure glaucoma (a rare eye disease).

In patients with severe heart failure, phenylephrine may worsen heart failure due to blood vessel constriction.

Your blood pressure will be monitored during treatment. If you have heart disease, additional monitoring of your vital functions will be performed.

Do not exceed the recommended dose.

If insomnia occurs (rarely), try to avoid applying the medication late in the afternoon or at night.

If symptoms persist for more than three days or worsen, consult your doctor.

Excessive or prolonged use of the medication (usually less than 5 consecutive days) should be avoided as it may cause rebound congestion with increased congestion and nasal secretion.

To avoid contagion, the medication should not be used by more than one person.

It is reported to athletes that this medication contains a component that may result in a positive analytical test for doping control.

Children

Consult your doctor to use this medication in children between 6 and 12 years old.

Do not administer to children under 6 years old.

Other medications and Disneumon pernasal

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 administered with antidepressants (monoamine oxidase inhibitors - MAOIs - or tricyclic antidepressants) as it may cause cardiovascular effects such as hypertension due to the vasoconstrictive effect of phenylephrine.

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.

Women breastfeeding should consult their doctor before using this medication.

Driving and operating machinery

Not described.If you experience drowsiness or dizziness, do not drive or operate machinery.

Disneumon pernasal contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per milliliter, which is essentially "sodium-free."

Follow exactly the administration instructions of the medication contained in this leaflet or those indicated by your doctor, pharmacist or nurse. In case of doubt, ask your doctor, pharmacist or nurse.

Adults and children over 12 years old: 1 application in each nasal orifice, which may be repeated every 4-6 hours. Do not shorten the time between applications.

For children between 6 and 12 years old

It is recommended to apply 1 application in each nasal orifice every 6 hours.

Use in children and adolescents

Children between 6 and 12 years old

Consult with your doctor to use this medication in children between 6 and 12 years old

Children under 6 years old

It should not be administered to children under 6 years old.

Administration form

Nasal route.

To administer this medication correctly, it is necessary for the bottle and head to remain in a vertical position, as indicated in the drawing, while pressing with the finger on the top of the diffuser. Each press should be brief, that is, the time necessary to press firmly and release.

At this moment and simultaneously, a deep inspiration should be made to facilitate the maximum penetration of the medication.

If the bottle or head is tilted while pressing, it may cause the gas propellant to escape, leaving the aerosol without pressure and unusable.

Following these recommendations, it is unlikely that any inconvenience will arise in the normal use of the medication. However, in some isolated cases, a mechanical failure of the valve or diffuser may occur, preventing the liquid from coming out. If this happens, the product should be replaced with a new one.

If you use more Disneumon pernasal than you should

With high doses or in case of accidental ingestion, unwanted effects such as headaches, nervousness, insomnia, palpitations, hypertension and blurred vision may appear.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to use Disneumon pernasal

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

If you interrupt the treatment with Disneumon pernasal

If you have any other doubt about the use of thismedication, ask your doctor, pharmacistor nurse.

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

Common adverse effects include headache, sneezing, nasal itching, rhinitis, nasal dryness or burning sensation, and medication dependence. The following adverse reactions are less common, especially when excessive doses are administered, and may include dizziness, nervousness, tachycardia, vertigo, vomiting, nausea, discomfort, skin rash, hypertension, and palpitations, and difficulty falling asleep.

Prolonged or excessive use of the medication may produce rebound congestion with increased congestion, nasal secretion, urinary difficulties, and urinary retention in patients with prostate problems.

If any other adverse reaction not previously described is observed, consult a doctor or pharmacist.

Prolonged or excessive use of the medication may produce rebound congestion with increased congestion and nasal secretion.

If any other adverse reaction not previously described is observed, consult a doctor or pharmacist.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System of 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.

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

The pressurized container should not be exposed to direct sunlight or temperatures above 50 °C.

Do not pierce, break, or burn, even if it appears to be empty.

Medications should not be disposed of through drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Disneumon pernasal

The active ingredient is phenylephrine (in the form of hydrochloride).Each ml of solution contains 5 mg of active ingredient.

- The other components (excipients) are: sodium saccharin (E-954), sodium chloride, sodium propionate, menthol aroma, eucalyptol aroma, purified water and compressed nitrogen.

Appearance of the product and contents of the packaging

Red glass vial with a white nasal applicator containing 25 ml of nasal spray solution.

Marketing Authorization Holder

Cooper Consumer Health B.V.

Verrijn Stuartweg 60,

1112 AX Diemen,

Netherlands

Responsible for Manufacturing

Recipharm Parets, S.L.

Ramón y Cajal, 2, 08150 Parets del Vallés (Barcelona)

Spain

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Vemedia Pharma Hispania, S.A.

C/ Aragón, 182, 5th floor

08011 - Barcelona

Spain

Last review date of this leaflet:April 2020

The detailed and updated information about this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) https://www.aemps.gob.es