Disneumon Pernasal 5 mg/ml solution for nasal spray
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Disneumon pernasal 5 mg/ml nasal spray solution
phenylephrine hydrochloride
Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.
- Keep this leaflet as you may need to read it again.
- If you have any questions, ask your doctor, pharmacist, or nurse.
- This medicine has been prescribed for you only; do not give it to others, even if they have the same symptoms as you, because it could harm them.
- If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are adverse effects not listed in this leaflet. See section 4.
Contents of the leaflet
- What Disneumon pernasal is and what it is used for
- What you need to know before using Disneumon pernasal
- How to use Disneumon pernasal
- Possible side effects
- How to store Disneumon pernasal
- Contents of the pack and other information
1. What Disneumon nasal is and what it is used for
The active substance in Disneumon nasal is phenylephrine hydrochloride, which belongs to a group of medicines called nasal decongestants.
Phenylephrine administered by the nasal route has a strong, rapid and prolonged local vasoconstrictor action, resulting in nasal decongestion.
It is indicated for the symptomatic treatment of nasal congestion and nasal discharge due to the common cold or allergic conditions, sinusitis, or other disorders of the upper respiratory tract in adults and children over 12 years of age.
If symptoms persist for more than three days or worsen, consult your doctor.
You should consult a doctor if your condition worsens or does not improve after 3 days.
2. What you need to know before using Disneumon nasal
Do not use Disneumon nasal
- If you are allergic to phenylephrine or any of the other ingredients of this medicine (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 medicines for depression (monoamine oxidase inhibitors (MAOIs) or within two weeks of stopping them, or tricyclic antidepressants).
If you have recently undergone head surgery (if you have had cranial, transnasal, or transoral surgery).
If you have a condition of the eye with increased pressure (closed-angle glaucoma) or dry nasal mucosa with crust formation (atrophic rhinitis).
Children under 6 years of age must not use this medicine.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Disneumon nasal.
Consult your doctor before using this medicine if:
- you have high blood sugar levels (diabetes)
- you have high blood pressure (hypertension)
- you have heart disease, including chronic heart conditions, peripheral vascular insufficiency, cardiac rhythm disorders, tachycardia (elevated heart rate), bradycardia (low heart rate), partial heart block, or angina pectoris;
- you have a blood vessel disorder such as arteriosclerosis (hardening and thickening of blood vessel walls);
- you have poor cerebral blood circulation;
- you have prostate disease with difficulty urinating (benign prostatic hyperplasia);
- you have a thyroid disorder (hyperthyroidism);
- you have Raynaud's syndrome;
- you are taking medications for depression or for asthma (from the group known as “adrenergic bronchodilators”);
- you have closed-angle glaucoma (a rare eye condition).
In patients with severe heart failure, phenylephrine may worsen cardiac insufficiency due to vasoconstriction.
Your blood pressure will be monitored during treatment. If you have heart disease, additional monitoring of vital functions will be performed.
Do not exceed the recommended dose.
If insomnia occurs (very rarely), avoid applying the medicine late in the afternoon or at night.
If symptoms persist for more than three days or worsen, consult your doctor.
Prolonged or excessive use of the medicine (usually more than 5 consecutive days) should be avoided, as it may cause rebound congestion, with increased nasal congestion and secretion.
To prevent transmission of infection, this medicine must not be used by more than one person.
Athletes are advised that this medicine contains a substance that may lead to a positive result in doping control tests.
Children
Consult your doctor before using this medicine in children aged 6 to 12 years.
Do not administer to children under 6 years of age.
Other medicines and Disneumon nasal
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 antidepressants (monoamine oxidase inhibitors - MAOIs - or tricyclic antidepressants), as it may cause cardiovascular effects such as hypertension due to the vasoconstrictive effect of phenylephrine. It should also not be used with adrenergic blockers used in the treatment of asthma.
Pregnancy, breastfeeding, and fertility
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine. This medicine should not be used during pregnancy.
Women who are breastfeeding should consult their doctor before using this medicine.
Driving and using machines
No effects have been reported. However, if you experience drowsiness or dizziness, do not drive or operate machinery.
Disneumon nasal contains sodium
This medicine contains less than 23 mg of sodium (1 mmol) per millilitre, which is essentially "sodium-free".
3. How to use Disneumon nasal
Follow exactly the instructions for use provided in this leaflet or those given by your doctor, pharmacist, or nurse. If in doubt, consult your doctor, pharmacist, or nurse.
Adults and children over 12 years of age: 1 spray into each nostril, which may be repeated every 4–6 hours. Do not shorten the interval between doses.
Children aged 6 to 12 years:
One spray into each nostril every 6 hours is recommended.
Use in children and adolescents
Children aged 6 to 12 years
Consult your doctor before using this medicine in children aged 6 to 12 years.
Children under 6 years of age
Do not administer to children under 6 years of age.
Method of administration
Nasal route.
For correct administration of this medicine, the bottle and head must remain in an upright position, as shown in the illustration, while pressing with your finger on the top of the spray nozzle. Each spray should be brief—only long enough to fully press and release.
At this moment, simultaneously take a deep breath in to facilitate maximum penetration of the medicine.
If you tilt the bottle or your head while pressing, this may cause the propellant gas to escape, resulting in loss of pressure and rendering the aerosol unusable.
Following these recommendations, problems during normal use of the medicine are unlikely. However, in isolated cases, a mechanical failure of the valve or spray nozzle may occur, preventing the liquid from being released. If this happens, the product should be replaced with a new one.
If you use more Disneumon nasal than you should
With high doses or accidental ingestion, undesirable effects such as headache, nervousness, insomnia, palpitations, hypertension, and blurred vision may occur.
In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, stating the name of the medicine and the amount ingested.
If you forget to use Disneumon nasal
Do not apply a double dose to make up for missed doses.
If you stop using Disneumon nasal
If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.
4. Possible adverse effects
Like all medicines, this medicine may produce adverse effects, although not everyone experiences them.
Common side effects are headache, sneezing, nasal itching, rhinitis, dryness or burning sensation in the nasal mucosa, and medication dependence. The following adverse reactions are uncommon, especially when excessive doses are administered: dizziness, nervousness, tachycardia, dizziness, vomiting, nausea, malaise, skin rash, hypertension, palpitations, and difficulty falling asleep.
Excessive or prolonged use of the medicine may cause rebound congestion with increased nasal congestion, nasal discharge, urinary difficulties, and urinary retention in patients with prostate problems.
If you notice any other adverse reaction not described above, consult your doctor or pharmacist.
Reporting of 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 leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Disneumon nasal
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after CAD or EXP. The expiry date is the last day of the month indicated.
The pressurized container must not be exposed to direct sunlight or temperatures above 50 °C.
Do not pierce, break, or burn the container, even if it appears to be empty.
Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their containers to the SIGRE point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Disneumon nasal
The active substance is phenylephrine (as hydrochloride). Each ml of solution contains 5 mg of active substance.
- The other components (excipients) are: sodium saccharin (E-954), sodium chloride, sodium propionate, menthol flavour, eucalyptol flavour, purified water and nitrogen under pressure.
Appearance of the product and contents of the container
25 ml glass bottle with white nasal applicator containing solution for nasal spray.
Marketing Authorization Holder
Cooper Consumer Health B.V.
Verrijn Stuartweg 60,
1112 AX Diemen,
The Netherlands
Manufacturer
Recipharm Parets, S.L.
Ramón y Cajal, 2, 08150 Parets del Vallés (Barcelona)
Spain
For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:
Vemedia Pharma Hispania, S.A.
C/ Aragón, 182, 5th floor
08011 - Barcelona
Spain
Date of the most recent revision of this leaflet: April 2020
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) https://www.aemps.gob.es