Nasalvicks 0.5 mg/ml solution for nasal spray
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
NasalVicks 0.5 mg/ml nasal spray solution
Oxymetazoline hydrochloride
Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.
Always follow exactly the instructions for use of this medicine as described in this leaflet or as directed by your doctor or pharmacist. This medicine is available without a prescription. However, to achieve the best results, it must be used correctly.
- Keep this leaflet as you may need to read it again.
- If you need advice or further information, consult your pharmacist.
- If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.
- You should consult your doctor or nurse if your condition worsens or does not improve.
Leaflet contents:
- What NasalVicks is and what it is used for
- What you need to know before using NasalVicks
- How to use NasalVicks
- Possible side effects
- How to store NasalVicks
- Contents of the pack and other information
1. What NasalVicks is and what it is used for
NasalVicks is a nasal spray used for the relief of local symptoms of nasal congestion associated with cold or rhinitis in adults, adolescents, and children from 6 years of age.
The effect of the solution begins within a few minutes and lasts up to 12 hours.
2. What you need to know before using NasalVicks
Do not use NasalVicks:
- if you are allergic (hypersensitive) to the active substance, oxymetazoline hydrochloride, or to any of the other components of this medicine (listed in section 6).
- if you are taking or have taken, within the last 2 weeks, monoamine oxidase inhibitor (MAO inhibitor) medicines (MAO inhibitors are used in the treatment of Parkinson's disease and depression).
- if you have acute heart disease or cardiac asthma.
- if you have increased intraocular pressure (narrow-angle glaucoma).
- if you have undergone surgery to remove your pituitary gland.
- if you have skin and nasal mucosa inflammation or crusts inside the nose (dry rhinitis).
Warnings and precautions
Talk to your doctor or pharmacist before starting to use NasalVicks if you have:
- high blood pressure
- ischemic heart disease, including angina pectoris
- diabetes mellitus
- thyroid problems
- enlarged prostate (prostatic hypertrophy)
- increased intraocular pressure
- pheochromocytoma (a rare tumor of the adrenal gland)
Using NasalVicks with other medicines
Tell your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.
- Monoamine oxidase inhibitors (MAOIs) are used in the treatment of Parkinson's disease and depression. Do not use NasalVicks if you have taken MAOIs within the last 2 weeks.
- Tricyclic antidepressants – Inform your doctor if you are taking medicines for depression, such as amitriptyline and imipramine.
- Beta-blockers or antihypertensive medicines – if you are taking any of these medicines, inform your doctor before use.
Pregnancy and breastfeeding
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.
Due to the lack of evidence regarding the use of this product during pregnancy and breastfeeding, the use of NasalVicks should be avoided unless advised by a doctor.
Driving and using machines
NasalVicks does not affect the ability to drive or operate machinery.
NasalVicks contains Benzalkonium Chloride and Benzyl Alcohol
This medicine contains 0.01 mg of Benzalkonium Chloride per dose (1 spray), equivalent to 0.2 mg/ml. Benzalkonium chloride may cause irritation or inflammation inside the nose, especially when used for long-term treatment.
This medicine contains 0.1 mg of benzyl alcohol per dose (1 spray), equivalent to 2 mg/ml. Benzyl alcohol may cause allergic reactions and/or moderate local irritation.
3. How to use NasalVicks
Follow exactly the instructions for use provided in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
The recommended dose is:
Adults and children over 10 years of age: 1-2 sprays in each nostril no more than 2-3 times daily.
Children from 6 to 10 years of age: 1 spray in each nostril no more than 2-3 times daily.
This medicine is not intended for children under 6 years of age. In this population, medicines with a lower concentration of oxymetazoline should be used.
This medicine should not be used for more than 7 consecutive days, and the recommended dose should not be exceeded. Use for longer periods or at higher doses than recommended may cause increased nasal congestion and may reduce the effectiveness of the product.
Avoid direct contact with the eyes.
Contact your doctor and stop treatment if symptoms worsen or do not improve.
Instructions for use:
- Remove the cap. Before first use, prime the pump by firmly pressing the rim until an even spray mist is produced (approximately 10 times). Hold the bottle in an upright position with the nasal applicator inserted into the nostril. Close the other nostril.
- Administer the spray and inhale deeply through the nose at the same time. Repeat in the other nostril.
- Adults and children over 10 years of age may repeat steps 1 and 2 once more if necessary.
- Clean the nasal applicator with a clean damp wipe and replace the cap immediately after use.
Use the product in an upright position.
If you use more NasalVicks than you should:
In case of overdose or accidental ingestion, go immediately to a medical center or call the Toxicology Information Service (telephone 91 562 04 20), indicating the medicine and the amount ingested.
An overdose may occur after accidental oral or nasal administration. Symptoms of overdose may include: hypertension, tachycardia, palpitations, cardiac arrhythmia, cardiac arrest, heart failure, sweating, agitation, convulsions, mydriasis, nausea, vomiting, cyanosis, fever, spasms, circulatory collapse, pulmonary edema, respiratory disorders, psychiatric disturbances, somnolence, pallor, miosis, decreased body temperature, bradycardia, shock-type hypotension, apnea, loss of consciousness, seizures, and coma.
If you forget to use NasalVicks:
Do not use a double dose to make up for a missed dose. Continue using it as indicated in the instructions for use of NasalVicks.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, NasalVicks can produce adverse effects, although not everyone will experience them.
In general, serious undesirable effects are not expected.
Uncommon (may affect up to 1 in 100 people): sneezing, and dryness or irritation of the nose, mouth, or throat after the nasal mucosa inflammation effect has worn off (reactive hyperemia).
Rare (may affect up to 1 in 1,000 people):
Anxiety, sedative effect, irritability, sleep disorders, tachycardia, palpitations, reduced effect of a dose, headache, skin rash, and visual disturbances.
Frequency unknown:
Nausea
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 may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: http;//www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of NasalVicks
Keep this medicine out of the sight and reach of children.
Do not store above 25°C.
Do not use this medicine after the expiry date stated on the container or on the label of the bottle following the abbreviation EXP. The expiry date refers to the last day of the month indicated.
Use this medicine within 12 months after first opening the bottle.
Medicines must not be disposed of via wastewater or household waste. Return empty containers and any unused medicines to the
6. Contents of the pack and other information
Composition of NasalVicks
The active substance is: Oxymetazoline hydrochloride 0.5 mg/ml. One spray (equivalent to 0.05 ml) contains approximately 25 micrograms of oxymetazoline hydrochloride.
The other components (excipients) are: sorbitol, sodium citrate, polysorbate 80, benzyl alcohol, anhydrous citric acid, benzalkonium chloride, potassium acesulfame, levomenthol, cineole, disodium edetate, dried aloe extract, levocarvone, - and purified water. (See section 2: NasalVicks contains benzalkonium chloride and benzyl alcohol).
Appearance of the product and contents of the container
It is presented as a solution packed in a bottle with a metered-dose pump for nasal application.
Each box contains one amber glass bottle with a white pump. The bottle contains 15 ml of solution. Each bottle contains a minimum of 265 sprays.
Marketing Authorization Holder:
Laboratorios Vicks S.L.
Avenida de Bruselas 24
28108 Alcobendas, Madrid
Spain
Local Representative: Procter & Gamble España, S.A.
Avenida de Bruselas 24,
28108 Alcobendas, Madrid.
Spain
Manufacturer:
Procter & Gamble Manufacturing GmbH
Procter & Gamble Strasse 1
D-64521 Gross-Gerau, Hessen
Germany
This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Austria: Nasivin Aloe & Eukalyptus 0.5 mg/ml Nasenspray 0.5 mg/ml Lösung
Belgium: Nesivine Eucalyptus, 0.5 mg/ml neusspray oplossing
Bulgaria: ???? ?????? ???? ? ???????? 0.5 mg/ml ????? ?? ???, ???????
Czech Republic: Sinex Vicks Aloe a Eucalyptus 0.5 mg/ml, nosní sprej, roztok
Estonia: Sinex
Finland: Vicks Sinex
Germany: WICK Sinex aloe Nasenspray 0.5 mg/ml Lösung
Greece: Vicks Sinex Spray spray solution 0.5 mg/ml
Hungary: Nasivin Aloe Vera és Eukaliptusz 0.5 mg/ml oldatos orrspray
Lithuania: Sinex 0.5 mg/ml nosies purškalas (tirpalas)
Latvia: Sinex 0.5 mg/ml deguna aerosols, škidums
Netherlands: Vicks Sinex Aloë 0.5 mg/ml neusspray oplossing
Poland: Nasivin Sinex Aloes I Eukaliptus
Portugal: SinexSensi 0.5 mg/ml solução para pulverização nasal
Romania: Vicks Sinex 0.5 mg/ml spray nazal, soluție
Spain: NasalVicks 0.5 mg/ml solución para pulverización nasal
Sweden: Vicks Sinex, 0.5 mg/ml, nässpray, lösning
United Kingdom: Vicks Sinex Soother 0.5 mg/ml Nasal Spray Solution
This leaflet was approved in June 2023
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS): http://www.aemps.gob.es