Prospect: information for the user

NasalVicks 0.5 mg/ml nasal spray solution

Oxymetazoline hydrochloride

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

Follow exactly the administration instructions for this medication contained in this prospect or those indicated by your doctor or pharmacist. This medication can be purchased without a prescription. Nevertheless, for the best results, it should be used properly.

• 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 your doctor or nurse if it worsens or does not improve

1. What is NasalVicks and for what it is used

2. What you need to know before using NasalVicks

3. How to use NasalVicks

4. Possible adverse effects

5. Conservation of NasalVicks

6. Contents of the package and additional information

NasalVicks is a nasal spray used for the relief of local symptoms of nasal congestion associated with colds or rhinitis in adults, adolescents, and children aged 6 years and above.

The effect of the solution begins a few minutes after use and lasts up to 12 hours.

No useNasalVicks:

• If you are allergic (hypersensitive) to the active ingredient, oxymetazoline hydrochloride, or to any other component of this medication (listed in section 6).
• If you are taking or have taken, within the last 2 weeks, monoamine oxidase inhibitors (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 high eye pressure (narrow-angle glaucoma).
• If you have undergone surgical treatment to remove your pituitary gland.
• If you have inflammation of the skin and mucous membranes of the nose or crusts inside the nose (dry rhinitis).

Warnings and Precautions

Consult 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 gland (prostatic hypertrophy)
• High intraocular pressure
• Phaeochromocytoma (a rare tumor of the adrenal gland)

Use of NasalVicks with other medications

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

• Monoamine oxidase inhibitors (MAO) are used in the treatment of Parkinson's disease and depression.Do not useNasalVicks if you have taken MAO within the last 2 weeks.
• Tricyclic antidepressants– Inform your doctor if you are taking medications for the treatment of depression, such as amitriptyline and imipramine.
• Beta-blockers or antihypertensive medications– If you are taking any of these medications, inform your doctor before using it

Pregnancy and lactation

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Due to the lack of evidence on the use of the product during pregnancy and lactation, the use of NasalVicks should be avoided unless advised by a doctor.

Driving and operating machinery

NasalVicks does not affect the ability to drive or operate machinery.

NasalVicks contains Benzalkonium Chloride and Bencilic AlcoholThis medication contains 0.01 mg of benzalkonium chloride in each dose (1 spray), equivalent to 0.2 mg/ml. Benzalkonium chloride may cause irritation or inflammation inside the nose, especially when used for a long treatment.

This medication contains 0.1 mg of bencilic alcohol in each dose (1 spray), equivalent to 2 mg/ml. Bencilic alcohol may cause allergic reactions and/or moderate local irritation.

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

The recommended dose is:

Adults and children over 10 years:1-2 sprays in each nasal orifice no more than 2-3 times a day.

Children aged 6 to 10 years::1 spray in each nasal orifice no more than 2-3 times a day.

This medication is not indicated for children under 6 years. In this population, medications with lower oxymetazoline concentration should be used.

This medication should not be used for more than 7 consecutive days and should not exceed the recommended dose. Using it for longer periods or higher doses than recommended may cause increased nasal congestion and may reduce the product's effectiveness.

Direct contact with the eyes should be avoided.

Contact your doctor and discontinue treatment if symptoms worsen or do not improve

Administration form:

1. Remove the cap. Before using it for the first time, prime the pump by pressing firmly on the edge until a uniform mist of spray appears (approximately 10 times). Keep the bottle in a vertical position with the nasal applicator in the nasal fossa. Keep the other nasal fossa closed.
2. Apply the spray and breathe deeply through the nose at the same time. Repeat in the other nasal fossa.
3. Adults and children over 10 years may repeat steps 1 and 2 again if necessary.
4. Clean the nasal applicator with a clean, damp cloth and secure it immediately after use.

Use the product in a vertical 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 Toxicological Information Service (phone 91 562 04 20), indicating the medication and the amount ingested..

A overdose may occur after accidental oral or nasal administration. Symptoms of an overdose may include: hypertension, tachycardia, palpitations, arrhythmia, cardiac arrest, heart failure, sweating, agitation, convulsions, mydriasis, nausea, vomiting, cyanosis, fever, spasm, circulatory collapse, pulmonary edema, respiratory disorders, psychiatric disorders, drowsiness, pallor, miosis, decreased body temperature, bradycardia, hypotension, shock, apnea, loss of consciousness, convulsions, and coma.

If you forgot to use NasalVicks

Do not use a double dose to compensate for a missed dose and continue using it as indicated in the administration instructions.

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

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

Generally, no severe undesirable effects are expected.

Rarely(may affect up to 1 in 100 people): sneezing and dryness or irritation of the nose, mouth, or throat after the effect of nasal mucosa inflammation has passed (reactive hyperemia).

Uncommon(may affect up to 1 in 1,000 people):

Anxiety, sedative effect, irritability, sleep disturbances, tachycardia, palpitations, increased blood pressure, reduced effect of a dose, headache, skin rash, and visual disturbances.

Unknown Frequency:

Nausea

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 Medicinal Products for Human Use: http;//www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

Do not store at a temperature above 25°C.

Do not use this medication after the date that appears on the packaging or on the label of the bottle after the abbreviation CAD. The expiration date corresponds to the last day of the month indicated.

Use this medication within 12 months after the first opening of the bottle.

Medications should not be disposed of through drains, or in the trash. Dispose of the containers and medications you no longer need 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 NasalVicks

The active ingredient 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, polisorbate 80, benzyl alcohol, anhydrous citric acid, benzalkonium chloride, acesulfame potassium, 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 package

It is presented as a solution packaged in a glass bottle with a dosing pump for nasal application.

Each box contains a brown glass bottle with a white pump. The bottle contains 15 ml of solution. Each bottle contains a minimum of 265 sprays.

Marketing Authorization Holder:

Vicks Laboratories S.L.

Avenida de Bruselas 24

280108, Alcobendas, Madrid

Local Representative: Procter & Gamble España, S.A.

Avenida de Bruselas 24,

28108 Alcobendas. Madrid.

Spain

Responsible for manufacturing:

Procter & Gamble Manufacturing GmbH

Procter & Gamble Strasse 1

D-64521 Gross-Gerau, Hessen

Germany.

This medicine is authorized in the Member States of the European Economic Area with the following names:

Austria:Nasivin Aloe & Eucalyptus 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 0,5mg/ml, nosni sprej, roztok

Estonia: Sinex

Finland: Vicks Sinex

Germany: WICK Sinex avera Nasenspray 0,5 mg/ml Lösung

Greece: VicksSinex Spray spray solution 0,5mg/ml

Hungary:Nasivin Aloe Vera és Eukaliptusz0.5mg/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 neussprayoplossing

Poland: Nasivin Sinex Aloes I Eukaliptus.

Portugal: SinexSensi 0,5mg/ml solução para pulverização nasal.

Romania: Vicks Sinex 0,5 mg/ml spray nazal, solu?ie.

Spain: NasalVicks 0,5mg/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

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