NASALVICKS 0.5mg/ml NASAL SPRAY SOLUTION

Introduction

Package Leaflet: Information for the User

NasalVicks 0.5 mg/ml Nasal Spray Solution

Oxymetazoline Hydrochloride

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

Follow the administration instructions for this medication exactly as stated in this package leaflet or as directed by your doctor or pharmacist. This medication can be obtained without a prescription. However, to achieve the best results, it should be used properly.

• Keep this package leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.
• You should consult your doctor or nurse if your symptoms worsen or do not improve.

Contents of the Package Leaflet:

1. What is NasalVicks and what is it used for
2. What you need to know before using NasalVicks
3. How to use NasalVicks
4. Possible side effects

5 Conservation of NasalVicks

1. Contents of the packaging and additional information

1. What is NasalVicks and what is it used for

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 from 6 years of age.

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

2. What you need to know before using NasalVicks

Do not useNasalVicks:

• if you are allergic (hypersensitive) to the active ingredient, oxymetazoline hydrochloride, or to any of the other components of this medication (listed in section 6).
• if you are taking or have taken, during the last 2 weeks, monoamine oxidase inhibitor medications (MAOIs are used in the treatment of Parkinson's disease and depression).
• if you have acute heart disease or cardiac asthma.
• if you have increased eye pressure (narrow-angle glaucoma).
• if you have undergone surgical treatment to remove the pituitary gland.
• if you have skin and nasal mucosa inflammation 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 (prostatic hyperplasia)
• increased intraocular pressure
• pheochromocytoma (a rare tumor of the adrenal gland)

Using NasalVicks with other medications

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

• Monoamine oxidase inhibitors (MAOIs)are used in the treatment of Parkinson's disease and depression. Do not useNasalVicks if you have taken MAOIs during 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 NasalVicks

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become 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 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 use machines.

NasalVicks contains Benzalkonium Chloride and Benzyl 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 long-term treatment.

This medication contains 0.1 mg of Benzyl Alcohol in each 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 the administration instructions for this medication exactly as stated in this package leaflet or as directed 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 nostril, no more than 2-3 times a day.

Children from 6 to 10 years:1 spray in each nostril, no more than 2-3 times a day.

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

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

Direct contact with the eyes should be avoided.

Consult your doctor and interrupt treatment if symptoms worsen or do not improve

Method of administration:

1. Remove the cap. Before using it for the first time, prime the pump by pressing the edge firmly until a uniform spray mist appears (approximately 10 times). Keep the bottle in a vertical position with the nasal applicator in the nostril. Keep the other nostril closed.
2. Apply the spray and breathe deeply through the nose at the same time. Repeat in the other nostril.
3. Adults and children over 10 years may repeat steps 1 and 2 once more if necessary.
4. Clean the nasal applicator with a clean, damp cloth and replace the cap 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 Toxicology Information Service (telephone 91 562 04 20), indicating the medication and the amount ingested.

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

If you forget to use NasalVicks

Do not use a double dose to make up for a forgotten 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.

4. Possible side effects

Like all medications, NasalVicks can cause side effects, although not everyone will experience them.

In general, no serious undesirable effects are expected.

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

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

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

Frequency not known:

Nausea

Reporting side effects:

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency (AEMPS) website: http://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Conservation of NasalVicks

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

Do not store above 25°C.

Do not use this medication after the expiration date stated 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 opening the bottle.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the pharmacy's collection point. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Contents of the packaging and additional information

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, polysorbate 80, benzyl alcohol, anhydrous citric acid, benzalkonium chloride, acesulfame potassium, levomenthol, cineole, disodium edetate, dry aloe extract, levocarvone, and purified water (See section 2 NasalVicks contains benzalkonium chloride and benzyl alcohol).

Appearance of the product and contents of the packaging

It is presented as a solution packaged in a 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:

Laboratorios Vicks S.L.

Avenida de Bruselas 24

28010, Alcobendas, Madrid

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 medication is authorized in the Member States of the European Economic Area under 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 avara Nasenspray 0,5 mg/ml Lösung

Greece: Vicks Sinex Spray spray solution 0,5mg/ml

Hungary: Nasivin Aloe Vera és Eukaliptusz 0.5mg/ml oldatos orrspray

Lithuania: Sinex 0,5 mg/ml nosies purškalas (tirpalas)

Latvia: Sinex 0,5 mg/ml deguna aerosols, šķidums

Netherlands: Vicks Sinex Aloë 0,5 mg/ml neusspray oplossing

Poland: Nasivin Sinex Aloes I Eukaliptus

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

Romania: Vicks Sinex 0,5 mg/ml spray nazal, soluție

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 package leaflet was approved in June 2023

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es