Nasivin Vicks Aloes i Eukaliptus

Leaflet attached to the packaging: patient information

Nasivin Vicks Aloes and Eucalyptus, 0.5 mg/ml, nasal spray, solution
Oxymetazoline hydrochloride

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in the patient leaflet or as advised by a doctor or pharmacist.
This medicine is available without a prescription. However, Nasivin Vicks Aloes and Eucalyptus should be used cautiously to achieve the best treatment result.

• Keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should tell their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse, they should contact their doctor or nurse.

Table of contents of the leaflet:

• 1. What is Nasivin Vicks Aloes and Eucalyptus and what is it used for
• 2. Important information before using Nasivin Vicks Aloes and Eucalyptus
• 3. How to use Nasivin Vicks Aloes and Eucalyptus
• 4. Possible side effects
• 5. How to store Nasivin Vicks Aloes and Eucalyptus
• 6. Contents of the pack and other information

1. What is Nasivin Vicks Aloes and Eucalyptus and what is it used for

Nasivin Vicks Aloes and Eucalyptus is a nasal spray used locally to relieve symptoms of nasal congestion in colds or rhinitis in adults, adolescents, and children aged 6 and older.
The effect occurs after a few minutes and lasts up to 12 hours.

2. Important information before using Nasivin Vicks Aloes and Eucalyptus

When not to use Nasivin Vicks Aloes and Eucalyptus:

• if the patient is allergic (hypersensitive) to the active substance, oxymetazoline hydrochloride, or any of the other ingredients of this medicine (listed in section 6).
• if the patient is using (or has used within the last two weeks) monoamine oxidase inhibitors (MAOIs used to treat Parkinson's disease and depression).
• if the patient has severe heart disease or shortness of breath in heart failure.
• if the patient has increased pressure in the eyeball (narrow-angle glaucoma).
• if the patient has had pituitary surgery.
• if the patient has skin or mucous membrane inflammation of the nasal vestibule or has nasal crusts.

Warnings and precautions

Before starting to use Nasivin Vicks Aloes and Eucalyptus, the patient should discuss it with their doctor if they have:

• high blood pressure,
• ischemic heart disease, including angina pectoris,
• diabetes,
• thyroid dysfunction,
• prostate enlargement,
• increased intraocular pressure,
• a pheochromocytoma (a rare tumor of the adrenal gland).

Nasivin Vicks Aloes and Eucalyptus and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking now or have taken recently, as well as any medicines they plan to take.

• monoamine oxidase inhibitors(MAOIs) used to treat Parkinson's disease and depression. Do not useNasivin Vicks Aloes and Eucalyptus if MAOIs have been taken within the last two weeks.
• tricyclic antidepressants- the patient should inform their doctor about taking medicines used to treat depression, such as amitriptyline and imipramine.
• beta-blockers or medicines used to treat high blood pressure- the patient should inform their doctor if they are taking any medicines from this group.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
Due to insufficient data, Nasivin Vicks Aloes and Eucalyptus should not be used during pregnancy and breastfeeding, unless advised by a doctor.

Driving and using machines

Nasivin Vicks Aloes and Eucalyptus does not affect the ability to drive or use machines.

Nasivin Vicks Aloes and Eucalyptus contains benzalkonium chloride and benzyl alcohol

The medicine contains 0.01 mg of benzalkonium chloride in each spray dose, which corresponds to 0.2 mg/ml.
Benzalkonium chloride may cause irritation or swelling of the nasal mucosa, especially with prolonged use.
The medicine contains 0.1 mg of benzyl alcohol in each spray dose, which corresponds to 2 mg/ml.
Benzyl alcohol may cause allergic reactions and (or) mild local irritation.

3. How to use Nasivin Vicks Aloes and Eucalyptus

This medicine should always be used exactly as described in the patient leaflet or as advised by a doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist.

Recommended dose:

Adults and children over 10 years:1-2 spray doses into each nostril, no more than 2-3 times a day.
Children from 6 to 10 years:1 spray dose into each nostril, no more than 2-3 times a day.
This medicine is not intended for children under 6 years of age. In this age group, medicines with a lower concentration of oxymetazoline should be used.

The medicine should not be used for more than 7 consecutive days, and the dose should not be exceeded.

Do not exceed the recommended dose.Using Nasivin Vicks Aloes and Eucalyptus for longer or in case of overdose may cause a feeling of a blocked nose and may reduce the effectiveness of the medicine.
Avoid direct contact with the eyes.
If symptoms worsen or do not improve, the patient should consult their doctor.

Method of administration:

• 1. Remove the cap. Before the first use, prime the pump by pressing the ring several times until a uniform mist is produced (about 5 to 10 times). Hold the bottle upright with the nasal applicator inserted into the nostril. The other nostril should be closed.
• 2. Spray and take a deep breath through the nose at the same time. Repeat the steps to administer the medicine to the other nostril.
• 3. Adults and children over 10 years may repeat the steps described in points 1 and 2 if necessary.
• 4. Clean the nasal applicator with a damp and clean cloth and put the protective cap on the applicator immediately after use.

The medicine should be used in an upright position.

Using a higher dose of Nasivin Vicks Aloes and Eucalyptus than recommended

If the patient has used too much Nasivin Vicks Aloes and Eucalyptus or in case of accidental ingestion, they should immediately go to their doctor, taking the bottle or packaging of the medicine with them.
Overdose may occur after nasal or accidental oral administration.
Symptoms of overdose (in case of moderate to severe overdose) may include:
increased blood pressure, rapid heartbeat, palpitations, arrhythmias, cardiac arrest, heart failure, sweating, excitement, seizures, dilated pupils, nausea, vomiting, blue skin or lips, fever, convulsions, circulatory collapse, too much fluid in the lungs, respiratory disorders, mental disorders, drowsiness, paleness, constricted pupils, decreased body temperature, slowed heart rate, hypotension similar to shock, transient cessation of breathing, loss of consciousness, seizures, and coma.

Missing a dose of Nasivin Vicks Aloes and Eucalyptus

Do not use a double dose to make up for a missed dose. Continue using the medicine as instructed.
If you have any further doubts about using the medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Severe side effects are not usually expected.

• Uncommon(may affect up to 1 in 100 people): Sneezing, dryness, or irritation in the nose, mouth, or throat, and reactive congestion of the nasal mucosa after the effect of the medicine has worn off.
• Rare(may affect up to 1 in 1,000 people): Anxiety, sedative effect, irritability, sleep disorders, rapid heartbeat, palpitations, increased blood pressure, reduced effect of the dose, headache, rash, and vision disorders.
• Frequency not knownNausea.

Reporting side effects

If side effects occur, including any side effects not listed in the leaflet, the patient should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Nasivin Vicks Aloes and Eucalyptus

The medicine should be stored out of sight and reach of children.
Do not store above 25°C.
Do not use this medicine after the expiry date stated on the carton and bottle after: "Expiry date" or "EXP:". The expiry date refers to the last day of the month.
Discard 12 months after first opening the bottle.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Nasivin Vicks Aloes and Eucalyptus contains

The active substanceof the medicine is oxymetazoline hydrochloride 0.5 mg/ml. One dose (which corresponds to 0.05 ml) contains approximately 25 micrograms of oxymetazoline hydrochloride.
Other ingredientsof the medicine are: sorbitol, sodium citrate, polysorbate 80, benzyl alcohol, anhydrous citric acid, benzalkonium chloride, solution, acesulfame potassium, levomenthol, cineole, disodium edetate, dry aloe extract, L-carvone, purified water. (See section 2 Nasivin Vicks Aloes and Eucalyptus contains benzalkonium chloride and benzyl alcohol).

What Nasivin Vicks Aloes and Eucalyptus looks like and contents of the pack

Nasivin Vicks Aloes and Eucalyptus nasal spray, solution, is a nasal spray with a dosing pump.
The pack contains a 15 ml glass bottle type III with a dosing pump (made of polypropylene) in a cardboard box.
Each bottle contains at least 265 doses.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Wick Pharma Zweigniederlassung der Procter & Gamble GmbH
Sulzbacher Str. 40
65824 Schwalbach am Taunus
Germany

Manufacturer:

Procter & Gamble Manufacturing GmbH
Procter & Gamble Strasse 1
64521 Gross Gerau, Hessen
Germany
To obtain more detailed information about this medicine, please contact:
Procter & Gamble Health Poland Sp. z o.o.
ul. Zabraniecka 20, 03-872 Warsaw
tel. 801 25 88 25

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

Austria: Wick Nasivin Aloe & Eucalyptus 0,5 mg/ml - Nasenspray
Belgium: Nesivine Eucalyptus, 0,5mg/ml neusspray oplossing
Bulgaria: Викс Синекс Алое и Евкалипт 0,5 mg/ml спрей за нос, разтвор
Czech Republic: Sinex Vicks Aloe a Eukalyptus 0,5mg/ml, nosni sprej, roztok
Estonia: Sinex
Finland: Vicks Sinex 0,5 mg/ml nenäsumute, liuos
Germany: WICK Sinex avera Nasenspray 0,5 mg/ml Lösung
Greece: Vicks Sinex nasal spray solution 0,5mg/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, šķīdums
Netherlands: Vicks Sinex Aloë 0,5 mg/ml neusspray oplossing
Poland: Nasivin Vicks Aloes i Eukaliptus, 0,5 mg/ml, aerozol do nosa, roztwór
Portugal: Vicks Sinex Aloe 0,5 mg/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

Date of approval of the leaflet: 04/2025