Nasivin vicks aloes and eucalyptus

Package leaflet: Information for the patient

Warning! Keep this leaflet. Information on the immediate packaging is in a foreign language.
Nasivin Vicks Aloes and Eucalyptus (Vicks Sinex)
0.5 mg/ml, nasal spray, solution
Oxymetazolini hydrochloridum
Nasivin Vicks Aloes and Eucalyptus and Vicks Sinex are different trade names for the same medicinal product.
Please read the following leaflet carefully before use, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by a
physician or pharmacist.
This medicine is available without a prescription. However, Nasivin Vicks Aloes and Eucalyptus should be used carefully to achieve the best treatment outcome.

• Keep this leaflet so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
• If there is no improvement or if you feel worse, contact your doctor or nurse.

Contents of the leaflet

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

Nasivin Vicks Aloes and Eucalyptus is a nasal spray for local use in the relief of nasal congestion associated with colds or nasal mucosal inflammation in adults, adolescents, and children aged 6 years and older.
The effect begins within 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 to any of the other ingredients of this medicine (listed in section 6).
• if the patient is currently taking (or has taken within the last two weeks) monoamine oxidase inhibitors (MAO inhibitors used in the treatment of Parkinson's disease and depression).
• if the patient has severe heart disease or dyspnea due to heart failure.
• if the patient has increased intraocular pressure (narrow-angle glaucoma).
• if the patient has undergone pituitary gland surgery.
• if the patient has skin inflammation or nasal vestibular mucosal inflammation, or nasal crusts.

Warnings and precautions
Before starting to use Nasivin Vicks Aloes and Eucalyptus, consult a doctor if the patient has:

• high blood pressure,
• ischemic heart disease, including angina pectoris,
• diabetes,
• thyroid dysfunction,
• prostatic hyperplasia,
• elevated intraocular pressure,
• pheochromocytoma (a rare adrenal gland tumor).

Nasivin Vicks Aloes and Eucalyptus and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

• Monoamine oxidase inhibitors (MAOIs) used in the treatment of Parkinson's disease and depression. Do not use Nasivin Vicks Aloes and Eucalyptus if MAO inhibitors have been taken within the last two weeks.
• Tricyclic antidepressants – inform the doctor about taking antidepressants such as amitriptyline and imipramine.
• Beta-blockers or medicines used to treat high blood pressure – inform the doctor if the patient is taking any medicines from these groups.

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

Driving and operating machinery
Nasivin Vicks Aloes and Eucalyptus has no effect on the ability to drive vehicles or operate machinery.

Nasivin Vicks Aloes and Eucalyptus contains benzalkonium chloride and benzyl alcohol
The medicine contains 0.01 mg of benzalkonium chloride per aerosol dose, equivalent to 0.2 mg/ml.
Benzalkonium chloride may cause irritation or swelling of the nasal mucosa, especially during prolonged use.
The medicine contains 0.1 mg of benzyl alcohol per aerosol dose, equivalent 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
your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Recommended dose:
Adults and children over 10 years of age: 1-2 sprays into each nostril no more frequently than 2-3
times per day.
Children aged 6 to 10 years: 1 spray into each nostril no more frequently than 2-3 times per
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.
Do not use this medicine for longer than 7 consecutive days or in higher doses than recommended.
Prolonged use or overdose of Nasivin Vicks Aloes and Eucalyptus may cause a feeling of nasal congestion and may reduce the effectiveness of the medicine.
Avoid direct contact with the eyes.
If symptoms worsen or do not improve, consult a doctor.
Method of administration:

1. Remove the cap. Before first use, prime the pump by pressing the collar firmly several times until a uniform spray is produced (approximately 5 to 10 times). Hold the bottle upright with the nasal applicator inserted into the nostril. Close the other nostril.
2. Spray and inhale deeply through the nose simultaneously. Repeat the procedure to administer the medicine into the other nostril.
3. Adults and children over 10 years of age may repeat the steps described in points 1 and 2 if necessary.
4. Clean the nasal applicator with a clean, damp cloth and immediately replace the protective cap after use.

The medicine should be used in an upright position.
Overdose of Nasivin Vicks Aloes and Eucalyptus
If an excessive dose of Nasivin Vicks Aloes and Eucalyptus has been used or if the medicine has been swallowed, seek immediate medical attention, taking the bottle or packaging with you.
Overdose may occur following nasal or accidental oral administration.
Symptoms of overdose (in cases of moderate to severe overdose) may include:
elevated blood pressure, rapid heartbeat, palpitations, cardiac arrhythmias, cardiac arrest, heart failure, sweating, agitation, seizures, dilated pupils, nausea, vomiting, blue skin or lips, fever, muscle spasms, circulatory collapse, excessive fluid in the lungs, breathing difficulties, psychiatric disturbances, drowsiness, pallor, constricted pupils, decreased body temperature, slowed heart rate, hypotension resembling shock, transient cessation of breathing, loss of consciousness, seizures, and coma.
Missed 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 regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
Severe adverse reactions are generally not expected.

• Uncommon (may occur in fewer than 1 in 100 people): Sneezing, dryness or irritation in the nose, mouth or throat, nasal mucosal swelling after the medicine wears off (rebound congestion).
• Rare (may occur in fewer than 1 in 1000 people): Anxiety, sedation, irritability, sleep disturbances, rapid heartbeat, palpitations, increased blood pressure, reduced effect of the dose, headache, rash, and visual disturbances.
• Frequency not known: Nausea.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in the leaflet, inform a doctor, pharmacist, or nurse.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 4921301, fax: +48 22 4921309, website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions allows the collection of additional information on the safety of the medicine.

5. How to store Nasivin Vicks Aloes and Eucalyptus

Keep the 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. The expiry date refers to the last day of the stated month.
Discard 12 months after first opening the bottle.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Nasivin Vicks Aloes i Eukaliptus contains
The active substance is oxymetazoline hydrochloride 0.5 mg/ml. One dose (corresponding to 0.05 ml) contains approximately 25 micrograms of oxymetazoline hydrochloride.
Other components are: sorbitol, sodium citrate (for pH adjustment), polysorbate 80, benzyl alcohol, citric acid (for pH adjustment), benzalkonium chloride, edetate disodium, acesulfame potassium, levomenthol, cineole, dry extract of aloe, L-carvone, purified water. (See section 2: "Nasivin Vicks Aloes i Eukaliptus contains benzalkonium chloride and benzyl alcohol".)
What Nasivin Vicks Aloes i Eukaliptus looks like and contents of the pack
Nasivin Vicks Aloes i Eukaliptus nasal spray solution is a nasal aerosol solution delivered via a pump spray.
The pack contains a 15 ml amber glass type III bottle with a PP dosing pump, packed in a cardboard box.
For more detailed information, please contact the marketing authorisation holder or parallel importer.
Marketing Authorisation Holder in Greece, country of export:
Procter & Gamble Hellas M.E.P.E., Agiou Konstantinou 49, 15124 Maroussi, Athens, Greece
Manufacturer:
Procter & Gamble Manufacturing GmbH, Procter & Gamble Strasse 1, 64521 Gross-Gerau, Hessen, Germany
Parallel Importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Marketing Authorisation Number in Greece, country of export: 61190/2-8-2016
Parallel Import Authorisation Number: 37/26
This medicinal product is authorised in the following names in the European Economic Area countries:
Austria: Wick Nasivin Aloe & Eukalyptus 0.5 mg/ml - Nasenspray
Belgium: Nesivine Eucalyptus, 0.5 mg/ml neusspray oplossing
Bulgaria: Викс Синекс Алое и Евкалипт 0.5 mg/ml спрей за нос, разтвор
Czech Republic: Sinex Vicks Aloe a Eukalyptus 0.5 mg/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 0.5 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, šķīdums
Netherlands: Vicks Sinex Aloë 0.5 mg/ml neusspray oplossing
Poland: Nasivin Vicks Aloes i Eukaliptus, 0.5 mg/ml, nasal spray solution
Portugal: Vicks Sinex Aloe 0.5 mg/ml solução para pulverização nasal
Romania: Vicks Sinex 0.5 mg/ml spray nazal, soluție
Spain: NasalVicks 0.5 mg/ml solución para pulverización nasal
Sweden: Vicks Sinex, 0.5 mg/ml, nässpray, lösning