Nasivin vicks aloes and eucalyptus

Patient Information Leaflet

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 medicine.
Please read this leaflet carefully before using the medicine, 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
your doctor 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 for future reference.
• If you need advice or further information, consult your pharmacist.
• If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If symptoms do not improve or if you feel worse, consult your doctor or nurse.

Table of Contents:

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, used to relieve symptoms of nasal congestion occurring in 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. 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 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 breathlessness 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 mucosal inflammation of the nasal vestibule, or nasal crusts.

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

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

Nasivin Vicks Aloes and Eucalyptus with other medicines
Inform 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 if the patient is taking medicines used to treat depression, 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 this group.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, 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 or operate machinery.

Nasivin Vicks Aloes and Eucalyptus contains benzalkonium chloride and benzyl alcohol
The medicine contains 0.01 mg of benzalkonium chloride per spray 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 spray 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 directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Recommended dose:
Adults and children over 10 years of age: 1–2 sprays into each nostril no more frequently than every 2–3 hours, up to a maximum of 2–3 times per day.
Children aged 6 to 10 years: 1 spray into each nostril no more frequently than every 2–3 hours, up to a maximum of 2–3 times per day.
This medicine is not intended for children under 6 years of age. In this age group, medicines containing a lower concentration of oxymetazoline should be used.
Do not use this medicine for longer than 7 consecutive days or in doses higher than recommended. Prolonged use or overdose of Nasivin Vicks Aloes and Eucalyptus may cause 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 fine, uniform mist is produced (approximately 5 to 10 times). Hold the bottle vertically with the nasal applicator inserted into one nostril. Close the other nostril with a finger.
2. Spray and inhale deeply through the nose at the same time. 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.

Use of a higher than recommended dose of Nasivin Vicks Aloes and Eucalyptus
If a patient has used too much Nasivin Vicks Aloes and Eucalyptus or accidentally swallowed the medicine, they should seek immediate medical attention, bringing the medicine bottle or packaging with them. Overdose may occur following nasal or accidental oral administration.
Symptoms of overdose (from moderate to severe) may include:
elevated blood pressure, rapid heartbeat, palpitations, cardiac arrhythmias, cardiac arrest, heart failure, sweating, restlessness, seizures, dilated pupils, nausea, vomiting, blue skin or lips, fever, muscle spasms, circulatory collapse, pulmonary edema, respiratory disturbances, psychiatric disturbances, drowsiness, pallor, constricted pupils, decreased body temperature, bradycardia, shock-like hypotension, 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 questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
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 (rebound congestion) after the medicine wears off.
• Rare (may occur in fewer than 1 in 1000 people): Anxiety, sedative effect, 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 this leaflet, tell your doctor, pharmacist, or nurse. Adverse reactions
can be reported directly to the Department of Monitoring Adverse Drug Reactions of the 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.
Adverse reactions can also be reported to the marketing authorization holder or parallel importer.
By reporting adverse reactions, more information on the safety of this medicine can be collected.

5. How to store Nasivin Vicks Aloes and Eucalyptus

Keep the medicine out of the sight and reach of children. Do not store at temperatures above 25°C.
Do not use this medicine after the expiry date stated on the packaging. 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 sewage or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the package and other information

What Nasivin Vicks Aloes and Eukalyptus 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 ingredients are: sorbitol, sodium citrate (for pH adjustment), polysorbate 80, benzyl alcohol,
citric acid (for pH adjustment), benzalkonium chloride, solution, acesulfame potassium, levomenthol,
cineole, disodium edetate, dry extract of aloe, L-carvone, purified water. (See section 2. Nasivin Vicks Aloes and Eukalyptus contains benzalkonium chloride and benzyl alcohol).
What Nasivin Vicks Aloes and Eukalyptus looks like and contents of the pack
Nasivin Vicks Aloes and Eukalyptus nasal spray solution is a nasal spray solution delivered via a pump spray.
The pack contains a 15 ml amber glass bottle (Type III) with a metered pump spray in a cardboard box.
Each bottle contains at least 265 doses.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Greece, the country of export:
Procter & Gamble Hellas M.E.P.E.
Agiou Konstantinou 49
15124 Marousi
Athens, Greece
Manufacturer:
Procter and Gamble Manufacturing GmbH
Procter & Gamble Strasse 1
64521 Gross-Gerau, Hessen
Germany
Parallel importer:
Allpharm Sp. z o.o. sp.k.
ul. M. Zdziechowskiego 11/4
02-659 Warsaw
Repackaged in:
CEFEA Sp. z o.o. Sp. komandytowa Synoptis Industrial Sp. z o.o. Shiraz Productions Sp. z o.o.
ul. Działkowa 56 ul. Forteczna 35-37 ul. Tymiankowa 24/28
02-234 Warsaw 87-100 Toruń 95-054 Ksawerów
Marketing authorisation number in Greece, the country of export: 61190/2-8-2016
Parallel import authorisation number: 257/25
This medicinal product is authorised in the European Economic Area countries under the following names:
Austria: 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, 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 0.5 mg/ml solución para pulverización nasal
Sweden: Vicks Sinex, 0.5 mg/ml, nässpray, lösning