Nasivin Sinex Aloes i Eukaliptus

Leaflet attached to the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Nasivin Sinex Aloes and Eucalyptus(Vicks Sinex)

0.5 mg/ml, nasal spray, solution

Oxymetazoline hydrochloride
Nasivin Sinex Aloes and Eucalyptus and Vicks Sinex are different trade names for the same medicine.

You should carefully read the contents of the leaflet 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 according to the doctor's or pharmacist's instructions.
This medicine is available without a prescription. However, you should use Nasivin Sinex Aloes and Eucalyptus carefully to get the best treatment result.

• Keep this leafletso that 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 Sinex Aloes and Eucalyptus and what is it used for
• 2. Important information before using Nasivin Sinex Aloes and Eucalyptus
• 3. How to use Nasivin Sinex Aloes and Eucalyptus
• 4. Possible side effects
• 5. How to store Nasivin Sinex Aloes and Eucalyptus
• 6. Contents of the packaging and other information

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

Nasivin Sinex 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 Sinex Aloes and Eucalyptus

When not to use Nasivin Sinex 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 due to 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 Sinex Aloes and Eucalyptus, you should discuss it with your doctor if you 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 Sinex Aloes and Eucalyptus and other medicines

You should tell your doctor or pharmacist about all medicines you are taking now or recently, and about medicines you plan to take.

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before using this medicine.
Due to insufficient data, Nasivin Sinex Aloes and Eucalyptus should not be used during pregnancy and breastfeeding, unless advised by a doctor.

Driving and using machines

Nasivin Sinex Aloes and Eucalyptus has no effect on the ability to drive and use machines.

Nasivin Sinex Aloes and Eucalyptus contains benzalkonium chloride and benzyl alcohol

The medicine contains 0.01 mg of benzalkonium chloride in each dose of the spray, which corresponds 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 in each dose of the spray, which corresponds to 2 mg/ml. Benzyl alcohol may cause allergic reactions and (or) mild local irritation.

3. How to use Nasivin Sinex Aloes and Eucalyptus

This medicine should always be used exactly as described in the patient leaflet or according to the doctor's or pharmacist's instructions. If you have any doubts, you should consult your doctor or pharmacist.

Recommended dose:

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

The medicine should not be used for more than 7 days in a row and the dose should not be

exceeded. Using Nasivin Sinex Aloes and Eucalyptus for a longer period or in case of overdose may cause a feeling of a blocked nose and may reduce the effectiveness of the medicine.
You should avoid direct contact with the eyes.
If symptoms worsen or do not improve, you should consult a 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 old can 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 Sinex Aloes and Eucalyptus than recommended

If you have used too much Nasivin Sinex Aloes and Eucalyptus or in case of accidental ingestion, you should immediately go to a doctor, taking the bottle or packaging of the medicine with you.
Overdose can 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, agitation, convulsions, dilated pupils, nausea, vomiting, blue skin or lips, fever, cramps, circulatory collapse, excessive fluid in the lungs, respiratory disorders, mental disorders, drowsiness, pallor, constricted pupils, decreased body temperature, slowed heart rate, hypotension similar to shock, transient cessation of breathing, loss of consciousness, convulsions, and coma.

Missing a dose of Nasivin Sinex Aloes and Eucalyptus

You should not take a double dose to make up for a missed dose. You should continue using the medicine according to the instructions.
If you have any further doubts about using the medicine, you should 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 occur less frequently than in 1 in 100 people):

Sneezing, dryness, or irritation in the nose, mouth, or throat, and swelling of the nasal mucosa (reactive hyperemia) after the effect of the medicine has worn off.

• Rare(may occur less frequently than in 1 in 1000 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 known

Nausea.

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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.
By reporting side effects, you can help gather more information on the safety of the medicine.

5. How to store Nasivin Sinex 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 packaging. 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. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Nasivin Sinex 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.
The other ingredientsof the medicine are: sorbitol, sodium citrate (to adjust pH), polysorbate 80, benzyl alcohol, citric acid (to adjust pH), benzalkonium chloride, solution, acesulfame potassium, levomenthol, cineole, disodium edetate, dry extract of aloe, L-carvone, purified water. (See section 2. Nasivin Sinex Aloes and Eucalyptus contains benzalkonium chloride and benzyl alcohol).

What Nasivin Sinex Aloes and Eucalyptus looks like and what the packaging contains

Nasivin Sinex Aloes and Eucalyptus nasal spray, solution, is a nasal spray with a dosing pump.
The packaging contains a 15 ml brown glass type III bottle with a dosing pump made of PP in a cardboard box.
Each bottle contains at least 265 doses.
For more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization 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:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in Greece, the country of export:61190/2-8-2016

Parallel import authorization number: 55/25

Date of leaflet approval: 07.02.2025

[Information about the trademark]