Nasivin sinex aloe and eucalyptus

Package leaflet: Information for the patient

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.
Nasivin Sinex Aloes i Eukaliptus (Vicks Sinex)
0.5 mg/ml, nasal spray, solution
Oxymetazolini hydrochloridum
Nasivin Sinex Aloes i Eukaliptus and Vicks Sinex are different trade names for the same medicine.
Please read the entire 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 according to
the instructions of a doctor or pharmacist.
This medicine is available without a prescription. However, Nasivin Sinex Aloes i Eukaliptus 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, 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 there is no improvement or if you feel worse, contact your doctor or nurse.

Table of contents of the leaflet:

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

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

Nasivin Sinex Aloes i Eukaliptus is a nasal spray intended for local use, used to relieve symptoms
of nasal congestion occurring in colds or inflammation of the nasal mucosa, 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 Sinex Aloes i Eukaliptus

When not to use Nasivin Sinex Aloes i Eukaliptus:

• 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 cardiac insufficiency with dyspnoea,
• if the patient has increased intraocular pressure (angle-closure glaucoma),
• if the patient has undergone pituitary surgery,
• if the patient has skin or mucous membrane inflammation of the nasal vestibule, or nasal crusts.

Warnings and precautions
Before using Nasivin Sinex Aloes i Eukaliptus, 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 Sinex Aloes i Eukaliptus 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 Sinex Aloes i Eukaliptus if MAO inhibitors have been taken within the last two weeks.
• Tricyclic antidepressants – inform the doctor if the patient is taking antidepressants such as amitriptyline or 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 Sinex Aloes i Eukaliptus should not be used during pregnancy or breastfeeding unless specifically instructed by a doctor.

Driving and operating machinery
Nasivin Sinex Aloes i Eukaliptus has no effect on the ability to drive or operate machinery.

Nasivin Sinex Aloes i Eukaliptus 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, particularly with 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 Sinex Aloes i Eukaliptus

This medicine should always be used exactly as described in the patient leaflet or as advised 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 2–3 times daily.
Children aged 6 to 10 years: 1 spray into each nostril no more frequently than 2–3 times daily.

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 higher doses than recommended. Prolonged use or overdose of Nasivin Sinex Aloes i Eukaliptus may cause a sensation 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.

Instructions for use:

1. Remove the cap. Before first use, prime the pump by firmly pressing the collar several times until a uniform spray is produced (approximately 5 to 10 times). Hold the bottle upright with the nasal applicator inserted into one 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 Sinex Aloes i Eukaliptus
If an excessive dose of Nasivin Sinex Aloes i Eukaliptus has been used or if the medicine has been swallowed, seek immediate medical attention and bring the medicine container or packaging with you. 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, agitation, 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 Sinex Aloes i Eukaliptus
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 side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Severe side effects 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 duration of effect, headache, rash and visual disturbances.

• Frequency not known

Nausea.
Reporting of side effects
If any side effects occur, including any side effects not listed in this leaflet, inform your doctor or pharmacist. Side effects can also be reported directly to the Department of Monitoring Adverse Drug Reactions, 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.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Nasivin Sinex Aloes i Eukaliptus

Keep the medicine 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 container. The expiry date refers to the last day of the specified 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 in use. This will help protect the environment.

6. Contents of the pack and other information

What Nasivin Sinex 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.
The 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 Sinex Aloes i Eukaliptus contains benzalkonium chloride and benzyl alcohol.)
What Nasivin Sinex Aloes i Eukaliptus looks like and contents of the pack
Nasivin Sinex Aloes i Eukaliptus nasal spray, solution, is a nasal spray delivered via a pump spray.
The pack contains a 15 ml brown glass type III bottle with a metering 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, 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 in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorisation number in Greece, country of export: 61190/2-8-2016
Parallel import authorisation number: 55/25