Nosox Classic

Leaflet attached to the packaging: patient information

NOSOX Classic

0.05%, nasal spray, solution

Oxymetazoline hydrochloride

Read the leaflet carefully before using the medicine, as it contains

important information for the patient.
The medicine should always be used exactly as described in this patient leaflet or as advised by
the doctor, pharmacist, or nurse.

• The leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, the pharmacist should be consulted.
• If the patient experiences any side effects, including those not listed in this leaflet, the doctor,
  pharmacist, or nurse should be informed. See section 4.
• If there is no improvement or the patient feels worse after 5 to 7 days, the doctor should be consulted.

Table of contents of the leaflet

• 1. What is Nosox Classic, 0.05%, nasal spray and what is it used for
• 2. Important information before using Nosox Classic, 0.05%, nasal spray
• 3. How to use Nosox Classic, 0.05%, nasal spray
• 4. Possible side effects
• 5. How to store Nosox Classic, 0.05%, nasal spray
• 6. Contents of the packaging and other information

1. What is Nosox Classic, 0.05%, nasal spray and what is it used for

Nosox Classic, 0.05%, nasal spray contains the active substance oxymetazoline hydrochloride, which
narrowes blood vessels. The administration of Nosox Classic, 0.05%, nasal spray reduces swelling of
the inflamed mucous membrane and inhibits excessive secretion, making it easier to breathe through
the nose. The reduction of nasal mucosa congestion also leads to the opening and expansion of the
paranasal sinuses and the unblocking of the Eustachian tube. This facilitates the removal of secretions
and the healing of bacterial infections.
Nosox Classic, 0.05%, nasal spray is used in swelling of the mucous membranes occurring in acute
rhinitis, vasomotor rhinitis, allergic rhinitis, sinusitis, Eustachian tube inflammation, and otitis media.
If there is no improvement or the patient feels worse after 5 to 7 days, the doctor should be consulted.

2. Important information before using Nosox Classic, 0.05%, nasal spray

When not to use Nosox Classic, 0.05%, nasal spray

• -If the patient is allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).
• -If the patient has dry rhinitis.
• -Nosox Classic, 0.05%, nasal spray should not be used in infants and children under 6 years of age. 1 / 5

Warnings and precautions

Before starting to use Nosox Classic, 0.05%, nasal spray, the doctor, pharmacist, or nurse should be
consulted.
Nosox Classic, 0.05%, nasal spray should be used with special caution and only after consulting a
doctor in patients:

• with cardiovascular diseases (e.g., coronary heart disease, hypertension),
• with increased intraocular pressure, especially with narrow-angle glaucoma,
• with prostate hyperplasia,
• with pheochromocytoma,
• with metabolic disorders (e.g., diabetes, hyperthyroidism),
• taking monoamine oxidase inhibitors (MAOIs) and other blood pressure-increasing medicines.

Longer use or overdose of the medicine should be avoided.
The effectiveness of nasal decongestants may decrease (tachyphylaxis) due to their longer use than
recommended or overdose. This can lead to the use of increasingly larger doses or more frequent
use of the medicine, which in turn can result in permanent use of the medicine. In the case of longer
use than recommended or misuse of the medicine, its use should be stopped immediately.
Permanent use of the medicine can lead to breathing difficulties due to reactive congestion of the
nasal mucosa (rebound effect) and chronic, drug-induced rhinitis ,as well as atrophy of the nasal
mucosa or dry rhinitis. The rebound effect and tachyphylaxis should resolve after discontinuation of the
medicine.
Similarly, misuse of locally used nasal medicines can lead to atrophy of the mucosa and reactive
congestion with drug-induced rhinitis.

Nosox Classic, 0.05%, nasal spray and other medicines

The doctor or pharmacist should be informed about all medicines currently or recently used by the
patient, as well as about medicines that the patient plans to use.
Concomitant use of tricyclic antidepressants or monoamine oxidase inhibitors (MAOIs) with Nosox
Classic, 0.05%, nasal spray may lead to an increase in blood pressure.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she
should consult a doctor or pharmacist before using this medicine.
Caution should be exercised when using the medicine during pregnancy or breastfeeding.
The recommended dose should not be exceeded.

Driving and using machines

In the case of using oxymetazoline, especially for a long period or in doses higher than recommended,
the effect on the cardiovascular system and the central nervous system cannot be excluded. In such
cases, the ability to drive vehicles and operate machines may be impaired.

Nosox Classic, 0.05%, nasal spray contains benzalkonium chloride

The medicine contains 2.3 μg (micrograms) of benzalkonium chloride in each 45 μL (microliters) dose of
the spray.
Benzalkonium chloride may cause irritation or swelling inside the nose, especially if used for a long
time.

3. How to use Nosox Classic, 0.05%, nasal spray

This medicine should always be used exactly as described in this patient leaflet or as advised by the
doctor, pharmacist, or nurse. In case of doubt, the doctor, pharmacist, or nurse should be consulted.
Intranasal administration.
Before the first use, the pump should be pressed several times until the first full spray appears. If the
break in using the medicinal product was longer than 4 days, the pump should be pressed several times
before the next use to release a full dose.

Adults and children over 6 years old:

1 dose of the spray (1 pump press) into each nostril 2 to 3 times a day.
The product should not be used more than 3 times a day.
Nosox Classic should not be used for longer than 5 to 7 days.
Re-treatment can be started after a few days' break.
The medicine should not be used in infants and children under 6 years of age.
One package of the medicinal product should not be used by more than one person.

Using a higher dose of Nosox Classic, 0.05%, nasal spray than recommended

Overdose or accidental ingestion of the medicine may cause: dilation of the pupils, nausea, vomiting,
cyanosis (bluish discoloration of the skin), fever, muscle cramps, increased heart rate, arrhythmias,
circulatory collapse, cardiac arrest, increased blood pressure, pulmonary edema (manifested by
rapidly increasing shortness of breath, restlessness, bluish discoloration of the skin, coughing up
foamy secretions tinged with blood), respiratory disorders, mental disorders. Additionally, central
nervous system depression with drowsiness, decreased body temperature, slowed heart rate, decreased
blood pressure, apnea, and coma may occur.
In case of using a higher dose of the medicine than recommended, the doctor or pharmacist should be
consulted immediately.

Missing a dose of Nosox Classic, 0.05%, nasal spray

A double dose should not be used to make up for a missed dose.
In case of any further doubts regarding the use of this medicine, the doctor, pharmacist, or nurse should be
consulted.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common side effects(occurring in 1 to 10 patients out of 100):

• burning or dryness of the nasal mucosa, sneezing, especially in sensitive patients.

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Uncommon side effects(occurring in 1 to 10 patients out of 1,000):

• systemic symptoms, such as palpitations, increased heart rate, and increased blood pressure, occurring
  after local (intranasal) use of the medicine.

Rare side effects(occurring in 1 to 10 patients out of 10,000):

• headaches and dizziness, restlessness, insomnia, fatigue.

In rare cases, after the effect of the medicine has worn off, there may be an exacerbation of nasal mucosa
congestion (so-called rebound congestion).
Prolonged or frequent use of oxymetazoline, as well as use in doses higher than recommended, may
lead to reactive congestion with drug-induced rhinitis. Such an effect may occur after 5-7 days of
treatment and, in the case of continued use of the medicine, may lead to permanent damage to the
nasal mucosa, decreased activity of the cilia, or dry rhinitis.
Long-term use or misuse of oxymetazoline can also lead to a decrease in the effectiveness of the medicine,
known as tachyphylaxis (frequency not known - cannot be estimated from the available data).

Reporting side effects

If any side effects occur, including those not listed in this leaflet, the doctor, pharmacist, or nurse should
be informed.
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
Aleje Jerozolimskie 181C, 02-222 Warsaw
tel.: 22 49 21 301, fax: 22 49 21 309
e-mail: ndl@urpl.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Nosox Classic, 0.05%, nasal spray

Store in a temperature below 25 °C. Store in the original packaging to protect from light.
The medicine should be kept out of the sight and reach of children.
The medicine should not be used after the expiry date stated on the packaging. The expiry date refers to
the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked
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 Nosox Classic, 0.05%, nasal spray contains

• The active substance of the medicine is oxymetazoline hydrochloride. 1 mL of the solution contains 0.5
  mg of oxymetazoline hydrochloride. One dose of the spray with a volume of 45 microliters contains 22.5
  micrograms of oxymetazoline hydrochloride. 4 / 5
• The other ingredients (excipients) are: disodium phosphate dodecahydrate, sodium dihydrogen phosphate
  dihydrate, sodium chloride, benzalkonium chloride, citric acid monohydrate, purified water.

What Nosox Classic, 0.05%, nasal spray looks like and what the packaging contains

Nosox Classic is a clear, colorless solution, odorless.
The packaging of the medicine is an HDPE bottle containing 10 mL (not less than 140 doses) of the
solution, closed with a PE/PP/Stainless Steel spray pump and an applicator with a PP/PE nozzle,
placed in a cardboard box.

Marketing authorization holder and manufacturer

“PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK” S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E
Information about the medicine
tel.: 22 742 00 22
e-mail: informacjaoleku@hasco-lek.pl

Date of the last update of the leaflet:

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