Nosox Iunior

Leaflet attached to the packaging: patient information

NOSOX Junior

0.025%, nasal spray, solution

Oxymetazoline hydrochloride

Read the 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, pharmacist, or nurse.

• This leaflet should be kept in case you need to read it again.
• If you need advice or additional information, you should consult a pharmacist.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform
  their doctor, pharmacist, or nurse. See section 4.
• If there is no improvement or the patient feels worse after 5 to 7 days, they should contact their doctor.

Table of contents of the leaflet

• 1. What is Nosox Junior, 0.025%, nasal spray and what is it used for
• 2. Important information before using Nosox Junior, 0.025%, nasal spray
• 3. How to use Nosox Junior, 0.025%, nasal spray
• 4. Possible side effects
• 5. How to store Nosox Junior, 0.025%, nasal spray
• 6. Contents of the packaging and other information

1. What is Nosox Junior, 0.025%, nasal spray and what is it used for

Nosox Junior, 0.025%, nasal spray contains the active substance oxymetazoline hydrochloride, which
narrowes blood vessels. Administration of Nosox Junior, 0.025%, nasal spray reduces swelling of the
inflamed mucous membrane and inhibits excessive secretion, making it easier to breathe freely through
the nose. The reduction of nasal mucosal congestion also leads to the opening and dilation of the paranasal
sinus drainage pathways and unclogs the Eustachian tubes. This facilitates the removal of secretions and
recovery from bacterial infection.
Nosox Junior, 0.025%, nasal spray is used in swelling of the mucous membranes occurring in acute
rhinitis, vasomotor rhinitis, allergic rhinitis, sinusitis, otitis media, and Eustachian tube inflammation.
If there is no improvement or the patient feels worse after 5 to 7 days, they should consult their doctor.

2. Important information before using the medicine

When not to use Nosox Junior, 0.025%, 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 atrophic rhinitis.
• -Nosox Junior, 0.025%, nasal spray should not be used in children under 1 year of age.

1/5

Warnings and precautions

Before starting to use Nosox Junior, 0.025%, nasal spray, the patient should discuss it with their doctor,
pharmacist, or nurse.
Nosox Junior, 0.025%, nasal spray should be used with caution and only after consulting a doctor in
patients with:

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

Avoid using the medicine for longer than recommended or overdosing.
The effectiveness of nasal decongestants may decrease (tachyphylaxis) due to their prolonged use or
overdosing. This may lead to the use of increasingly larger doses or more frequent use of the medicine,
which in turn may result in permanent use of the medicine. In case of prolonged use or abuse of the
medicine, its use should be stopped immediately.
Permanent use of the medicine may lead to a breathing difficulty caused by reactive nasal mucosal
congestion (rebound effect) and chronic, drug-induced rhinitis, as well as atrophy of the nasal mucosa or
atrophic rhinitis. The rebound effect and tachyphylaxis should resolve after discontinuation of the
medicine.
Similarly, abuse of locally used nasal medicines may lead to atrophy of the nasal mucosa and reactive
congestion with drug-induced rhinitis.

Nosox Junior, 0.025%, nasal spray and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently using or have
recently used, as well as any medicines they plan to use.
Concomitant use of tricyclic antidepressants or monoamine oxidase inhibitors (MAOIs) with Nosox
Junior, 0.025%, nasal spray may lead to increased blood pressure.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they
should consult their 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 operating machinery

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

Nosox Junior, 0.025%, nasal spray contains benzalkonium chloride

The medicine contains 2.3 μg (micrograms) of benzalkonium chloride in each 45 μl (microliters) dose of
the spray.
2/5
Benzalkonium chloride may cause irritation or swelling inside the nose, especially if used for a long
time.

3. How to use Nosox Junior, 0.025%, nasal spray

This medicine should always be used exactly as described in this patient leaflet or as directed by the
doctor, pharmacist, or nurse. In case of doubt, the patient should consult their doctor, pharmacist, or
nurse.
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.

Children over 1 year of age to 6 years:

1 spray dose (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 Junior 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 children under 1 year of age.
One package of the medicinal product should not be used by more than one person.

Using a higher dose of Nosox Junior, 0.025%, nasal spray than recommended

Overdose or accidental ingestion of the medicine may cause: mydriasis, nausea, vomiting, cyanosis
(bluish discoloration of the skin), fever, muscle cramps, accelerated heart rate, arrhythmias, circulatory
collapse, cardiac arrest, increased blood pressure, pulmonary edema (manifested by rapidly progressing
shortness of breath, restlessness, bluish discoloration of the skin, coughing up frothy sputum tinged with
blood), respiratory disorders, mental disorders. Additionally, there may be inhibition of the central nervous
system activity with drowsiness, decreased body temperature, slowed heart rate, decreased blood pressure,
apnea, and coma.
In case of using a higher dose of the medicine than recommended, the patient should immediately
consult their doctor or pharmacist.

Missing a dose of Nosox Junior, 0.025%, 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 patient should consult their doctor,
pharmacist, or nurse.

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.

3/5
Uncommon side effects(occurring in 1 to 10 patients out of 1,000):

• systemic symptoms, such as palpitations, accelerated 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, or fatigue.

In rare cases, after the effect of the medicine has worn off, there may be an exacerbation of nasal mucosal
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 as early as 5-7 days into
treatment and, if the medicine is continued, may lead to permanent damage to the nasal mucosa, decreased
ciliary activity, or atrophic rhinitis.
Long-term use or abuse of oxymetazoline may also lead to decreased effectiveness of the medicine, i.e.,
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 patient should inform their doctor,
pharmacist, or nurse.
Side effects can be reported directly to the Department for 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
phone: 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Nosox Junior, 0.025%, 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.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last
day of the month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their
pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the packaging and other information

What Nosox Junior, 0.025%, nasal spray contains

• The active substance of the medicine is oxymetazoline hydrochloride. 1 ml of the solution contains 0.25
  mg of oxymetazoline hydrochloride. 1 spray dose of 45 microliters contains 11.25 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 Junior, 0.025%, nasal spray looks like and what the pack contains

Nosox Junior 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 spray pump made of PE/PP/stainless steel and an applicator with a nozzle made of
PP/PE, 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
phone: 22 742 00 22
e-mail: informacjaoleku@hasco-lek.pl

Date of last revision of the leaflet:

5/5