Nosox junior

Patient Information Leaflet

NOSOX Junior
0.025% nasal spray, solution
Oxymetazolini hydrochloridum
Please read all of this leaflet carefully before using this medicine, because it contains
important information for you.
This medicine should always be used exactly as described in this patient leaflet or as directed by your
doctor, pharmacist, or nurse.

• Keep this leaflet so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any side effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
• If there is no improvement within 5 to 7 days, or if you feel worse, consult your doctor.

Contents of the leaflet

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

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

Nosox Junior 0.025% nasal spray, solution contains as the active substance oxymetazoline hydrochloride, which constricts blood vessels. Administration of Nosox Junior 0.025% nasal spray reduces swelling of the inflamed mucous membrane and inhibits excessive secretion, thereby facilitating free nasal breathing. Reduction of nasal mucosal congestion also opens and widens the drainage pathways of the paranasal sinuses and unblocks the Eustachian tubes. This helps remove secretions and supports recovery from bacterial infection.
Nosox Junior 0.025% nasal spray, solution is used in mucosal swelling associated with acute rhinitis, vasomotor rhinitis, allergic rhinitis, sinusitis, Eustachian tube inflammation, and otitis media.
If there is no improvement within 5 to 7 days, or if you feel worse, consult your 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 to any of the other ingredients of this medicine (listed in section 6).
• If the patient has dry rhinitis (dry inflammation of the nasal mucosa).
• Nosox Junior 0.025% nasal spray must not be used in children during the first year of life.

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Warnings and precautions
Before starting to use Nosox Junior 0.025% nasal spray, consult your doctor, pharmacist, or nurse.
Nosox Junior 0.025% nasal spray should be used with particular caution and only after consultation with a doctor in patients:

• with cardiovascular diseases (e.g. ischemic heart disease, arterial hypertension),
• with increased intraocular pressure, especially narrow-angle glaucoma,
• with benign prostatic hyperplasia,
• with pheochromocytoma,
• with metabolic disorders (e.g. diabetes, hyperthyroidism),
• who are concurrently using monoamine oxidase inhibitors (MAOIs) or other medicines that increase arterial blood pressure.

Prolonged use beyond the recommended duration or overdosing should be avoided.
The effectiveness of nasal decongestants may decrease (tachyphylaxis) when used for longer than recommended or overdosed. This may lead to the need for increasingly higher doses or more frequent administration, which in turn may result in chronic use of the medicine. In cases of prolonged use beyond the recommended duration or misuse, the treatment should be discontinued immediately.
Chronic use of the medicine may lead to breathing difficulties caused by reactive hyperemia of the nasal mucosa (rebound effect) and chronic drug-induced rhinitis, as well as atrophy of the mucosa or dry rhinitis. The rebound effect and tachyphylaxis should resolve after discontinuation of the medicine.
Similarly, misuse of locally applied nasal medicines may lead to atrophy of the mucosa and reactive hyperemia with drug-induced rhinitis.

Nosox Junior 0.025% nasal spray and other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned for use.
Concurrent 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, breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Caution should be exercised when using this medicine during pregnancy or breastfeeding.
The recommended dose should not be exceeded.

Driving and operating machinery
When using oxymetazoline, especially for prolonged periods or in doses higher than recommended, effects on the cardiovascular system and central nervous system cannot be ruled out. In such cases, the ability to drive or 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 (microliter) spray dose.

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Benzalkonium chloride may cause irritation or swelling inside the nose, especially if used for a prolonged period.

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 prescribed by your doctor, pharmacist, or nurse. If in doubt, consult your doctor, pharmacist, or nurse.

For nasal use only.

Before first use, press the pump several times until the first full spray is released. If the medicinal product has not been used for more than 4 days, press the pump several times before the next use to ensure a full dose is delivered.

Children over 1 year of age up to 6 years:
1 spray (1 full press of the pump) into each nostril 2 to 3 times daily. Do not use the product more than 3 times a day.

Do not use Nosox Junior for longer than 5 to 7 days.
Treatment may be repeated after a break of several days.

Do not use this medicine in children under 1 year of age.

One medicinal product container should not be used by more than one person.

Overdose of Nosox Junior 0.025% nasal spray
Overdose or accidental oral ingestion may cause: pupil dilation, nausea, vomiting, cyanosis (bluish skin discoloration), fever, muscle spasms, increased heart rate, cardiac arrhythmia, circulatory collapse, cardiac arrest, increased blood pressure, pulmonary oedema (manifesting, among others, as rapidly worsening breathlessness, restlessness, bluish skin discoloration, cough with frothy sputum tinged with blood), respiratory disturbances, and mental disorders. Additionally, central nervous system depression may occur, including drowsiness, decreased body temperature, slowed heart rate, drop in blood pressure, apnoea, and coma.

In case of overdose, seek immediate medical advice from a doctor or pharmacist.

Missed dose of Nosox Junior 0.025% nasal spray
Do not use a double dose to make up for a missed dose.

If you have any further doubts concerning the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Common adverse effects (occur in 1 to 10 out of 100 patients):

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

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Uncommon adverse effects (occur in 1 to 10 out of 1,000 patients):

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

Rare adverse effects (occur in 1 to 10 out of 10,000 patients):

• headache, dizziness, anxiety, insomnia, or fatigue.

In rare cases, after the effect of the medicine wears off, worsening of nasal mucosal swelling may occur (so-called reactive hyperaemia).

Prolonged or frequent use of oxymetazoline, as well as use in doses higher than recommended, may lead to reactive hyperaemia with drug-induced rhinitis. Such an effect may occur as early as after 5–7 days of treatment and, if treatment is continued, may lead to permanent damage to the nasal mucosa, reduced ciliary activity, or atrophic rhinitis.

Long-term use or abuse of oxymetazoline may also lead to reduced effectiveness of the medicine, i.e. tachyphylaxis (frequency not known – frequency cannot be estimated based on available data).

Reporting of adverse effects

If any adverse effects occur, including any possible adverse effects not listed in this leaflet, inform your doctor, pharmacist, or nurse.

Adverse effects 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
Aleje Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49 21 301, Fax: +48 22 49 21 309
Email: [email protected]

Adverse effects can also be reported to the marketing authorization holder.

Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Nosox Junior 0.025% nasal aerosol

Store below 25 °C. Keep in the original packaging to protect from light.
Keep the medicine 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 stated month.
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 the medicine Nosox Junior, 0.025%, nasal spray contains

• The active substance is oxymetazoline hydrochloride. 1 ml of solution contains 0.25 mg of oxymetazoline hydrochloride. One 45 microlitre spray dose contains 11.25 micrograms of oxymetazoline hydrochloride. 4/5
• Other components (excipients): 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 contents of the pack
Nosox Junior is a clear, colourless, odourless solution.
The medicine pack consists of an HDPE bottle containing 10 mL (not less than 140 doses) of solution,
closed with a pump dispenser made of PE/PP/Stainless steel and a nozzle applicator made of PP/PE,
placed in a cardboard box.
Marketing Authorisation Holder and Manufacturer
„PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK” S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E
Medicine Information
tel.: 22 742 00 22
e-mail: [email protected]
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