Package leaflet: Information for the user

NOSOX Classic
0.05%, 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, as you may need to read it again.
If you need advice or further information, consult your pharmacist.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. See section 4.
If there is no improvement after 5 to 7 days, or if you feel worse, consult your doctor.

Contents of the leaflet

What Nosox Classic 0.05% nasal spray, solution is and what it is used for
Important information before using Nosox Classic 0.05% nasal spray, solution
How to use Nosox Classic 0.05% nasal spray, solution
Possible side effects
How to store Nosox Classic 0.05% nasal spray, solution
Contents of the pack and other information

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

Nosox Classic 0.05% nasal spray, solution contains as the active substance oxymetazoline hydrochloride, which constricts blood vessels. Administration of Nosox Classic 0.05% nasal spray reduces inflammation of the nasal mucosa and inhibits excessive secretion, thus facilitating free nasal breathing. Reduction of nasal mucosal congestion also opens and widens the sinus drainage pathways and unblocks the Eustachian tubes. This facilitates removal of secretions and helps resolve bacterial infection.
Nosox Classic 0.05% nasal spray, solution is used for mucosal oedema occurring in acute rhinitis, vasomotor rhinitis, allergic rhinitis, sinusitis, Eustachian tube inflammation, and otitis media.
If there is no improvement after 5 to 7 days, or if you feel worse, consult your doctor.

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 to any of the other ingredients of this medicine (listed in section 6).
If the patient has atrophic rhinitis.
Nosox Classic 0.05% nasal spray must 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, consult a
doctor, pharmacist or nurse.
Nosox Classic 0.05% 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) with prolonged use beyond the recommended duration or due to overdosing. This may lead to the need for increasingly higher doses or more frequent administration, which in turn may result in chronic, continuous use of the medicine. In case 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 hyperaemia of the nasal mucosa (rebound effect) and chronic medicamentosa rhinitis, as well as atrophy or atrophic rhinitis of the nasal mucosa. The rebound effect and tachyphylaxis should resolve after discontinuation of the medicine.
Similarly, misuse of topically applied nasal medicines may lead to atrophy of the mucosa and reactive hyperaemia with medicamentosa rhinitis.

Nosox Classic 0.05% nasal spray and other medicines
Inform the doctor or pharmacist about all medicines currently used or recently used, as well as any medicines the patient intends to use.
Concomitant use of tricyclic antidepressants or monoamine oxidase inhibitors (MAOIs) with Nosox Classic 0.05% nasal spray may lead to increased arterial blood pressure.

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.
Caution should be exercised when using this medicine during pregnancy or breastfeeding.
Do not exceed the recommended dose.

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 Classic 0.05% nasal spray contains benzalkonium chloride
The medicine contains 2.3 μg (micrograms) of benzalkonium chloride in each 45 μL (microlitre) spray dose.
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Benzalkonium chloride may cause irritation or swelling inside the nose, especially if used for prolonged periods.

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 directed by a doctor, pharmacist, or nurse. If in doubt, consult a doctor, pharmacist, or nurse.

For nasal use only.

Before first use, press the pump several times until the first full spray appears. If the medicine has not been used for more than 4 days, press the pump several times before the next use to ensure release of a full dose.

Adults and children over 6 years of age:
1 spray (1 full pump press) into each nostril 2 to 3 times daily. Do not use the product more than 3 times daily.

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

Do not use this medicine in infants and children under 6 years of age.

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

Overdose of Nosox Classic, 0.05% nasal spray

Overdose or accidental oral ingestion of the medicine may cause: pupil dilation, nausea, vomiting, cyanosis (bluish skin discoloration), fever, muscle spasms, increased heart rate, heart rhythm disturbances, circulatory collapse, cardiac arrest, increased blood pressure, pulmonary edema (manifested by rapidly worsening shortness of breath, restlessness, bluish skin discoloration, cough with frothy sputum tinged with blood), breathing difficulties, and mental disturbances. Additionally, central nervous system depression may occur, with symptoms such as drowsiness, decreased body temperature, slowed heart rate, low blood pressure, respiratory arrest, and coma.

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

Missed dose of Nosox Classic, 0.05% nasal spray

Do not use a double dose to make up for a missed dose.

If you have any further questions about 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 sensation 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 and dizziness, anxiety, insomnia, fatigue.

In rare cases, after the effect of the medicine wears off, there may be a worsening of nasal mucosal swelling (so-called reactive hyperemia).
Prolonged or frequent use of oxymetazoline, as well as use in doses higher than recommended, may lead to reactive hyperemia with drug-induced rhinitis (rhinitis medicamentosa). This effect may occur as early as after 5–7 days of treatment and, if the medicine continues to be used, may result in permanent damage to the nasal mucosa, reduced 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 – frequency cannot be estimated from 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
Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309
E-mail: [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 Classic 0.05% 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 container. The expiry date refers to the last day of the specified month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Following this advice helps protect the environment.

6. Contents of the packaging and other information

What Nosox Classic, 0.05%, nasal spray contains

The active substance is oxymetazoline hydrochloride. 1 mL of solution contains 0.5 mg of oxymetazoline hydrochloride. One spray dose of 45 microlitres contains 22.5 micrograms of oxymetazoline hydrochloride. 4 / 5
Other components (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 contents of the pack
Nosox Classic is a clear, colourless, odourless solution.
The packaging 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 nasal applicator with a nozzle 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
Medical information
tel.: 22 742 00 22
e-mail: [email protected]
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