Xilorin Protect

Package Leaflet: Information for the User

Xylorin Protect, 0.5 mg/ml, nasal spray, solution
Oxymetazoline hydrochloride

Read the package 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 package leaflet for the patient, or as directed by a doctor or pharmacist.

• This package leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including those not listed in this package leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse, they should contact their doctor.

Table of Contents of the Package Leaflet

• 1. What is Xylorin Protect and what is it used for
• 2. Important information before using Xylorin Protect
• 3. How to use Xylorin Protect
• 4. Possible side effects
• 5. How to store Xylorin Protect
• 6. Contents of the pack and other information

1. What is Xylorin Protect and what is it used for

Xylorin Protect is used for the short-term treatment of nasal congestion caused by a cold and sinusitis in adults and children from 10 years of age.
Xylorin Protect has a rapid decongestant effect, reducing nasal congestion and sinusitis, making breathing easier. The effect occurs within a few minutes and lasts up to 12 hours.
Xylorin Protect also contains dexpanthenol, which moisturizes the dry nasal mucosa.

2. Important information before using Xylorin Protect

When not to use Xylorin Protect

• if the patient is allergic to oxymetazoline hydrochloride or any of the other ingredients of this medicine (listed in section 6)
• if the patient has chronic nasal mucosa inflammation with very dry nasal passages (atrophic rhinitis or dry rhinitis).

Warnings and precautions

Before using Xylorin Protect, the patient should discuss it with their doctor or pharmacist if:

• the patient has cardiovascular diseases (e.g., angina pectoris)
• the patient has high blood pressure
• the patient has diabetes
• the patient has a benign adrenal tumor (pheochromocytoma) that produces large amounts of adrenaline and noradrenaline
• the patient has difficulty urinating and/or has an enlarged prostate
• the patient has increased eye pressure (narrow-angle glaucoma)
• the patient has hyperthyroidism
• the patient is taking antidepressants (tricyclic and tetracyclic antidepressants, e.g., amitriptyline, imipramine) or has taken such treatment in the last two weeks.

Children

Xylorin Protect should not be used in children under 10 years of age.

Xylorin Protect and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
It is especially important to inform about:

• Tricyclic and tetracyclic antidepressants (for depression, e.g., amitriptyline, imipramine). If the patient is taking or has taken these medicines in the last two weeks, blood pressure may rise significantly (hypertensive crisis).
• Monoamine oxidase inhibitors (used to treat depression). If the patient is taking or has taken these medicines in the last two weeks, blood pressure may rise significantly (hypertensive crisis).
• Beta-adrenergic blockers (used to treat high blood pressure). The oxymetazoline in Xylorin Protect may affect the action of some beta-adrenergic blockers.
• Medicines with an adrenaline-like effect (e.g., ephedrine, pseudoephedrine), as they may enhance the effect of Xylorin Protect.

Pregnancy, breastfeeding, and fertility

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.
Pregnancy
As there are limited data on the use of this medicine during pregnancy, Xylorin Protect should be used during pregnancy only after consulting a doctor.
Breastfeeding
As no studies have been conducted, it is not known whether Xylorin Protect passes into breast milk.
Fertility
The effect of Xylorin Protect on fertility is not known.

Driving and using machines

Xylorin Protect has no or negligible influence on the ability to drive and use machines.

3. How to use Xylorin Protect

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

Recommended dose:

Adults and children from 10 years of age: 2 sprays into each nostril 2 to 3 times a day.

Xylorin Protect should not be used for more than 10 consecutive days and the recommended dose should not be exceeded.

Using Xylorin Protect for a long time may cause nasal mucosa congestion and nasal obstruction.

Instructions for use

Before first use, the pump should be primed. The bottle should be held upright and the medicine sprayed 5 times into the air until a uniform spray is achieved. If the pump has not been used for a long time, it should be primed with 3 sprays into the air.

• 1. Blow the nose. Remove the protective cap.
• 2. Hold the bottle as shown in the picture.
• 3. Insert the tip into one nostril and spray the prescribed number of doses (according to the dosing instructions above). Repeat the procedure for the other nostril.
• 4. Replace the protective cap.

As it may be difficult to empty the bottle completely, it is filled with a slightly larger amount of solution than 7.5 ml. This ensures that the declared amount is delivered.

Using a higher dose of Xylorin Protect than recommended

In case of overdose, the patient should immediately consult their doctor or pharmacist.

Missing a dose of Xylorin Protect

A double dose should not be used to make up for a missed dose.
In case of any further doubts about using this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Xylorin Protect can cause side effects, although not everybody gets them.
Uncommon (may affect up to 1 in 100 people): sneezing, dryness of the mouth and throat.
Rare (may affect up to 1 in 1,000 people): restlessness, irritability, local nasal irritation, sleep disturbances in children.
Using Xylorin Protect for a long time may cause nasal mucosa congestion and nasal obstruction.

Reporting side effects

If the patient experiences any side effects, including those not listed in this package leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Pharmacovigilance of the 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
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Xylorin Protect

The medicine should be stored out of sight and reach of children.
Store in a temperature below 25°C.
Do not use this medicine after the expiry date stated on the carton and bottle after: "Expiry date" or "EXP". 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 that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Xylorin Protect contains

• The active substance is oxymetazoline hydrochloride. 1 ml of Xylorin Protect, 0.5 mg/ml, nasal spray contains: 0.5 mg of oxymetazoline hydrochloride.
• The other ingredients are: dexpanthenol, disodium edetate, sodium dihydrogen phosphate dihydrate, disodium phosphate dihydrate, sodium chloride, and purified water.

Xylorin Protect, nasal spray does not contain preservatives. Therefore, for technical reasons, the bottle is not completely filled.

What Xylorin Protect looks like and contents of the pack

Xylorin Protect, 0.5 mg/ml, nasal spray, solution, is a clear, colorless or slightly colored solution in a 7.5 ml HDPE bottle with a PP nasal applicator with a metered-dose pump (HDPE/PP/PE/stainless steel) and a PP protective cap in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder
Perrigo Poland Sp. z o.o.
ul. Domaniewska 48
02-672 Warsaw
tel.: +48 (22) 852 55 51
Manufacturer
Curida AS
Solbærvegen 5
No-2409 Elverum
Norway
Farmaclair
440 Avenue du Général de Gaulle
14200 Hérouville-Saint-Clair
France

This medicine is authorized in the Member States of the European Economic Area under the following names:

Sweden Nezebi
Poland Xylorin Protect

Date of last revision of the package leaflet: August 2024