Package leaflet: Information for the user

Xylopronal, 1 mg/mL, nasal spray, solution
Xylometazolini hydrochloridum
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Please read all of this leaflet carefully before using this medicine, as 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 or pharmacist.

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 adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement after 7 days of treatment, or if your symptoms worsen, consult your doctor.

Table of contents

What Xylopronal is and what it is used for
Important information before using Xylopronal
How to use Xylopronal
Possible side effects
How to store Xylopronal
Contents of the pack and other information

1. What Xylopronal is and what it is used for

The active substance in Xylopronal is xylometazoline hydrochloride.
Xylopronal is a locally acting medicine that reduces nasal congestion and swelling of the nasal mucosa by constricting blood vessels, thereby decreasing mucus secretion.
It helps patients with a stuffy nose to breathe more easily through the nose. The effect of Xylopronal begins within a few minutes and lasts for several hours.
Xylopronal is indicated for use in adults and adolescents over 12 years of age.
If there is no improvement after 7 days of use, or if symptoms worsen, you should consult your doctor.

Indications
Excessive congestion of the nasal mucosa occurring during colds, hay fever, allergic rhinitis, and sinusitis. The medicine facilitates drainage of secretions from inflamed paranasal sinuses. By reducing congestion of the nasopharyngeal mucosa, it may be used as supportive treatment in otitis media. Xylopronal facilitates nasal speculum examination (examination of the nasal cavity).

2. Important information before using Xylopronal

When not to use Xylopronal:

if the patient is allergic to xylometazoline hydrochloride or any of the other ingredients of this medicine (listed in section 6),
if the patient has undergone surgery via the nose, e.g. removal of the pituitary gland or surgery involving exposure of the dura mater (brain surgery performed through the nose or mouth),
if the patient has narrow-angle glaucoma (increased pressure in the eye),
if the patient has very dry nasal mucosa (atrophic rhinitis or drying inflammation of the nasal mucosa).

Warnings and precautions
Before starting to use Xylopronal, consult a doctor if the patient:

has high blood pressure,
has heart disease (e.g. long QT syndrome),
has hyperthyroidism,
has diabetes,
has benign prostatic hyperplasia,
has a benign tumour of the adrenal gland producing large amounts of adrenaline and noradrenaline (pheochromocytoma),
is taking certain antidepressant medicines known as monoamine oxidase inhibitors (MAOIs) or has taken them within the last 2 weeks,
is hypersensitive to substances with effects similar to xylometazoline. In sensitive patients, Xylopronal may cause insomnia, dizziness, irregular heartbeat, increased blood pressure, or tremor.

Do not use Xylopronal for longer than 7 consecutive days. If symptoms persist, contact a doctor.
Using the medicine for longer than 7 days or in doses higher than recommended may worsen symptoms or cause their recurrence.
Do not apply Xylopronal to the eyes or inside the mouth.
Do not exceed the recommended dose, especially in children and elderly patients.

Children and adolescents
Do not use Xylopronal in children under 12 years of age.

Xylopronal and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Do not use Xylopronal while taking certain medicines used to treat depression. These include:

monoamine oxidase inhibitors (MAOIs): DO NOT use Xylopronal if taking MAOIs or have taken such medicines within the last 14 days,
tricyclic and tetracyclic antidepressants.

If taking any of the above medicines, consult a doctor before using Xylopronal.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.
Do not use Xylopronal during pregnancy.
During breastfeeding, Xylopronal should only be used after consulting a doctor.

Driving and operating machinery
Xylopronal, when used at recommended doses, has no effect or has a negligible effect on the ability to drive and operate machinery.

Xylopronal contains benzalkonium chloride
The medicine contains 0.138 mg of benzalkonium chloride per dose, equivalent to 1 mg/mL.
Benzalkonium chloride may cause irritation or swelling inside the nose, especially if used for a prolonged period.

3. How to use Xylopronal

This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor. If in doubt, consult your doctor or pharmacist.
Xylopronal should be used only in the nose (including in middle ear inflammation).
To avoid spreading infection, one package of the medicine should be used by only one patient.

Dosage
Adults and adolescents over 12 years of age:
1 spray dose of Xylopronal into each nostril 3 times daily.
Do not use more than 3 times a day. An interval of 8–10 hours should be maintained between doses.
It is recommended to take the last dose immediately before going to bed.
Do not use for longer than 7 consecutive days.
Xylopronal should not be used in children under 12 years of age.

Method of administration
The medicine is intended for nasal use.
Take care not to spray the aerosol into the eyes.

Do not cut the tip of the applicator. The aerosol is ready for use.
Remove the protective cap.
Before first use, press the pump several times until one dose of the medicine is released into the air. The pump is then ready for further use. For subsequent administrations, it is not necessary to prime the pump repeatedly.
Clear the nose.
Hold the bottle upright, supporting the bottom with your thumb, and hold the tip between two fingers.
Tilt your head forward and insert the tip into one nostril.
Press the pump while simultaneously inhaling through the nose to ensure proper distribution of the aerosol.
Repeat the procedure when administering the medicine into the other nostril.
After use, replace the protective cap.

The nasal aerosol allows precise dosing and ensures proper distribution of the solution over the entire nasal mucosal surface. This eliminates the possibility of accidental overdose.

Use of more than the recommended dose of Xylopronal
If more than the recommended dose has been used, seek immediate medical advice from your doctor or pharmacist.
In case of overdose, symptoms may include headache, dizziness, sweating, lowered body temperature, slowed heart rate, elevated blood pressure, breathing difficulties, coma, and seizures.

Missed dose of Xylopronal
Do not use a double dose to make up for a missed dose.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
You should DISCONTINUE use of Xylopronal and immediately contact a doctor if any of the following adverse reactions occur, which may be symptoms of an allergic reaction:

difficulty breathing or swallowing,
swelling of the face, lips, tongue or throat,
itching with red rash or blisters.
These symptoms occur very rarely (in fewer than 1 in 10,000 people taking the medicine).

Common adverse reactions (occur in fewer than 1 in 10 people):
dryness or irritation of the nasal mucosa, nausea, headache, burning sensation at the site of application.
Uncommon adverse reactions (occur in fewer than 1 in 100 people):
nosebleeds.
Very rare adverse reactions (occur in fewer than 1 in 10,000 people):
allergic reaction (skin rash, itching), transient visual disturbances, arrhythmia or
accelerated heart rate.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions 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:
Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309,
website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to gather more information on the safety of the medicine.

5. How to store Xylopronal

Keep this medicine out of sight and reach of children.
Store below 25°C. Do not freeze.
Do not use this medicine after the expiry date stated on the container. The expiry date refers to the last day of the month indicated.
Period of validity after first opening the bottle: 1 month.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the packaging and other information

What Xylopronal contains

The active substance in Xylopronal is xylometazoline hydrochloride. One mL of solution contains 1 mg of xylometazoline hydrochloride. One dose of the medicine contains 0.138 mg of xylometazoline hydrochloride.
Other components of the medicine are: benzalkonium chloride, 1% solution (benzalkonium chloride, solution; purified water), disodium edetate, disodium phosphate dodecahydrate, sodium chloride, sodium dihydrogen phosphate dihydrate, purified water.

What Xylopronal looks like and contents of the pack
Xylopronal is supplied in a 10 ml amber glass bottle (Type III) with an atomising pump dispenser No. 1 (PP/PE/Stainless steel) and a protective cap made of HDPE, or with an atomising pump dispenser No. 2 (PP/HDPE+LDPE/LDPE/Stainless steel/chlorobutyl rubber) and a protective cap made of PP, placed in a cardboard box.
Marketing Authorisation Holder:
Silesian Pharma Sp. z o.o.
Szopienicka Street 77
40-431 Katowice
Poland
Tel: (32) 20 80 600
Manufacturer:
Basic Pharma Manufacturing B.V.
Burgemeester Lemmensstraat 352
Geleen, 6163 JT
The Netherlands