Xilopronal

Package Leaflet: Information for the User

Xylopronal, 1 mg/mL, Nasal Spray, Solution

Xylometazoline Hydrochloride
{logo of the marketing authorization holder}

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 or as directed by your doctor or pharmacist.

• Keep this package leaflet, you may need to read it again.
• If you need advice or further information, consult your pharmacist.
• If you experience any side effects, including those not listed in this package leaflet, tell your doctor or pharmacist. See section 4.
• If after 7 days there is no improvement or you feel worse, you should contact your doctor.

Table of Contents of the Package Leaflet

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

1. What is Xylopronal and what is it used for

The active substance of Xylopronal is xylometazoline hydrochloride.
Xylopronal is a locally acting medicine that, by constricting blood vessels, reduces congestion and swelling of the nasal mucosa and the amount of discharge.
It makes breathing through the nose easier for patients with a stuffy nose. The effect of Xylopronal starts within a few minutes and lasts for several hours.
Xylopronal is indicated for use in adults and adolescents over 12 years of age.
If after 7 days there is no improvement or you feel worse, you should contact your doctor.

Indications for Use

Excessive congestion of the nasal mucosa occurring in the course of a cold, hay fever, allergic rhinitis, sinusitis. The medicine facilitates the outflow of discharge from inflamed paranasal sinuses. By reducing congestion of the nasal and pharyngeal mucosa, it can be used as an adjunct in the treatment of otitis media. Xylopronal facilitates nasal endoscopy (examination of the nasal cavity).

2. Important Information Before Using Xylopronal

When Not to Use Xylopronal:

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

Warnings and Precautions

Before starting to use Xylopronal, you should discuss it with your doctor in case of:

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

Xylopronal should not be used for more than 7 consecutive days. If symptoms persist, you should contact your doctor.
Using the medicine for a period longer than 7 days or in doses larger than recommended may cause worsening of symptoms or their recurrence.
Xylopronal should not be used in the eyes or in the mouth.
Do not use a higher dose than recommended, especially in children and the elderly.

Children and Adolescents

Xylopronal should not be used in children under 12 years of age.

Xylopronal and Other Medicines

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as any medicines you plan to take.
Do not use Xylopronal while taking certain medicines used to treat depression. These are:

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

If you have taken any of the above medicines before using Xylopronal, consult your doctor.

Pregnancy, Breast-feeding, and Fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Do not use Xylopronal during pregnancy.
During breast-feeding, Xylopronal can be used only after consulting a doctor.

Driving and Using Machines

Xylopronal used in recommended doses does not affect or has a negligible effect on the ability to drive and use machines.

Xylopronal Contains Benzalkonium Chloride

The medicine contains 0.138 mg of benzalkonium chloride in each dose, which corresponds to 1 mg/mL. Benzalkonium chloride may cause irritation or swelling inside the nose, especially if used for a long time.

3. How to Use Xylopronal

This medicine should always be used exactly as described in this package leaflet or as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.

Xylopronal Should Be Used Exclusively in the Nose (Also in the Case of Otitis Media).

To avoid the spread of infection, one package of the medicine should be used by only one patient.

Dosage

Adults and adolescents over 12 years of age:
1 dose of Xylopronal spray into each nostril 3 times a day.
Do not use more than 3 times a day. Maintain 8-10 hour intervals between doses.
It is recommended to take the last dose of the medicine directly before going to bed.
Do not use for more than 7 consecutive days.
Xylopronal should not be used in children under 12 years of age.

Method of Administration

The medicine is intended for use in the nose.
Be careful not to spray the aerosol into the eyes.

• 1. Do not cut the tip of the applicator. The aerosol is ready for use.
• 2. Remove the protective cap.
• 3. Before the first administration, press the pump several times until one dose of the medicine is released into the air. The pump will be ready for further use. For subsequent administration, it is not necessary to press the pump several times.
• 4. Clean the nose.
• 5. Hold the bottle upright, with your thumb on the bottom of the bottle and the tip between two fingers.
• 6. Tilt your head forward and place the tip in the nostril.
• 7. Press the pump and simultaneously inhale through the nose to ensure proper distribution of the aerosol.
• 8. Repeat the actions when administering the medicine to the other nostril.
• 9. After use, put the protective cap back on.

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

Using a Higher Than Recommended Dose of Xylopronal

In case of using a higher dose of the medicine than recommended, you should immediately contact your doctor or pharmacist.
In case of overdose, the following may occur: headaches and dizziness, sweating, lowering of body temperature, slowing of heart rate, increased blood pressure, respiratory disorders, coma, convulsions.

Missing a Dose of Xylopronal

Do not use a double dose to make up for a missed dose.
If you have any further doubts about using this medicine, consult your doctor or pharmacist.

4. Possible Side Effects

Like all medicines, Xylopronal can cause side effects, although not everybody gets them.
STOP using Xylopronal and contact your doctor immediately if you experience any of the following side effects, 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 (less often than 1 in 10,000 people using the medicine).

Common side effects(occurring less often than 1 in 10 people):
dryness or irritation of the nasal mucosa, nausea, headache, burning sensation at the site of administration.
Uncommon side effects(occurring less often than 1 in 100 people):
nasal bleeding.
Very rare side effects(occurring less often than 1 in 10,000 people):
allergic reaction (skin rash, itching), transient vision disturbances, irregular or accelerated heart rate.

Reporting Side Effects

If you experience any side effects, including those not listed in this package leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of 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, 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, you can help provide more information on the safety of this medicine.

5. How to Store Xylopronal

Keep the medicine out of the sight and reach of children.
Store in a temperature below 25°C. Do not freeze.
Do not use this medicine after the expiry date stated on the package. The expiry date refers to the last day of the month.
Shelf life after opening the bottle: 1 month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the Package and Other Information

What Xylopronal Contains

• The active substance of Xylopronal is xylometazoline hydrochloride. One mL of the solution contains 1 mg of xylometazoline hydrochloride. One dose of the medicine contains 0.138 mg of xylometazoline hydrochloride.
• The other ingredients 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 What the Package Contains

The package of Xylopronal is a bottle made of transparent, orange glass type III with a spray pump No. 1 (made of PP/PE/stainless steel) and a protective cap made of HDPE, or with a spray pump No. 2 (made of PP/HDPE+LDPE/LDPE/stainless steel/rubber chlorobutyl) and a protective cap made of PP, containing 10 mL of the solution, placed in a cardboard box.

Marketing Authorization Holder:

Silesian Pharma Sp. z o.o.
ul. Szopienicka 77
40-431 Katowice
tel: (32) 20 80 600

Manufacturer:

Basic Pharma Manufacturing B.V.
Burgemeester Lemmensstraat 352
Geleen, 6163 JT
Netherlands

Date of Last Revision of the Package Leaflet: