Xilogel 0,1%

Package Leaflet: Information for the Patient

XYLOGEL 0.1%, 1 mg/g, Nasal Gel

Xylometazoline 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 advised by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If after 5 to 7 days in adults and 3 to 5 days in adolescents over 12 years of age, there is no improvement or you feel worse, consult a doctor.

Table of Contents of the Leaflet

• 1. What is Xylogel 0.1% and what is it used for
• 2. Important information before using Xylogel 0.1%
• 3. How to use Xylogel 0.1%
• 4. Possible side effects
• 5. How to store Xylogel 0.1%
• 6. Contents of the pack and other information

1. What is Xylogel 0.1% and what is it used for

Xylogel 0.1% in the form of a gel contains xylometazoline hydrochloride. When applied to the nasal mucosa, it causes vasoconstriction, reduces excessive secretion, decreases swelling and congestion of the nasal-pharyngeal mucosa, making it easier for patients with a stuffy nose to breathe. It clears the nasal passages and the passages leading from the nasal cavity to the paranasal sinuses. It facilitates the drainage of blocked secretions and improves nasal patency. Additionally, the medicine, being in the form of a gel, moisturizes the nasal mucosa and does not drip down to the bottom of the nasal cavity and into the throat. Xylogel 0.1% is intended for use in adults and adolescents over 12 years of age.

Xylogel 0.1% is used locally in the nose as an auxiliary treatment for:

• acute viral or bacterial rhinitis;
• acute or chronic exacerbating sinusitis;
• allergic rhinitis;
• acute otitis media - to clear the Eustachian tube.

2. Important information before using Xylogel 0.1%

When not to use Xylogel 0.1%:

• in patients after pituitary surgery or other surgical procedures involving exposure of the dura mater;
• in case of atrophic rhinitis.

Warnings and precautions

Before starting to use Xylogel 0.1%, discuss it with your doctor or pharmacist.

Be particularly cautious when using Xylogel 0.1%:

• If you have experienced symptoms such as insomnia, dizziness, tremors, heart rhythm disturbances, and increased blood pressure after using other similar-acting medicines (sympathomimetics);
• If you have cardiovascular diseases (e.g., hypertension, angina pectoris), heart disease (e.g., long QT syndrome), diabetes, glaucoma with a closed angle, prostatic hyperplasia, hyperthyroidism. Patients with these diseases should consult a doctor before using the medicine.

Do not use the medicine in patients with chronic or vasomotor rhinitis, as they tend to use it for longer than the recommended treatment period.

Using the medicine for a period longer than recommended may lead to secondary rebound congestion and consequently to secondary drug-induced rhinitis.

Children and adolescents

Xylogel 0.1% can be used in adolescents over 12 years of age.

Xylogel 0.1% and other medicines

Do not use Xylogel 0.1% during treatment with tricyclic antidepressants and MAO inhibitors (medicines used, among others, in depression), as cases of interactions have been reported.

Avoid concomitant use of the medicine with other similar-acting medicines (sympathomimetics), such as ephedrine, pseudoephedrine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, 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 Xylogel 0.1% during pregnancy.

Breastfeeding women should consult a doctor before using the medicine.

Driving and using machines

The medicine has no influence on the ability to drive vehicles and operate machines if used in recommended doses and for a short period.

In the case of prolonged use of the medicine or use in high doses, side effects from the cardiovascular system and the central nervous system may occur and have a negative impact on the performance of these activities.

Xylogel 0.1% contains benzalkonium chloride

The medicine contains 0.1 mg of benzalkonium chloride per gram of gel. Benzalkonium chloride may cause irritation or swelling inside the nose, especially if used for a long time.

3. How to use Xylogel 0.1%

This medicine should always be used exactly as described in this package leaflet for the patient or as advised by a doctor or pharmacist.

Xylogel 0.1% is intended exclusively for nasal use(also in otitis media).

1 dose contains 0.1 mg of xylometazoline hydrochloride.

Xylogel 0.1% is intended for use in adults and adolescents over 12 years of age.

Adults and adolescents over 12 years of age: 1 dose of gel into each nostril every 8 to 10 hours.

Do not use higher doses than recommended.

Xylogel 0.1% should not be used for longer than 5 to 7 days in adults and longer than 3 to 5 days in adolescents over 12 years of age.

For hygiene reasons, the packaging of the medicine should only be used by one patient.

Method of administration

Each time before using the medicine, remove the protective cap.

Before using a new bottle for the first time, after removing the cap, press the dispenser 3-5 times until the medicine appears.

Insert the tip of the dispenser into the nostril. Holding the bottle upright, press the dispenser, which will cause the dose of the medicine to be sprayed into the nose.

Using a higher dose of Xylogel 0.1% than recommended

In case of overdose or accidental ingestion of the medicine, especially in children, the following symptoms may occur: rapid and irregular heartbeat, increased blood pressure, drowsiness, irregular breathing or respiratory depression, impaired consciousness.

In children, excessive sedation may occur.

If these symptoms occur, seek medical attention immediately. Symptomatic treatment - as advised by a doctor.

Missing a dose of Xylogel 0.1%

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

4. Possible side effects

Like all medicines, Xylogel 0.1% can cause side effects, although not everybody gets them.

Uncommon (occurring in less than 1 in 100 people):

• nosebleeds.

Rare (occurring in less than 1 in 10,000 people):

• headache, drowsiness, vision disturbances,
• palpitations, increased heart rate, increased blood pressure (especially in people with cardiovascular diseases),
• sneezing,
• nausea, weakness, fatigue, allergic reactions (dyspnea, angioedema - a severe allergic reaction that causes swelling of the face and throat).

The following may occur: dryness of the nasal mucosa, irritation of the nasal mucosa, burning sensation in the nose and throat.

Using the medicine for a period longer than recommended and/or in doses higher than recommended may lead to secondary drug-induced rhinitis.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist.

Side effects can be reported directly to the Department of Post-Marketing Surveillance 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, you can help provide more information on the safety of this medicine.

5. How to store Xylogel 0.1%

Store the bottle tightly closed, at a temperature below 25°C. 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 month stated.

The shelf life of the medicine after opening the bottle is 12 weeks.

Medicines should not be disposed of via wastewater or household waste.

Ask your 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 Xylogel 0.1% contains

• The active substance of the medicine is xylometazoline hydrochloride. Each gram of nasal gel contains 1 mg of xylometazoline hydrochloride.
• The other ingredients of the medicine are: sodium chloride, disodium phosphate dodecahydrate, sodium dihydrogen phosphate monohydrate, disodium edetate, benzalkonium chloride solution, sorbitol, hydroxyethylcellulose, glycerol, purified water.

What Xylogel 0.1% looks like and contents of the pack

Xylogel 0.1% is a nasal gel. The packaging of the medicine consists of an HDPE bottle closed with a dosing pump with an applicator and a protective cap, containing 10 g of gel, in a cardboard box.

Marketing authorization holder

Zakłady Farmaceutyczne POLPHARMA S.A.

ul. Pelplińska 19, 83-200 Starogard Gdański

tel. +48 22 364 61 01

Manufacturer

Zakłady Farmaceutyczne POLPHARMA S.A.

Oddział Medana w Sieradzu

ul. Władysława Łokietka 10, 98-200 Sieradz

Date of last revision of the leaflet:December 2024