Xilogel dla dzieci

Package Leaflet: Information for the Patient

Xylogel for Children 0.5 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 the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If after 3 to 5 days there is no improvement or the patient feels worse, they should contact their doctor.

Table of Contents of the Leaflet

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

1. What is Xylogel for Children and what is it used for

Xylogel for Children 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 for Children is intended for use in children aged 3 to 12 years.

This medicine is used locally in the nose for auxiliary treatment:

• 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 for Children

When not to use Xylogel for Children:

• if the patient is allergic to xylometazoline hydrochloride or any of the other ingredients of this medicine (listed in section 6);
• in patients after hypophysectomy or after other surgical procedures involving exposure of the dura mater;
• in case of atrophic rhinitis.

Warnings and precautions

Before starting to use Xylogel for Children, the patient should discuss it with their doctor or pharmacist.

Particular caution should be exercised when using Xylogel for Children:

• If the patient has experienced symptoms such as insomnia, dizziness, tremors, heart rhythm disturbances, and increased blood pressure after using other similar-acting medicines (sympathomimetics);
• If the patient has 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 their doctor before using the medicine.

Xylogel for Children should not be used in patients with chronic or vasomotor rhinitis, as they tend to use it for longer than 5 days. Using the medicine for a longer period than recommended may lead to secondary rebound vasodilation and consequently to secondary drug-induced rhinitis.

Children

Xylogel for Children is intended for use in children aged 3 to 12 years.

Xylogel for Children and other medicines

Xylogel for Children should not be used during treatment with tricyclic antidepressants and MAO inhibitors (medicines used, among others, in depression), as cases of interactions have been reported.

The patient should avoid using the medicine with other similar-acting medicines (sympathomimetics), such as ephedrine, pseudoephedrine.

Pregnancy and breastfeeding

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.

Xylogel for Children should not be used during pregnancy.

Breastfeeding patients should consult their doctor before using the medicine.

Driving and using machines

The medicine does not affect the ability to drive and use machines if used in recommended doses and for a short period. However, in the case of prolonged use of the medicine or use in higher doses, side effects from the cardiovascular system and central nervous system may occur, which may adversely affect the performance of these activities.

Xylogel for Children contains benzalkonium chloride

The medicine contains 0.1 mg of benzalkonium chloride in each 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 for Children

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

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

1 dose contains 0.05 mg of xylometazoline hydrochloride.

Xylogel for Children is intended for use in children aged 3 to 12 years.

Children aged 3 to 12 years: 1 dose of gel into each nostril every 8 to 10 hours.

Do not use higher doses than recommended.

Xylogel for Children should not be used for longer than 3 to 5 days.

For hygiene reasons, the packaging of the medicine should be used by only 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 vertically, press the dispenser, which will spray a dose of the medicine into the nose.

Using a higher dose of Xylogel for Children than recommended

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

If these symptoms occur, the patient should immediately consult their doctor. Symptomatic treatment - as advised by the doctor.

Missing a dose of Xylogel for Children

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

4. Possible side effects

Like all medicines, Xylogel for Children 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 patients 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 longer period than recommended and/or in higher doses than recommended may lead to secondary drug-induced rhinitis.

Reporting side effects

If side effects occur, including those not listed in this leaflet, the patient should inform their 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

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, it is possible to gather more information on the safety of the medicine.

5. How to store Xylogel for Children

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. 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 Xylogel for Children contains

• The active substance of the medicine is xylometazoline hydrochloride. Each gram of nasal gel contains 0.5 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 for Children looks like and what the pack contains

Xylogel for Children is a nasal gel. The packaging of the medicine consists of an HDPE bottle closed with a dosing pump and an applicator with 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