Xylogel for children

Package leaflet: Information for the patient

Xylogel dla dzieci, 0.5 mg/g, nasal gel
Xylometazolini hydrochloridum
Please read the entire 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 patient leaflet or as directed by
the doctor or pharmacist.

• Keep this leaflet for future reference.
• If advice or further information is needed, consult a pharmacist.
• If any adverse reactions occur, including any not listed in this leaflet, inform a doctor or pharmacist. See section 4.
• If there is no improvement after 3 to 5 days, or if symptoms worsen, consult a doctor.

Table of contents

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

1. What Xylogel dla dzieci is and what it is used for

Xylogel dla dzieci is a nasal gel containing xylometazoline hydrochloride. When applied to the nasal mucosa, it causes constriction of blood vessels, reduces excessive secretion, decreases swelling and congestion of the nasal and nasopharyngeal mucosa, thereby facilitating easier breathing in patients experiencing nasal congestion. It clears the nasal passages and the channels connecting the nasal cavity to the paranasal sinuses. It aids in drainage of blocked secretions and improves nasal patency. Additionally, due to its gel formulation, Xylogel dla dzieci moisturizes the nasal mucosa and does not drip down into the nasal cavity or throat. Xylogel dla dzieci is intended for use in children aged 3 to 12 years.

Xylogel dla dzieci is used locally in the nose as an adjunctive treatment for:

• Acute viral or bacterial rhinitis;
• Acute or exacerbation of chronic sinusitis;
• Allergic rhinitis;
• Acute otitis media – to clear the Eustachian tube.

2. Important information before using Xylogel dla dzieci

When not to use Xylogel dla dzieci:

• if the patient is allergic to xylometazoline hydrochloride or any of the other ingredients of this medicine (listed in section 6);
• in patients who have undergone pituitary gland removal or other surgical procedures involving exposure of the dura mater;
• in cases of atrophic rhinitis.

Warnings and precautions
Before starting treatment with Xylogel dla dzieci, consult your doctor or pharmacist.
Exercise particular caution when using Xylogel dla dzieci:

• if the patient has previously experienced symptoms such as insomnia, dizziness, tremor, heart rhythm disturbances, or increased blood pressure after using similar-acting medicines (sympathomimetics);
• if the patient suffers from cardiovascular diseases (e.g. hypertension, angina pectoris), heart disease (e.g. long QT syndrome), diabetes, narrow-angle glaucoma, prostate enlargement, or hyperthyroidism. Patients with these conditions should consult a doctor before using this medicine.

Do not use the medicine in patients with chronic or vasomotor rhinitis, as they tend to use it for longer than 5 days. Use beyond the recommended duration may lead to secondary vasodilation and consequently to secondary drug-induced rhinitis.

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

Xylogel dla dzieci and other medicines
Do not use Xylogel dla dzieci during treatment with tricyclic antidepressants or MAO inhibitors (medicines used, among others, for depression), as interactions have been reported.
Avoid concomitant use of this medicine with other similarly acting medicines (sympathomimetics), such as ephedrine, pseudoephedrine.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Do not use Xylogel dla dzieci during pregnancy.
Breastfeeding patients should consult a doctor before using this medicine.

Driving and operating machinery
Xylogel dla dzieci has no effect on the ability to drive or operate machinery when used at recommended doses and for short periods. However, prolonged use or use at high doses may cause adverse effects on the cardiovascular and central nervous systems, which could negatively affect the performance of these activities.

Xylogel dla dzieci 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 prolonged period.

3. How to use Xylogel dla dzieci

This medicine should always be used exactly as described in this patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Xylogel dla dzieci is intended for nasal use only (including in cases of otitis media).
One dose contains 0.05 mg of xylometazoline hydrochloride.
Xylogel dla dzieci 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 exceed the recommended dosage.
Xylogel dla dzieci should not be used for longer than 3 to 5 days.
For hygienic reasons, the medicine container should be used by only one patient.
Instructions for use
Before each use, remove the protective cap.
Before first use of a new bottle, after removing the cap, press the pump 3 to 5 times until the medicine appears. Insert the nozzle into the nostril. Holding the bottle upright, press the pump to release a dose of medicine into the nose.

Overdose of Xylogel dla dzieci
After an overdose or accidental oral 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, and disturbances of consciousness. In children, excessive sedation may occur.
If these symptoms occur, seek immediate medical advice. Symptomatic treatment – as directed by a physician.
Missed dose of Xylogel dla dzieci
Do not use a double dose to make up for a missed dose.

4. Possible adverse reactions

Like all medicines, Xylogel dla dzieci can cause adverse reactions, although they do not occur in everyone.
Not frequently (occurring in fewer than 1 in 100 people):

• nosebleeds.

Very rarely (occurring in fewer than 1 in 10,000 people):

• headache, drowsiness, visual disturbances,
• palpitations, increased heart rate, elevated blood pressure (especially in people with cardiovascular diseases),
• sneezing,
• nausea, weakness, fatigue, allergic reactions (shortness of breath, angioedema - a severe allergic reaction causing 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.
Prolonged use beyond the recommended period and/or use in doses higher than recommended may lead to secondary drug-induced inflammation of the nasal mucosa.
Reporting of adverse reactions
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 492 1301
Fax: +48 22 492 1309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions may also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store the medicine Xylogel dla dzieci

Keep the bottle tightly closed and store 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 stated month.
The shelf life of the medicine after first opening the bottle is 12 weeks.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the package and other information

What Xylogel for children contains

• The active substance is xylometazoline hydrochloride. Each gram of nasal gel contains 0.5 mg of xylometazoline hydrochloride.
• The other ingredients 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 contents of the pack
Xylogel for children is a nasal gel. The medicinal product comes in an HDPE bottle closed with a pump dispenser and a nozzle with a protective cap, containing 10 g of gel, packed in a cardboard box.
Marketing Authorisation 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.
Medana Plant in Sieradz
ul. Władysława Łokietka 10, 98-200 Sieradz