Xylogel 0.1%

Package leaflet: Information for the patient

XYLOGEL 0.1%, 1 mg/g, nasal gel
Xylometazolini hydrochloridum
Please read this 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
a doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• 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 5 to 7 days in adults and 3 to 5 days in adolescents over 12 years of age, or if symptoms worsen, consult a doctor.

Table of contents

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

Xylogel 0.1% is a gel containing xylometazoline hydrochloride. When applied to the nasal mucosa, it constricts blood vessels, reduces excessive secretion, and decreases swelling and congestion of the nasal and nasopharyngeal mucosa, thereby facilitating easier breathing in patients suffering from nasal congestion. It clears the nasal passages and the channels connecting the nasal cavity to the paranasal sinuses. It promotes drainage of blocked secretions and improves nasal patency. Additionally, due to its gel formulation, Xylogel 0.1% moisturizes the nasal mucosa and does not drip to the back of the nasal cavity or 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 adjunctive treatment for:

• Acute viral or bacterial rhinitis;
• Acute or exacerbating chronic 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%:

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

Warnings and precautions
Before starting to use Xylogel 0.1%, discuss this with your doctor or pharmacist.
Exercise particular caution when using Xylogel 0.1%:

• if the patient has experienced symptoms such as insomnia, dizziness, tremor, heart rhythm disturbances, or increased blood pressure after using other similarly acting medicines (sympathomimetics);
• if the patient has cardiovascular diseases (e.g. hypertension, angina pectoris), heart disease (e.g. long QT syndrome), diabetes, narrow-angle glaucoma, benign prostatic hyperplasia, or hyperthyroidism. Patients with these conditions 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 longer than the recommended duration of use.
Prolonged use beyond the recommended period may lead to secondary dilation of blood vessels and consequently to rebound rhinitis (medication-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 or MAO inhibitors (medicines used, among others, for depression), as cases of interactions have been reported.
Avoid concomitant use of this medicine with other similarly acting drugs (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 0.1% during pregnancy.
Breastfeeding women should consult a doctor before using this medicine.

Driving and operating machinery
Xylogel 0.1% has no effect on the ability to drive or operate machinery when used at recommended doses and for a short period.
However, prolonged use or use in high doses may cause adverse effects on the cardiovascular system and central nervous system, which could negatively affect 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 nasal irritation or swelling, especially if used for prolonged periods.

3. How to use Xylogel 0.1%

This medicine should always be used exactly as described in this patient information leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Xylogel 0.1% is intended for nasal use only (also in middle ear inflammation).
One 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:
One dose of gel into each nostril every 8 to 10 hours.
Do not use doses larger than recommended.
Xylogel 0.1% should not be used for longer than 5 to 7 days in adults and for longer than 3 to 5 days in adolescents over 12 years of age.
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 deliver a dose of the medicine into the nose.

Use of more than the recommended dose of Xylogel 0.1%
After 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, 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 0.1%
Do not use a double dose to make up for a missed dose.

4. Possible adverse reactions

Like all medicines, Xylogel 0.1% can cause adverse reactions, although not everyone will experience them.

Not commonly (occur in fewer than 1 in 100 people):

• nosebleeds.

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

• headache, drowsiness, visual disturbances,
• palpitations, increased heart rate, elevated blood pressure (especially in individuals 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 also occur: dryness of the nasal mucosa, irritation of the nasal mucosa, burning sensation in the nose and throat.

Prolonged use of the medicine beyond the recommended duration and/or in doses higher than recommended may lead to secondary drug-induced inflammation of the nasal mucosa.

Reporting of adverse reactions

If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of 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 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 enhance the safety information available for this medicine.

5. How to store Xylogel 0,1% medicine

Keep the bottle tightly closed and store 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 0.1% contains

• The active substance is xylometazoline hydrochloride. Each gram of nasal gel contains 1 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 0.1% looks like and contents of the pack
Xylogel 0.1% is a nasal gel. The medicinal product is packed in an HDPE bottle closed with a metering pump
and a nozzle with a protective cap, containing 10 g of gel, in a cardboard box.
Marketing Authorisation Holder
POLPHARMA Pharmaceutical Works S.A.
Pelplińska Street 19, 83-200 Starogard Gdański
tel. + 48 22 364 61 01
Manufacturer
POLPHARMA Pharmaceutical Works S.A.
Medana Plant in Sieradz
Władysława Łokietka Street 10, 98-200 Sieradz