Xylodex 0.05% regeneration

Package leaflet: information for the patient

Xylodex 0.05% regeneracja, (0.05 mg + 5.0 mg)/dose, nasal spray, solution
Xylometazolini hydrochloridum + Dexpanthenolum
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 the patient leaflet or as advised by
the doctor or pharmacist.

• Keep this leaflet, so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 7 days of treatment, or if you feel worse, consult your doctor.

Table of contents

1. What Xylodex 0.05% regeneracja is and what it is used for
2. Important information before using Xylodex 0.05% regeneracja
3. How to use Xylodex 0.05% regeneracja
4. Possible side effects
5. How to store Xylodex 0.05% regeneracja
6. Contents of the pack and other information

1. What Xylodex 0.05% regeneracja is and what it is used for

Xylodex 0.05% regeneracja is a nasal spray medicine containing as active substances xylometazoline hydrochloride (classified as a sympathomimetic agent) and dexpanthenol (classified as a vitamin B group substance).
When applied to the nasal mucosa, Xylodex 0.05% regeneracja reduces swelling and congestion, decreases mucus secretion, and facilitates sinus drainage. Xylodex 0.05% regeneracja accelerates wound healing and supports the regeneration process of the nasal mucosa.
Xylodex 0.05% regeneracja clears nasal passages and supports regeneration of the nasal mucosa.
Xylodex 0.05% regeneracja is indicated for:

• symptomatic treatment of nasal congestion during colds (rhinitis);
• after nasal surgery, to promote healing of the mucosa and improve nasal patency.

Xylodex 0.05% regeneracja is intended for children aged 2 to 6 years.
If there is no improvement after 7 days of treatment, or if you feel worse, consult your doctor.

2. Important information before using Xylodex 0,05% regeneracja

When not to use Xylodex 0,05% regeneracja:

• if the patient is allergic (symptoms such as rash, facial and throat swelling, difficulty breathing) to xylometazoline hydrochloride, dexpanthenol, or any of the other ingredients of this medicine (listed in section 6);
• in children under 2 years of age;
• if the patient has recently undergone neurosurgery (brain surgery) or surgery performed through the nose (e.g. removal of the pituitary gland);
• if the patient has defects or changes in the nasal mucosa.

Warnings and precautions
Before starting to use Xylodex 0,05% regeneracja, discuss it with your doctor or pharmacist.
Exercise particular caution when using Xylodex 0,05% regeneracja:

• If excitation or difficulty sleeping occurs in children during treatment, discontinue the medicine.
• If symptoms such as dizziness, insomnia, tremor, irregular heartbeat, or increased blood pressure occur during treatment, discontinue the medicine. This especially applies to patients who previously experienced such symptoms after using other similarly acting medicines.
• The patient should consult a doctor before using the medicine if they have:
• high blood pressure;
• severe heart disease (e.g. long QT syndrome);
• diabetes (elevated blood sugar levels);
• glaucoma (increased eye pressure);
• hyperthyroidism;
• pheochromocytoma (a tumor located in the glands above the kidneys);
• a metabolic disorder called porphyria;
• benign prostatic hyperplasia.

Due to the risk of atrophy of the nasal mucosa, use of the medicine in chronic inflammation of the nasal mucosa should only occur under medical supervision.

• Do not use Xylodex 0,05% regeneracja for longer than 7 days, as prolonged use may lead to difficult-to-treat changes in the nasal mucosa.

Xylodex 0,05% regeneracja and other medicines
Tell your doctor or pharmacist about all medicines you are currently using, have recently used, or plan to use (including nasal medicines).

• Do not use Xylodex 0,05% regeneracja while being treated with antidepressant medicines known as tricyclic antidepressants, medicines that increase blood pressure, or monoamine oxidase inhibitors (MAOIs) such as tranylcypromine.
• Avoid taking Xylodex 0,05% regeneracja at the same time as medicines such as ephedrine or pseudoephedrine (components of cold remedies).

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Studies on the effects of the medicine on fetal development are insufficient; therefore, Xylodex 0,05% regeneracja should not be used in pregnant women.
It is not known whether xylometazoline hydrochloride passes into breast milk; therefore, Xylodex 0,05% regeneracja should not be used in breastfeeding women.

Driving and operating machinery
When used according to recommendations, no effect on the ability to drive or operate machinery is expected.

Xylodex 0,05% regeneracja contains benzalkonium chloride
The medicine contains 0.2 mg of benzalkonium chloride per ml of solution. Benzalkonium chloride may cause irritation or swelling inside the nose, especially if used for prolonged periods.

3. How to use Xylodex 0,05% regeneracja

This medicine should always be used exactly as described in the patient leaflet or as directed by a physician. If in doubt, consult a doctor or pharmacist.

• This medicine is for nasal use only.
• Xylodex 0,05% regeneracja should be administered to a child only by a caregiver.
• For hygienic reasons, the medicine container should be used by only one patient.
• Do not use the medicine for longer than 7 days. If there is no improvement after 7 days, or if the patient feels worse, consult a doctor.
• Always seek medical advice regarding the duration of treatment in children.
• A several-day break should be observed before reapplying the medicine.
• Do not exceed the doses stated below.

Children aged 2 to 6 years
One spray into each nostril once or twice daily (every 8–10 hours).
Do not administer more than 3 sprays into each nostril per day (maximum total of 6 sprays per day).

Instructions for use

1. Remove the protective cap.
2. Before first use, press the pump several times until a fine mist appears. For subsequent uses, repeated priming is not necessary.
3. Insert the pump tip into the nostril.
4. Holding the bottle upright, press the pump to release a dose of the medicine into the nose.
5. Repeat the procedure when administering the medicine into the other nostril.
6. Replace the protective cap after use.

Use of a higher than recommended dose of Xylodex 0,05% regeneracja
If a caregiver administers a higher than recommended dose (overdose) or accidentally gives the medicine orally to the child, contact a doctor immediately.
Symptoms of overdose may include:

• restlessness, agitation, hallucinations, and seizures;
• decreased body temperature, fatigue, drowsiness, and coma;
• constricted pupils, dilated pupils, sweating, fever, pallor, cyanosis, nausea, increased heart rate (tachycardia), slow heart rate (bradycardia), cardiac arrhythmia, cardiac arrest, hypertension, hypotension resembling shock, pulmonary edema, respiratory disturbances, and apnea.

Missed dose of Xylodex 0,05% regeneracja
Do not use a double dose to make up for a missed dose, and do not exceed 3 sprays into each nostril per day.
If you have any further doubts about the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.

Uncommon (occurs in 1 to 10 people per 1,000):

• hypersensitivity reactions (e.g. angioedema, rash, itching).

Rare (occurs in 1 to 10 people per 10,000):

• palpitations;
• increased heart rate;
• elevated arterial blood pressure (hypertension).

Very rare (occurs in fewer than 1 person per 10,000):

• excitation, insomnia, fatigue (e.g. drowsiness, sedation), headache, hallucinations (particularly in children);
• cardiac arrhythmias (heart rhythm disorders);
• increased mucosal swelling due to diminished drug effect, nosebleeds;
• convulsions (particularly in children).

Not known (frequency cannot be estimated from available data):

• sensation of burning and dryness of the nasal mucosa, sneezing.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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. Adverse reactions can 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 Xylodex 0,05% regeneracja

No special storage instructions are required for this medicinal product.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and bottle after: EXP.
The expiry date refers to the last day of the stated month.
The shelf life of Xylodex 0,05% regeneracja after first opening the bottle is 12 weeks.
Medicines must not be disposed of via wastewater or household waste. You should ask
your pharmacist how to dispose of medicines no longer required. Such measures will help
protect the environment.

6. Contents of the package and other information

What Xylodex 0.05% regeneracja contains

• The active substances are: xylometazoline hydrochloride and dexpanthenol. Each nasal spray dose contains 0.05 mg of xylometazoline hydrochloride and 5.0 mg of dexpanthenol.
• Other components: disodium phosphate dodecahydrate; potassium dihydrogen phosphate; benzalkonium chloride, solution; purified water.

What Xylodex 0.05% regeneracja looks like and contents of the pack
Xylodex 0.05% regeneracja is a nasal spray in the form of a colourless or almost colourless, transparent solution.
Xylodex 0.05% regeneracja is available in a 15 ml bottle containing 10 ml of solution, closed with a metered-dose pump spray delivering 0.1 ml per dose, equipped with an aluminium cap and a nasal applicator with a nozzle, 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 Branch in Sieradz
ul. Władysława Łokietka 10, 98-200 Sieradz