Xilodex 0,05% regeneracia

Leaflet attached to the packaging: patient information

Xylodex 0.05% regeneration, (0.05 mg + 5.0 mg)/dose, nasal spray, solution
Xylometazoline hydrochloride+Dexpanthenol

You should carefully read the contents of the leaflet 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
your doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If you experience any side effects, including those not listed in the leaflet, you should tell your doctor or pharmacist. See section 4.
• If after 7 days there is no improvement or you feel worse, you should contact your doctor.

Table of contents of the leaflet

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

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

Xylodex 0.05% regeneration is a nasal spray containing xylometazoline hydrochloride (a sympathomimetic agent) and dexpanthenol (a vitamin B complex).
Xylodex 0.05% regeneration, when applied to the nasal mucosa, reduces its swelling and congestion,
reduces the amount of discharge and facilitates its flow from the sinuses. Xylodex 0.05% regeneration accelerates
wound healing and participates in the regeneration of the nasal mucosa.
Xylodex 0.05% regeneration clears the nose and supports the regeneration of the nasal mucosa.
Xylodex 0.05% regeneration is used:

• for symptomatic treatment of nasal congestion during a cold (rhinitis);
• after nasal surgery to stimulate wound healing and improve nasal patency.

Xylodex 0.05% regeneration is intended for children aged 2 to 6 years.
If after 7 days there is no improvement or the patient feels worse, you should consult a doctor.

2. Important information before using Xylodex 0.05% regeneration

When not to use Xylodex 0.05% regeneration:

• if you are allergic (symptoms such as rash, facial and throat swelling, shortness of breath) 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 you have recently undergone neurosurgical surgery (brain) or surgery performed through the nose (e.g., removal of the pituitary gland);
• if you have defects or changes in the nasal mucosa.

Warnings and precautions

Before starting to use Xylodex 0.05% regeneration, you should discuss it with your doctor or
pharmacist.
You should be particularly careful when using Xylodex 0.05% regeneration:

• If, during the use of the medicine in children, excitement or difficulty falling asleep occurs, it should be discontinued.
• If, during the use of the medicine, symptoms such as dizziness, insomnia, tremors, irregular heartbeat, increased blood pressure, the medicine should be discontinued. This applies especially to patients who have previously experienced such symptoms after using similar 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;
• prostate enlargement.

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

• Xylodex 0.05% regeneration should not be used for more than 7 days, as prolonged use of the medicine may cause irreversible changes in the nasal mucosa.

Xylodex 0.05% regeneration and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken (including nasal medicines), as well as any medicines you plan to take.

• Xylodex 0.05% regeneration should not be used during treatment with antidepressant medicines called tricyclic antidepressants, as well as medicines that increase blood pressure and monoamine oxidase inhibitors (MAOIs) such as tranylcypromine.
• You should avoid taking Xylodex 0.05% regeneration with medicines such as ephedrine, pseudoephedrine (which are ingredients in cold medicines).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before using this medicine.
Studies on the effect of the medicine on fetal development are insufficient, so Xylodex 0.05% regeneration should not be used in pregnant women.
It is not known whether xylometazoline hydrochloride passes into breast milk, so Xylodex 0.05% regeneration should not be used in breastfeeding women.

Driving and using machines

If the medicine is used as recommended, you should not expect it to affect your ability to drive or operate machinery.

Xylodex 0.05% regeneration contains benzalkonium chloride

The medicine contains 0.2 mg of benzalkonium chloride in each ml of solution. Benzalkonium chloride may cause irritation or swelling inside the nose, especially if used for a long time.

3. How to use Xylodex 0.05% regeneration

This medicine should always be used exactly as described in the patient leaflet or as advised by
your doctor or pharmacist. If you are unsure, you should consult your doctor or pharmacist.

• The medicine should only be used in the nose.
• Xylodex 0.05% regeneration should only be administered to a child by an adult.
• For hygiene reasons, the medicine packaging should only be used by one patient.
• The medicine should not be used for more than 7 days. If after 7 days there is no improvement or the patient feels worse, you should consult a doctor.
• You should always consult a doctor about the duration of use of the medicine in children.
• You should maintain a few-day break before reusing the medicine.
• You should not use higher doses than those specified below.

Children aged 2 to 6 years
One dose of nasal spray into each nostril once or twice a day (every 8-10 hours).
Do not administer more than 3 doses into each nostril per day (a total of 6 doses per day).
Method of administration

• 1. Remove the protective cap.
• 2. Before the first administration, press the pump several times until a mist of medicine appears. For subsequent administrations, it is not necessary to press the pump several times.
• 3. Insert the pump nozzle into the nostril.
• 4. Holding the bottle upright, press the pump, which will spray a dose of medicine into the nose.
• 5. Repeat the steps when administering the medicine to the other nostril.
• 6. After use, replace the protective cap.

Using a higher dose of Xylodex 0.05% regeneration than recommended

If the caregiver has administered a higher dose than recommended (overdosed) or accidentally administered the medicine orally to the child, they should immediately contact a doctor.
In case of overdose, the following may occur:

• restlessness, excitement, hallucinations, and convulsions;
• decreased body temperature, fatigue, drowsiness, and coma;
• pupillary constriction, pupillary dilation, sweating, fever, pallor, cyanosis, nausea, accelerated heart rate (tachycardia), slow heart rate (bradycardia), cardiac arrhythmia, cardiac arrest, hypertension, hypotension similar to shock, pulmonary edema, respiratory disorders, and apnea.

Missing a dose of Xylodex 0.05% regeneration

You should not use a double dose to make up for a missed dose, and you should not use more than 3 doses into each nostril per day.
If you have any further doubts about using this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Xylodex 0.05% regeneration can cause side effects, although not everybody gets them.
Uncommon (affecting 1 to 10 people in 1,000):

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

Rare (affecting 1 to 10 people in 10,000):

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

Very rare (affecting less than 1 person in 10,000):

• excitement, insomnia, fatigue (e.g., drowsiness, sedation), headache, hallucinations (especially in children)
• cardiac arrhythmias;
• increased swelling of the nasal mucosa due to decreased effectiveness of the medicine, nasal bleeding;
• convulsions (especially in children).

Unknown (frequency cannot be estimated from available data):

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

Reporting side effects

If you experience any side effects, including those not listed in the leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Medicinal Product Monitoring
of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 181C
02-222 Warsaw
Phone: +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 Xylodex 0.05% regeneration

There are no special precautions for storing the medicine.
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 month.
The shelf life of Xylodex 0.05% regeneration after opening the bottle is 12 weeks.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Xylodex 0.05% regeneration contains

• The active substances of the medicine are xylometazoline hydrochloride and dexpanthenol. Each dose of nasal spray contains 0.05 mg of xylometazoline hydrochloride and 5.0 mg of dexpanthenol.
• The other ingredients are disodium phosphate dodecahydrate; potassium dihydrogen phosphate; benzalkonium chloride solution; purified water.

What Xylodex 0.05% regeneration looks like and contents of the packaging

Xylodex 0.05% regeneration is a nasal spray in the form of a colorless or almost colorless, clear solution.
Xylodex 0.05% regeneration is available in a 15 ml bottle containing 10 ml of solution, sealed with a dosing pump with a volume of 0.1 ml, with an aluminum cap and applicator with a nozzle, in a cardboard box.

Marketing authorization holder

Zakłady Farmaceutyczne POLPHARMA S.A.
Pelplińska 19, 83-200 Starogard Gdański
phone: +48 22 364 61 01

Manufacturer

Zakłady Farmaceutyczne POLPHARMA S.A.
Medana branch in Sieradz
Władysława Łokietka 10, 98-200 Sieradz
Date of last revision of the leaflet:December 2024