Xilo-pantenol

Package Leaflet: Information for the Patient

Xylo-Pantenol, (1 mg + 50 mg)/mL,

nasal spray, solution
Xylometazoline hydrochloride+ Dexpanthenol
For use in adults and children over 6 years of age.

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 or as directed by your doctor, pharmacist, or nurse.

• Keep this leaflet, you may need to read it again.
• If you need advice or further information, ask your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, 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 Xylo-Pantenol and what is it used for
• 2. Important information before using Xylo-Pantenol
• 3. How to use Xylo-Pantenol
• 4. Possible side effects
• 5. How to store Xylo-Pantenol
• 6. Contents of the pack and other information

1. What is Xylo-Pantenol and what is it used for

Xylo-Pantenol contains two active substances: xylometazoline hydrochloride and dexpanthenol.
Xylometazoline constricts blood vessels, which leads to a reduction in nasal mucosa swelling.
The active substance dexpanthenol is a derivative of pantothenic acid, a vitamin that supports wound healing and has a protective effect on mucous membranes.
Xylo-Pantenol is used to reduce nasal mucosa swelling in rhinitis and as an adjunctive treatment in wound healing and skin and mucous membrane lesions, as well as in the treatment of nasal congestion (vasomotor rhinitis) and difficulty breathing through the nose after nasal surgery.
Xylo-Pantenol is indicated for use in adults and children over 6 years of age.
If after 7 days there is no improvement or you feel worse, you should consult your doctor.

2. Important information before using Xylo-Pantenol

When not to use Xylo-Pantenol:

• if you are allergic to xylometazoline hydrochloride, dexpanthenol, or any of the other ingredients of the medicine (listed in section 6),
• if you have atrophic rhinitis (a chronic form of rhinitis that causes dryness of the nasal mucosa with crust formation),
• if you have recently undergone neurosurgical procedures (transsphenoidal hypophysectomy or other surgery that exposes the dura mater),
• in children under 6 years of age.

Warnings and precautions

You should consult your doctor or pharmacist before using Xylo-Pantenol if:

• you are taking certain antidepressants, known as monoamine oxidase inhibitors (MAOIs) or other medicines that may increase blood pressure (e.g., doxapram, ergotamine, oxytocin).
• you are taking blood pressure-lowering medicines (e.g., methyldopa).
• you have increased intraocular pressure, especially if you have narrow-angle glaucoma,
• you have severe cardiovascular diseases (e.g., long QT syndrome) or high blood pressure (hypertension),
• you have a pheochromocytoma (a tumor of the adrenal gland),
• you have metabolic disorders, such as hyperthyroidism and diabetes,
• you have a metabolic disorder called porphyria (a disorder that affects the skin and/or nervous system),
• you have prostatic hyperplasia (enlargement of the prostate gland).

Using this medicine in the case of chronic rhinitis should be done under medical supervision, due to the risk of damage to the nasal mucosa (tissue inside the nose).

Children

Do not use in children under 6 years of age. For children between 2 and 6 years of age, a nasal spray with a lower concentration of xylometazoline hydrochloride (the active substance that constricts the mucous membranes) is available.
Long-term use or use in higher doses than recommended should be avoided, especially in children. Higher doses should only be given after consulting a doctor.

Xylo-Pantenol and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take.
Using Xylo-Pantenol with certain medicines, such as those that improve mood (monoamine oxidase inhibitors like tranylcypromine or tricyclic antidepressants), as well as medicines that can increase blood pressure (e.g., doxapram, ergotamine, oxytocin), may cause an increase in blood pressure as a result of their effect on the cardiovascular system.
Do not use this medicine at the same time as blood pressure-lowering medicines (e.g., methyldopa), due to the possible effect of xylometazoline on blood vessels (increased blood pressure).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Due to the lack of data on safety, this medicine should not be used in pregnant women.
It is not known whether xylometazoline hydrochloride passes into breast milk, therefore, Xylo-Pantenol should not be used during breastfeeding.

Driving and using machines

Using this medicine as directed is not expected to have a negative effect on the ability to drive or use machines.

3. How to use Xylo-Pantenol

This medicine should always be used exactly as described in this package leaflet or as directed by your doctor or pharmacist. If you are unsure, ask your doctor or pharmacist.

Recommended dose Unless your doctor has told you otherwise, adults and children over 6 years of age should use one spray of Xylo-Pantenol into each nostril as needed, but no more than three times a day.

Dosing depends on individual sensitivity and response to the medicine.

Caution

Before first use or if the spray has not been used for more than 7 days, press the pump several times until a uniform mist appears. For subsequent applications, the spray is ready for immediate use.
Before using the nasal spray, gently blow your nose. It is recommended to take the last dose of each day before going to bed.
For hygiene reasons and to avoid infection, each bottle with an applicator should be used by only one person.

Duration of use

Do not use Xylo-Pantenol for more than 7 days, unless your doctor has explicitly advised you to continue using it.
Re-use should only occur after a few days' break.
When using in children, always consult your doctor regarding the duration of use.
Continuous use of Xylo-Pantenol may lead to chronic swelling and eventually cause atrophy of the nasal mucosa.
Patients with increased intraocular pressure (with glaucoma, especially narrow-angle glaucoma) should consult their doctor before using this medicine.
If the effect of Xylo-Pantenol is too strong or too weak, consult your doctor or pharmacist.

Using a higher dose of Xylo-Pantenol than recommended

If you use a higher dose of Xylo-Pantenol than recommended or accidentally swallow the medicine, the following symptoms may occur: constriction of the pupils, dilation of the pupils, fever, sweating, paleness, cyanosis of the lips, nausea, seizures, cardiovascular disorders (e.g., arrhythmias, tachycardia, bradycardia), hypotension, respiratory disorders (e.g., pulmonary edema, respiratory distress), and psychological disorders. Additionally, drowsiness, decreased body temperature, slowed heart rate, a shock-like drop in blood pressure, respiratory arrest, and loss of consciousness (coma) may occur.
If you suspect that you have used a higher dose of the medicine than recommended, contact your doctor immediately.

Method of administration The medicine is intended for nasal use. After removing the protective cap, place the spray nozzle (applicator) in the nostril and press the pump once. During spraying, breathe gently through the nose. After each use, carefully wipe the dosing tip with a clean tissue and replace the protective cap.

In case of an overdose, your doctor will start appropriate treatment if necessary.

Missing a dose of Xylo-Pantenol

Do not use a double dose to make up for a missed dose. Continue treatment as directed.

4. Possible side effects

Like all medicines, Xylo-Pantenol can cause side effects, although not everybody gets them.
The frequency of side effects is defined as follows:
Very common: may affect more than 1 in 10 people,
Common: may affect up to 1 in 10 people,
Uncommon: may affect up to 1 in 100 people,
Rare: may affect up to 1 in 1,000 people,
Very rare: may affect up to 1 in 10,000 people,
Frequency not known: frequency cannot be estimated from the available data.
Immune system disorders:
Uncommon: allergic reactions (hypersensitivity) - skin and mucous membrane swelling, rash, itching
Psychiatric disorders:
Very rare: excitement, insomnia, hallucinations (especially in children)
Nervous system disorders:
Very rare: fatigue (drowsiness, sedation), headache, seizures (especially in children)
Cardiac disorders:
Rare: palpitations, tachycardia
Very rare: arrhythmias
Vascular disorders:
Rare: hypertension
Respiratory, thoracic, and mediastinal disorders:
Very rare: rebound congestion and nasal mucosa swelling after the effect of the medicine has stopped, nosebleeds
Frequency not known: burning sensation and dryness of the nasal mucosa, sneezing

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, 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.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Xylo-Pantenol

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and label after "Expiry Date" or "EXP". The expiry date refers to the last day of the month.
There are no special precautions for storage.
Shelf life after first opening: 6 months.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Xylo-Pantenol contains

The active substances are xylometazoline hydrochloride and dexpanthenol. One spray of the nasal spray (0.1 mL solution) contains 0.1 mg of xylometazoline hydrochloride and 5.0 mg of dexpanthenol. 1 mL of solution contains: xylometazoline hydrochloride 1 mg and dexpanthenol 50 mg.
The other ingredients are:

• Potassium dihydrogen phosphate
• Disodium phosphate heptahydrate
• Water for injections

What Xylo-Pantenol looks like and contents of the pack

One bottle with 10 mL of solution contains at least 90 single sprays.
Xylo-Pantenol is a clear, almost colorless solution in a 10 mL round plastic bottle, sealed with a pump spray (applicator) with a protective cap.

Marketing authorization holder:

Teva B.V.
Swensweg 5
2031 GA Haarlem
Netherlands

Manufacturer:

Merckle GmbH
Ludwig-Merckle-Strasse 3
89143 Blaubeuren
Germany
PLIVA Hrvatska d.o.o.
(PLIVA Croatia Ltd.)
Prilaz baruna Filipovica 25
10000 Zagreb
Croatia

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Germany: Xylometazolin/Dexpanthenol Teva 1 mg/mL + 50 mg/mL Nasenspray Lösung
Poland: Xylo-Pantenol
To obtain more detailed information on this medicine and its names in other Member States of the European Economic Area, contact the representative of the marketing authorization holder:
Teva Pharmaceuticals Polska Sp. z o.o.,
Emilii Plater 53,
00-113 Warsaw,
phone (22) 345 93 00

Date of last revision of the leaflet: