Patient Information Leaflet

Xylo-Pantenol Kids, (0.5 mg + 50 mg/mL),
nasal spray, solution
Xylometazoline hydrochloride + Dexpanthenol
For use in children aged 2 to 6 years.
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, pharmacist, or nurse.

Keep this leaflet for future reference.
If you need advice or further information, please consult your pharmacist.
If the patient experiences any adverse reactions, including any not listed in this leaflet, inform a doctor or pharmacist. See section 4.
If there is no improvement after 7 days, or if the patient feels worse, consult a doctor.

Table of contents

What Xylo-Pantenol Kids is and what it is used for
What you need to know before using Xylo-Pantenol Kids
How to use Xylo-Pantenol Kids
Possible side effects
How to store Xylo-Pantenol Kids
Contents of the pack and other information

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

Xylo-Pantenol Kids contains two active substances: xylometazoline hydrochloride and dexpanthenol.
Xylometazoline constricts blood vessels, thereby reducing swelling of the nasal mucosa.
The active substance dexpanthenol is a derivative of pantothenic acid, a vitamin supporting wound healing and providing protective effects on mucous membranes.
Xylo-Pantenol Kids is used to reduce swelling of the nasal mucosa in nasal mucosal inflammation and as supportive treatment in healing skin and mucosal lesions, as well as in treating episodic nasal discharge (vasomotor rhinitis) and in managing impaired nasal breathing following nasal surgery.
Xylo-Pantenol Kids is indicated for use in children aged 2 to 6 years.
If there is no improvement after 7 days, or if the patient feels worse, consult a doctor.

2. Important information before using Xylo-Pantenol Kids

When not to use Xylo-Pantenol Kids:

if the patient is allergic to xylometazoline hydrochloride, dexpanthenol, or to any of the other ingredients of the medicine (listed in section 6),
if the patient suffers from atrophic rhinitis (a chronic form of rhinitis causing dryness of the nasal mucosa with formation of crusts),
if the patient has recently undergone neurosurgery (transsphenoidal removal of the pituitary gland or any other surgical procedure exposing the meninges of the brain),
in children under 2 years of age.

Warnings and precautions
Consult a doctor or pharmacist before using Xylo-Pantenol Kids if:

taking certain antidepressant medicines known as monoamine oxidase inhibitors (MAO inhibitors) or other medicines that may increase blood pressure (e.g. doxapram, ergotamine, oxytocin),
taking medicines for lowering blood pressure (e.g. methyldopa),
increased intraocular pressure, especially in patients with narrow-angle glaucoma,
severe cardiovascular disorders (e.g. long QT syndrome) or high blood pressure (hypertension),
pheochromocytoma (a tumour of the adrenal gland),
metabolic disorders such as hyperthyroidism or diabetes,
a metabolic disorder called porphyria (a metabolic disorder affecting the skin and/or nervous system),
prostate enlargement (benign prostatic hyperplasia).

Use of this medicine in chronic rhinitis should be under medical supervision due to possible damage to the nasal mucosa (tissue inside the nose).
Children
Do not use in children under 2 years of age.
Prolonged use or use in doses higher than recommended should be avoided, especially in children. Higher doses should only be administered after consultation with a doctor.
Xylo-Pantenol Kids and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently using or has recently used, as well as any medicines the patient plans to use.
Concomitant use of Xylo-Pantenol Kids with certain medicines, such as antidepressants (e.g. tranylcypromine-type MAO inhibitors or tricyclic antidepressants), as well as medicines that may potentially increase blood pressure (e.g. doxapram, ergotamine, oxytocin), may lead to elevated arterial blood pressure due to effects on the cardiovascular system.
This medicine should not be used simultaneously with antihypertensive medicines (e.g. methyldopa), due to the possible vasoconstrictive effect of xylometazoline (increasing blood pressure).
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.
Due to lack of safety data, this medicine should not be used during pregnancy. It is unknown whether xylometazoline hydrochloride passes into breast milk; therefore, Xylo-Pantenol Kids should not be used during breastfeeding.
Driving and operating machinery
When Xylo-Pantenol Kids is used according to the recommendations, a negative influence on the ability to drive or operate machinery is not expected.

3. How to use Xylo-Pantenol Kids

This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Recommended dose
Unless otherwise advised by a doctor, children aged 2 to 6 years should use one spray of Xylo-Pantenol Kids
into each nostril, as needed, but no more than three times daily. The dosage depends on individual sensitivity and the patient's response to the medicine.

Hand holding a bottle with labels indicating the protective cap, spray nozzle, and an arrow showing the upward pumping direction

Route of administration
The medicine is intended for nasal use. After removing the protective cap, insert the spray nozzle (applicator) into the nostril and press the pump once. While spraying, breathe gently through the nose. After each use, carefully wipe the spray nozzle with a clean tissue and replace the protective cap.

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

Duration of use
Do not use Xylo-Pantenol Kids for longer than 7 days unless your doctor has clearly advised continuing treatment.
Re-treatment should only be resumed after a break of several days.
When used in children, always consult a doctor regarding the duration of treatment.
Continuous use of Xylo-Pantenol Kids may lead to chronic swelling and ultimately may cause atrophy of the nasal mucosa.
Patients with increased intraocular pressure (glaucoma, particularly narrow-angle glaucoma) should consult a doctor before using this medicine.
If the effect of Xylo-Pantenol Kids is too strong or too weak, consult a doctor or pharmacist.

Use of a higher than recommended dose of Xylo-Pantenol Kids
If a higher than recommended dose of Xylo-Pantenol Kids is used or if the product is accidentally swallowed, the following symptoms may occur: constriction of the pupils (miosis), dilatation of the pupils, fever, sweating, pallor, bluish discoloration of the lips (cyanosis), nausea, convulsions, cardiovascular disorders, e.g. heart rhythm disturbances (tachycardia, bradycardia, cardiac arrhythmia), circulatory collapse, cardiac arrest, high blood pressure (hypertension); pulmonary complications (pulmonary edema, respiratory disturbances), psychiatric disturbances. In addition, drowsiness, decreased body temperature, slowed heart rate, shock-like drop in blood pressure, respiratory arrest, and loss of consciousness (coma) may occur.
If an overdose is suspected, contact a doctor immediately. If necessary, the doctor will initiate appropriate treatment.

Missed dose of Xylo-Pantenol Kids
Do not use a double dose to make up for a missed dose. Continue treatment according to the described instructions for use.

4. Possible adverse effects

Like all medicines, Xylo-Pantenol Kids can cause adverse effects, although not everyone will experience them.
The frequency of adverse effects is defined according to the following convention:
Very common: may occur in more than 1 in 10 patients,
Common: may occur in less than 1 in 10 patients,
Uncommon: may occur in less than 1 in 100 patients,
Rare: may occur in less than 1 in 1000 patients,
Very rare: may occur in less than 1 in 10,000 patients,
Frequency not known: frequency cannot be estimated from the available data.

Immune system disorders:
Uncommon: allergic reactions (hypersensitivity) – skin and mucosal swelling, skin rash, itching

Psychiatric disorders:
Very rare: restlessness, insomnia, hallucinations (especially in children)

Nervous system disorders:
Very rare: fatigue (drowsiness, sedation), headache, convulsions (especially in children)

Cardiac disorders:
Rare: palpitations, increased heart rate (tachycardia)
Very rare: heart rhythm disturbances (arrhythmia)

Vascular disorders:
Rare: increased blood pressure (hypertension)

Respiratory, thoracic and mediastinal disorders:
Very rare: increased nasal mucosal swelling after stopping the medicine, nosebleeds
Frequency not known: burning sensation and dryness of the nasal mucosa, sneezing

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the 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 effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Xylo-Pantenol Kids

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

6. Contents of the pack and other information

What Xylo-Pantenol Kids contains
The active substances are: xylometazoline hydrochloride + dexpanthenol. One spray (0.1 mL of solution) contains 0.05 mg of xylometazoline hydrochloride and 5.0 mg of dexpanthenol.
1 mL of solution contains: xylometazoline hydrochloride 0.5 mg and dexpanthenol 50 mg.
Other components are:

Potassium dihydrogen phosphate
Disodium hydrogen phosphate heptahydrate
Water for injections

What Xylo-Pantenol Kids looks like and contents of the pack
One bottle with 10 mL of solution contains at least 90 single sprays.
Xylo-Pantenol Kids is a clear, almost colourless solution in a 10 mL round plastic bottle, sealed with a spray pump (applicator) and protective cap.
Marketing Authorisation Holder:
Teva B.V.
Swensweg 5
2031 GA Haarlem
The 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 authorised in the European Economic Area member states under the following names:
Germany: Xylometazoolin/Dexpanthenol Teva 0.5 mg/mL + 50 mg/mL Nasenspray, Lösung
Poland: Xylo-Pantenol Kids
For more detailed information about this medicine and its names in other European Economic Area countries, please contact the representative of the Marketing Authorisation Holder:
Teva Pharmaceuticals Polska Sp. z o.o.,
Emilii Plater 53 Street,
00-113 Warsaw,
Phone: (22) 345 93 00