Xilo-pantenol Kids

Package Leaflet: Information for the Patient

Xylo-Pantenol Kids, (0.5 mg + 50 mg)/mL,

Nasal Spray, Solution
Xylometazoline Hydrochloride+ Dexpanthenol
For use in children from 2 to 6 years of age.

Please Read Carefully the Contents of the Leaflet Before Using the Medication, as it Contains

Important Information for the Patient.
This medication should always be used exactly as described in this patient leaflet or as advised by your doctor, pharmacist, or nurse.

• -You should keep this leaflet, so you can read it again if you need to.
• -If you need advice or further information, you should speak to your pharmacist.
• -If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. 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 Kids and what is it used for
• 2. Important information before using Xylo-Pantenol Kids
• 3. How to use Xylo-Pantenol Kids
• 4. Possible side effects
• 5. How to store Xylo-Pantenol Kids
• 6. Contents of the pack and other information

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

Xylo-Pantenol Kids contains two active substances: xylometazoline hydrochloride and dexpanthenol.
Xylometazoline constricts blood vessels, which leads to a reduction in nasal mucosal swelling.
The active substance dexpanthenol is a derivative of pantothenic acid, a vitamin that supports wound healing and acts protectively on mucous membranes.
Xylo-Pantenol Kids is used to reduce nasal mucosal swelling in rhinitis and as an adjunctive treatment for wound healing on the skin and mucous membranes, as well as for the treatment of rhinitis medicamentosa (nasal decongestant-induced rhinitis) and to facilitate breathing through the nose after nasal surgery.
Xylo-Pantenol Kids is indicated for use in children from 2 to 6 years of age.
If after 7 days there is no improvement or the patient feels worse, you should consult a doctor.

2. Important information before using Xylo-Pantenol Kids

When not to use Xylo-Pantenol Kids:

• -if the patient is hypersensitive to xylometazoline hydrochloride, dexpanthenol, or any of the other ingredients of the medication (listed in section 6),
• if the patient has atrophic rhinitis (a chronic form of rhinitis that causes dryness and crusting of the nasal mucosa),
• -if the patient has recently undergone neurosurgical procedures (transsphenoidal hypophysectomy or other surgical procedures exposing the dura mater),
• -in children under 2 years of age.

Warnings and precautions

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

• -you are taking certain antidepressants, known as monoamine oxidase inhibitors (MAOIs) or other medications that may increase blood pressure (e.g., doksapram, ergotamine, oxytocin),
• -you are taking medications that lower blood pressure (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 medication in the case of chronic rhinitis should be done under medical supervision, due to the risk of damage to the nasal mucosa.

Children

Do not use in children under 2 years of age.
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 Kids and other medications

You should tell your doctor or pharmacist about all medications you are currently taking or have recently taken, as well as any medications you plan to take.
Concomitant use of Xylo-Pantenol Kids with certain medications, e.g., medications that improve mood (monoamine oxidase inhibitors such as tranylcypromine or tricyclic antidepressants), as well as medications that may increase blood pressure (e.g., doksapram, ergotamine, oxytocin), may cause an increase in blood pressure as a result of the effect on the cardiovascular system.
Do not use this medication concomitantly with medications that lower blood pressure (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 medication.
Due to the lack of data on the safety of use, this medication should not be used in pregnant women. It is not known whether xylometazoline hydrochloride passes into breast milk; therefore, Xylo-Pantenol Kids should not be used during breastfeeding.

Driving and using machines

If Xylo-Pantenol Kids is used as recommended, it is not expected to have a negative impact on the ability to drive or operate machinery.

3. How to use Xylo-Pantenol Kids

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

Recommended dose If your doctor has not advised otherwise, children from 2 to 6 years of age should use one spray of Xylo-Pantenol Kids

into each nostril, as needed, but no more than three times a day. The dosage depends on the individual sensitivity and response of the patient to the medication.

Method of administration The medication is intended for nasal use. After removing the protective cap, place the spray nozzle (actuator) 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.

Caution

Before the 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 with the measured dose 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 actuator should be used by only one person.

Duration of use

Xylo-Pantenol Kids should not be used 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, you should always consult a doctor regarding the duration of use.
Continuous use of Xylo-Pantenol Kids may lead to chronic swelling and eventually may cause atrophy of the nasal mucosa.
Patients with increased intraocular pressure (with glaucoma, especially with narrow-angle glaucoma) should consult their doctor before using this medication.
If the effect of Xylo-Pantenol Kids is too strong or too weak, you should consult your doctor or pharmacist.

Using a higher dose of Xylo-Pantenol Kids than recommended

In case of using a higher dose of Xylo-Pantenol Kids than recommended or accidental oral ingestion, 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 (accelerated heart rate, slowed heart rate, cardiac arrhythmia), circulatory collapse, cardiac arrest, high blood pressure (hypertension); respiratory disorders (pulmonary edema, respiratory disorders), psychiatric 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 there is a suspicion of using a higher dose of the medication, you should immediately contact your doctor. If necessary, the doctor will start appropriate treatment.

Missing a dose of Xylo-Pantenol Kids

You should not use a double dose to make up for a missed dose. You should continue treatment as described in the instructions for use.

4. Possible side effects

Like all medications, Xylo-Pantenol Kids 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 edema, rash, itching
Psychiatric disorders:
Very rare: agitation, insomnia, hallucinations (especially in children)
Nervous system disorders:
Very rare: fatigue (drowsiness, sedation), headache, seizures (especially in children)
Cardiac disorders:
Rare: palpitations, accelerated heart rate (tachycardia)
Very rare: arrhythmias (cardiac arrhythmia)
Vascular disorders:
Rare: high blood pressure (hypertension)
Respiratory, thoracic, and mediastinal disorders:
Very rare: increased nasal mucosal swelling after the effect of the medication has ceased, nasal bleeding
Frequency not known: burning sensation and dryness of the nasal mucosa, sneezing

Reporting side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Department of Medicinal Product Monitoring of 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
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 medication.

5. How to store Xylo-Pantenol Kids

Keep this medication out of the sight and reach of children.
Do not use this medication 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.
Medications should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Xylo-Pantenol Kids contains

The active substances are xylometazoline hydrochloride and dexpanthenol. One spray of the nasal spray (0.1 mL solution) contains 0.05 mg xylometazoline hydrochloride and 5.0 mg dexpanthenol. 1 mL solution contains: xylometazoline hydrochloride 0.5 mg and dexpanthenol 50 mg.
The other ingredients are:

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

What Xylo-Pantenol Kids looks like and contents of the pack

One bottle with 10 mL solution contains at least 90 single sprays.
Xylo-Pantenol Kids is a clear, almost colorless solution in a 10 mL round plastic bottle, containing 10 mL solution, sealed with a pump spray (actuator) 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: Xylometazoolin/Dexpanthenol Teva 0.5 mg/mL + 50 mg/mL Nasenspray, Lösung
Poland: Xylo-Pantenol Kids
To obtain more detailed information on this medication and its names in other Member States of the European Economic Area, you should contact the representative of the marketing authorization holder:
Teva Pharmaceuticals Polska Sp. z o.o.,
ul. Emilii Plater 53,
00-113 Warsaw,
phone (22) 345 93 00

Date of last revision of the leaflet: