Xilometazoline + Dexpanthenol Teva Kids

Leaflet attached to the packaging: patient information

Xylometazoline + Dexpanthenol Teva Kids, (0.5 mg + 50 mg)/mL,

nasal spray, solution
Xylometazoline hydrochloride+ Dexpanthenol
For use in children from 2 to 6 years old.

Read the 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 your doctor, pharmacist, or nurse.

• -Keep this leaflet, you may need to read it again.
• -If you need advice or additional 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, contact your doctor.

Table of contents of the leaflet

• 1. What is Xylometazoline + Dexpanthenol Teva Kids and what is it used for
• 2. Important information before using Xylometazoline + Dexpanthenol Teva Kids
• 3. How to use Xylometazoline + Dexpanthenol Teva Kids
• 4. Possible side effects
• 5. How to store Xylometazoline + Dexpanthenol Teva Kids
• 6. Contents of the pack and other information

1. What is Xylometazoline + Dexpanthenol Teva Kids and what is it used for

Xylometazoline + Dexpanthenol Teva Kids 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.
Xylometazoline + Dexpanthenol Teva Kids is used to reduce nasal mucosa swelling in rhinitis and as an adjunctive treatment for wound healing on the skin and mucous membranes, as well as for the treatment of nasal congestion (vasomotor rhinitis) and difficulty breathing through the nose after nasal surgery.
Xylometazoline + Dexpanthenol Teva Kids is indicated for use in children from 2 to 6 years old.
If after 7 days there is no improvement or the patient feels worse, consult a doctor.

2. Important information before using Xylometazoline + Dexpanthenol Teva Kids

When not to use Xylometazoline + Dexpanthenol Teva Kids:

• -if the patient is allergic to xylometazoline hydrochloride, dexpanthenol, or any of the other ingredients of the medicine (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 surgery that exposes the dura mater),
• -in children under 2 years of age.

Warnings and precautions

Before starting to use Xylometazoline + Dexpanthenol Teva Kids, discuss with your doctor or pharmacist if you are:

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

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.

Xylometazoline + Dexpanthenol Teva Kids and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take.
Concomitant use of Xylo-Pantenol Kids with certain medicines, e.g., mood-enhancing medicines (monoamine oxidase inhibitors of the tranylcypromine type or tricyclic antidepressants), as well as medicines 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 medicine concomitantly with medicines 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 medicine.
Due to the lack of data on the safety of use, this medicine should not be used in pregnant women.
It is not known whether xylometazoline hydrochloride passes into breast milk, therefore Xylometazoline + Dexpanthenol Teva Kids should not be used during breastfeeding.

Driving and using machines

If Xylometazoline + Dexpanthenol Teva Kids is used as directed, no negative effect on the ability to drive and use machines is expected.

3. How to use Xylometazoline + Dexpanthenol Teva Kids

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

Recommended dose If your doctor has not prescribed otherwise, children from 2 to 6 years old should use one spray of Xylometazoline + Dexpanthenol Teva Kids into each nostril, as needed, but no more than three times

per day.The dosage depends on the individual sensitivity and response of the patient to the medicine.

Method of administration The medicine 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 cloth and replace the protective cap.

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 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

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

Using a higher dose of Xylometazoline + Dexpanthenol Teva Kids than recommended

In case of using a higher dose of Xylometazoline + Dexpanthenol Teva Kids than recommended or accidental oral ingestion, the following symptoms may occur: pupil constriction (miosis), pupil dilation, fever, sweating, paleness, cyanosis of the lips, nausea, convulsions, cardiovascular disorders, e.g., arrhythmias (tachycardia, bradycardia, cardiac arrhythmia), circulatory collapse, cardiac arrest, high blood pressure (hypertension); respiratory disorders (pulmonary edema, respiratory disorders), mental 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 a doctor immediately. If necessary, the doctor will start appropriate treatment.

Missing a dose of Xylometazoline + Dexpanthenol Teva Kids

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

4. Possible side effects

Like all medicines, Xylometazoline + Dexpanthenol Teva 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 swelling, rash, itching
Psychiatric disorders:
Very rare: excitement, 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: arrhythmias (cardiac arrhythmia)
Vascular disorders:
Rare: high blood pressure (hypertension)
Respiratory, thoracic, and mediastinal disorders:
Very rare: increased nasal mucosa swelling after the effect of the medicine has ceased, nosebleeds
Frequency not known: burning 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 of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Aleje 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 medicine.

5. How to store Xylometazoline + Dexpanthenol Teva Kids

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and label after “EXP” or “EXP” . The expiry date refers to the last day of that month.
There are no special storage precautions for this medicine.
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 Xylometazoline + Dexpanthenol Teva 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 hydrogen phosphate heptahydrate
• Water for injections

What Xylometazoline + Dexpanthenol Teva Kids looks like and contents of the pack

One bottle with 10 mL solution contains at least 90 single sprays.
Xylometazoline + Dexpanthenol Teva 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: Xylometazoline + Dexpanthenol Teva Kids
To obtain more detailed information on the 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.,
ul. Emilii Plater 53,
00-113 Warsaw,
phone: (22) 345 93 00

Date of last revision of the leaflet: