Xylometazoline + dexpanthenol teva kids

Package leaflet: Information for the user

Xylometazoline + Dexpanthenol Teva Kids, (0.5 mg + 50 mg)/mL,
nasal spray, solution
Xylometazolini hydrochloridum + Dexpanthenolum
For use in children aged 2 to 6 years.
Please read the entire leaflet carefully before use, 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 you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 7 days, or if symptoms worsen, consult a doctor.

Contents of the leaflet

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

Xylometazoline + Dexpanthenol Teva 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 that supports wound healing and provides protective action on mucous membranes.
Xylometazoline + Dexpanthenol Teva Kids is used to reduce swelling of the nasal mucosa in nasal mucositis and as supportive treatment in healing skin and mucosal lesions, as well as in treating paroxysmal nasal discharge (vasomotor rhinitis) and in managing impaired nasal breathing following nasal surgery.
Xylometazoline + Dexpanthenol Teva 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, a doctor should be consulted.

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 dry rhinitis (a form of chronic rhinitis causing dry inflammation 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 dura mater of the brain),
• in children under 2 years of age.

Warnings and precautions
Before starting to use Xylometazoline + Dexpanthenol Teva Kids, discuss with a doctor or pharmacist if:

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

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.
Xylometazoline + Dexpanthenol Teva Kids and other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned for use.
Concomitant use of Xylometazoline + Dexpanthenol Teva Kids with certain medicines, such as mood-enhancing medicines (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 increased arterial blood pressure due to effects on the cardiovascular system.
Do not use this medicine simultaneously with medicines that lower blood pressure (e.g. methyldopa), due to the possible effect of xylometazoline on blood vessels (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 data on safety, this medicine should not be used during pregnancy.
It is unknown whether xylometazoline hydrochloride passes into breast milk; therefore, Xylometazoline + Dexpanthenol Teva Kids should not be used during breastfeeding.
Driving and operating machinery
If Xylometazoline + Dexpanthenol Teva Kids is used as directed, a negative effect on the ability to drive or operate machinery is not expected.

3. How to use Xylometazoline + Dexpanthenol Teva Kids

This medicine should always be used exactly as described in this patient leaflet or as recommended by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Recommended dose
If a doctor has not prescribed otherwise, children aged 2 to 6 years should use one spray of Xylometazoline +
Dexpanthenol Teva Kids into each nostril, as needed, but no more than three times daily. The dosage depends on the individual sensitivity and response of the patient to the medicine.

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 in 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 spray with measured dose is ready for immediate use.
Before using the nasal spray, gently blow your 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 the applicator should be used by only one person.

Duration of treatment
Do not use Xylometazoline + Dexpanthenol Teva Kids for longer than 7 days unless otherwise clearly advised by a doctor.
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 Xylometazoline + Dexpanthenol Teva Kids may lead to chronic swelling and ultimately may result in 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 Xylometazoline + Dexpanthenol Teva Kids is too strong or too weak, consult a doctor or pharmacist.

Use of a higher than recommended dose of Xylometazoline + Dexpanthenol Teva Kids
If a higher than recommended dose of Xylometazoline + Dexpanthenol Teva Kids is used or if the product is accidentally swallowed orally, the following symptoms may occur: pupillary constriction (miosis), pupillary dilation (mydriasis), fever, sweating, pallor, bluish discoloration of the lips (cyanosis), nausea, convulsions, cardiovascular disorders such as heart rhythm disturbances (tachycardia, bradycardia, arrhythmia), circulatory collapse, cardiac arrest, high blood pressure (hypertension); pulmonary complications (pulmonary edema, breathing difficulties), and psychiatric disturbances. Additionally, drowsiness, decreased body temperature, slowed heart rate, shock-like drop in arterial 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 Xylometazoline + Dexpanthenol Teva 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 reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
The frequency of adverse reactions is defined according to the following convention:
Very common: may occur in more than 1 in 10 patients,
Common: may occur in up to 1 in 10 patients,
Uncommon: may occur in up to 1 in 100 patients,
Rare: may occur in up to 1 in 1,000 patients,
Very rare: may occur in up to 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 disorders (arrhythmia)

Vascular disorders:
Rare: increased blood pressure (hypertension)

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

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

5. How to store Xylometazoline + Dexpanthenol Teva 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 following: "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.
Usable period after first opening of 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. This will help protect the environment.

6. Contents of the package and other information

What Xylometazoline + Dexpanthenol Teva 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 of the medicine are:

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

What Xylometazoline + Dexpanthenol Teva Kids looks like and contents of the pack
One 10 mL bottle contains no less than 90 single sprays.
Xylometazoline + Dexpanthenol Teva Kids is a clear, almost colourless solution in a 10 mL round plastic bottle containing 10 mL of solution, sealed with a spray pump (applicator) and a 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 countries under the following names:
Germany: Xylometazoolin/Dexpanthenol Teva 0.5 mg/mL + 50 mg/mL Nasenspray, Lösung
Poland: Xylometazoline + Dexpanthenol Teva Kids

For further 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.,
ul. Emilii Plater 53,
00-113 Warsaw,
tel. (22) 345 93 00