Sudafed xylospray for children

Package leaflet: Information for the user

Warning! Keep this leaflet! The information on the immediate packaging is in a foreign language.
Sudafed XyloSpray dla dzieci (Olynth)
0.5 mg/ml, nasal spray, solution
Xylometazolini hydrochloridum
Sudafed XyloSpray dla dzieci and Olynth are different brand names of the same medicine.
Please read this leaflet carefully before using the medicine, as it contains
important information for the user.
This medicine should always be used exactly as described in this patient leaflet or as directed by a
physician or pharmacist.

• Keep this leaflet, so that you can read it again if necessary.
• If you need advice or further information, please contact your pharmacist.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 3 days, or if you feel worse, consult your doctor.

Contents of the leaflet

1. What Sudafed XyloSpray dla dzieci is and what it is used for
2. Important information before using Sudafed XyloSpray dla dzieci
3. How to use Sudafed XyloSpray dla dzieci
4. Possible side effects
5. How to store Sudafed XyloSpray dla dzieci
6. Contents of the package and other information

1. What Sudafed XyloSpray dla dzieci is and what it is used for

Sudafed XyloSpray dla dzieci contains xylometazoline, which helps constrict blood vessels inside the nasal cavity, thereby reducing swelling of the nasal mucosa (nasal lining) and making breathing easier.
The nasal spray is used for short-term treatment of nasal congestion or sinus congestion with watery nasal discharge occurring during colds or sinusitis.

2. Important information before using Sudafed XyloSpray dla dzieci

When NOT to use Sudafed XyloSpray dla dzieci:

• if the patient is allergic to xylometazoline or any of the other ingredients of this medicine (listed in section 6);
• if the patient has increased intraocular pressure, especially in the case of narrow-angle glaucoma;
• if the patient has chronic inflammation of the nasal mucosa (long-term nasal irritation) with little or no discharge (rhinitis sicca);
• if the patient is taking or has taken monoamine oxidase inhibitors (MAO inhibitors) within the last two weeks;
• if the patient is taking other medicines that may increase blood pressure;
• if the patient has inflammation caused by nasal blood vessel hypersensitivity;
• if the patient has inflammation associated with thinning of the nasal mucosa, with or without discharge;
• if the patient has undergone brain surgery performed via the nose or mouth.

The aerosol should NOT be used in children under 2 years of age.
Warnings and precautions
Before starting to use this medicine, consult a doctor or pharmacist if:

• the patient has a strong reaction to sympathomimetics (substances similar to adrenaline), as use of Sudafed XyloSpray dla dzieci in such patients may cause insomnia, dizziness, uncontrollable muscle tremors, irregular heartbeat, or increased blood pressure;
• the patient has heart disease (e.g. long QT syndrome), hypertension, or cardiovascular disease;
• the patient has hyperthyroidism, diabetes, or another metabolic disorder;
• the patient has adrenal gland disease;
• the patient has an enlarged prostate gland (prostate enlargement).

Prolonged use of this medicine over a long period may worsen sinusitis or inflammation of the nasal mucosa.
Sudafed XyloSpray dla dzieci and other medicines
Before starting to use Sudafed XyloSpray dla dzieci, consult a doctor or pharmacist.
Do NOT take this medicine while using:

• certain antidepressants, such as tricyclic and tetracyclic antidepressants, monoamine oxidase inhibitors, or within two weeks after using monoamine oxidase inhibitors (see section "When NOT to use Sudafed XyloSpray dla dzieci");
• other medicines that increase blood pressure.

Inform the pharmacist about all medicines currently or recently taken by the patient, including those available without a prescription.
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.
Sudafed XyloSpray dla dzieci should NOT be used during pregnancy due to lack of data on its effects on the fetus.
Breastfeeding patients should consult their doctor before using this medicine.
It is unknown whether the active substance of this medicine passes into human milk.
Driving and operating machinery
No effect of Sudafed XyloSpray dla dzieci on the ability to drive or operate machinery has been observed.
Sudafed XyloSpray dla dzieci contains benzalkonium chloride
This medicine contains 0.2 mg of benzalkonium chloride per ml, equivalent to 0.014 mg/0.070 ml (per dose). Benzalkonium chloride may cause irritation or swelling inside the nose, especially if used for prolonged periods.

3. How to use Sudafed XyloSpray for children

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.
Children aged 2 to 12 years
Unless otherwise advised by a doctor or pharmacist, administer one dose of Sudafed XyloSpray for
children into each nostril, up to 3 times daily for no longer than 7 days. Do not exceed the recommended dose.

1. Remove the protective cap. Before first use, press the pump several times until a fine, uniform spray appears (see Fig. 1). The medicine is now ready for use.
2. Hold the bottle in an upright or nearly upright position. Insert the applicator into the nostril – do not spray the medicine if the tip of the applicator is below the nostril opening (see Fig. 2).
3. Press the pump once, while inhaling through the nose. Repeat the same steps when administering the medicine into the other nostril.
4. After use, replace the protective cap on the bottle.

To minimize the risk of spreading infections, the medicine container should not be used by more than
one person, and the applicator should be rinsed after each use.
DO NOT use this medicine in children under 2 years of age.
Overdose of Sudafed XyloSpray for children
Contact a doctor, pharmacist, or nearest emergency department immediately, bringing the medicine
package or this leaflet with you.
An overdose may cause central nervous system disturbances, such as loss of muscle function,
fatigue, dry mouth, sweating, rapid and irregular heartbeat, and increased blood pressure.
Missed dose of Sudafed XyloSpray for children
If a dose is missed, take it as soon as possible. However, if it is almost time for the next dose, skip
the missed dose and continue with the regular dosing schedule. Do not take a double dose to make
up for a missed dose.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
STOP using the medicine and seek immediate medical advice if any of the following adverse reactions occur, which may be symptoms of an allergic reaction:

• difficulty breathing or swallowing, swelling of the face, lips, tongue or throat;
• itching with red rash or blisters.

Other adverse reactions:
Common (occur less frequently than in 1 out of 10 people):

• stinging or burning sensation in the nose and throat, and dryness of the nasal mucosa

Uncommon (occur less frequently than in 1 out of 100 people):

• nosebleeds

Rare (occur less frequently than in 1 out of 1000 people):

• headache, increased blood pressure, nervousness, nausea, dizziness, insomnia and palpitations
• transient visual disturbances and systemic allergic reactions

Frequency not known (frequency cannot be estimated from available data):

• worsening of symptoms of sinusitis or nasal mucosa inflammation after discontinuation of the medicine

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions 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, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Sudafed XyloSpray for children

Keep the medicine out of the sight and reach of children.
Do not store at temperatures above 30°C.
After first opening the Sudafed XyloSpray for children container, do not store for longer than 12 weeks.
Do not use Sudafed XyloSpray for children after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
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 packaging and other information

What Sudafed XyloSpray for children contains
The active substance is xylometazoline hydrochloride. 1 ml of solution contains 0.5 mg of xylometazoline hydrochloride. Each dose (0.070 ml) of Sudafed XyloSpray for children contains 35 micrograms (or 0.035 mg) of xylometazoline hydrochloride.
Other ingredients are: benzalkonium chloride, sorbitol liquid non-crystallizing, sodium chloride, sodium dihydrogen phosphate dihydrate, disodium phosphate dihydrate, disodium edetate, purified water.

What Sudafed XyloSpray for children looks like and contents of the pack
The spray is a clear, colourless solution contained in a 10 ml amber glass bottle with a metered pump dispenser, packed in a cardboard box.

For further detailed information, please contact the responsible party or the parallel importer.

Marketing Authorisation Holder in Germany, the country of export:
Johnson & Johnson GmbH
Johnson & Johnson Platz 2
41470 Neuss
Germany

Manufacturer:
Johnson & Johnson GmbH
Johnson & Johnson Platz 2
41470 Neuss
Germany
Delpharm Orléans
5, avenue de Concyr
45071 Orléans Cedex 2
France

Parallel Importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Poland

Repackaged by:
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
Poland
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland

German Marketing Authorisation Number (country of export): 6460123.00.00
Parallel Import Authorisation Number: 230/18

This medicinal product is authorised for sale in the European Economic Area countries under the following names:
Poland: Sudafed XyloSpray for children
Romania: Olynth 0.5 mg/ml nasal spray, solution