Sudafed xylospray ha for children

Patient Information Leaflet

Warning! Keep this leaflet. The packaging label is in a foreign language.
Sudafed XyloSpray HA dla dzieci (Olynth N)
0.5 mg/ml, nasal spray, solution
Xylometazolini hydrochloridum
Sudafed XyloSpray HA dla dzieci and Olynth N are different brand names for the same medicine.
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
physician or pharmacist.

• Keep this leaflet for future reference.
• If you need advice or further information, 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 3 days or if symptoms worsen, consult your doctor.

Table of contents:

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

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

Sudafed XyloSpray HA dla dzieci contains xylometazoline, which helps constrict blood vessels inside the nasal cavity, thereby reducing swelling of the nasal mucosa and making breathing easier. Sudafed XyloSpray HA dla dzieci also contains hyaluronic acid (in the form of sodium salt), which protects and moisturizes the nasal mucosa.
The nasal spray is used for short-term treatment of nasal mucosal congestion with watery nasal discharge occurring during colds or sinusitis.

2. Important information before using Sudafed XyloSpray HA for children

When NOT to use Sudafed XyloSpray HA for children:

• 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 undergone brain surgery performed through the nose or mouth.

This medicine is not intended for 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 HA for children 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), blood vessel disorders, or high blood pressure;
• the patient has hyperthyroidism, diabetes, or another metabolic disorder;
• the patient has adrenal gland disease;
• the patient has benign prostatic hyperplasia (enlarged prostate).

Prolonged continuous use of the medicine may worsen symptoms of nasal congestion.
Sudafed XyloSpray HA for children and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently using, has recently used, or plans to use.
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 HA for children”);
• other medicines that increase blood pressure.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Sudafed XyloSpray HA for children should not be used during pregnancy due to lack of data on its effects on the fetus.
Breastfeeding women 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 effects of Sudafed XyloSpray HA for children on the ability to drive or operate machinery have been observed.

3. How to use Sudafed XyloSpray HA for children

This medicine should always be used exactly as described in this patient leaflet or as advised by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Children aged 2 to 12 years
Unless otherwise directed by a doctor or pharmacist, administer one dose of Sudafed XyloSpray HA for children into each nostril, up to 3 times daily, for no longer than 5–7 days. Do not exceed the recommended dose.

1. Remove the protective cap. Before first use, press the pump several times until a fine, uniform mist is produced (see Fig. 1). The medicine is now ready for use.
2. Hold the bottle in an upright or nearly upright position. Insert the nozzle into one nostril – do not spray the medicine if the applicator tip 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, this medicine should not be shared between 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.

Accidental overdose of Sudafed XyloSpray HA for children
Contact your doctor, pharmacist, or nearest emergency department immediately, and bring the medicine packaging or this leaflet with you.
Taking more than the recommended dose 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 HA 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 one.

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 experiences 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;
• severe itching with red rash or blisters.

Other adverse reactions:
Common (affects fewer than 1 in 10 people):

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

Uncommon (affects fewer than 1 in 100 people):

• nosebleeds

Rare (affects fewer than 1 in 1000 people):

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

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

• worsening of nasal congestion symptoms after stopping the medicine

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your 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 HA for children

Keep the medicine out of the sight and reach of children.
Do not store above 25°C.
The shelf life of Sudafed XyloSpray HA for children after first opening the bottle: 1 year.
Do not use Sudafed XyloSpray HA 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 in use. This will help protect the environment.

6. Contents of the pack and other information

What Sudafed XyloSpray HA for children contains
Active substance: Xylometazoline hydrochloride. 1 ml of solution contains 0.5 mg of xylometazoline hydrochloride. Each dose (70 μl (microlitres), equivalent to 0.070 ml) of Sudafed XyloSpray HA for children contains 35 μg (or 0.035 mg) of xylometazoline hydrochloride.
Other ingredients: Sodium hyaluronate, sorbitol (E 420), glycerol (E 422), disodium phosphate dihydrate, sodium dihydrogen phosphate dihydrate, sodium chloride, water for injections.

What Sudafed XyloSpray HA for children looks like and contents of the pack
The spray is a clear to slightly opalescent, colourless to slightly yellowish solution contained in a 10 ml white HDPE bottle with a metered pump dispenser and a protective cap, placed in a cardboard box. The solution provides enough for 110 doses.

For further 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
URSAPHARM Arzneimittel GmbH, Industriestraße 35, 66129 Saarbrücken, Germany
Famar Health Care Services Madrid, S.A.U., Avenida de Leganés, 62, 28923 Alcorcón-Madrid, Spain

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

Repackaged by:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland

German Marketing Authorisation Number (country of export): 26497.00.00
Parallel Import Authorisation Number: 72/25