Sudafed xylospray ha for children

Package leaflet: Information for the patient

Warning! Keep the leaflet. Information on the immediate packaging in a foreign language.
Sudafed XyloSpray HA dla dzieci
0.5 mg/ml, nasal spray, solution
Xylometazolini hydrochloridum
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 or pharmacist.

• Keep this leaflet for future reference.
• If advice or further information is needed, consult a pharmacist.
• If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor, pharmacist, or nurse. See section 4.
• If there is no improvement after 3 days, or if the patient feels worse, consult a doctor.

Table of contents:

1. What Sudafed XyloSpray HA dla dzieci is and what it is 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 Sudafed XyloSpray HA dla dzieci is and what it is 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 facilitating easier breathing. 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 dla dzieci

When NOT to use Sudafed XyloSpray HA 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 rhinitis (long-term nasal mucosa 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 using Sudafed XyloSpray HA dla dzieci may cause insomnia, dizziness, uncontrolled muscle tremors, irregular heartbeat, or increased blood pressure;
• the patient has heart disease (e.g. long QT syndrome), vascular disease, or high blood pressure;
• the patient has hyperthyroidism, diabetes, or another metabolic disorder;
• the patient has an adrenal gland disorder;
• the patient has benign prostatic hyperplasia (enlarged prostate).

Prolonged use of this medicine over a long period may worsen nasal congestion symptoms.
Sudafed XyloSpray HA dla dzieci and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
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 dla dzieci");
• 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.
Do not use Sudafed XyloSpray HA dla dzieci 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 breast milk.
Driving and operating machinery
No influence of Sudafed XyloSpray HA dla dzieci on the ability to drive or operate machinery has been observed.

3. How to use Sudafed XyloSpray HA dla dzieci

This medicine should always be used exactly as described in this patient leaflet or as directed by your
doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Children aged 2 to 12 years
Unless otherwise advised by a doctor or pharmacist, administer one dose of Sudafed XyloSpray HA dla dzieci 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 spray appears (see Fig. 1). The medicine is now ready for use.
2. Hold the bottle in an approximately vertical position. Insert the applicator into the nostril – do not spray the medicine if the applicator tip is positioned below the nostril opening (see Fig. 2).
3. Press the pump once while inhaling through the nose. Repeat the same procedure 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 shared between individuals, and the applicator should be rinsed after each use.
DO NOT use this medicine in children under 2 years of age.
Use of more than the recommended dose of Sudafed XyloSpray HA dla dzieci
Contact your doctor, pharmacist, or nearest emergency department immediately, taking the medicine packaging or this leaflet with you.
Using 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 dla dzieci
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 doubts about using this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
You should STOP using the medicine and immediately consult a doctor if any of the following adverse effects 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 effects:
Common (affects less than 1 in 10 people):

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

Uncommon (affects less than 1 in 100 people):

• nosebleeds

Rare (affects less than 1 in 1,000 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 nasal congestion symptoms after stopping use of the medicine

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects can also 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 effects 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 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 required. Such measures help protect the environment.

6. Contents of the package and other information

What Sudafed XyloSpray HA for children contains
The active substance is 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 are: sodium hyaluronate, sorbitol (E 420), glycerol (E 422), sodium dihydrogen phosphate dihydrate, disodium 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 metering pump and a protective cap, placed in a cardboard box. The solution is sufficient for 110 doses.

For further information, please contact the marketing authorisation holder 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

Parallel Importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź, Poland

Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź, Poland

German marketing authorisation number (country of export): 26497.00.00
Parallel Import Authorisation Number: 221/22

This medicinal product is authorised for marketing in the European Economic Area under the following names:
Latvia: Olynth HA 0.5 mg/ml nasal spray, solution without preservative
Poland: Sudafed XyloSpray HA for children