Sudafed Xilosprai Ha dla dzieci

Leaflet attached to the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Sudafed XyloSpray HA for children

0.5 mg/ml, nasal spray, solution

Xylometazoline hydrochloride

You should carefully read the contents of the leaflet 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 or pharmacist.

• The leaflet should be kept so that it can be re-read if necessary.
• If advice or additional information is needed, you should consult a pharmacist.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.
• If there is no improvement after 3 days or if the patient feels worse, they should contact their doctor.

Table of contents of the leaflet:

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

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

Sudafed XyloSpray HA for children contains xylometazoline, which helps to constrict blood vessels inside the nasal cavity, reducing swelling of the nasal mucosa and making it easier to breathe. Sudafed XyloSpray HA for children also contains hyaluronic acid (in the form of sodium salt), which protects and moisturizes the nasal mucosa.
The spray is used for the short-term treatment of nasal congestion with a runny nose, occurring in the course of a cold 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 rhinitis (long-term nasal irritation) with a small amount of discharge or without discharge (rhinitis sicca);
• if the patient is taking or has taken monoamine oxidase inhibitors (MAOIs) in the last two weeks;
• if the patient is taking other medicines that may cause an increase in blood pressure;
• if the patient has vasculitis of the nasal blood vessels;
• 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 the medicine, you should discuss it with your doctor or pharmacist if:

• you have a strong reaction to sympathomimetics (substances similar to adrenaline), as the use of Sudafed XyloSpray HA for children may cause insomnia, dizziness, uncontrolled muscle tremors, irregular heartbeat, or increased blood pressure;
• you have heart disease (e.g., long QT syndrome), vascular disease, or high blood pressure;
• you have hyperthyroidism, diabetes, or another metabolic disorder;
• you have adrenal disease;
• you have prostatic hyperplasia (enlargement of the prostate).

Continuous useof the medicine for a long period may cause worsening of nasal congestion symptoms.

Sudafed XyloSpray HA for children and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
DO NOT take the medicine while using:

• certain antidepressants, such as tricyclic and tetracyclic antidepressants, monoamine oxidase inhibitors, and within two weeks of using monoamine oxidase inhibitors (see "When NOT to use Sudafed XyloSpray HA for children");
• other medicines that may increase blood pressure.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should consult your doctor or pharmacist before using this medicine.
Do not use Sudafed XyloSpray HA for children during pregnancy due to the lack of data on its effects on the fetus.
Breastfeeding women should consult their doctor before using the medicine.
It is not known whether the active substance of this medicine passes into breast milk.

Driving and using machines

No effects of Sudafed XyloSpray HA for children on the ability to drive and use machines have been found.

3. How to use Sudafed XyloSpray HA for children

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, you should consult your doctor or pharmacist.

Children from 2 to 12 years old

Unless your doctor or pharmacist has told you otherwise, you should use one dose of Sudafed XyloSpray HA for children into each nostril, up to 3 times a day, for no longer than 5-7 days.
Do not exceed the recommended dose.

• 1. Remove the protective cap. Before the first use, press the pump several times until a uniform mist of the sprayed medicine appears (see Fig. 1). The medicine is now ready for use.
• 2. Hold the bottle in a position close to vertical. Insert the applicator into the nostril – do not spray the medicine if the tip of the applicator is below the nostril (see Fig. 2)
• 3. Press the pump once, while inhaling through the nose. Repeat the same steps when administering the medicine to the other nostril.

• 4. After use, replace the protective cap on the bottle.

To minimize the risk of spreading infections, the packaging of the medicine should not be used by more than one person, and the applicator should be rinsed after each use.
DO NOT use the medicine in children under 2 years of age.

Using a higher dose of Sudafed XyloSpray HA for children than recommended

You should immediately contact your doctor, pharmacist, or the nearest emergency department, taking the packaging of the medicine or this leaflet with you.
Using a higher dose of the medicine than recommended may cause central nervous system depression, e.g., loss of muscle function, fatigue, dry mouth, sweating, rapid and irregular heartbeat, and increased blood pressure.

Missing a dose of Sudafed XyloSpray HA for children

If you miss a dose, you should take it as soon as possible. However, if it is almost time for the next dose, do not take the missed dose, just continue using the medicine as directed. Do not take a double dose to make up for the missed dose.
If you have any further doubts about using this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
STOP using the medicine and contact your doctor immediatelyif you experience any of the following side effects, 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 side effects:

Common (occurring in less than 1 in 10 people):

• feeling of tingling or burning in the nose and throat, as well as dryness of the nasal mucosa

Uncommon (occurring in less than 1 in 100 people):

• nasal bleeding

Rare (occurring in less than 1 in 1000 people):

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

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

• worsening of nasal congestion symptoms after stopping the use of the medicine

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring 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
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Sudafed XyloSpray HA for children

The medicine should be stored out of sight and reach of children.
Do not store above 25°C.
The shelf life of Sudafed XyloSpray HA for children after 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 month.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Sudafed XyloSpray HA for children contains

The active substanceis xylometazoline hydrochloride. 1 ml of the solution contains 0.5 mg of xylometazoline hydrochloride. Each dose (70 μl (micrograms) which is equivalent to 0.070 ml) of Sudafed XyloSpray HA for children contains 35 μg (or 0.035 mg) of xylometazoline hydrochloride.
Other ingredientsare: 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 what the packaging contains

The spray is a clear to slightly opalescent, colorless to slightly yellowish solution, placed in a 10 ml HDPE bottle with a dosing pump and protective cap, in a cardboard box. The solution is sufficient for 110 doses.
For more detailed information, you should contact the marketing authorization holder or parallel importer.

Marketing authorization 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

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
German export license number: 26497.00.00

Parallel import license number: 221/22

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Latvia
Olynth HA 0.5 mg/ml deguna aerosols bez konservantiem, šķīdums
Poland
Sudafed XyloSpray HA for children

Date of leaflet approval: 13.12.2023

[Information about the trademark]