SUDAFED 0.5 mg/ml Aerosol

Contents of the leaflet

1. Package Leaflet: Information for the Patient
   1. Read the package leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Table of Contents of the Package Leaflet
2. What is Sudafed XyloSpray for Children and what is it used for
3. Important information before using Sudafed XyloSpray for Children
   1. When NOT to use Sudafed XyloSpray for Children:
   2. Warnings and precautions
   3. Sudafed XyloSpray for Children and other medicines
   4. Pregnancy and breastfeeding
   5. Driving and using machines
   6. Sudafed XyloSpray for Children contains benzalkonium chloride
4. How to use Sudafed XyloSpray for Children
   1. Children from 2 to 12 years of age
   2. Using a higher dose of Sudafed XyloSpray for Children than recommended
   3. Missing a dose of Sudafed XyloSpray for Children
5. Possible side effects
   1. Other side effects:
   2. Common (occurring in less than 1 in 10 people):
   3. Uncommon (occurring in less than 1 in 100 people):
   4. Rare (occurring in less than 1 in 1000 people):
   5. Frequency not known (frequency cannot be estimated from the available data):
6. How to store Sudafed XyloSpray for Children
7. Contents of the package and other information
   1. What Sudafed XyloSpray for Children contains
   2. What Sudafed XyloSpray for Children looks like and what the package contains
   3. Marketing authorization holder and manufacturer
   4. Marketing authorization holder:
   5. Manufacturer:
   6. This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Package Leaflet: Information for the Patient

Sudafed XyloSpray for Children, 0.5 mg/ml, Nasal Spray, Solution
Xylometazoline Hydrochloride

Read the package 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 package leaflet for the patient or as directed by a doctor or pharmacist.

• The package leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any not listed in this package leaflet, the doctor or pharmacist should be informed. See section 4.
• If there is no improvement after 3 days or the patient feels worse, a doctor should be contacted.

Table of Contents of the Package Leaflet

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

1. What is Sudafed XyloSpray for Children and what is it used for

Sudafed XyloSpray for Children contains xylometazoline, which helps to constrict blood vessels inside the nasal cavity, reducing swelling of the nasal mucosa (nasal lining) and making it easier to breathe.
The spray is used for the short-term treatment of nasal congestion or sinusitis with a runny nose, occurring in the course of a cold or sinusitis.

2. Important information before using Sudafed XyloSpray for Children

When NOT to use Sudafed XyloSpray 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 increase blood pressure;
• if the patient has vasculitis of the nasal mucosa;
• if the patient has atrophy of the nasal mucosa, with or without discharge;
• if the patient has had brain surgery performed through the nose or mouth.

Sudafed XyloSpray for Children should NOT be used in children under 2 years of age.

Warnings and precautions

Before starting to use the medicine, the patient should discuss it with a doctor or pharmacist in the following cases:

• strong reaction to sympathomimetics (substances similar to adrenaline), as the use of Sudafed XyloSpray for Children in such patients may cause insomnia, dizziness, uncontrolled muscle tremors, irregular heartbeat, or increased blood pressure;
• heart disease (e.g., long QT syndrome), hypertension, or circulatory system disease;
• hyperthyroidism, diabetes, or other metabolic system disease;
• adrenal gland disease;
• enlarged prostate (prostatic hyperplasia).

Continuous useof the medicine for a long period may cause worsening of sinusitis or nasal mucosa inflammation.

Sudafed XyloSpray for Children and other medicines

Before starting to use Sudafed XyloSpray for Children, the patient should consult a doctor or pharmacist.
The medicine should NOT be taken 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 for Children");
• other medicines that may increase blood pressure.

The pharmacist should be informed about all medicines the patient is currently taking or has recently taken, including those available without a prescription.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before using this medicine.
The medicine should NOT be used during pregnancy due to the lack of data on its effects on the fetus.
Breastfeeding patients 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 for Children on the ability to drive and use machines have been observed.

Sudafed XyloSpray for Children contains benzalkonium chloride

The medicine contains 0.2 mg of benzalkonium chloride per ml, which corresponds to 0.014 mg/0.070 ml (dose). Benzalkonium chloride may cause irritation or swelling inside the nose, especially if used for a long time.

3. How to use Sudafed XyloSpray for Children

This medicine should always be used exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist. In case of doubts, a doctor or pharmacist should be consulted.

Children from 2 to 12 years of age

Unless otherwise directed by a doctor or pharmacist, one dose of Sudafed XyloSpray for Children should be used in each nostril, up to 3 times a day, not longer than for 7 days.The recommended dose should not be exceeded.

• 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 applicator tip 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, put the protective cap back on the bottle.

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

Using a higher dose of Sudafed XyloSpray for Children than recommended

A doctor, pharmacist, or the nearest emergency department should be contacted immediately, taking the medicine packaging or this package 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 for Children

If a dose of the medicine is missed, it should be taken as soon as possible. However, if it is almost time for the next dose, the missed dose should not be taken, and the medicine should be continued according to the recommendations. A double dose should not be taken to make up for a missed dose.
In case of any further doubts about using this medicine, a doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
STOPusing the medicine and immediately consult a doctorif any of the following side effects 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 side effects:

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

• feeling of tingling or burning in the nose and throat, and 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 sinusitis or nasal mucosa inflammation after stopping the use of the medicine

Reporting side effects
If any side effects occur, including any not listed in this package leaflet, the doctor or pharmacist should be informed. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Aleje Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309,
website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Sudafed XyloSpray for Children

The medicine should be stored out of sight and reach of children.
Store in a temperature below 25°C.
After opening the medicine packaging, Sudafed XyloSpray for Children should not be used for more than 20 weeks.
The medicine should not be used after the expiry date stated on the packaging. The expiry date refers to the last day of the given month.
Medicines should not be disposed of via wastewater or household waste. A pharmacist should be asked how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the package and other information

What Sudafed XyloSpray for Children contains

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

What Sudafed XyloSpray for Children looks like and what the package contains

The spray is a clear, colorless solution in a 10 ml glass bottle with a dosing pump, in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder:

McNeil Healthcare (Ireland) Limited
Office 5, 6 & 7, Block 5
High Street, Tallaght
Dublin 24, D24 YK8N
Ireland

Manufacturer:

Delpharm Orléans
5, avenue de Concyr
45071 Orléans Cedex 2
France

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

Poland
Sudafed XyloSpray for Children
Romania
Olynth 0.5 mg/ml nasal spray, solution
Date of last revision of the package leaflet:June 2024