Sudafed Xilosprai Ha dla dzieci

Package Leaflet: Information for the Patient

Sudafed XyloSpray HA 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.

• This 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, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement after 3 days or the patient feels worse, they should contact their doctor.

Package Leaflet Contents:

• 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. Package contents 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) within 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 nose;
• if the patient has had 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, the patient should discuss it with their doctor or pharmacist in the following cases:

• strong reaction to sympathomimetics (substances similar to adrenaline), as the use of Sudafed XyloSpray HA 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), vascular disease, or high blood pressure;
• hyperthyroidism, diabetes, or other metabolic disorders;
• adrenal gland disease;
• prostate enlargement (prostate hypertrophy).

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

Sudafed XyloSpray HA for Children and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
DO NOTtake 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 the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their 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 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 observed.

3. How to use Sudafed XyloSpray HA 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 doubt, the patient should consult their doctor or pharmacist.

Children from 2 to 12 years of age

Unless otherwise directed by a doctor or pharmacist, one dose of Sudafed XyloSpray HA for Children should be used in each nostril, up to 3 times a day, not longer than for 5-7 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, replace the protective cap 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.
DO NOTuse the medicine in children under 2 years of age.

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

The patient should immediately contact their doctor, pharmacist, or the nearest emergency department, taking the medicine packaging or this package leaflet with them.
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 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 patient should continue using the medicine as directed. A double dose should not be taken to make up for a missed dose.
If the patient has any further doubts about using this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
STOP USINGthe medicine IMMEDIATELY AND CONSULTa doctor if 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;
• 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 medicine

Reporting side effects
If side effects occur, including any not listed in this package leaflet, the patient should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Medicines Monitoring 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. By reporting side effects, more information can be collected 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.
Store at a temperature below 25°C.
The shelf life of Sudafed XyloSpray HA for Children after opening the bottle: 1 year.
DO NOTuse Sudafed XyloSpray HA for Children after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents 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) of Sudafed XyloSpray HA for Children contains 35 μg (or 0.035 mg) of xylometazoline hydrochloride.
Other ingredientsare: sodium hyaluronate, sorbitol (E420), glycerol (E422), sodium dihydrogen phosphate dihydrate, disodium phosphate dihydrate, sodium chloride, water for injections.

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

The spray is a clear to slightly opalescent, colorless to slightly yellowish solution, in a 10 ml white HDPE bottle with a dosing pump and a protective cap made of HDPE, in a cardboard box. The solution is sufficient for 110 doses.

Marketing authorization holder

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

Manufacturer

Famar Health Care Services Madrid, S.A.U.
Avda. Leganés, 62
Alcorcón
28923 Madrid
Spain
Ursapharm Arzneimittel GmbH
Industriestraße 35
66129 Saarbrücken
Germany

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
To obtain more detailed information, please contact:
email: [email protected]

Date of the last revision of the package leaflet: