Xedine Ha dla dzieci

Leaflet attached to the packaging: patient information

Xedine 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.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. 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 Xedine HA for children and what is it used for
• 2. Important information before using Xedine HA for children
• 3. How to use Xedine HA for children
• 4. Possible side effects
• 5. How to store Xedine HA for children
• 6. Contents of the packaging and other information

1. What is Xedine HA for children and what is it used for

Xedine HA for children belongs to a group of sympathomimetic medicines used in nasal diseases. This medicine contains xylometazoline hydrochloride, which helps to narrow the blood vessels in the nose, thereby reducing swelling of the nasal mucosa.
Xedine HA for children also contains hyaluronic acid (in the form of sodium hyaluronate), which protects and moisturizes the nasal mucosa.
Xedine HA for children is used to:
reduce swelling of the nasal mucosa caused by inflammation of the nasal mucosa (rhinitis) or inflammation of the sinus mucosa (sinusitis).
Xedine HA for children at a concentration of 0.5 mg/ml is indicated for use in children aged 2 to 12 years.

2. Important information before using Xedine HA for children

When not to use Xedine 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 little or no 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 nasal vessel hypersensitivity;
• if the patient has undergone brain surgery through the nose or mouth.

This medicine is not intended for children under 2 years of age.

Warnings and precautions

Before starting to use Xedine HA for children, you should discuss it with your doctor or pharmacist if:
you have a strong reaction to sympathomimetics (substances similar to adrenaline), as using this medicine 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 other metabolic disorders;
you have adrenal gland disease;
you have prostate enlargement (prostate hypertrophy).
Continuous use of Xedine HA for children for a long periodmay worsen nasal congestion symptoms.

Xedine HA for children and other medicines

You should 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.
You should not take this 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 Xedine HA for children");
• other medicines that may increase blood pressure.

Pregnancy and breastfeeding

Xedine HA for children at a concentration of 0.5 mg/ml is intended for use in children. However, the following information concerns the active substance xylometazoline hydrochloride.
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.
There are insufficient data on the use of xylometazoline hydrochloride in pregnant women, so this medicine should not be used during pregnancy.
Since there are no data on the penetration of xylometazoline hydrochloride into human milk, this medicine should not be used during breastfeeding.

Driving and using machines

The effect of Xedine HA for children on the ability to drive and use machines is not known.

3. How to use Xedine 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 aged 2 to 12 years

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

The spray should be administered to the child while they are in an upright position. It is best if small children sit on an adult's lap while the medicine is being administered. Before using the medicine, the child should clean their nose. Remove the protective cap, as shown in Figure 1.	Figure 1
Hold the bottle between your index and middle fingers, with your thumb on the bottom of the bottle, as shown in Figure 2. To spray a dose, press the pump towards the bottom of the bottle. Before the first use, you need to spray the pump into the air several times (five times) to get a uniform dose. If the medicine has not been used for several days, you should spray at least one dose into the air to get a uniform dose.	Figure 2
Insert the upper part of the dosing pump into the nostril, as shown in Figure 3 (do not spray under the nostril). Press the pump once and ask the child to inhale through their nose at the same time. Gently close the other nostril with your index finger. Release the pump and remove it from the nostril. Repeat this process in the other nostril. After use, clean the dosing pump with a dry and clean tissue and replace the protective cap.	Figure 3

For hygiene reasons and to avoid the spread of infections, each spray bottle should only be used by one person.
This medicine should not be used in children under 2 years of age.

Using a higher dose of Xedine HA for children than recommended

If a child (or adult) has used a higher dose of the medicine than recommended, they should immediately contact their doctor, who will start the appropriate treatment.
The following overdose symptoms may occur (mainly in children):

• severe central nervous system depression
• drowsiness
• dry mouth
• sweating
• rapid heartbeat
• irregular heartbeat
• increased blood pressure.

Missing a dose of Xedine HA for children

You should not take a double dose to make up for a missed dose. You should continue using the medicine as described in this leaflet.
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.
You should STOP using Xedine HA for children and immediately consult your doctorif 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 skin itching with red rash or blisters.

Other side effects:
Common(may affect up to 1 in 10 people)
feeling of burning or stinging in the nose and throat, as well as dryness of the nasal mucosa
Rare(may affect up to 1 in 1,000 people)
headache, high 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
• nasal bleeding.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should inform your 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: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49 21 301, fax: 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, you can help provide more information on the safety of this medicine.

5. How to store Xedine HA for children

The medicine should be stored out of sight and reach of children.
There are no special precautions for storage.
The shelf life after opening the bottle is 6 months.
Do not use this medicine after the expiry date stated on the carton and bottle after "EXP". The expiry date refers to the last day of the month stated.
The batch number is stated after "Lot".
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Xedine HA for children contains

• The active substance of the medicine is xylometazoline hydrochloride. Each 1 ml of Xedine HA for children contains 0.5 mg of xylometazoline hydrochloride. Each dose (70 microliters) contains 0.035 mg of xylometazoline hydrochloride.
• The other ingredients (excipients) are: purified sea water, potassium dihydrogen phosphate, sodium hyaluronate, purified water.

What Xedine HA for children looks like and what the pack contains

Clear, colorless, sterile solution. Does not contain preservatives.
White plastic bottle containing 10 ml of solution, closed with a dosing pump and nasal applicator, and a protective cap, placed in a cardboard box.

Marketing authorization holder:

Ranbaxy (Poland) Sp. z o. o.
ul. Idzikowskiego 16
00-710 Warsaw

Manufacturer:

Jadran-Galenski laboratorij d.d.
Svilno 20
51000 Rijeka
Croatia
S.C. Terapia SA
124 Fabricii Street
400 632 Cluj Napoca
Romania

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Latvia
Xylometazolini hydrochloridum Ranbaxy
Romania
RHINXYL HA
Date of last revision of the leaflet: 31.05.2023