Xedine ha for children

Package leaflet: Information for the user

Xedine HA for children, 0.5 mg/ml, nasal spray, solution
Xylometazolini hydrochloridum
Please read all of this leaflet carefully before using this medicine, because it contains
important information for you.
This medicine should always be used exactly as described in this patient leaflet or as directed
by your doctor or pharmacist.

• Keep this leaflet so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If there is no improvement after 3 days, or if you feel worse, contact your doctor.

Table of contents

1. What Xedine HA for children is and what it is 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 pack and other information

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

Xedine HA for children belongs to a group of medicines called sympathomimetics, used in nasal disorders. This medicine contains xylometazoline hydrochloride, which helps constrict 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 (nasal catarrh) or inflammation of the sinus mucosa (sinusitis).
Xedine HA for children 0.5 mg/ml is indicated for use in children aged 2 to 12 years.

2. Important information before using Xedine HA dla dzieci

When not to use Xedine HA dla dzieci:

• if the patient is allergic to xylometazoline or to 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 inflammation of the nasal mucosa (long-term nasal irritation) with little or no nasal 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 Xedine HA dla dzieci, consult a doctor or pharmacist if:
the patient has a strong reaction to sympathomimetics (substances similar to adrenaline), as use of this medicine in such patients may cause insomnia, dizziness, uncontrollable muscle tremors, irregular heartbeat or heart rhythm disorders, 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 adrenal gland disease;
the patient has benign prostatic hyperplasia (enlarged prostate).
Prolonged continuous use of Xedine HA dla dzieci may lead to worsening of nasal congestion symptoms.
Xedine 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 stopping monoamine oxidase inhibitors (see section "When not to use Xedine HA dla dzieci");
• other medicines that increase blood pressure.

Pregnancy and breastfeeding
Xedine HA dla dzieci at a strength of 0.5 mg/ml is intended for use in children. However, the following information refers to the active substance xylometazoline hydrochloride.
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.
There is insufficient data on the use of xylometazoline hydrochloride in pregnant women; therefore, this medicine should not be used during pregnancy.
Due to lack of data on the passage of xylometazoline hydrochloride into human milk, this medicine must not be used during breastfeeding.
Driving and operating machinery
The effect of Xedine HA dla dzieci on the ability to drive and operate machinery is unknown.

3. How to use Xedine HA dla dzieci

This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Children aged 2 to 12 years
Unless otherwise advised by a doctor or pharmacist, apply one dose of Xedine HA dla dzieci to each nostril, up to 3 times daily, for no longer than 5-7 days. Do not exceed the recommended dose.

The aerosol should be administered to a child in an upright position. Therefore, it is best for young children to sit on an adult's lap during administration. Before administering the medication, the child should clear their nose. Remove the protective cap as shown in Figure 1.	Figure 1
Hold the bottle between the index and middle fingers, supporting the bottom of the bottle with the thumb, as shown in Figure 2. To spray the dose, press the pump towards the bottom of the bottle. Before first use, it is necessary to prime the pump by spraying the aerosol into the air several times (five times) to ensure a uniform dose. If the medication has not been used for several days, at least one spray should be released into the air to ensure consistent dosing.	Figure 2
Insert the upper part of the metering pump into the nostril as shown in Figure 3 (do not apply the aerosol under the nostril). Press the pump once, while instructing the child to inhale through the nose. At the same time, gently close the other nostril with the index finger of the other hand. Release the pump and remove it from the nostril. Repeat this procedure in the other nostril. After use, clean the metering pump thoroughly with a dry and clean tissue, then replace the protective cap.	Figure 3

For hygienic reasons and to avoid the spread of infections, each bottle
of aerosol should be used by only one person.
This medicine should not be used in children under 2 years of age.
Use of a higher than recommended dose of Xedine HA dla dzieci
If a child (or an adult) has used more than the recommended dose of the medicine, contact a doctor immediately, who will initiate appropriate treatment.
The following symptoms of overdose may occur (mainly in children):

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

Missed dose of Xedine HA dla dzieci
Do not use a double dose to make up for a missed dose. Continue using the medicine as directed in this leaflet.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
DISCONTINUE use of Xedine HA dla dzieci and seek immediate medical advice
if any of the following adverse symptoms occur, which may be signs of
an allergic reaction:

• difficulty breathing or swallowing, swelling of the face, lips, tongue, or throat
• severe skin itching with red rash or raised hives.

Other adverse reactions:
Common (may occur in less than 1 in 10 people)
sensation of stinging or burning in the nose and throat, and dryness of the nasal mucosa
Rare (may occur in less than 1 in 1,000 people)
headache, high blood pressure, nervousness, nausea, dizziness, insomnia, and palpitations
transient visual disturbances and systemic allergic reactions
Frequency unknown (frequency cannot be estimated from the available data):

• worsening of nasal congestion symptoms after discontinuation of the medicine
• nosebleeds.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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.
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Xedine HA dla dzieci

Keep the medicine out of sight and reach of children.
There are no special requirements for storage conditions of this medicine.
The shelf life after first opening the bottle is 6 months.
Do not use this medicine after the expiry date stated on the carton and bottle following the abbreviation:
EXP. The expiry date refers to the last day of the specified month. The batch number is indicated after the abbreviation:
Lot.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Xedine HA for children contains

• The active substance 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 seawater, potassium dihydrogen phosphate, sodium hyaluronate, purified water.

What Xedine HA for children looks like and contents of the pack
A clear, colourless, sterile solution. It does not contain preservatives.
A white plastic bottle containing 10 ml of solution, closed with a metered dose pump spray with a nasal applicator and a protective cap, placed in a cardboard box.
Marketing Authorisation Holder:
Ranbaxy (Poland) Sp. z o.o.
Idzikowskiego Street 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 medicinal product is authorised 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