Package leaflet: Information for the user

Xedine HA, 1 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, 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.

Leaflet contents

What Xedine HA is and what it is used for
Important information before using Xedine HA
How to use Xedine HA
Possible side effects
How to store Xedine HA
Contents of the pack and other information

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

Xedine HA 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 also contains hyaluronic acid (in the form of sodium hyaluronate), which protects and moisturizes the nasal mucosa.
Xedine HA is used to:
reduce swelling of the nasal mucosa caused by inflammation of the nasal mucosa (nasal rhinitis) or inflammation of the sinus mucosa (sinusitis).
Xedine HA 1 mg/ml is indicated for use in adults and children aged 12 years and older.

2. Important information before using Xedine HA

When not to use Xedine HA:
if the patient is allergic to xylometazoline hydrochloride 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 inflammation of the nasal mucosa (chronic nasal irritation)
with little or no 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 an inflammatory condition associated with thinning of nasal membranes, with or without discharge;
if the patient has undergone brain surgery performed via the nose or mouth.
Xedine HA is not intended for children under 12 years of age.

Warnings and precautions
Before starting to use this medicine, consult a doctor if the patient:
has a strong reaction to sympathomimetics (substances similar to adrenaline), as use of
Xedine HA in such patients may cause insomnia, dizziness, uncontrollable muscle tremors,
irregular heartbeat or heart rhythm disorders, or increased blood pressure;
has heart disease (e.g. long QT syndrome), vascular disease or high blood pressure;
has hyperthyroidism, diabetes or another metabolic disorder;
has adrenal gland disease;
has benign prostatic hyperplasia (enlarged prostate).

Prolonged continuous use of Xedine HA may worsen nasal congestion symptoms.

Xedine HA and other medicines
Inform 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 using monoamine oxidase inhibitors (see section "When not to use Xedine HA");
other medicines that increase blood pressure.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Xedine HA should not be used during pregnancy due to lack of data on the use of xylometazoline hydrochloride (the active substance) in pregnant women.
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 on the ability to drive and operate machinery is unknown.

3. How to use Xedine HA

This medicine should always be used exactly as described in the patient leaflet, or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Adults and children aged 12 years and over:
Unless otherwise advised by a doctor or pharmacist, apply one dose of Xedine HA to each nostril, up to 3 times daily, for no longer than 7 days.

Before using the medication, the patient should clean the 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 a dose, press the pump towards the bottom of the bottle. Before the 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 dose should be sprayed into the air to ensure proper dosing.	Figure 2
Insert the upper part of the dosing pump into the nostril as shown in Figure 3 (do not spray the aerosol under the nostril). While pressing the pump once, inhale gently through the nose and, 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 dosing pump thoroughly with a dry and clean tissue and replace the protective cap.	Figure 3

To minimize the risk of spreading infections, the medicine package should not be
used by more than one person, and the applicator should be rinsed after each use.
The medicine should not be used in children under 12 years of age.
Use of a higher than recommended dose of Xedine HA
Contact your doctor, pharmacist, or nearest emergency department immediately,
taking the medicine package or this leaflet with you.
The following symptoms of overdose may occur (mainly observed in children):

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

Missed dose of Xedine HA
If a dose is missed, it should be taken as soon as the patient remembers. If it is almost time for the next dose, the missed dose should be skipped. The next dose should be taken at the usual time. Do not use a double dose to make up for a missed dose.
If there are 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.
You should STOP using Xedine HA and immediately contact a doctor if any of the following adverse reactions occur, 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 raised blisters.

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 not known (frequency cannot be estimated from 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 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
Adverse reactions can also be reported directly to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Xedine HA

Keep this medicine out of the sight and reach of children.
No special requirements for storage conditions of the 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 label:
EXP. The expiry date refers to the last day of the stated month. The batch number is indicated following the label:
Lot.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Xedine HA contains

The active substance is xylometazoline hydrochloride. Each 1 ml of Xedine HA contains 1 mg of xylometazoline hydrochloride. Each dose (140 microlitres) contains 0.140 mg of xylometazoline hydrochloride.
The other ingredients (excipients) are: purified seawater, potassium dihydrogen phosphate, sodium hyaluronate, purified water.

What Xedine HA 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