Xyladur 0,5 mg/ml neusspray, oplossing

1. WHAT IS AND WHAT IT IS USED FOR

The active ingredient in this medicine is xylometazoline. It constricts blood vessels in the nasal mucosa, thereby reducing its swelling due to various causes, and makes breathing through the nose easier.

<Invented name> is used for short-term treatment of nasal congestion in children between 2 and 10 years old.

2. BEFORE YOU USE

Do not use <Invented name>

• if your child is allergic (hypertensive) to xylometazoline or any of the other ingredients of the medicine.
• if your child has had recent brain surgery through the nose or mouth.

Take special care with <Invented name>

Version 5.0, 10.09.2013

Page 1 of 7

Ask your doctor or pharmacist for advice before using this medicine if your child has:

• a tendency to hypersensitivity to sympathomimetics (drugs, such as adrenaline); <Invented name> may cause insomnia, dizziness, trembling, arrhythmia or increased blood pressure.
• cardiovascular disease (heart disease, high blood pressure)
• hyperthyroidism (overactive thyroid gland)
• diabetes mellitus
• phaeochromocytoma (tumour in the medulla of the adrenal glands that produces hormones)
• prostatic hypertrophy (enlarged prostate)
• inherited diseases caused by defective enzymes (porphyria)
• been receiving treatment with a drug for depression (MAO inhibitors)
• increased intra-ocular pressure (narrow angled glaucoma)
• a chronic cold with little or no secretion.

Mucous swelling (swelling of the inner lining of the nose) may recur in connection with stopping long-term treatment with xylometazoline. In order to prevent this, the treatment period should be kept as short as possible.

If you think that you have a bacterial infection, please consult with your doctor as an infection must be treated appropriately. This medicinal product should not be used by more than one person in order to prevent the risk of spreading infections.

If any of the above applies to your child, consult a doctor before using <Invented name>.

Using other medicines

Please tell your doctor or pharmacist if your child is taking or has recently taken any other medicines, including medicines obtained without a prescription.

It is not recommended to use this medicine together with certain antidepressants, such as:

• tri- or tetracyclic antidepressants
• MAO inhibitors (monoamine oxidase inhibitors) or if your child has taken MAO inhibitores within the last two weeks.

Also, it is not recommended to use this medicine:

• in combination with anti-hypertensive medicaments (e.g. methyldopa) due to the potential hypertensive effects of xylometazoline
• with other medicaments with potential hypertensive effect (e.g. doxapram, ergotamine, oxytocin) as they can potentiate each others hypertensive effects.

Pregnancy and breast-feeding

This strength of <Invented name> is intended for use in children yet, this information applies to the active ingredient xylometazoline.

Pregnant or breast-feeding women should consult their doctor before using this medicine.

Pregnancy:

Version 5.0, 10.09.2013

Page 2 of 7

Please consult your doctor before using this medicine when you are pregnant. Only use this medicine when your doctor has determined that you can safely do so.

Breast-feeding:

It is unknown whether xylometazoline is excreted in human milk. Risk to the breast- feeding child cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from using <Invented name>, taking into account the benefit of breast-feeding the child and the benefit of therapy for the mother.

As overdosing may lead to a reduction of milk production the recommended dose of xylometazoline must not be exceeded during breast-feeding.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

When taken properly, this medicine does not affect the ability to drive or operate machines, however if you feel drowsy or sleepy while using this medicine, you should not drive op operate machines.

3. HOW TO USE

Before the first application it is necessary to spray a few times (4 times) in the air, to achieve a uniform dose. The bottle should be in a vertical position. If the product is not used for several days at least one test spray in the air should be done in order to achieve a uniform dose.

<Invented name> 0.5 mg/ml is intended for the treatment of nasal congestion in children between 2-10 years.

Dosage

The usual dosage for children is one spray into each nostril, every 10-12 hours (no more than three times daily) for a maximum of 5 days.

<Invented name> 0.5 mg/ml is not recommended for children younger than 2 years. The safety and efficacy of <Invented name> 0.5 mg/ml in children younger than 2 years have not yet been established.

Patients older than 10 years should use <Invented name> 1 mg/ml.

Duration of treatment

The duration of the therapy should be as short as possible. After long-term therapy, swollen mucosa (inner lining of the nose) may reappear. The recommended dose should not be exceeded. You must talk to a doctor if you neither do nor feel better or if you feel worse after 3 days of continuous treatment.

If the symptoms of your child’s illness have not improved

Version 5.0, 10.09.2013

Page 3 of 7

Contact your doctor if the symptoms of your child’s illness persist or get worse after 5 days.

The doctor may give you different dosage instructions than those provided in this patient information leaflet. Always use <Invented name> exactly according to the instructions mentioned in this leaflet or as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Instructions for use

The spray should be administered to the child Picture 1 while they are in an upright position.

Therefore, it is best for small children to sit on your lap during the application.

Blow your child’s nose before using this medicine. Remove the cap as shown in picture 1.

Hold the bottle between your index and	Picture 2
middle fingers while supporting the bottom
with your thumb as shown in picture 2; To
spray, press the pump in a downward
direction.
When using this medicine for the first time,
spray into the air a few times (4 times) in
order to get fine mist. It is also good to test
the pump before each use by pressing it down
at least 1 time.
Insert the pump into the nostril, as shown in	Picture 3
picture 3. Press the pump downwards and at
the same time have the child breathe in
through the nose while you gently close the
other nostril with the index finger of your
other hand. Release the pump and remove
from the nostril. Repeat this process in the
other nostril.
Whip off the pump and replace the plastic cap
after use.

Note: if the same spray bottle is used by several people, it may cause spread of the infection.

Version 5.0, 10.09.2013

Page 4 of 7

If your child uses more <Invented name> than he or she should

If your child (or if someone else) has taken an overdose of this medicine, visit your doctor immediately. Overdose may cause a depression of the central nervous system, dry mouth, sweating and symptoms caused by stimulation of the sympathetic nervous system (fast, irregular pulse and increased blood pressure).

If you forget to use <Invented name>

If you forget to give a dose of this medicine skip the missed dose and carry on with the dosing schedule. Do not take a double dose to make up for a forgotten dose.

If you stop using <Invented name>

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Like all medicines, <Invented name> can cause side effects, although not everybody gets them.

The following side effects have been reported:

Common side effects these may affect 1 to 10 users in 100 people:

• itching or burning in the nose and throat
• dry nasal mucosa.

Uncommon side effects these may affect 1 to 10 users in 1.000 people:

• systemic allergic reactions
• increased swelling of the nasal mucosa after discontinuation of treatment
• epistaxis (nose bleeding)

Rare side effects these may affect 1 to 10 users in 10.000 people:

• heart palpitations and tachycardia (rapid heart rate)
• nausea
• high blood pressure.

Very rare side effects these may affect less than 1 in 10.000 people:

• nervousness
• insomnia
• fatigue
• headache
• arrhythmia

Version 5.0, 10.09.2013

Page 5 of 7

• mainly in children and after overdosing: sleepiness/drowsiness, nervousness, insomnia, hallucinations and convulsions. Cases of irregular breathing have been recorded in infants and neonates.

If any of the side effects gets serious, or if you notice any side effects that are not listed in this leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE

Keep out of the reach and sight of children.

Do not use <Invented name> after the expiry date which is stated on the carton after ‘Exp’. The expiry date refers to the last day of the month.

Use within 3 months of opening.

Do not freeze. This medicine does not require any special storage conditions.

Medicine should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

What <Invented name> contains

• The active substance is xylometazoline hydrochloride, whereby 1 millilitre of the solution contains 0.5 mg. 1 spray of <Invented name> 0.5 mg/ml (= 90 microlitres) contains 45 micrograms of xylometazoline hydrochloride.
• Other ingredients are purified sea water, potassium dihydrogen phosphate, and purified water.

What <Invented name> looks like and contents of the pack

Clear, colourless solution.

Bottle of 10 ml.

Marketing authorization holder

Jadran Galenski Laboratorij d.o.o. Litostrojska cesta 46A

1000 Ljubljana Slovenia

Manufacturer

HBM Pharma,

Sklabinská 30,

Version 5.0, 10.09.2013

Page 6 of 7

03680 Martin,

Slovak Republic

This medicinal product is authorised in the Member States of the EEA under the following names:

<Procedure NL/H/1990/002/DC:>

<Procedure NL/H/1992/002/DC:>

<Netherlands Nasonal 0.5 mg/ml Neusspray, oplossing > <Czech Republic Nasomaris 0.5 mg/ml Nosní sprej, roztok > <Slovak Republic Maresyl 0.5 mg/ml Nosová roztoková

aerodisperzia >

<Procedure NL/H/1995/002/DC:>

<Netherlands Nasomaris 0.5 mg/ml Neusspray, oplossing >

<Portugal Meryxol 0.5 mg/ml Solução para pulverização nasal >

<Procedure NL/H/1996/002/DC:>

<Netherlands	Nasadur 0.5 mg/ml Neusspray, oplossing >
<Germany	Imidin ® für Kinder o.K. 0,05 %
	Nasenspray, Lösung >

This medicine information leaflet was last approved in oktober 2013

Version 5.0, 10.09.2013

Page 7 of 7