EURNEFFY 2 mg Nasal Spray, Solution

Зміст інструкції

1. EURneffy 2 mg nasal spray, single-dose container solution
   1. What is EURneffy and what is it used for
   2. What you need to know before using EURneffy
   3. How to use EURneffy
2. EURneffy 2 mg nasal spray:
   1. Possible side effects
   2. How to store EURneffy
   3. Contents of the pack and other information

EURneffy 2 mg nasal spray, single-dose container solution

adrenaline
Read this leaflet carefully before using this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

• 1. What EURneffy is and what it is used for
• 2. What you need to know before you use EURneffy
• 3. How to use EURneffy.
• 4. Possible side effects
• 5. How to store EURneffy
• 6. Contents of the pack and other information

1. What is EURneffy and what is it used for

EURneffy contains the active ingredient adrenaline (epinephrine), an adrenergic medicine (a
medicine that acts on the sympathetic nervous system, the part of the nervous system that increases
heart rate, blood pressure, breathing rate and pupil size).
EURneffy is used in adults and children with a body weight of 30 kg or more for the
emergency treatment of allergic reactions, including anaphylaxis (sudden, severe and sometimes life-threatening
allergic reactions), due to insect stings or bites, food, medicines and other
allergens (substances that cause an allergy) as well as idiopathic anaphylaxis (where the cause is unknown) or
anaphylaxis caused by exercise. EURneffy is intended for immediate self-administration by
an individual (or administered to an individual by a caregiver or medical personnel) with
a history of or known risk of severe allergic reaction that may cause anaphylactic shock.
The active ingredient of EURneffy, adrenaline, is a natural hormone released by the body in response
to stress. It acts directly on the cardiovascular (heart and circulatory) and
respiratory (lung) systems to stop the potentially fatal effects of a severe allergic reaction that may
lead to anaphylactic shock. In acute allergic reactions, it improves blood pressure, the
cardiac function and breathing, and reduces tissue swelling.
EURneffy is an emergency life-saving therapy, but emergency medical assistance must be sought immediately
to carefully monitor the anaphylactic episode and in
case further treatment is required. Always inform friends and family that you carry EURneffy with you (see section 2 Warnings and precautions).

2. What you need to know before using EURneffy

Do not use EURneffy
There is no known reason why you should not use EURneffy in an emergency allergic situation.

Warnings and precautions
You, or anyone who might need to administer EURneffy to you (for example, a parent, a
caregiver, or a teacher), must receive thorough instructions from your doctor or nurse
on how and when to use EURneffy correctly (see the instructions for use in section 3 “How
to use EURneffy”).
Symptoms indicating the onset of anaphylactic shock appear within minutes
of exposure to the allergen and include: skin itching; raised rash (like
hives); redness; swelling of the lips, throat, tongue, hands and feet; wheezing; hoarseness; shortness of
breath; nausea; vomiting; stomach cramps and, in some cases, loss of
consciousness; restlessness, rapid heartbeat, convulsions, diarrhea (loose stools), loss of
bladder control. Use EURneffy at the first signs or symptoms of a severe allergic reaction.
Symptoms of anaphylaxis can recur within 72 hours of the initial episode, even without a new
exposure to the allergen that triggered the allergic reaction.
Make sure you understand why EURneffy has been prescribed to you. You need to
ensure you know exactly how and when to use EURneffy. Explain how to use EURneffy to
your family, caregivers, colleagues or teachers: they need to know how to use it
before you experience a possible anaphylactic reaction.

If you are at risk of a severe allergic reaction, you should always carry EURneffy with you.Patients with
a history or known risk of a severe allergic reaction that can lead to anaphylactic shock must
have quick access to EURneffy.
If you have asthma, you may be at increased risk of developing a severe
allergic reaction.
Anyone who has an episode of anaphylaxis should consult their doctor to undergo testing to
identify the substances to which they may be allergic, so that they can strictly avoid them in
the future. It is important to be aware that an allergy to one substance can cause allergies
to a range of related substances.

People with a higher risk of adverse effects due to the use of adrenaline
You may be at increased risk of developing adverse effects with EURneffy if:

• you have cardiovascular disease (a disease affecting the heart and blood circulation);
• you have increased pressure in the eye;
• you have reduced kidney function;
• you have prostatic adenoma [a benign (non-cancerous) condition in which excessive growth of prostate tissue presses against the urethra and bladder, blocking urine flow];
• you have hypercalcemia (high levels of calcium in the blood);
• you have hypokalaemia (low levels of potassium in the blood);
• you have Parkinson’s disease;
• you suffer from hyperthyroidism (overactivity of the thyroid gland);
• you suffer from hypertension (high blood pressure);
• you have diabetes;
• you are an elderly person;
• you are pregnant (see section 2 Pregnancy, breastfeeding and fertility).

Talk to your doctor if any of the above conditions apply to you or if you have any doubts.

Children and adolescents
Do not give this medicine to children weighing less than 30 kg. The safety and efficacy of
this medicine have not been established in children with a body weight of less than 30 kg.

Other medicines and EURneffy
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
This is particularly important if you are taking any of the following medicines as they can reduce
the effect of adrenaline:

• alpha- and beta-blockers, for example propranolol;
• medicines that neutralize the pressor effects of adrenaline (vasodilators or alpha-adrenergic blockers, for example phentolamine).

You should also tell your doctor or pharmacist if you are taking any of the following medicines, as
they can increase the risk of adverse effects of adrenaline:

• medicines that can make the heart sensitive to arrhythmias (abnormal or irregular heartbeat), such as digoxin, mercurial diuretics (medicines that increase urine production and that act primarily on sodium transport) (for example, chlormerodrin, novasurol, mersalyl acid, meralluride, mercaptomerin, mercurophyllin, meretoxillin procaine) or quinidine;
• antidepressants such as tricyclic antidepressants, for example imipramine, or monoamine oxidase inhibitors (MAO inhibitors) (for example isocarboxazide, phenelzine, selegiline, tranylcypromine);
• medicines for the treatment of Parkinson’s disease such as catechol-O-methyltransferase inhibitors (COMT inhibitors) (for example entacapone, tolcapone, carbidopa-levodopa-entacapone, opicapone) and levodopa;
• medicines for thyroid diseases such as levothyroxine;
• medicines that make breathing easier, used for asthma (theophylline);
• medicines used in labour (oxytocin);
• medicines used to treat allergies such as diphenhydramine or chlorpheniramine (antihistamines);
• medicines that act on the nervous system (parasympatholytics) (for example atropine, cyclopentolate, homatropine, ioscine, tropicamide).

Patients with diabetes should carefully monitor their glucose levels after using EURneffy,
as adrenaline can reduce the amount of insulin produced by the body, thus increasing
blood glucose levels.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant, are planning a pregnancy or are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.
Knowledge about the use of adrenaline in pregnancy is limited. If you are pregnant, do
not hesitate to use EURneffy in emergency situations, as you and your baby may be in
danger. If you are pregnant, talk to your doctor.
It is expected that the amount of EURneffy that passes through breast milk is minimal.
For the emergency treatment of anaphylaxis, in breastfeeding women EURneffy should be
used as in patients who are not breastfeeding.

EURneffy with alcohol
Tell your doctor if you drink alcohol as it can increase the adverse effects
of adrenaline.

Driving and using machines
This medicine does not impair the ability to drive and operate machinery. Do
not drive if you are experiencing an anaphylactic reaction.

EURneffy contains sodium metabisulphite and benzalkonium chloride
EURneffy contains sodium metabisulphite, which can cause severe allergic reactions (hypersensitivity)
or breathing difficulties (bronchospasm).
This medicine contains 0.04 mg of benzalkonium chloride in each dose. Benzalkonium chloride can
cause irritation or swelling inside the nose, especially if used repeatedly.

3. How to use EURneffy

Use EURneffy always following the doctor's or pharmacist's instructions carefully. If you have doubts
consult your doctor or pharmacist.

When to carry EURneffy
You should always carry EURneffy with you or keep it readily available in case of an allergic emergency.
Always carry at least two containers of EURneffy with you in case a second
dose is needed due to an error in administration or an insufficient response after the first
dose.
Always inform your friends and family that you are carrying EURneffy.

Dose
The recommended dose for patients with a body weight of 30 kg or more is a single
dose of EURneffy nasal spray delivering 2 mg of adrenaline. The maximum dose of adrenaline for the
emergency treatment of allergic reactions is 4 mg, administered as two separate single-dose nasal
sprays.

Use in children
The recommended dose for patients with a body weight of 30 kg or more is a single
nasal administration of 2 mg of adrenaline. The maximum dose that can be administered is
4 mg, administered as two separate single-dose nasal sprays.

Method of administration
EURneffy must be administered only by the nasal route (inside the nose). EURneffy is a single-dose nasal
spray ready for use that delivers the entire content (2 mg) upon activation.
EURneffy can also be used in the presence of a cold or congested nose.
Press the plunger only after inserting the EURneffy nasal spray inside a nostril,
otherwise the single dose will be lost before use.
EURneffy must be administered exclusively as a nasal spray inside a
nostril; do not spray EURneffy into the eyes or mouth.
It is necessary to follow the instructions for use carefully for correct use of EURneffy.
If you notice signs of an acute allergic reaction (see section 2 Warnings and precautions), use
EURneffy immediately. Seek immediate emergency medical assistance to
subject the anaphylactic episode to careful monitoring and in case further
treatment is necessary. Ideal administration is performed by holding the spray in the dominant hand and
administering it into the nostril on the same side (for example, with the right hand in the right nostril or
with the left hand in the left nostril).
Sometimes a single dose of EURneffy may not be sufficient to completely cancel
the effects of a severe allergic reaction. If symptoms have not improved or have worsened
within approximately 10 minutes of using the first EURneffy nasal spray, you or the person with you
must administer a second EURneffy nasal spray into the same nostril as the first dose.
It is necessary to follow the instructions for use below.

Instructions for use
Before the need to use it arises, familiarize yourself with EURneffy, including when and
how it should be used.
EURneffy 2 mg nasal spray

EURneffy 2 mg nasal spray:

Nozzle/
Plunger
Follow these instructions only when you are ready to use.

A
Remove EURneffy 2 mg nasal spray from the packaging.
Open the packaging to remove EURneffy 2 mg nasal spray.

B

Hold the nasal spray as shown.
Hold the nasal spray with your thumb on the bottom of the plunger and one finger
on both sides of the nozzle.

• Do not pull or push on the plunger
• Do not perform tests or attempts to spray; each nasal spray hasonly one dose.

C

Insert the tip of the nasal spray into one nostril until your fingers
touch your nose.
Keep the nozzle straight inside the nose pointing towards your forehead. Do not
tilt the nasal spray towards the inner or outer walls of the nose.

D

Press the plunger firmly until it clicks to deliver the
spray into the nostril.
Do not tilt the nasal spray towards the inner or outer walls of the nose.
Seek immediate medical attention after use.
Immediately request emergency medical assistance to carefully monitor the
anaphylactic episode and if further treatment is necessary.

Monitor the patient's symptoms
If symptoms continue to worsen or reappear after approximately 10 minutes, or in case of any
administration error, use a new EURneffy nasal spray to deliver a second dose
into the SAME nostril as the first dose and immediately request emergency medical assistance.
If necessary, it is permissible to lie down with your feet elevated. If this position prevents breathing, it
is necessary to sit up. Unconscious patients should be placed on their side in a
safe position to prevent choking. If symptoms do not disappear, it is necessary, if possible,
to remain with another person until medical assistance arrives.

If you use more EURneffy than you should
In case of adrenaline overdose, you should always seek immediate medical attention.
Overdose may cause a sudden increase in blood pressure (with symptoms including
headache or dizziness), bleeding in the brain tissue, palpitations (forced, rapid or irregular heartbeats), reduced blood flow and fluid accumulation in the lungs (causing
symptoms including difficulty breathing). It will need to be monitored.
If you have any questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If any of the side effects listed below becomes serious or worsens, tell your
doctor or pharmacist.
The following side effects are associated with the use of EURneffy nasal spray:

Very common(may affect more than 1 in 10 people)

• Nasal discomfort
• Headache
• Feeling of agitation
• Throat irritation

Common(may affect up to 1 in 10 people)

• Increased blood pressure
• Palpitations (forced, accelerated or irregular heartbeats)
• Rhinorrhea (runny nose)
• Anxiety
• Nasal edema (itching and burning in the nose. The nose is swollen, warm and red)
• Rhinalgia (nasal pain)
• Increased heart rate
• Nasal congestion

Uncommon(may affect up to 1 in 100 people)

• Dizziness
• Increased lacrimation (watery eyes)
• Tremor (shaking)
• Oropharyngeal pain (pain in the tongue, soft palate, lateral and posterior walls of the throat, and tonsils).
• Nausea
• Nasal pruritus (irritation or inflammation of the nose).
• Endonasal paresthesia (sensations such as numbness, tingling, pins and needles in the nose)
• Sneezing
• Paranasal sinus discomfort (nasal obstruction and congestion, thick, opaque and colored nasal discharge, and facial pain or pressure)
• Oral paresthesia (sensations such as numbness, tingling, pins and needles in the mouth or back of the throat)
• Paresthesia (sensations such as numbness, tingling, pins and needles)
• Hypersalivation (excessive saliva production)
• Toothache
• Head discomfort
• Nasal dryness
• Nasal mucosa pathology (inflammation of the tissue lining the nasal cavity)
• Gum discomfort (irritation of the gums and mouth)
• Increased energy
• Fatigue (feeling tired)
• Feeling of warmth
• Increased body temperature
• Presyncope (feeling of fainting)
• Euphoric mood
• Nervousness
• Pruritus (skin itching)
• Epistaxis (nosebleed)
• Chest discomfort

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any side effects not
listed in this leaflet. You can also report side effects directly through the national reporting system
listed in Annex V. By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store EURneffy

Keep this medicine out of the sight and reach of children to whom it is not intended.
Do not use this medicine after the expiry date which is reported on the label of the nasal spray
after Exp. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
In case of accidental freezing, the nasal spray will not work. Allow the nasal spray to thaw
for at least one hour; do not use if the contents are still frozen or not completely thawed.
Freezing does not affect the shelf life of the product.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What EURneffy contains

• The active ingredient is adrenaline (epinephrine). Each dose of nasal spray solution delivers 2 mg of adrenaline in 100 µL.
• The other ingredients are sodium chloride, dodecylmaltoside, disodium edetate, benzalkonium chloride, sodium metabisulfite (E 223), concentrated hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment), water for injections (see section 2. EURneffy contains sodium metabisulfite and benzalkonium chloride).

Description of the appearance of EURneffy and contents of the pack
EURneffy 2 mg nasal spray, solution in a single-dose container is a non-pressurized dispenser that
delivers a single-dose spray containing the active ingredient in a clear and colourless to pinkish-brown
solution.
EURneffy is available in packs of 1 or 2 single-dose nasal sprays.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
ALK-Abelló A/S
Bøge Allé 6-8
2970 Hørsholm
Denmark

Manufacturer
Tiofarma B.V.
Hermanus Boerhaavestraat 1
3261 ME Oud-Beijerland
Netherlands
For further information on this medicinal product, contact the local representative of the Marketing
Authorisation Holder:

België/Belgique/Belgien
ALK-Abelló B.V.
Tél/Tel: +32 (0)28990835

Lietuva
ALK-Abelló A/S
Tel: + 45 45747576

България
ALK-Abelló A/S
Teл.: + 45 45747576

Luxembourg/Luxemburg
ALK-Abelló A/S
Tél/Tel: + 45 45747576

Česká republika
ALK Slovakia s.r.o. – odštěpný závod
Tel: +420 233 312 907

Magyarország
ALK-Abelló A/S
Tel: + 45 45747576

Danmark
ALK-Abelló Nordic A/S
Tlf.: +45 38 16 70 70

Malta
ALK-Abelló A/S
Tel: + 45 45747576

Deutschland
ALK-Abelló Arzneimittel GmbH
Tel: +49 40 703845-0

Nederland
ALK-Abelló B.V.
Tel: +31 (0)365397840

Eesti
ALK-Abelló A/S
Tel: + 45 45747576

Norge
ALK-Abelló Nordic
Tlf: +47 99 44 60 40

Ελλάδα
ALK-Abelló A/S
Τηλ: + 45 45747576

Österreich
ALK-Abelló Allergie-Service GmbH
Tel: +43 732 38 53 72-0

España
ALK-Abelló, S.A.
Tel: +34 3276100

Polska
ALK-Abelló A/S
Tel.: + 45 45747576

France
ALK
Tél: (+33) 03 29 80 71 62

Portugal
ALK-Abelló A/S
Tel: + 45 45747576

Hrvatska
ALK-Abelló A/S
Tel: + 45 45747576

Ireland
ALK-Abelló A/S
Tel: + 45 45747576

România
ALK-Abelló A/S
Tel: + 45 45747576

Slovenija
ALK-Abelló A/S
Tel: + 45 45747576

Ísland
ALK-Abelló A/S
Sími: +45 45747576

Slovenská republika
ALK Slovakia s.r.o.
Tel: +421 2 546 503 71

Italia
ALK-Abelló A/S
Tel: + 45 45747576

Suomi/Finland
ALK-Abelló Nordic A/S, sivuliike
Suomessa/filial i Finland
Puh/Tel: +358 (0)9 5842 2120

ΚύπροςSverige
ALK-Abelló A/S
Τηλ: + 45 45747576
ALK Nordic A/S, Danmark Filial
Tel: +46 (0)300 - 185 45

Latvija
ALK-Abelló A/S
Tel: + 45 45747576
More detailed information on this medicinal product is available on the website of the European
Medicines Agency: https://www.ema.europa.eu.