Eurneffy

Package leaflet: Information for the user

EURneffy 2 mg nasal spray, solution in single-dose container

adrenaline
Read this entire leaflet carefully before using this medicine because 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 other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact 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 using 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 EURneffy is and what it is used for

EURneffy contains the active substance adrenaline (epinephrine), a sympathomimetic medicine (a medicine that acts on the sympathetic nervous system, the part of the nervous system that increases heart rate, blood pressure, respiratory 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 potentially life-threatening allergic reactions), due to insect stings or bites, foods, medicines, and other allergens (substances that cause an allergy), as well as idiopathic anaphylaxis (of unknown cause) or exercise-induced anaphylaxis. EURneffy is intended for immediate self-administration (or administration by another person assisting the patient or by medical personnel) in individuals with a history or known risk of severe allergic reaction that may lead to anaphylactic shock.
The active substance in EURneffy, adrenaline, is a natural hormone released by the body in response to stress. It acts directly on the cardiovascular (heart and blood circulation) and respiratory (lungs) systems to counteract the potentially fatal effects of a severe allergic reaction that may cause anaphylactic shock. In acute allergic reactions, it improves blood pressure, cardiac function, and breathing, and reduces tissue swelling.
EURneffy is an emergency rescue therapy, but emergency medical assistance must be sought immediately to ensure careful monitoring of the anaphylactic episode and in case further treatment is required. Always inform your 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 EURneffy should not be used in case of an allergic emergency.
Warnings and precautions
You, or any person who might need to administer EURneffy to you (e.g., a parent, caregiver, or teacher), must receive clear instructions from your doctor or nurse on how and when to correctly use EURneffy (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 skin rash (such as hives); flushing; 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, seizures, diarrhea (watery stools), loss of bladder control. Use EURneffy at the first signs or symptoms of a severe allergic reaction.
Symptoms of anaphylaxis may recur within 72 hours after the initial episode, even without further exposure to the allergen that triggered the reaction.
Ensure you understand why EURneffy has been prescribed for you. You must be certain of exactly how and when to use EURneffy. Explain how to use EURneffy to your family members, caregivers, colleagues, or teachers: they should know how to use it before you experience a possible anaphylactic reaction.
If you are at risk of a severe allergic reaction, you must always carry EURneffy with you. Patients with a history or known risk of severe allergic reactions that may lead to anaphylactic shock must have rapid access to EURneffy.
If you have asthma, you may be at increased risk of developing a severe allergic reaction.
Anyone who has experienced an episode of anaphylaxis should consult their doctor for testing to identify substances to which they may be allergic, so these can be strictly avoided in the future. It is important to be aware that an allergy to one substance may lead to allergies to related substances.
Populations at higher risk of adverse effects due to adrenaline use
You may have an increased risk of developing adverse effects with EURneffy if:

• you have cardiovascular disease (a condition affecting the heart and blood circulation);
• you have increased intraocular pressure;
• you have reduced kidney function;
• you have benign prostatic hyperplasia [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 hypokalemia (low levels of potassium in the blood);
• you have Parkinson’s disease;
• you have hyperthyroidism (overactive thyroid gland);
• you have hypertension (high blood pressure);
• you have diabetes;
• you are elderly;
• you are pregnant (see section 2 Pregnancy, breastfeeding and fertility).

Consult your doctor if any of the above conditions apply to you or if you have any doubts.
Children and adolescents
Do not administer this medicine to children weighing less than 30 kg. The safety and efficacy of this medicine are not known in children with body weight below 30 kg.
Other medicines and EURneffy
Inform 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 may reduce the effect of adrenaline:

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

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

• medicines that may make the heart sensitive to arrhythmias (abnormal or irregular heartbeats), such as digoxin, mercurial diuretics (medicines that increase urine production and primarily affect sodium transport) (e.g., chlormerodrin, novasurol, mersalyl acid, meralluride, mercaptomerin, mercurophylline, meretoxilline procaine) or quinidine;
• antidepressants such as tricyclic antidepressants, for example imipramine, or monoamine oxidase inhibitors (MAO inhibitors) (e.g., isocarboxazid, phenelzine, selegiline, tranylcypromine);
• medicines for Parkinson’s disease such as catechol-O-methyltransferase inhibitors (COMT inhibitors) (e.g., entacapone, tolcapone, carbidopa-levodopa-entacapone, opicapone) and levodopa;
• medicines for thyroid disorders such as levothyroxine;
• medicines that facilitate breathing, used for asthma (theophylline);
• medicines used during labor (oxytocin);
• medicines used to treat allergies such as diphenhydramine or chlorpheniramine (antihistamines);
• medicines acting on the nervous system (anticholinergics) (e.g., atropine, cyclopentolate, homatropine, hyoscine, tropicamide).

Patients with diabetes should closely monitor their glucose levels after using EURneffy, as adrenaline may reduce the amount of insulin produced by the body, thereby increasing blood glucose levels.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Knowledge regarding the use of adrenaline during pregnancy is limited. In an emergency situation, do not hesitate to use EURneffy, as both you and your baby may be at life-threatening risk. If you are pregnant, discuss this with your doctor.
The amount of EURneffy expected to pass into breast milk is minimal. For emergency treatment of anaphylaxis, EURneffy should be used in breastfeeding women as it is in non-breastfeeding patients.
EURneffy and alcohol
Inform your doctor if you consume alcoholic beverages, as they may increase the adverse effects of adrenaline.
Driving and using machines
This medicine does not impair the ability to drive or operate machinery. However, do not drive if you are experiencing an anaphylactic reaction.
EURneffy contains sodium metabisulfite and benzalkonium chloride
EURneffy contains sodium metabisulfite, which may cause severe allergic reactions (hypersensitivity) or breathing difficulties (bronchospasm).
This medicine contains 0.04 mg of benzalkonium chloride per dose. Benzalkonium chloride may cause irritation or swelling inside the nose, especially if used repeatedly.

3. How to use EURneffy

Use EURneffy exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
When to carry EURneffy with you
You must always carry EURneffy with you or keep it readily accessible in case of an allergic emergency.
Always carry at least two EURneffy devices in case a second dose is needed due to incorrect administration of the medicine or an inadequate response after the first dose.
Always inform your friends and family members that you carry EURneffy with you.
Dosage
The recommended dose for patients weighing 30 kg or more is one single nasal spray of EURneffy delivering 2 mg of adrenaline. The maximum dose of adrenaline for emergency treatment of allergic reactions is 4 mg, administered as two separate single-dose nasal sprays.
Use in children
The recommended dose for patients weighing 30 kg or more is one single nasal administration of 2 mg of adrenaline. The maximum dose that may be administered is 4 mg, given as two separate single-dose nasal sprays.
Method of administration
EURneffy must be administered only intranasally (into the nose). EURneffy is a ready-to-use, single-dose nasal spray that delivers the full content (2 mg) upon activation.
EURneffy can be used even if you have a cold or nasal congestion.
Press the plunger only after inserting the EURneffy nasal spray into one nostril; otherwise, the single dose will be lost before use.
EURneffy must be administered exclusively as a nasal spray into one nostril; do not spray EURneffy into the eyes or mouth.
It is essential to carefully follow the instructions for use to ensure proper administration of EURneffy.
If you notice signs of an acute allergic reaction (see section 2, Warnings and precautions), use EURneffy immediately. Immediately call for emergency medical assistance to ensure close monitoring of the anaphylactic episode and in case further treatment is required. The ideal administration is performed by holding the spray in your dominant hand and administering it into the nostril on the same side (for example, right hand into the right nostril or left hand into the left nostril).
Sometimes a single dose of EURneffy may not be sufficient to completely reverse the effects of a severe allergic reaction. If symptoms do not improve or worsen within approximately 10 minutes after using the first EURneffy nasal spray, you or the person assisting you must administer a second EURneffy nasal spray into the SAME nostril as the first dose.
You must follow the instructions for use provided below.
Instructions for use
Before you need to use it, become familiar 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 ready to use.
A
Remove EURneffy 2 mg nasal spray from the packaging.

Open the packaging to remove the 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 each side of the nozzle.

• Do not pull or push the plunger
• Do not perform test sprays or practice sprays; each nasal spray contains only one dose.

C

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

Firmly press the plunger until it clicks to deliver the spray into the nostril.

Do not tilt the nasal spray toward the inner or outer walls of the nose.

Seek immediate medical attention after use.
Call immediately for emergency medical assistance to ensure close monitoring of the anaphylactic episode and in case further treatment is required.
Monitor the patient's symptoms
If symptoms continue to worsen or recur after approximately 10 minutes, or if there was any administration error, use a new EURneffy nasal spray to administer a second dose into the SAME nostril as the first dose, and immediately call for emergency medical assistance.
If necessary, lie down with your feet elevated. If this position makes breathing difficult, sit up. Unconscious patients should be placed on their side in the recovery position to prevent choking. If symptoms do not resolve, remain with another person, if possible, until medical help 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 brain tissue, palpitations (forceful, rapid, or irregular heartbeats), reduced blood flow, and fluid accumulation in the lungs (causing symptoms such as difficulty breathing). You will need to be monitored.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them. If any of the side effects listed below occurs or worsens, inform 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 restlessness
• Sore throat

Common (may affect up to 1 in 10 people)

• Increased blood pressure
• Palpitations (forceful, rapid, or irregular heartbeat)
• Rhinorrhea (runny nose)
• Anxiety
• Nasal edema (itching and burning in the nose; the nose is swollen, warm, and red)
• Rhinalgia (pain in the nose)
• Increased heart rate
• Nasal congestion

Uncommon (may affect up to 1 in 100 people)

• Dizziness
• Increased lacrimation (watery eyes)
• Tremor (shakiness)
• Oropharyngeal pain (pain in the tongue, soft palate, lateral and posterior throat walls, 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 blockage 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
• Dry nose
• Nasal mucosal disorder (inflammation of the tissue lining the nasal cavity)
• Gum discomfort (irritation of gums and mouth)
• Increased energy
• Fatigue (feeling of tiredness)
• Feeling of warmth
• Increased body temperature
• Presyncope (feeling faint)
• Euphoric mood
• Nervousness
• Pruritus (itching of the skin)
• Epistaxis (nosebleed)
• Chest discomfort

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please contact your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system detailed 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 medicinal product out of the sight and reach of children to whom it is not intended for use.
Do not use this medicinal product after the expiry date stated on the nasal spray label after "Exp". The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
In case of accidental freezing, the nasal spray will not function properly. 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 medicinal product via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What EURneffy contains

• The active substance is adrenaline (epinephrine). Each dose of nasal spray solution delivers 2 mg of adrenaline in 100 µL.
• The other components are sodium chloride, dodecyl maltoside, 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 substance in a clear solution ranging from colourless to pinkish-brown.
EURneffy is available in packs containing 1 or 2 single-dose nasal sprays.
Not all pack sizes may be marketed.

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

Manufacturer
Tiofarma B.V.
Hermanus Boerhaavestraat 1
3261 ME Oud-Beijerland
The Netherlands

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

België/Belgique/Belgien Lietuva
ALK-Abelló B.V. ALK-Abelló A/S
Tél/Tel: +32 (0)28990835 Tel: +45 45747576

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

Česká republika Magyarország
ALK Slovakia s.r.o. – odštěpný závod ALK-Abelló A/S
Tel: +420 233 312 907 Tel: +45 45747576

Danmark Malta
ALK-Abelló Nordic A/S ALK-Abelló A/S
Tlf.: +45 38 16 70 70 Tel: +45 45747576

Deutschland Nederland
ALK-Abelló Arzneimittel GmbH ALK-Abelló B.V.
Tel: +49 40 703845-0 Tel: +31 (0)365397840

Eesti Norge
ALK-Abelló A/S ALK-Abelló Nordic
Tel: +45 45747576 Tlf: +47 99 44 60 40

Ελλάδα Österreich
ALK-Abelló A/S ALK-Abelló Allergie-Service GmbH
Tel: +45 45747576 Tel: +43 732 38 53 72-0

España Polska
ALK-Abelló, S.A. ALK-Abelló A/S
Tel: +34 3276100 Tel: +45 45747576

France Portugal
ALK ALK-Abelló A/S
Tél: (+33) 03 29 80 71 62 Tel: +45 45747576

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

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

Ísland Slovenská republika
ALK-Abelló A/S ALK Slovakia s.r.o.
Sími: +45 45747576 Tel: +421 2 546 503 71

Italia Suomi/Finland
ALK-Abelló A/S ALK-Abelló Nordic A/S, sivuliike
Tel: +45 45747576 Suomessa/filial i Finland
Puh/Tel: +358 (0)9 5842 2120

Κύπρος Sverige
ALK-Abelló A/S ALK Nordic A/S, Danmark Filial
Tel: +45 45747576 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.