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

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

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

There is no known reason why anyone should not use EURneffy during an allergic emergency.

You, or anyone who may need to give EURneffy to you (such as a parent, caregiver, or teacher), should be carefully instructed by 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 that signal the onset of an anaphylactic shock occur within minutes of exposure to the allergen and include: itching of the skin, raised rash (like a nettle rash), 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, apprehension, a fast heartbeat, fitting, diarrhoea (loose stools), loss of bladder control. Use EURneffy at the first signs or symptoms of a severe allergic reaction.

Symptoms of anaphylaxis can reoccur within 72 hours of the initial episode, even without new exposure to the allergen that triggered the allergic reaction.

You must make sure you understand the reason EURneffy has been prescribed for you. You should be confident that you know exactly how and when to use EURneffy. Explain how to use EURneffy to your family, carers, co-workers, or teachers. They will need to know how to use it before you suffer an anaphylactic reaction.

If you are at risk of a severe allergic reaction, you should always keep EURneffy with you.

Patients with a history or a recognised risk of a severe allergic reaction that can lead to anaphylactic shock should have quick access to EURneffy.

If you have asthma, you may be at increased risk of a severe allergic reaction.

Anyone who has an episode of anaphylaxis should see their doctor about testing for substances they may be allergic to, so these can be strictly avoided in future. It is important to be aware that an allergy to one substance can lead to allergies to a number of related substances.

Populations with an increased risk of side effects from the use of adrenaline

You may have a greater risk of developing side effects with EURneffy if you:

• have cardiovascular disease (disease affecting the heart and blood circulation).
• have increased pressure in your eyes.
• have reduced renal (kidney) function.
• have prostatic adenoma (a benign (not cancer) condition in which an overgrowth of prostate tissue pushes against the urethra and the bladder, blocking the flow of urine).
• have hypercalcaemia (high blood calcium levels).
• have hypokalaemia (low blood potassium levels).
• have Parkinson’s disease.
• have hyperthyroidism (an overactive thyroid gland).
• have hypertension (high blood pressure).
• have diabetes.
• are elderly.
• 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 are not sure.

Do not give this medicine to children weighing less than 30 kg. The safety and efficacy of this medicinal product are unknown in children below 30 kg body weight.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

This is especially important if you take any of the following as they may reduce the effect of adrenaline:

• Alpha and beta-blocking medicines, e.g. propranolol.
• Medicines that counteract the pressor effects of adrenaline (vasodilators or alpha-adrenergic-blocker, e.g. phentolamine).

You must also tell your doctor or pharmacist if you take any of the following as they may increase the risk of side effects of adrenaline:

• Medicines that may make the heart sensitive to arrhythmias (abnormal or irregular heartbeat), such as digoxin, mercurial diuretics (medicines that increase urine production which act mainly on the transport of sodium) (e.g. chlormerodrin, merbaphen, mersalyl acid, meralluride, mercaptomerin, mercurophylline, merethoxylline procaine) or quinidine.
• Antidepressants such as tricyclic antidepressants, e.g. imipramine, or monoamine oxidase inhibitors (MAO inhibitors) (e.g. isocarboxazid, phenelzine, selegiline, tranylcypromine).
• Medicines for the treatment of Parkinson’s disease such as catechol-O-methyl transferase inhibitors (COMT inhibitors) (e.g. entacapone, tolcapone, carbidopa-levodopa-entacapone, opicapone) and levodopa.
• Medicines for thyroid disease such as levothyroxine.
• Medicines that make you breathe more easily; 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) (e.g. atropine, cyclopentolate, homatropine, hyoscine, tropicamide).

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

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

There is limited experience of the use of adrenaline during pregnancy. If you are pregnant, do not hesitate to use EURneffy in an emergency, since you and your baby’s lives may be in danger. Discuss this with your doctor if you are pregnant.

It is expected that the amount of EURneffy that is passed through breastfeeding is very low. For the emergency treatment of anaphylaxis, EURneffy should be used in breastfeeding women in the same manner as for non-breastfeeding patients.

Alcohol can increase the effect of adrenaline.

The ability to drive and use machines is unlikely to be affected by this medicine. Do not drive if you are having an anaphylactic reaction.

EURneffy contains sodium metabisulphite, which may cause severe allergic reactions (hypersensitivity) or breathing difficulty (bronchospasm).

This medicine contains 0.04 mg benzalkonium chloride in each dose. Benzalkonium chloride may cause irritation or swelling inside the nose, especially if used repeatedly.

• Use EURneffy immediately if you have any signs of anaphylaxis. If in doubt use. Don’t delay.
• Dial 999 - say anaphylaxis (“ana-fill-axis”) as you might need further treatment for your anaphylaxis.
• Lie down and raise your legs.
• Use a new EURneffy to give a second dose - in the same nostril - if you haven’t improved after 5 minutes.
• Sit up if you are struggling to breathe but don’t change position suddenly.
• Lie down again as soon as you can.
• Stay lying down even if you are feeling better.
• You must not stand up even if someone encourages you to.

• Carry two EURneffy nasal sprays with you at all times.
• You must use your EURneffy as soon as you notice any signs of anaphylaxis.
• Make sure you know beforehand what the signs are so you can act swiftly.
• Make sure you know how to use your EURneffy before you need to.
• Familiarise yourself with the trainer device. Practise regularly and often with the trainer device.

You should always carry EURneffy with you or have it close at all times in the event of an allergic emergency. Always carry at least two EURneffy nasal sprays in the event a second dose is needed due to a mistake in taking the medicine or insufficient response after the first dose.

Always tell your friends and family that you carry EURneffy with you.

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, taken as two separate single-dose nasal sprays.

The recommended dose for patients with a body weight of 30 kg or more is a single nasal administration of 2 mg adrenaline. The maximum dose that may be given is 4 mg taken as two separate single-dose nasal sprays.

EURneffy must be given nasally (in the nose) only. EURneffy is a ready-to-use single-dose nasal spray that delivers its entire content (2 mg) upon activation. EURneffy can be used even if you have a cold or a congested nose.

Do not press the plunger before inserting the EURneffy nasal spray into a nostril, otherwise the single dose will be lost prior to use.

EURneffy should only be given as a nasal spray into a nostril; do not spray EURneffy into the eyes or mouth.

The instructions for use must be carefully followed in order to use EURneffy correctly.

If you notice the signs of a severe allergic reaction (see section 2 Warnings and precautions), use EURneffy immediately. Seek emergency medical assistance immediately (dial 999) as you might need further treatment for your anaphylaxis. Ideal dosing is to use the dominant hand to hold the sprayer and administer to the same side nostril (e.g. right hand to right nostril; or left hand to left nostril).

Sometimes a single dose of EURneffy may not be sufficient to completely reverse the effects of a severe allergic reaction. If your symptoms have not improved or have deteriorated within 5 minutes after using the first nasal spray of EURneffy, either you or the person with you should use a new EURneffy nasal spray to give a second dose in the same nostril as the first dose.

The instructions for use given below must be followed.

Before you need to use it, fully familiarise yourself with EURneffy, including when and how it should be used.

Follow these instructions only when ready to use

A Remove EURneffy 2 mg nasal spray from the packaging.

Pull 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 either side of the nozzle.

• Do not pull or push on the plunger.
• Do not test or pre-spray; each nasal spray has only one dose.

C Insert the tip of nasal spray into a nostril until your fingers touch your nose.

Keep the nozzle straight into the nose pointed toward your forehead. Do not angle the nasal spray to the inner or outer walls of the nose.

D Press the plunger up firmly until it snaps up and sprays into the nostril.

Do not angle the nasal spray to the inner or outer walls of the nose.

Seek immediate medical attention after use

Seek immediate medical attention after use

Seek emergency medical assistance immediately (dial 999) as you might need further treatment for your anaphylaxis.

Monitor patient symptoms

If symptoms continue to worsen or reoccur after 5 minutes, or in case of any error in administration, use a new EURneffy nasal spray, to give a second dose in the SAME nostril as the first dose and seek emergency medical assistance.

You should lie down with feet raised. If this makes you breathless, you can gently sit up.

You should not change position suddenly and should lie down again as soon as possible.

You should not stand up even if someone encourages you to. You should stay lying down even if you feel better. Pregnant women should lie on their left side. Unconscious patients should be placed on their side in the recovery position to prevent choking. If symptoms do not resolve, you should, if possible, remain with another person until medical assistance arrives.

In case of an overdose of adrenaline, you should always seek immediate medical help.

Overdose may cause a sudden increase in blood pressure (with symptoms including headache or dizziness), bleeding in brain tissue, palpitations (forceful heartbeats that may be rapid or irregular), reduced blood flow and accumulation of fluid in the lungs (causing symptoms including difficulty breathing). You will need to be monitored.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

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

The EURneffy 2 mg nasal spray, solution in a single-dose container is a non-pressurised dispenser delivering a single-dose spray containing the active substance in a clear and colourless to pink brownish solution.

EURneffy is available in packs containing 1 or 2 nasal single-dose sprays.

Not all pack sizes may be marketed.