Leaflet: information for the user

Emerade 150 micrograms solution for injection in a pre-filled pen EFG

Emerade 300 micrograms solution for injection in a pre-filled pen EFG

Emerade 500 micrograms solution for injection in a pre-filled pen

adrenaline

Read this leaflet carefully before you start using the medicine because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What Emerade is and what it is used for

2. What you need to know before you start using Emerade

3. How to use Emerade

4. Possible side effects

5. Storage of Emerade

6. Contents of the pack and additional information

Emerade is an auto-injector device containing adrenaline in a solution for intramuscular injection.

Adrenaline counteracts the drop in blood pressure in anaphylactic reactions. It also stimulates the heart and facilitates breathing.

Emerade is used as emergency treatment for severe allergic reactions (anaphylaxis) caused by food allergens, medications, insect bites or stings, and other allergens, as well as those triggered by exercise or unknown causes.

Your doctor will have explained when and how to use Emerade. If you are not completely sure or have any doubts, you should contact your doctor.

Warnings and precautions

Emerade can always be used in an allergic emergency. If you are allergic (hypersensitive) to sodium metabisulphite or any of the other components of Emerade, your doctor will explain in what circumstances you should use Emerade.

Consult your doctor before starting to use Emerade if you have:

• heart disease,
• high blood pressure,
• hyperthyroidism,
• diabetes,
• an adrenal gland tumor,
• increased eye pressure (glaucoma),
• reduced kidney function,
• prostate disease,
• low levels of potassium or high levels of calcium in the blood.

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

Anyone who has had an anaphylactic episode should see a doctor and have tests to identify substances to which they may be allergic, in order to avoid them in the future. It is essential to note that an allergy to a substance can lead to allergies to related substances.

If you are allergic to a food, it is essential to check the composition of everything you ingest (including medicines), as even small amounts can cause severe reactions.

There is also a greater risk of adverse effects in older people or pregnant women.

Follow the usage instructions carefully to avoid accidental injection.

Emerade must be injected intramuscularly in the outer thigh. It should not be injected into the buttock due to the risk of accidental injection into a vein.

Warnings

Accidental injection into the hands or feet can lead to reduced blood flow in the affected area. If an accidental injection occurs in these areas, you should immediately go to the nearest emergency service for treatment.

If you have a thick layer of subcutaneous fat, there is a risk that a single dose of Emerade may not be sufficient. This may increase the need for a second injection of Emerade. Follow the usage instructions carefully as given in section 3.

Children

Emerade should not be used in children weighing less than 15 kg.

In the case of children weighing less than 15 kg, a dose below 150 micrograms cannot be administered with sufficient precision, and therefore its use is not recommended unless it is a potentially life-threatening situation and under medical advice.

Use in athletes:

This medicine contains adrenaline, which can produce a positive result in doping control tests.

Use of Emerade with other medicines

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medicine.

This is particularly important if you are using any of the following medications:

• Antidepressants such as tricyclic antidepressants or monoamine oxidase inhibitors (MAO inhibitors), as the effects of adrenaline may be increased.
• Medicines to treat Parkinson's disease, such as catechol-O-methyltransferase inhibitors (COMT inhibitors), as they may increase the effect of adrenaline.

• Medicines that can cause the heart to tend to irregular heartbeats (arrhythmias), such as Digitalis and quinidine.

• Medicines called alpha or beta blockers for heart disease or nervous system disorders, as they may reduce the effect of adrenaline.

Diabetic patients should carefully control their blood glucose levels after using Emerade, as adrenaline can increase blood glucose levels.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medicine.

The experience with the use of adrenaline during pregnancy is limited. However, if you are pregnant, you should not avoid using Emerade in an emergency situation where your life may be at risk.

You can continue to breastfeed your child after using Emerade.

Driving and operating machinery

It is unlikely that the ability to drive and operate machinery will be affected by the administration of an adrenaline injection, but it may be affected by a severe allergic reaction. If your ability is affected, do not drive.

Emerade contains sodium metabisulphite

In rare cases, sodium metabisulphite can cause severe hypersensitivity reactions or difficulty breathing (bronchospasm). If you are allergic (hypersensitive) to sodium metabisulphite, your doctor will explain in what circumstances you should use Emerade.

Emerade contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per dose, which is essentially "sodium-free".

Ensure you have received training on the use of Emerade and follow exactly the instructions for Emerade as indicated by your doctor. In case of doubt, consult your doctor or pharmacist.

Check the expiration date of your adrenaline auto-injectors and ask your doctor or nurse to prescribe new ones before they expire. Expired injectors may not function.

Emerade must be used immediately if you begin to experience signs or symptoms of a severe allergic reaction (anaphylaxis). Reactions can appear within a few minutes after contact with the allergen and symptoms can include, for example, skin rash, sweating, or swelling. More severe reactions can also affect the circulatory system and breathing.

Before you need to use Emerade, make sure you understand in what situations you should use it. If you are at risk of anaphylaxis, it is essential that you always carry two adrenaline pens with you at all times. Emerade should be stored in the original box, although during patient/caregiver transport, it is acceptable to store it in the specially designed container in which it is delivered. You should always carry the pen in this container to ensure the protection of the pen and the label that shows how to use it in an emergency. Always keep this informational leaflet in the case.

Dosage

The dose will be decided by your doctor, who will adjust the dose individually, for example, depending on your body weight.

Adults

Adults weighing less than 60 kg

The usual dose is 300 micrograms

Adults weighing more than 60 kg

The usual dose is 300 to 500 micrograms

Children and adolescents

Emerade 500 micrograms is not recommended for use in children.

Children weighing 15 to 30 kg

The usual dose is 150 micrograms.

Children weighing more than 30 kg

The usual dose is 300 micrograms.

Adolescents weighing more than 30 kg

Follow the recommendations indicated for adults.

How to administer Emerade

Follow the usage instructions carefully to avoid accidental injection.

It is recommended that your family members, caregivers, or teachers also receive instructions on how to administer Emerade correctly.

Emerade should only be used by injecting it into the outer thigh at the first signs of a severe allergic reaction. The injection is administered by pressing Emerade against the thigh. It can be administered through clothing. Do not inject into the buttocks.

If an Emerade adrenaline pen does not activate, immediately attempt to do so again using more force to press the pen against the injection site.

If you are unsuccessful, proceed immediately to use your second pen.

1. Remove the cap.

1. Place Emerade against the outer thighwith a 90-degree angle and press firmly so that the needle shield retracts. You will hear a "click" when the device activates and the needle penetrates the thigh.

and

Hold Emerade firmly pressed against the thigh for 5 seconds. Then, gently massage the injection area.

1. Seek medical attention immediately.

The needle of Emerade is protected before, during, and after injection.

When the injection is complete, the needle shield of Emerade appears visibly longer and the plunger is visible in the inspection window when lifting the label.

Key messages for patients:

• Occasionally, a single dose of adrenaline may not be sufficient to completely counteract the effects of a severe allergic reaction. Therefore, your doctor should prescribe two Emerade pens.
• If your symptomsdo not improve or have worsened in the 5-15 minutes after the first injection, either you or the person with you should administer a second. This is why you should always carry two Emerade pens with you.
• Emerade is designed as emergency treatment.Immediately after using Emerade, you must always seek medical attention. Ask someone to stay with you until the ambulance arrives, in case you feel unwell again.
• Call 112,request an ambulance and indicate that it is a case of 'anaphylaxis',even if it seems that the symptoms are improving. You should go to the hospital for observation or to receive further treatment, as needed. This is because a certain time later, the reaction may reappear. Bring the used pen with you.
• While waiting for the ambulanceyou should remain lying down with your feet elevated, unless this position does not allow you to breathe, in which case you should sit up.
• Unconscious patients should be placed on their side, in the recovery position.

After using the Emerade pen following the instructions, the patient can verify if the pen has been activated. The images below (Fig.1-Fig.2) refer to all Emerade doses (150 micrograms, 300 micrograms, and 500 micrograms).

The unused Emerade pen (before activation) has the needle shield in its normal position (Fig. 1).

Fig 1.

The activated Emerade pen will have the needle shield extended (Fig. 2).

Fig. 2

If the needle shield is not extended, the pen has not been activated.

An Emerade pen that has been activated and has administered a successful dose of adrenaline will show a colored plunger in the inspection window (which is revealed by lifting the label):

150 micrograms: yellow

300 micrograms: green

500 micrograms: blue.

If the inspection window still shows a transparent liquid (adrenaline solution), the pen has not administered a correct dose of adrenaline. The arrow on the pen label indicates where the label can be lifted to reveal the inspection window.

Do not remove the cap unless it is necessary to administer the injection.

After the injection, there may be some liquid left in the auto-injector. The auto-injector cannot be reused.

There are needle-free auto-injectors (demonstration pens) available for training.

Please consult your doctor.

If you use more Emerade than you should

If you administer a higher dose or if you accidentally inject Emerade into a blood vessel or hand, you must seek medical attentionimmediately.

Your blood pressure may rise suddenly. Overdose can cause a sudden increase in blood pressure, irregular heartbeat, and fluid accumulation in the lungs, which can make breathing difficult.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 915620420, indicating the medication and the amount ingested.

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

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

The following adverse effects are based on experience with the use of adrenaline, although their frequency cannot be estimated:

• cardiac problems, such as rapid and irregular heartbeat, chest pain,
• increased blood pressure, narrowing of blood vessels,
• sweating,
• nausea, vomiting,
• difficulty breathing,
• headache, dizziness,
• weakness, tremors,
• anxiety, hallucinations,
• syncope,
• changes in blood values, such as increased blood sugar, reduced potassium, and increased acidity

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use https://www.notificaRAM.es

By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the sight and reach of children.

Store in the plastic protective container in which it is delivered. The plastic container containing the pen/pens may be stored in the outer box.

Store below 25 °C. Do not freeze.

Do not use this medication after the expiration date that appears on the label and on the outer box. The expiration date is the last day of the month indicated. After the expiration date, discard Emerade and replace it with another container. Periodically inspect the solution through the inspection window by lifting the label to ensure that the solution remains transparent and colorless. Do not use this medication if you observe that the solution has changed color or contains any precipitate.

Inspect the auto-injector if it has been dropped. Replace it if you observe any damage or leakage.

Medications should not be disposed of through drains or in the trash. Deposit the containers and medications you no longer need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Emerade

The active principle is adrenaline in the form of tartrate.

Emerade 150 micrograms releases 150 micrograms of adrenaline in 0.15 ml of solution.

Emerade 300 micrograms releases 300 micrograms of adrenaline in 0.3 ml of solution.

Emerade 500 micrograms releases 500 micrograms of adrenaline in 0.5 ml of solution.

The other components are: sodium chloride, sodium metabisulphite (E223), disodium edetate, hydrochloric acid, and water for injection.

Appearance of Emerade and contents of the packaging

Emerade is an auto-injector that releases a single dose of adrenaline. Emerade contains an injection solution, transparent and colourless, inside a glass syringe. Emerade does not contain latex.

The device is a white cylinder with a cover that covers the needle and a trigger mechanism.

Exposed needle length:

Emerade 150 micrograms: 16mm

Emerade 300 micrograms and 500 micrograms: 23mm.

Packaging sizes: 1 or 2 pre-loaded pens.

Not all packaging sizes may be marketed.

Marketing authorisation holder and manufacturer responsible

Marketing Authorisation Holder

PharmaSwiss Ceská republika s.r.o.

Jankovcoca 1569/2c, 170 00 Prague 7.

Czech Republic.

Manufacturer Responsible

Rechon Life Science AB

Soldattorpsvägen 5, SE-216 13 Limhamn.

Sweden

Last review date of this leaflet: December 2021

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

You can access detailed and updated information on this medicine by scanning with your smartphone the QR code included in the leaflet. You can also access this information at the following internet address:

https://cima.aemps.es/info/80146

https://cima.aemps.es/info/80147

https://cima.aemps.es/info/80149