Package Insert: Information for the User

Jext 150 micrograms injectable solution in pre-filled pen

Jext 300 micrograms injectable solution in pre-filled pen

Adrenaline

Read this package insert carefully before you start using this medicine, because it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed to you alone, and you must 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 package insert. See section 4.

1. What Jext is and how it is used

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

3. How to use Jext

4. Possible side effects

5. Storage of Jext

6. Contents of the pack and additional information

Jextcontainsa sterile solutionof adrenaline inside a self-injectorforthe emergency injectionof a single dose of adrenaline in the outer part of the thigh muscle (intramuscular injection).

Jext is used for the emergency treatment of sudden allergic reactions that threaten life (“anaphylactic shock”),insect bites or stings, foods, medications, or exercise.

The symptoms that signal the onset of anaphylactic reaction occur within a few minutes after exposure to the allergen and include: itching of the skin,eruption (such as urticaria); flushing; swelling of the lips, throat, tongue, hands, and feet; wheezing; hoarseness;difficulty breathing;nausea; vomiting; abdominal cramps and, in some cases, loss of consciousness.

Jext can be used in an allergic emergency. If you are allergic (hypersensitive) to sodium metabisulfite or any other ingredient in Jext, your doctor must instruct you on the circumstances under which you should use Jext. For more information on hypersensitivity to sulfites, please see the section:

Jext contains sodium metabisulfite and sodium chloride.

Warnings and precautionsConsult your doctor when Jext is prescribed

• If you have a heart condition
• If you have hyperthyroidism
• If you have high blood pressure
• If you have diabetes
• If you have a tumor in the adrenal gland (pheochromocytoma)
• If you have increased pressure in the eye (glaucoma)
• If you have kidney or prostate disease
• If you have low levels of potassium or high levels of calcium in the blood.
• And/or if you are an elderly person, pregnant, or a child weighing less than 15 kg, as there is a higher risk of adverse effects.

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

Anyone who has experienced an episode of anaphylaxis should see a doctor to undergo skin allergy tests, and thus avoid the substances to which they are allergic strictly in the future. It is essential to know that an allergy to a substance can lead to allergies to a number of related substances.

If you are allergic to foods, it is essential that you check the ingredients of everything you ingest (including medications), as even small amounts can cause severe reactions.

Your doctor or nurse should give you detailed instructions on when and how to useJext correctly.

Precautions

Accidental injection in the hands or feet may 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 subcutaneous fat layer, there is a risk that a single dose of Jext may not be sufficient. A second injection may be necessary. Please follow the detailed usage instructions in section 3 carefully.

Wounds on the skin (lacerations) may occur if the injection is administered by someone other than the patient and if the patient's leg is not immobilized during the injection. To prevent wounds, the detailed usage instructions in section 3 should be followed carefully.

Use in athletes:

This medication contains adrenaline, which can produce a positive result in doping control tests. Adrenaline associated with local anesthetic agents or administered locally (e.g., nasal, ophthalmic) is not prohibited.

Use of Jext with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

It is especially important if you are taking any of the following medications:

• Antidepressants such as tricyclic antidepressants or monoamine oxidase inhibitors (MAO inhibitors)
• Medications for Parkinson's disease, such as catechol-O-methyltransferase inhibitors (COMT inhibitors) and levodopa
• Medications that can make the heart sensitive to irregular heartbeats (arrhythmias), such as digitalis or quinidine.
• Medications for thyroid disorders (e.g., levotiroxine).
• Medications that facilitate breathing; those used for asthma (theophylline).
• Medications that facilitate childbirth (oxytocin).
• Medications for allergy treatment, such as diphenhydramine, chlorphenamine (first-generation antihistamines).
• Alpha and beta blockers for heart disease.
• Medications that act on the parasympathetic nervous system, which regulates the body's unconscious functions, such as heart rate and lung function (parasympatholytics, parasympathomimetics).

Patients with diabetes should carefully control their blood glucose levels after usingJextas adrenaline can increase blood glucose levels.

Use of Jext with alcohol

Alcohol can increase the effect of adrenaline.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medication.

The experience of using adrenaline during pregnancy is limited. If you are pregnant, do not hesitate to use Jext in a critical situation, as your life and that of your child may be at risk.

Jext is not expected to have any effect on the infant.

Driving and operating machinery

The ability to drive and operate machinery will not be affected by the administration of an adrenaline injection, but it may be affected by anaphylactic reactions. If this occurs, do not drive.

Jext contains sodium metabisulfite and sodium chloride.

This medication can produce severe allergic reactions and bronchospasm (sudden feeling of choking) because it contains sodium metabisulfite.Your doctor should instruct you on the circumstances in which you should use Jext.

This medication contains less than 23 mg (1 mmol) of sodium per dose, making it essentially "sodium-free".

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. Make sure you understand in what situations you should use Jext. If in doubt, consult your doctor or pharmacist again.

Dose

Adults and children over 30 Kg- The recommended dose for allergic emergencies is 300 micrograms of adrenaline for injection in the outer aspect of the thigh (intramuscular use).

Children between 15 Kg and 30 Kg- The recommended dose for allergic emergencies is 150 micrograms of adrenaline for injection in the outer aspect of the thigh (intramuscular use).Remember:The appropriate dose of Jext depends on body weight. The dose should be increased as the child grows and it will be necessary to consult with the doctor.

If you detect signs of an acute allergic reaction, useJextimmediately, even through clothing if necessary.

After use, some liquid will remain in the auto-injector, but it should not be reused.

At times, a single dose of adrenaline may not be sufficient to completely counteract the effects of a severe allergic reaction. For this reason, your doctor may prescribe more than one unit of Jext. If your symptoms have not improved or have worsened in the 5-15 minutes after the first injection, either you or the person with you should administer a second injection. For this reason, you should always carry more than one unit of Jext with you.

Administration method

Jexthas been designed to be used through clothing or directly through the skin of the outer aspect of the thigh.

Jextmust be pressed firmlyagainst the outer aspect of the thigh in the longest part of the thigh muscle. When pressingJextfirmlyagainst the thigh, a spring is activated, which activates the plunger, pushing the hidden needle through the membrane at the end of the black cover of the needle, into the thigh muscle, injecting a dose of adrenaline.

The usage instructions forJextmust be followed carefully.

Jextshould onlybe injected into the outer aspect of the thigh.Do not inject into the buttocks.

Usage instructions

Before having to use it, you must become completely familiar with Jext, when and how you should use it. During the instruction on the proper use of Jext, your doctor may use a Jext Simulator, to ensure that you, other family members or caregivers are sure of what you should do in case of an emergency allergic reaction.

It is recommended that family members, caregivers or teachers are also trained in the correct use of the Jext auto-injector. If you are a caregiver, you must instruct the patient not to move and, if necessary, immobilize the patient's leg during the injection to minimize the risk of lacerations.

The auto-injector is for single use and cannot be reused.

Follow these instructions only when you are ready to use it:

Never place your finger, feet or hand on the black cover of the needle, as this is where the needle comes out.

Never removethe yellow cap untilJextis about to be used.

To administer correctly, observe the diagrams and follow these steps:

The inspection window on the label is filled up to the height of the colored plastic rod (white inJext300 and blue inJext150) to confirm that the auto-injector has been activated and the adrenaline solution has been injected.

A small air bubble may appear inJext. This does not affect the product's effectiveness.

Although after use, most of the liquid will remain inJext, it should not be reused.

Jexthas been designed as an emergency treatment. You must always receive immediate medical attention after using Jext. Call 112, request an ambulance and say you are suffering from anaphylaxis,even if it seems that your symptoms are improving. You will need to go to a hospital for observation and subsequent treatment if necessary. This is because the reaction may appear again at a later time.

While waiting for the ambulance, lie on your back with your feet raised, unless this would make it difficult for you to breathe, in which case you should sit. Ask someone to stay with you until the ambulance arrives in case you feel unwell again.

Unconscious patients should be placed in a lateral recovery position.

Inform the healthcare professional that you have received an intramuscular injection of adrenaline. You can also hand over the used Jext for safe disposal.

If you use more Jext than you should

In case of overdose or accidental injection of adrenaline, you must seekimmediatelymedical help. You should consult your doctor to replace the used Jext as soon as possible.

Your blood pressure may rise. An overdose could cause a sudden increase in blood pressure, irregular heartbeats, abnormal kidney function, reduced blood circulation, and fluid accumulation in the lungs.

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

In case of overdose or accidental injection, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20.

Like all medications, this medication may have adverse effects, although not all people may experience them.

The following adverse effects are based on experience with the use of adrenaline.

Unknown frequency (cannot be estimated with available data):

• Trembling
• Reactions at the injection site such as hematoma, pain, and swelling
• Dizziness
• Fainting
• Headache
• Sensation of tingling or numbness
• Sensation of rapid or irregular heartbeats
• Muscle stiffness
• Nausea
• Vomiting
• Dry mouth
• Decreased blood flow to hands and feet in case of accidental injection in these areas
• Increased blood pressure
• Sensation of weakness
• Sweating
• Discomfort or pain in the chest
• Changes in your blood such as increased sugar levels, decreased potassium levels, and harmful accumulation of acid in the body

Accidental injections of adrenaline into fingers or feet have been described, which may cause decreased blood flow to the affected area, as well as coldness, lack of coloration, sensation of tingling, and numbness, hematomas, pain, bleeding, and swelling at the injection site. In case of accidental injection, always seek immediate medical help.

Jext contains sodium metabisulfite, which rarely could cause hypersensitivity reactions including respiratory difficulty.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly throughthe Spanish System for Pharmacovigilance of Medicines for Human Usewww.notificaRAM.es.

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

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

Do not usethis medicationafter the expiration date that appears on the label and on the packaging after CAD. The expiration date is the last day of the month indicated.

Store below 25°C.

Do not freeze.

Remember to periodically examine the contents of the glass cartridge in Jextthrough the window on the label every now and then, to ensure that the liquid remains transparent, colorless, and free of visible particles.Replace Jext on its expiration date or before. Do not use this medication if you observe that the solution has changed color or contains a precipitate (solid particles).It may be helpful to write the expiration date in your calendar or diary to ensure that you replaceJexton time.

Jext is supplied in a plastic pouch to protect it during transport or storage. Jext must be removed from its pouch before use as well as during inspection of Jext. Store Jext in its pouch after inspection.

Medicines should not be thrown down the drain or in the trash. Dispose of the containers and medicines you no longer need at the SIGRE Point at the pharmacy. In case of doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. In this way, you will help protect the environment.

Composition of Jext

The active ingredient is adrenaline.

1 ml of solution contains 1 mg of adrenaline (in the form of tartrate).

Jext 150 micrograms injects a single dose of 150 micrograms of adrenaline in 0.15 ml of injectable solution.

Jext 300 micrograms injects a single dose of 300 micrograms of adrenaline in 0.3 ml of injectable solution.

The other components are:

Sodium chloride,

Sodium metabisulphite (E223),

Hydrochloric acid,

Water for injectable preparations.

Appearance of the product and contents of the packaging

Jext is an injectable solution in a preloaded pen. It contains a transparent, colourless and particle-free solution in a sealed glass cartridge with rubber that does not contain latex. The preloaded pen is supplied in a plastic case.

Length of the exposed needle:

Jext 150 micrograms: 13 mm

Jext 300 micrograms: 15 mm

Package size: Single unit package with 1 preloaded pen. Multiple unit package with 2 preloaded pens.

Only some package sizes may be commercially available

Marketing authorisation holder

ALK-Abelló A/S, Bøge Allé 6-8, DK-2970 Hørsholm.

Responsible for manufacturing

ALK-Abelló, S.A. C/ Miguel Fleta, 19. 28037 – Madrid.

Local representative: ALK-Abelló, S.A. C/ Miguel Fleta, 19. 28037 – Madrid

This medicinal product is authorised in the member states of the European Economic Area with the name:

Revision date of this leaflet:08/2023

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