JEXT 150 micrograms INJECTABLE SOLUTION IN PRE-FILLED PEN

Introduction

Package Leaflet: Information for the User

Jext 150 micrograms solution for injection in pre-filled pen

Jext 300 micrograms solution for injection in pre-filled pen

Adrenaline

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

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

1. What is Jext and what is it used for

Jext contains a sterile solution of adrenaline in an auto-injector for emergency injection of a single dose of adrenaline into the outer part of the thigh muscle (intramuscular injection).

Jext is used for the emergency treatment of severe allergic reactions (anaphylaxis) that are life-threatening, caused by insect bites or stings, foods, medicines, or exercise.

The symptoms that indicate the start of an anaphylactic reaction occur within minutes of exposure to the allergen and include: itching of the skin, rash (like hives); 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.

2. What you need to know before you use Jext

Jext can always be used in an allergic emergency. If you are allergic (hypersensitive) to sodium metabisulfite or any other ingredient of Jext, your doctor should 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 to you

• If you have a heart disease
• 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 potassium or high calcium levels in the blood.
• And/or if you are elderly, 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 suffering a severe allergic reaction.

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

If you have a food allergy, it is crucial that you check the ingredients of everything you eat (including medicines), as even small amounts can cause severe reactions.

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

The instructions for use must be followed carefully to avoid accidental injection.

Jext should only be injected intramuscularly into the outer part of the thigh.Do not inject into the buttock due to the risk of accidental injection into a vein.

Precautions

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 subcutaneous fat layer, there is a risk that a single dose of Jext may not be sufficient. A second injection may be necessary. Follow the detailed instructions for use carefully in section 3.

Skin injuries (lacerations) can 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 injuries, the instructions for use should be followed carefully in section 3.

Use in athletes:

This medicine contains adrenaline, which may produce a positive result in doping tests. Adrenaline associated with local anesthetics or by local administration (e.g., nasal, ophthalmic) is not prohibited.

Use of Jext with other medicines

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

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

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

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

Use of Jext with alcohol

Alcohol may increase the effect of adrenaline.

Pregnancy, breastfeeding, and fertility

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 using this medicine.

Experience with the use of adrenaline during pregnancy is limited. If you are pregnant, do not hesitate to use Jext in a life-threatening situation, as your life and that of your child may be at risk.

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

Driving and using machines

Your ability to drive and use machines will not be affected by the administration of an adrenaline injection, but it may be affected by the anaphylactic reaction. If this occurs, do not drive.

Jext contains sodium metabisulfite and sodium chloride.

This medicine may cause severe allergic reactions and bronchospasm (sudden feeling of suffocation) because it contains sodium metabisulfite. Your doctor should instruct you on the circumstances under which you should use Jext.

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

3. How to use Jext

Follow the instructions for administration of this medicine indicated by your doctor or pharmacist. Make sure you understand in which situations you should use Jext. In case of 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 into the outer part 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 into the outer part of the thigh (intramuscular use). Remember:The correct dose of Jext depends on body weight. The dose should be increased as the child grows and will need to be consulted with the doctor.

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

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

Sometimes, a single dose of adrenaline may not be enough 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 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.

Method of administration

Jext is designed to be used through clothing or directly through the skin of the outer part of the thigh.

Press Jext firmly against the outer part of the thigh in the longest part of the thigh muscle. When you press Jext firmly against the thigh, a spring is activated that triggers the plunger to push the hidden needle through the membrane at the end of the black needle cover, in the direction of the thigh muscle, injecting a dose of adrenaline.

The instructions for use of Jext should be followed carefully.

Jext should onlybe injected into the outer part of the thigh. Do not inject into the buttock (your backside).

Instructions for use

Before you need to use it, you should be completely familiar with Jext, when and how you should use it. During the instruction in the correct use of Jext, your doctor may use a Jext Simulator, to ensure that you, other family members, or caregivers are safe and know what to do in case of an allergic emergency.

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 should 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 put your thumb, feet, or hand over the black needle cover as the needle comes out through it.

Do not remove the yellow capuntil Jext is ready to be used.

For correct administration, observe the diagrams and follow these steps:

The inspection window on the label is filled to the height of the colored plastic rod (white in Jext 300 and blue in Jext 150) to confirm that the auto-injector has been activated and the adrenaline solution has been injected.

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

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

Jext is designed as an emergency treatment. You should always receive medical help immediately after using Jext. Call 112, ask for an ambulance, and say you are suffering from anaphylaxis, even if your symptoms seem to be improving. You will need to go to the hospital for observation and further treatment if necessary. This is because the reaction can occur again sometime later.

While waiting for the ambulance, you should lie on your back with your feet raised, unless this makes 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 the recovery position.

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

If you use more Jext than you should

In case of overdose or accidental injection of adrenaline, you should seek immediatemedical 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 on 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.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

Frequency not known (cannot be estimated from the available data):

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

There have been reports of accidental injection of adrenaline into fingers or toes, which can cause reduced blood flow in the affected area, as well as coldness, lack of color, tingling, and numbness, hematoma, pain, bleeding, and swelling at the injection site. In case of accidental injection, always seek medical help immediately.

Jext contains sodium metabisulfite, which may rarely cause hypersensitivity reactions, including difficulty breathing.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use www.notificaRAM.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Jext

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

Do not use this medicine after the expiry date which is stated on the label and on the carton after EXP. The expiry date is the last day of the month stated.

Store below 25°C.

Do not freeze.

Remember to periodically inspect the contents of the glass cartridge in Jext through the window in the label from time to time, to ensure that the liquid remains transparent, colorless, and free of visible particles.Replace Jext on its expiry date or before. Do not use this medicine if you notice that the solution has changed color or contains a precipitate (solid particles).It may be useful to write the expiry date in your calendar or diary to ensure you replace Jext on time.

Jext is supplied in a plastic case to protect it during transport or storage. Jext should be removed from its case before use and during inspection of Jext. Store Jext in its case after inspection.

Medicines should not be disposed of via wastewater or household waste. Return the containers and any unused medicines to the pharmacy. If you are unsure, ask your pharmacist how to dispose of the containers and any unused medicines. This will help protect the environment.

6. Container Content and Additional Information

Jext Composition

The active ingredient is adrenaline.

1 ml of solution contains 1 mg of adrenaline (as 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 metabisulfite (E223),

Hydrochloric acid,

Water for injectable preparations.

Product Appearance and Container Content

Jext is an injectable solution in a pre-loaded pen. It contains a clear, colorless, and particle-free solution in a sealed glass cartridge with a latex-free rubber stopper. The pre-loaded pen is supplied in a plastic case.

Exposed needle length:

Jext 150 micrograms: 13 mm

Jext 300 micrograms: 15 mm

Container size: Single unit package with 1 pre-loaded pen. Multiple package with 2 pre-loaded pens.

Only some package sizes may be marketed

Marketing Authorization Holder

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

Manufacturer

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 authorized in the Member States of the European Economic Area under the name:

Date of the last revision 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 Health Products (AEMPS) http://www.aemps.gob.es.