Iext

Leaflet accompanying the packaging: patient information

Jext, 150 micrograms, solution for injection in a pre-filled pen

Jext, 300 micrograms, solution for injection in a pre-filled pen

Adrenaline

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• 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 a specific person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Jext and what is it used for
• 2. Important information before using Jext
• 3. How to use Jext
• 4. Possible side effects
• 5. How to store 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 a pre-filled, semi-automatic pen, intended for immediate injection of a single dose of adrenaline into the outer aspect of the thigh (intramuscular injection). Jext is intended for the treatment of life-threatening acute allergic reactions (anaphylaxis) caused by insect bites or stings, food, drugs, or physical exertion. Symptoms indicating the onset of anaphylaxis appear within minutes of exposure to the allergen and include: skin itching, raised rash (resembling hives), sudden flushing of the face, 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.

2. Important information before using Jext

In the event of an acute allergic reaction, Jext can be used at any time. If the patient is allergic (hypersensitive) to sodium metabisulfite or any of the other ingredients of Jext, the doctor will instruct the patient on when to use Jext. For further information on hypersensitivity to sulfites, see the section: Jext contains sodium metabisulfite and sodium chloride.

Warnings and precautions

If the doctor has prescribed Jext to the patient, they should discuss the following with their doctor:

• if the patient has heart disease
• if the patient has hyperthyroidism
• if the patient has high blood pressure
• if the patient has diabetes
• if the patient has a pheochromocytoma (a tumor of the adrenal gland)
• if the patient has increased intraocular pressure (glaucoma)
• if the patient has severe kidney or prostate disease
• if the patient has low potassium or high calcium levels in the blood
• and/or if the patient is elderly, pregnant, or breastfeeding, or if the patient is a child with a body weight of less than 15 kg, due to the increased risk of side effects.

If the patient has asthma, they may be at increased risk of an allergic reaction. Any patient who has experienced an anaphylactic reaction should see a doctor to undergo tests to identify the substances to which they are allergic, in order to avoid them in the future. It is important to be aware that an allergy to one substance can lead to allergies to numerous related substances. If the patient has a food allergy, it is essential to check all ingredients (including medications), as even small amounts can cause severe allergic reactions. The doctor or nurse will instruct the patient on when and how to use Jext correctly. To avoid accidental injection, the patient must follow the instructions for use carefully. Jext can only be injected into the outer aspect of the thigh. The patient should not inject the medicine into the buttock, due to the risk of accidental injection into a vein. Warning: Accidental injection into the hand or fingers can cause blood flow to be cut off to that area. If the patient accidentally injects Jext into these areas, they should immediately go to the emergency room of the nearest hospital for treatment. If the patient has a thick layer of subcutaneous fat, there is a risk that a single dose of Jext may be insufficient. A second dose of Jext may be necessary. The patient should follow the instructions for use described in section 3. If the injection is performed by another person, and the patient's leg is not immobilized during the injection, there is a risk of injury. To avoid injury to the leg, the patient must follow the instructions for use of Jext, as described in section 3.

Jext and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. This is especially important for patients taking:

• Antidepressant medicines, such as tricyclic antidepressants or monoamine oxidase inhibitors (MAOIs).
• Medicines used to treat Parkinson's disease, such as catechol-O-methyltransferase inhibitors (COMT inhibitors) and levodopa.
• Medicines that increase the heart's sensitivity to arrhythmias, such as digoxin or quinidine.
• Medicines used to treat thyroid disorders (e.g., levothyroxine).
• Medicines that make breathing easier, used in asthma (theophylline).
• Medicines used during childbirth (oxytocin).
• Medicines used to treat allergies, such as diphenhydramine or chlorpheniramine (first-generation antihistamines).
• Alpha- or beta-adrenergic blockers used in heart disease.
• Medicines that affect the parasympathetic nervous system, which regulates involuntary functions of the body, such as heart rate and lung function (parasympatholytic or parasympathomimetic medicines).

Patient with diabetes should carefully monitor their blood glucose levels after using Jext, as adrenaline may increase blood glucose levels.

Jext and alcohol

Alcohol may enhance the effects of adrenaline.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should ask their doctor or pharmacist for advice before using this medicine. Data on the use of adrenaline during pregnancy are limited. In life-threatening emergencies, pregnant women may use Jext without hesitation, due to the risk to their life or the life of their child. It is not expected that Jext will have any effect on breastfed infants.

Driving and using machines

It is unlikely that the administration of adrenaline by injection will affect the ability to drive or use machines, but it may be impaired due to a severe allergic reaction. In such cases, the patient should not drive.

Jext contains sodium metabisulfite and sodium chloride

In rare cases, sodium metabisulfite (E 223) may cause severe allergic reactions or respiratory problems (bronchospasm). The doctor must instruct the patient on when to use Jext. This medicine contains less than 1 mmol of sodium (23 mg) per dose, which means it is considered "sodium-free".

3. How to use Jext

This medicine should always be used as directed by the doctor or pharmacist. The patient should make sure they know when to use Jext. If they are unsure, they should ask their doctor or pharmacist.

Dosage

Adults and children over 30 kg- the recommended dose in life-threatening allergic reactions is 300 micrograms of adrenaline, administered by injection into the outer aspect of the thigh (intramuscular injection). Children between 15 kg and 30 kg- the recommended dose in life-threatening allergic reactions is 150 micrograms of adrenaline, administered by injection into the outer aspect of the thigh (intramuscular injection). Note: The correct dose of Jext depends on body weight. The dose should be increased as the child grows, and this should be discussed with the doctor. Jext should be used immediately when the patient observes symptoms of an acute allergic reaction, if necessary through clothing. After the injection, some solution remains in the auto-injector, which cannot be used again. Sometimes, a single dose of adrenaline may not be sufficient to completely eliminate the symptoms of a severe allergic reaction. For this reason, the doctor will likely prescribe more than one Jext auto-injector to the patient. If the symptoms do not subside or worsen within 5 to 15 minutes after the first injection, a second injection should be administered by the patient or someone else. For this reason, the patient should always carry more than one Jext auto-injector with them.

Method of administration

Jext has been designed to be injected through clothing or directly through the skin of the outer aspect of the thigh. After pressing the auto-injector against the thigh, a spring-loaded plunger will push the hidden needle through the protective cover at the end of the black needle cap, which will puncture the thigh muscle and inject the dose of adrenaline. The patient must follow the instructions for use of Jext carefully. Jext should only be injected into the outer aspect of the thigh.

Do not inject into the buttock.

Instructions for use of Jext

Before using Jext, the patient should be sure they fully understand when and how to use this device. For training purposes, the doctor may use a demonstration Jext Trainer auto-injector to ensure that the patient or their family members or caregivers know how to proceed in the event of an acute allergic reaction. It is also recommended that the patient's family members, caregivers, or teachers be instructed on how to properly use the Jext auto-injector. In the event of an injection performed by a caregiver, the patient should be instructed not to move or, if necessary, to immobilize their leg during the injection, in order to minimize the risk of injury to the leg. The auto-injector is for single use only and cannot be used again. The patient should follow the instructions only in case of need to use the medicine.

• Never touch the black end of the needle cap with their thumb, fingers, or hand, as the needle will come out of this place.
• DO NOTremove the yellow protective cap until the auto-injector is ready for use.

To administer the medicine correctly, the patient should follow the diagram and perform the following steps:

	1. The patient should hold the Jext auto-injector with their dominant hand (the hand used for writing), with their thumb as close as possible to the yellow protective cap.
	2. The patient should remove the yellow protective cap with their other hand.
	3. The patient should place the black end of the auto-injector at a 90-degree angle to the outer aspect of the thigh.
	4. The patient should firmly press the black end of the auto-injector against the outer aspect of the thigh until they hear a "click" confirming the start of the injection, and then hold it in place. The patient should hold the auto-injector firmly against the thigh for 10 seconds (counting slowly to 10), and then remove it. The black end will automatically retract, covering the needle.
	5. The patient should gently massage the injection site for 10 seconds. The patient should immediately seek medical help. The patient should call the emergency number 112, ask for an ambulance, and report an anaphylactic reaction.

In the viewing window, there is a colored, plastic rod (white in Jext 300 and blue in Jext 150), to confirm the activation of the auto-injector and the injection of the adrenaline solution. The Jext auto-injector may contain a small air bubble. This does not affect the effectiveness of the medicine. Although most of the solution remains in the Jext auto-injector after use, it cannot be used again. Jext is intended for the treatment of emergency situations. After using Jext, the patient should always seek medical help immediately. The patient should call the emergency number 112, ask for an ambulance, and report an "anaphylactic reaction", even if the symptoms subside. The patient should go to the hospital for observation or further treatment if necessary, as the anaphylactic reaction may recur after some time. While waiting for the ambulance, the patient should lie down with their legs raised, unless this causes difficulty breathing; in such cases, the patient should sit up. The patient should ask someone to stay with them until the ambulance arrives, in case they feel unwell again. Unconscious patients should be placed on their side in the recovery position. The patient should inform the medical staff that they have received adrenaline by intramuscular injection. The patient can also hand over the used Jext auto-injector for safe disposal.

Overdose of Jext

In the event of an overdose of Jext or accidental injection of adrenaline, the patient should alwaysseek medical help immediately. The patient should contact their doctor as soon as possible to replace the used Jext auto-injector. The patient's blood pressure may rise sharply. Overdose may lead to a sudden increase in blood pressure, irregular heart rhythm, abnormal kidney function, decreased blood flow, and fluid accumulation in the lungs. If the patient has any further questions about the use of this medicine, they should ask their doctor or pharmacist.

4. Possible side effects

Like all medicines, Jext 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 (frequency cannot be estimated from the available data):

• Tremors
• Injection site reactions, such as bruising, pain, and swelling
• Dizziness
• Fainting
• Headache
• Feeling of tingling or numbness
• Feeling of rapid or irregular heartbeat
• Muscle stiffness
• Nausea
• Vomiting
• Dry mouth
• Decreased blood flow to the hands and feet in case of accidental injection into these areas
• Increased blood pressure
• Feeling of weakness
• Excessive sweating
• Discomfort or pain in the chest
• Changes in blood test results, such as increased blood sugar levels, decreased potassium levels, and accumulation of harmful acids in the body.

Accidental injection of adrenaline into the hand or foot has been reported, which can cause blood flow to be cut off to that area, as well as cooling, pallor, tingling, numbness, bruising, painful bleeding, and swelling at the injection site. In the event of accidental injection of Jext, the patient should always seek medical help immediately. Jext contains sodium metabisulfite, which may rarely cause severe hypersensitivity reactions, including respiratory problems.

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Jext

The medicine should be stored out of sight and reach of children. Do not use this medicine after the expiry date stated on the label and carton after: "Expiry date (EXP)". The expiry date refers to the last day of the month stated. Store in a temperature below 25°C. Do not freeze.

Remember to check the contents of the glass container of the Jext auto-injector through the viewing window from time to time, to ensure that the solution is clear, colorless, and free of visible particles. The patient should replace Jext before the expiry date or

earlier. Do not use this medicine if the solution has changed color or has become a suspension (visible particles). It may be helpful to write the expiry date in a calendar or diary to ensure that Jext is replaced at the right time.Jext is provided in a plastic case to protect the medicine during transport or storage. The patient should remove Jext from the case before use or when checking the medicine. After checking, the patient should put Jext back in the case. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Jext contains

The active substance is adrenaline. 1 mL of solution contains 1 mg of adrenaline (as tartrate). One Jext 150 micrograms auto-injector delivers 150 micrograms of adrenaline in 0.15 mL of solution for injection. One Jext 300 micrograms auto-injector delivers 300 micrograms of adrenaline in 0.3 mL of solution for injection. The other ingredients are: Sodium chloride, Sodium metabisulfite (E 223), Hydrochloric acid, Water for injections.

What Jext looks like and contents of the pack

Jext is a solution for injection in a pre-filled, semi-automatic pen, in a carton. The auto-injector contains a clear and colorless solution, free of visible particles, in a glass cartridge with a rubber stopper, latex-free. The pre-filled auto-injector is provided in a plastic case. Length of exposed needle: Jext 150 micrograms: 13 mm, Jext 300 micrograms: 15 mm. Pack size: single pack containing 1 pre-filled, single-dose auto-injector.

Marketing authorization holder and manufacturer

Marketing authorization holder

Miguel Fleta 19, 28037 Madrid, Spain.

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Date of last revision of the leaflet:17.08.2023