Epipen Ir.

Patient Information Leaflet: User Information

EpiPen Jr., 150 micrograms, solution for injection in a pre-filled syringe

Epinephrine

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, pharmacist, or nurse.
• This medicine has been prescribed for a specific person. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

• 1. What is EpiPen Jr. and what is it used for
• 2. Important information before using EpiPen Jr.
• 3. How to use EpiPen Jr.
• 4. Possible side effects
• 5. How to store EpiPen Jr.
• 6. Contents of the pack and other information

1. What is EpiPen Jr. and what is it used for

EpiPen Jr. is a sterile solution for injection in a pre-filled syringe for intramuscular use in life-threatening conditions.
Automatic EpiPen Jr. injectors (epinephrine) are intended for the emergency treatment of severe allergic reactions (anaphylaxis) caused by allergens such as food, drugs, or insect bites, as well as reactions caused by exercise or unknown causes.
Automatic EpiPen Jr. injectors are intended for the immediate administration of epinephrine (adrenaline) to patients with a confirmed increased risk of anaphylaxis, including those with a history of anaphylactic reactions.
Symptoms that may indicate a severe allergic reaction include: skin itching; hives (like nettle rash); redness; swelling of the mouth, throat, tongue, hands, and feet; wheezing; hoarseness; nausea; vomiting; abdominal cramps; and, in some cases, loss of consciousness.
The injector contains epinephrine (adrenaline), an adrenergic drug.
Epinephrine acts directly on the cardiovascular system (heart and circulation) and the respiratory system (lungs), counteracting the potentially fatal consequences of a severe allergic reaction by rapidly constricting blood vessels and relaxing muscles in the lungs, making it easier to breathe, reducing swelling, and accelerating heart rate.

2. Important information before using EpiPen Jr.

When not to use EpiPen Jr.

There are no known reasons why EpiPen Jr. should not be used in the event of a severe allergic reaction.

Warnings and precautions

If the patient has asthma, they may be at increased risk of an allergic reaction.
Any patient who has experienced an anaphylactic reaction should consult a doctor to undergo tests for the presence of substances to which they may be allergic, in order to avoid them in the future.
It is essential to remember that an allergy to one substance can lead to an allergy to numerous related substances.
If the patient has a food allergy, it is crucial to check all ingredients (including medications), as even small amounts can cause severe allergic reactions.
Tell your doctor if you have:

• heart disease
• hyperthyroidism
• high blood pressure
• diabetes
• increased intraocular pressure (glaucoma)
• severe kidney disease
• prostate gland tumor (prostate)
• high calcium levels or low potassium levels in the blood
• Parkinson's disease

Despite the above reservations, epinephrine is essential in the treatment of severe allergic reactions. Patients with the above conditions and all individuals who may find themselves in a situation where EpiPen Jr. needs to be administered to a patient with a severe allergic reaction should be properly instructed on when to use this medicine.

To avoid accidental injection, follow the instructions for using the automatic injector.

EpiPen Jr. can only be injected into the outer thigh. Do not inject 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 accidental injection occurs, seek immediate medical attention at the nearest hospital emergency room.
If the patient has a thick layer of subcutaneous fat, there is a risk that a single dose of EpiPen Jr. may be insufficient. A second dose of the medicine may be necessary.
Follow the instructions for use described in section 3.

Children and adolescents

Children with a body weight of less than 15 kg:

The suitability of EpiPen Jr. will be assessed by the doctor for each patient individually.
EpiPen Jr. is not recommended for use in children with a body weight of less than 7.5 kg, unless in life-threatening situations and on the explicit advice of a doctor.

Children and adolescents with a body weight of more than 30 kg:

For these patients, EpiPen Senior is available, containing 300 micrograms of epinephrine in a single dose.

EpiPen Jr. and other medicines

Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
This is especially important for patients taking:

• antidepressants, such as tricyclic antidepressants or monoamine oxidase inhibitors (MAOIs), as they may enhance the effects of epinephrine
• medicines used in Parkinson's disease, such as catechol-O-methyltransferase (COMT) inhibitors and levodopa, due to the possibility of enhanced epinephrine effects
• medicines that increase the heart's susceptibility to arrhythmias, such as digoxin or quinidine
• medicines belonging to the group of beta-adrenergic receptor antagonists (beta-blockers) used in heart diseases or medicines used in nervous system diseases, due to the possibility of reduced epinephrine effects
• medicines used in thyroid diseases
• medicines that facilitate breathing in asthma (theophylline)
• medicines used during childbirth (oxytocin)
• medicines used in allergies, such as diphenhydramine or chlorphenamine (antihistamines)
• medicines that affect the nervous system (parasympatholytics)

Patients with diabetes should carefully monitor their blood glucose levels after using EpiPen Jr., as epinephrine may affect insulin release and thereby increase blood glucose levels.

Using EpiPen Jr. with food, drink, and alcohol

Food and drinks do not affect the use of EpiPen Jr.
People who consume alcohol should inform their doctor, as alcohol may enhance the effects of epinephrine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
In life-threatening situations, pregnant women may use EpiPen Jr. without hesitation, due to the risk to their life or the life of their child. Data on the use of epinephrine during pregnancy are limited.
Breastfeeding
It is not expected that EpiPen Jr. will have any effect on breastfed infants.

Driving and using machines

Not applicable.

EpiPen Jr. contains sodium metabisulfite (E 223) and sodium chloride

In rare cases, sodium metabisulfite may cause severe allergic reactions or breathing difficulties (bronchospasm).
This medicine contains less than 1 mmol of sodium (23 mg) per dose, which means it is considered "sodium-free".

3. How to use EpiPen Jr.

A patient prescribed EpiPen Jr. should ensure that the reason for the prescription is fully understood. The patient should be convinced that they fully understand how to use the device. EpiPen Jr. should always be used according to the doctor's or pharmacist's instructions. In case of doubts about its use, contact a doctor, nurse, or pharmacist to repeat the instructions for use.
It is also recommended to instruct the patient's family members, caregivers, or teachers on how to properly use the EpiPen Jr. injector.
In the event of an injection performed by a caregiver, the patient's leg should be immobilized during the injection to minimize the risk of injury to the leg.
A used injector should never be used again.
A demonstration injector EpiPen Jr. (without medicine, without needle) is available for training and demonstration purposes. Do not carry a demonstration injector and an automatic EpiPen Jr. injector together to avoid confusion in an emergency situation.
EpiPen Jr. is intended for use in children with a body weight between 15 and 30 kilograms.
For adults, adolescents, and children with a body weight over 30 kg, EpiPen Senior is available in an automatic injector, containing 300 micrograms of epinephrine in a single dose.
For children with a body weight of less than 15 kg, see above - "Children and adolescents" section.

Dosage

The dose will be determined by the doctor and adjusted individually for the patient. The recommended dose of EpiPen Jr. for children (15-30 kg) in life-threatening conditions caused by an allergy is 150 micrograms of epinephrine administered intramuscularly.
EpiPen Jr. should be used immediately if the patient observes symptoms of a severe allergic reaction.
Each automatic EpiPen Jr. injector allows for the administration of a single dose of 0.3 ml of solution, equivalent to 150 micrograms of epinephrine. After the injection, a small amount of solution remains in the injector, which cannot be used again.
Sometimes, a single dose of epinephrine (adrenaline) may not be sufficient to completely eliminate the symptoms of a severe allergic reaction. Therefore, the doctor will likely prescribe more than one EpiPen Jr. injector to the patient. If the symptoms do not disappear or worsen within 5 to 15 minutes after the first injection, a second injection should be administered by the patient or the person accompanying them. Therefore, it is essential to always carry more than one injector

EpiPen Jr.

How to administer EpiPen Jr.

EpiPen Jr. has been designed to be easily used by people without medical training. The EpiPen Jr. injector should be firmly inserted into the outer thigh from a distance of about 10 cm. There is no need to precisely choose the injection site on the outer thigh. After pressing the injector against the thigh, a spring-loaded plunger pushes the hidden needle, which performs the intramuscular injection and injects the dose of epinephrine. If the patient is clothed, the EpiPen Jr. injector can be inserted through clothing.
EpiPen Jr. should be used according to the instructions for use.
EpiPen Jr. should only be injected into the outer thigh.

Do not inject the medicine into the buttock.

Method of use

Make sure you are familiar with the design of the automatic EpiPen Jr. injector and know when and how to use the medicine.

Follow the instructions only in case of a need to use the medicine.
Hold the injector in the middle of its length, never by one of the ends. To administer the medicine correctly, familiarize yourself with the diagram and follow these steps:

• Never touch the orange tip with your thumb, fingers, or hand. Never press or push the orange tip with your thumb, fingers, or hand.
• The needle comes out of the orange tip.
• Do not remove the blue protective cap until the injector is ready for use.
• 1. Hold the EpiPen Jr. injector with your dominant hand (the hand you use for writing) so that your thumb is closest to the blue cap, and your hand is clenched in a fist around the injector (orange tip facing down).

• 2. Remove the blue protective cap by pulling it straight up with your other hand.

• 3. Hold the EpiPen Jr. injector at a distance of about 10 cm from the outer part of the thigh. The orange tip should be facing the outer surface of the thigh.
• 4. Strike the automatic EpiPen Jr. injector firmlyagainst the outer thigh at a right angle (90 degrees) (until you hear a click).

• 5. Hold the injector firmly in place for 3 seconds. After this time, the injection is complete, and the viewing window of the automatic injector will be darkened.
• 6. Then, remove the EpiPen Jr. injector (the orange needle shield will come out to cover the needle) and dispose of it safely.

Gently massage the injection site for 10 seconds.
Call the emergency number 112, ask for an ambulance, and report an anaphylactic reaction.

The EpiPen Jr. injector may contain a small bubble. This does not affect the effectiveness of the medicine.
Although most of the solution (about 90%) remains in the EpiPen Jr. injector after use, it cannot be used again.
If the orange needle shield is extended and the viewing window is darkened, it means that a correct dose of the medicine has been administered. After using the EpiPen Jr. injector, place it in the provided tube and take it with you to the doctor's office, hospital, or pharmacy.
EpiPen Jr. is intended for use in emergency situations. After using EpiPen Jr., always seek medical attention immediately. Call the emergency number 112, ask for an ambulance, and report an "anaphylactic reaction", even if the symptoms disappear. Go to the hospital for observation or further treatment if necessary, as anaphylaxis can occur again after some time. While waiting for the ambulance, lie down with your legs raised, unless this causes difficulty breathing, in which case sit down.
Ask someone to stay with you until the ambulance arrives in case you feel unwell again.
Unconscious patients should be placed on their side in a safe position.

In case of overdose of EpiPen Jr.

In case of overdose or accidental injection of epinephrine, always seek medical attention immediately.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
There have been reports of rare cases of severe skin and soft tissue infections (infection of the injection site). If you experience symptoms such as swelling, redness, increased skin temperature, or pain at the injection site, always seek medical attention immediately.
Accidental injection into the hand or foot has been reported, which can cause blood flow to be cut off to that area. If accidental injection occurs, seek medical attention immediately.
Patients allergic to sodium metabisulfite may experience allergic reactions. In patients treated with epinephrine, rare cases (in less than 1 in 1,000 people) of stress-induced cardiomyopathy have been observed.
Frequency not known (frequency cannot be estimated from the available data): rapid and irregular heartbeat, sometimes strong, severe chest pain, increased blood pressure, breathing difficulties, pallor, excessive sweating, nausea, vomiting, headache, dizziness, weakness, tremors, and nervousness or anxiety, injury at the injection site, such as bruising, bleeding, redness.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your 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 181C, 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, you can help provide more information on the safety of this medicine.

5. How to store EpiPen Jr.

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and label. The expiry date refers to the last day of the month.
Do not store above 25 °C. Do not store in the refrigerator or freeze.
Store the injector in the outer packaging to protect it from light.
Epinephrine decomposes rapidly in the air or light and discolors the solution to pink or brown. Remember to check the contents of the EpiPen Jr. automatic injector at regular intervals and ensure that the solution is clear and has not changed color.
Replace the automatic injector before the expiry date or earlier if the solution has changed color or has become a suspension (visible particles of the solid substance).
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What EpiPen Jr. contains

The active substance of the medicine is epinephrine (adrenaline). Each dose contains 150 micrograms of epinephrine.
The other ingredients are: sodium chloride, sodium metabisulfite (E 223), hydrochloric acid, water for injections.

What EpiPen Jr. looks like and contents of the pack

A clear, colorless solution in a pre-filled syringe (automatic injector).
The automatic injector contains 2 ml of solution for injection. One automatic injector can administer a single dose (0.3 ml) of 0.15 mg of epinephrine.
The length of the exposed and protected needle is approximately 13 mm.
Pack sizes:
1 automatic injector.
2 automatic injectors.
Not all pack sizes may be marketed.

Marketing authorization holder

Viatris Healthcare Limited
Damastown Industrial Park
Mulhuddart
Dublin 15
DUBLIN
Ireland

Manufacturer

MEDA Pharma GmbH & Co. KG
Benzstrasse 1
61352 Bad Homburg
Germany

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

For more information, contact the representative of the marketing authorization holder:
Viatris Healthcare Sp. z o.o.
tel.: 22 546 64 00

Date of last revision of the leaflet: