Epipen Senior

Patient Information Leaflet: User Information

EpiPen Senior, 300 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. The medicine 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 EpiPen Senior is and what it is used for
• 2. Important information before using EpiPen Senior
• 3. How to use EpiPen Senior
• 4. Possible side effects
• 5. How to store EpiPen Senior
• 6. Contents of the pack and other information

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

EpiPen Senior is a sterile solution for injection in a pre-filled syringe for intramuscular use in life-threatening conditions.
The EpiPen Senior automatic injector (epinephrine) is 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.
The EpiPen Senior automatic injector is intended for 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; intestinal cramps; and, in some cases, loss of consciousness.
The contents of the automatic injector (pen) are epinephrine (adrenaline), an adrenergic agent.
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 increasing heart rate.

2. Important information before using EpiPen Senior

When not to use EpiPen Senior

There are no known reasons why EpiPen Senior 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 see 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
• 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 Senior 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 Senior can only be injected into the outer thigh. Do not inject into the buttocks 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 medical attention immediately.
If the patient has a thick layer of subcutaneous fat, there is a risk that a single dose of EpiPen Senior 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 15 kg to 30 kg:

For children with a body weight of 15 kg to 30 kg, EpiPen Jr. is available in an automatic injector containing 150 micrograms of epinephrine in a single dose.

Children with a body weight of less than 15 kg:

Whether EpiPen Jr. (150 micrograms) is suitable will be determined by the doctor on an individual basis for each patient.
EpiPen Senior 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.

EpiPen Senior 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 to treat Parkinson's disease, such as catechol-O-methyltransferase (COMT) inhibitors and levodopa, due to the potential for enhanced epinephrine effects
• medicines that increase the heart's susceptibility to arrhythmias, such as digoxin or quinidine
• beta-adrenergic receptor antagonists (beta-blockers) used to treat heart conditions or neurological disorders, due to the potential for reduced epinephrine effects
• medicines used to treat thyroid disorders
• medicines that facilitate breathing in asthma (theophylline)
• medicines used during childbirth (oxytocin)
• medicines used for 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 Senior, as epinephrine may affect insulin levels and increase blood glucose levels.

Using EpiPen Senior with food, drink, and alcohol

Food and drink do not affect the use of EpiPen Senior.
Individuals 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 are planning 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 Senior 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 Senior will have any effect on breastfed infants.

Driving and using machines

Administration of epinephrine by injection will not affect the ability to drive or use machines, but it may be impaired due to the severe allergic reaction. In such cases, do not drive.

EpiPen Senior contains sodium metabisulfite (E 223) and sodium chloride

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

3. How to use EpiPen Senior

Patient for whom EpiPen Senior has been prescribed 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 Senior should always be used in accordance with the doctor's or pharmacist's recommendations. 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 Senior 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.
Under no circumstances should a used injector be used again.
A demonstration injector EpiPen Senior (without medicine, without needle) is available for training and demonstration purposes. Do not carry the demonstration injector and the automatic EpiPen Senior injector together to avoid confusion in an emergency situation.
EpiPen Senior is intended for use in individuals weighing more than 30 kilograms.
For children with a body weight of less than 30 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 Senior for adults in life-threatening situations due to an allergy is 300 micrograms of epinephrine administered intramuscularly.
EpiPen Senior should be used immediately if the patient observes symptoms of a severe allergic reaction.
Each EpiPen Senior automatic injector contains a single dose of 0.3 ml of solution, equivalent to 300 micrograms of epinephrine. After the injection, a small volume of solution remains in the injector, which cannot be reused.
Sometimes, a single dose of epinephrine (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 EpiPen Senior 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 either the patient or someone else. Therefore, it is essential to always carry more than one EpiPen Senior injector.

How to administer EpiPen Senior

EpiPen Senior has been designed to be easily used by individuals without medical training. The EpiPen Senior injector should be firmly inserted at a 90-degree angle (perpendicular) to 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 is released, pushing the hidden needle to perform the intramuscular injection and administer the dose of epinephrine. If the patient is clothed, the EpiPen Senior injector can be inserted through clothing.
EpiPen Senior should be used in accordance with the instructions for use.
EpiPen Senior should only be injected into the outer thigh.

Do not inject the medicine into the buttocks.

Method of use

Make sure to familiarize yourself with the structure of the EpiPen Senior automatic 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 extends from the orange tip.
• Do not remove the blue protective cap until the injector is ready for use.

• 1. Hold the EpiPen Senior injector with your dominant hand (the hand used 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 Senior injector at a distance of about 10 cm from the outer thigh. The orange tip should be facing the outer thigh surface.

• 4. Firmly strike the EpiPen Senior automatic injector against the outer thigh surface at a 90-degree angle (perpendicular) until you hear a click.
• 5. Hold the injector firmly in place for 3 seconds. After this time, the injection is complete, and the automatic injector's viewing window will be obscured.

• 6. Then, remove the EpiPen Senior injector (the orange needle shield will extend 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.
There may be a small bubble in the EpiPen Senior injector. This does not affect the effectiveness of the medicine.
Although most of the solution (about 90%) remains in the EpiPen Senior injector after use, it cannot be reused.
If the orange needle shield is extended and the viewing window is obscured, it indicates that a proper dose of the medicine has been administered.
After using the EpiPen Senior injector, place it in the provided tube and take it with you to the doctor's office, hospital, or pharmacy.
EpiPen Senior is intended for use in emergency situations. After using EpiPen Senior, always seek medical attention immediately. Call the emergency number 112, ask for an ambulance, and report an "anaphylactic reaction", even if the symptoms are disappearing. 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 up.
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 Senior

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

4. Possible side effects

Like all medicines, EpiPen Senior can cause side effects, although not everybody gets them.
There have been rare reports of severe skin and soft tissue infections (infection at the injection site). If you experience symptoms such as swelling, redness, increased skin temperature, or pain at the injection site, 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 or 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
phone: +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 Senior

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 that 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 presence of air or light and discolors the solution to pink or brown. Remember to check the contents of the EpiPen Senior 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 formed a precipitate (visible particles of solid substance).
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What EpiPen Senior contains

The active substance is epinephrine (adrenaline). Each dose contains 300 micrograms of epinephrine.
The other ingredients are sodium chloride, sodium metabisulfite (E 223), hydrochloric acid, and water for injections.

What EpiPen Senior 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 deliver a single dose (0.3 ml) of 0.3 mg of epinephrine.
The length of the exposed and protected needle is approximately 15 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:

To obtain more detailed information, contact the representative of the marketing authorization holder:
Viatris Healthcare Sp. z o.o.
phone: 22 546 64 00

Date of last revision of the leaflet: