EPIPEN JR.
PolandThe medicine is used in life-threatening situations for the immediate treatment of sudden, severe allergic reactions (anaphylaxis). This may occur as a result of contact with allergens in food, medications, insect stings, or due to physical exertion.
Frequently asked questions
How should EpiPen Jr. be used?
The injector should be firmly inserted into the outer thigh (this can be done through clothing) from a distance of approximately 10 cm until a click is heard. Then, hold the device in the injection site for 3 seconds, remove it, and gently massage the injection site for 10 seconds. After use, immediately call for medical assistance by dialing 112.
Can a second dose be administered?
If symptoms do not subside or if they worsen within 5 to 15 minutes after the first injection, a second injection should be administered. For this reason, it is always recommended to carry more than one injector with you.
Who is this medicine intended for?
EpiPen Jr. is intended for children weighing between 15 and 30 kg. In the case of children weighing less than 15 kg, the use of the medicine must be individually assessed by a physician, and for children weighing over 30 kg, a different preparation is used (EpiPen Senior).
What are the possible side effects of EpiPen Jr.?
Possible side effects include, among others, rapid or irregular heartbeat, chest pain, increased blood pressure, difficulty breathing, paleness, excessive sweating, nausea, vomiting, pain or dizziness, tremors, anxiety, and injection site symptoms such as bruising or redness.
What precautions should be taken before using the medicine?
The physician should be informed about heart disease, hyperthyroidism, diabetes, high blood pressure, kidney disease, Parkinson's disease, or glaucoma. It is also important to report the use of other medications, especially antidepressants, Parkinson's medications, or beta-blockers, as they may affect the efficacy of the preparation.
Where should the medicine not be injected?
The medicine should be injected only into the outer thigh. It must never be injected into the buttocks or accidentally into the hands or fingers.
How should the injector be stored?
The medicine should be stored in its outer packaging to protect it from light, at a temperature not exceeding 25°C. Do not freeze or store in a refrigerator. Regularly check that the solution is clear and has not changed color to pink or brown.
Instructions for use
Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.
EpiPen Jr., 150 micrograms, solution for injection in auto-injector
Epinephrinum
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.
- Keep this leaflet for future reference.
- If you have any questions, consult your doctor, pharmacist, or nurse.
- This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are identical.
- If the patient experiences any adverse reactions, including any not listed in this leaflet, inform the doctor, pharmacist, or nurse. See section 4.
Table of contents of the leaflet
- What is EpiPen Jr. and what is it used for
- Important information before using EpiPen Jr.
- How to use EpiPen Jr.
- Possible side effects
- How to store EpiPen Jr.
- Contents of the pack and other information
1. What is EpiPen Jr. and what is it used for
EpiPen Jr. is a sterile solution in an auto-injector for intramuscular injection used in life-threatening conditions.
EpiPen Jr. auto-injectors (epinephrine) are intended for the treatment of sudden, severe allergic reactions (anaphylaxis) caused by allergens such as food, medications, or insect stings and bites, as well as reactions triggered by exercise or of unknown origin.
EpiPen Jr. auto-injectors are intended for immediate administration of epinephrine (adrenaline) in patients with confirmed increased risk of anaphylaxis, including those with a history of anaphylactic reactions.
Symptoms indicating a severe allergic reaction include: skin itching; urticaria (resembling nettle rash); redness; swelling of lips, throat, tongue, hands, and feet; wheezing; hoarseness; nausea; vomiting; intestinal cramps, and in some cases, loss of consciousness.
The content of the auto-injector (pen) is epinephrine (adrenaline), an adrenergic agent.
Epinephrine acts directly on the cardiovascular system (heart and circulation) and respiratory system (lungs), counteracting potentially fatal consequences of a severe allergic reaction by rapidly constricting blood vessels, relaxing muscles in the lungs to ease breathing, reducing swelling, and increasing 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 during a sudden
allergic reaction.
Warnings and precautions
If the patient has asthma, they may be at increased risk of an allergic reaction.
Every patient who has experienced an anaphylactic reaction should consult a doctor to
undergo tests for substances to which they may be allergic, in order to avoid them in the future.
It is important to remember that allergy to one substance may lead to allergies to numerous
related substances.
If the patient has a food allergy, it is important to check all ingested ingredients (including
medicines), as even small amounts may cause severe allergic reactions.
Tell the doctor if the patient has:
- heart disease
- hyperthyroidism
- high blood pressure
- diabetes
- increased intraocular pressure (glaucoma)
- severe kidney disease
- prostate gland tumor (prostate adenoma)
- high calcium levels or low potassium levels in the blood
- Parkinson's disease
Despite the above-mentioned precautions, epinephrine is essential in the treatment of severe
allergic reactions. Patients with the conditions listed above, as well as all individuals who may find
themselves in a situation requiring administration of EpiPen Jr. to a patient experiencing a rapidly
progressing allergic reaction, must be properly instructed on when to use this
medication.
To avoid accidental injection, always follow the instructions for use of the auto-injector.
EpiPen Jr. may only be injected into the outer thigh. Do not inject the medication into the buttock due
to the risk of accidental intravenous injection.
Warnings: Accidental injection into the hands or fingers may cause loss of blood flow to the affected area. In case of accidental injection into these body areas, seek immediate medical attention at the nearest hospital emergency department for appropriate treatment.
If the patient has a thick layer of subcutaneous fatty tissue, there is a risk that a single dose of
EpiPen Jr. may be insufficient. A second dose of the medication may be necessary.
Follow the instructions for use described in section 3.
Children and adolescents
Children weighing less than 15 kg:
Whether EpiPen Jr. is appropriate will be assessed individually by the doctor for each patient.
Use of EpiPen Jr. is not recommended in children weighing less than 7.5 kg, unless in life-threatening situations and on explicit medical advice.
Children and adolescents weighing over 30 kg:
For these patients, EpiPen Senior, containing 300 micrograms of epinephrine per dose, is available.
EpiPen Jr. and other medicines
Tell your doctor or pharmacist about all medicines currently taken or recently used, as well as any medicines the patient plans to use.
This is particularly important for patients taking the following medicines:
- antidepressants, such as tricyclic antidepressants or monoamine oxidase inhibitors (MAO inhibitors), as they may enhance the effects of epinephrine
- medications used in Parkinson's disease, such as catechol-O-methyltransferase inhibitors (COMT inhibitors) and levodopa, due to the possibility of enhanced epinephrine effects
- medications increasing the heart's susceptibility to cardiac rhythm disturbances (arrhythmias), such as digoxin or quinidine
- medications belonging to the class of beta-adrenergic receptor antagonists (beta-blockers) used in heart diseases or medications used in neurological disorders, due to the possibility of reduced epinephrine effectiveness
- medications used in thyroid disorders
- respiratory medications used in asthma (theophylline)
- medications used during childbirth (oxytocin)
- medications used in allergies, such as diphenhydramine or chlorpheniramine (antihistamines)
- medications affecting the nervous system (parasympatholytics)
Patients with diabetes should carefully monitor blood glucose levels after administration of EpiPen Jr.,
as epinephrine may affect insulin secretion and thereby increase blood glucose levels.
Use of EpiPen Jr. with food, drink, and alcohol
Food and beverages have no effect on the use of EpiPen Jr.
Individuals consuming alcohol should inform their doctor, as alcohol may enhance the effects of epinephrine.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medication.
Pregnancy
In life-threatening emergencies, pregnant women may use EpiPen Jr. without hesitation due to the risk of losing their own life or that of their unborn child. Data on the use of epinephrine during pregnancy are limited.
Breastfeeding
EpiPen Jr. is not expected to have any effect on breastfed infants.
Driving and operating machinery
Not applicable.
EpiPen Jr. contains sodium metabisulfite (E 223) and sodium chloride
In rare cases, sodium metabisulfite may cause severe allergic reactions or breathing problems (bronchospasm).
This medication contains less than 1 mmol of sodium (23 mg) per dose, meaning the medication is considered "sodium-free."
3. How to use EpiPen Jr.
The patient prescribed EpiPen Jr. should ensure that the reason for prescribing this medication is fully understood. The patient must be confident that they fully understand how to use this device. EpiPen Jr. should always be used according to the instructions provided by the doctor or pharmacist. If there are any doubts regarding its use, the patient should contact their doctor, nurse, or pharmacist to request a repeat explanation of the instructions.
It is also recommended to train family members, caregivers, or teachers on the correct use of the EpiPen Jr. auto-injector.
When the injection is administered by a caregiver, the patient's leg should be immobilized during the injection to minimize the risk of leg injury.
Under no circumstances should a used auto-injector be reused.
A training (demonstration) EpiPen Jr. auto-injector (without medication, without needle) is available for educational and demonstration purposes. The demonstration device and the active EpiPen Jr. auto-injector should not be carried together to avoid confusion in an emergency.
EpiPen Jr. is intended for use in children weighing between 15 and 30 kilograms. For adults, adolescents, and children weighing over 30 kg, EpiPen Senior is available in an auto-injector containing 300 micrograms of epinephrine per dose.
For children weighing less than 15 kg, see above – section "Children and adolescents".
Dosage
The dose will be determined by the doctor and individually adjusted for the patient. The recommended dose of EpiPen Jr. in children (15–30 kg) for life-threatening allergic reactions is 150 micrograms of epinephrine administered intramuscularly.
EpiPen Jr. should be used immediately if the patient experiences symptoms of a severe allergic reaction.
Each EpiPen Jr. auto-injector delivers a single dose of 0.3 ml of solution, equivalent to 150 micrograms of epinephrine. After administration, a small volume of solution remains in the auto-injector, which cannot be reused.
Sometimes a single dose of epinephrine (adrenaline) may not be sufficient to completely relieve symptoms of a severe allergic reaction. For this reason, the doctor will likely prescribe more than one EpiPen Jr. auto-injector. If symptoms do not improve or worsen within 5 to 15 minutes after the first injection, a second dose should be administered by either the patient or a person accompanying them. For this reason, always carry more than one EpiPen Jr. auto-injector.
How to administer EpiPen Jr.
EpiPen Jr. has been designed to be easily used by individuals without medical training. The EpiPen Jr. auto-injector should be firmly injected into the outer side of the thigh from a distance of approximately 10 cm. There is no need for precise selection of the injection site within the outer thigh surface. When the auto-injector is pressed firmly against the thigh, a spring-loaded plunger is released, driving the hidden needle to perform an intramuscular injection and deliver the dose of epinephrine. If the patient is wearing clothing, the EpiPen Jr. auto-injector can be used directly through the fabric.
EpiPen Jr. should be used strictly according to the instructions for use.
EpiPen Jr. should be administered ONLY into the outer side of the thigh.
Do not inject the medication into the buttock.
Instructions for use
Carefully familiarize yourself with the structure of the EpiPen Jr. auto-injector and know when and how to use the medication.
blue cap viewing window orange protective tip
Follow the instructions only when there is a need to use the medication. Hold the auto-injector in the middle of its length, never by either end. To correctly administer the medication, refer to the diagram and follow the steps below:
- 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 auto-injector is ready for use.
- Hold the EpiPen Jr. in your dominant hand (the hand you write with), with your thumb closest to the blue cap and your hand clenched into a fist around the auto-injector (orange tip pointing downward).
- With the other hand, remove the blue protective cap by pulling it straight upward.
- Hold the EpiPen Jr. approximately 10 cm from the
outer part of the thigh. The orange tip should be directed toward the outer surface of the thigh.
- Firmly push the EpiPen Jr. auto-injector against the
outer thigh surface at a 90-degree angle (until a click is heard).
- Hold the auto-injector firmly in place for 3 seconds. After this time, the injection is complete and the viewing window of the auto-injector will be darkened.
- Remove the EpiPen Jr. auto-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 emergency number 112, request an ambulance, and report an anaphylactic reaction.
The EpiPen Jr. auto-injector may contain a small air bubble. This does not affect the effectiveness of the medication.
Even though most of the solution (approximately 90%) remains in the EpiPen Jr. after use, it must not be reused.
If the orange needle shield has extended and the viewing window is darkened, this indicates that the correct dose of medication has been delivered. After using the EpiPen Jr. auto-injector, place it safely in the provided tube and bring it with you to the doctor's office, hospital, or pharmacy.
EpiPen Jr. is intended for emergency treatment. After administering EpiPen Jr., medical help must always be sought immediately. Call emergency number 112, request an ambulance, and report an "anaphylactic reaction," even if symptoms improve. Proceed to a hospital for observation or further treatment if necessary, as an anaphylactic reaction may recur after some time. While waiting for the ambulance, lie down with your legs elevated unless this causes breathing difficulties; in that case, sit up.
Ask someone to stay with you until the ambulance arrives, in case symptoms return.
Unconscious patients should be placed in a stable side-lying position.
In case of accidental overdose or accidental injection of epinephrine
In the event of an overdose or accidental injection of epinephrine, seek immediate medical help.
4. Possible adverse reactions
Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Rare cases of severe skin and soft tissue infections (injection site infection) have been reported. If symptoms such as swelling, redness, increased warmth of the skin, or pain occur at the injection site, medical help should always be sought immediately.
Accidental injection into the hand or foot has been described and may cause impaired blood flow to the affected area. In the event of accidental injection, medical help should always be sought immediately.
Allergic reactions may occur in patients sensitive to sodium metabisulfite. Rare cases (in less than 1 in 1,000 people) of stress-induced cardiomyopathy have been observed in patients treated with epinephrine.
Frequency unknown (frequency cannot be estimated from available data): rapid and irregular heartbeat, sometimes strong, severe chest pain, increased blood pressure, difficulty breathing, pallor, excessive sweating, nausea, vomiting, headache, dizziness, weakness, tremor, nervousness or anxiety, injection site reactions such as bruising, bleeding, redness.
Reporting of adverse reactions
If any adverse reactions occur, including any possible adverse reactions not listed in the leaflet, inform your doctor or pharmacist. Adverse reactions can also be reported directly to the Department of Monitoring Adverse Drug Reactions 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.
Reporting adverse reactions helps to provide more information on the safety of the medicine.
5. How to store EpiPen Jr.
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Store the auto-injector in its outer carton to protect it from light. Do not store above 25°C. Do not store in the refrigerator or freeze.
Epinephrine may rapidly degrade and the solution may turn pink or brown when exposed to air or light. It is important to periodically check the contents of the glass cartridge of the EpiPen Jr. auto-injector and ensure that the solution is clear and has not changed colour. The auto-injector should be replaced before the expiry date or earlier if the solution changes colour or becomes a suspension (visible solid particles).
Medicines must not be disposed of via the sewage system 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 Jr. contains
The active substance is epinephrine (adrenaline). Each dose contains 150 micrograms of epinephrine.
The other ingredients are: sodium chloride, sodium metabisulfite (E 223), hydrochloric acid (for pH adjustment), water for injections.
What EpiPen Jr. looks like and contents of the pack
A clear, colourless solution in a pre-filled syringe (auto-injector).
The auto-injector contains 2 ml of solution for injection. One auto-injector delivers a single dose (0.3 ml) of 0.15 mg epinephrine.
The length of the exposed and shielded needle is approximately 13 mm.
Pack size
1 auto-injector.
For more detailed information, please contact the responsible party or parallel importer.
Marketing Authorisation Holder in Austria, country of export:
Viatris Healthcare Limited
Damastown Industrial Park
Mulhuddart, Dublin 15, Dublin, Ireland
Manufacturer:
Meda Pharma GmbH & Co KG
Benzstrasse 1
61352 Bad Homburg, Germany
Parallel Importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Poland
Relabelled and repackaged by:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland
Austrian, country of export, Marketing Authorisation Number: 1-22472
Parallel Import Authorisation Number: 299/25
This medicinal product is authorised for sale in the European Economic Area under the following names:
| Member State | Trade name |
| Iceland, Norway, Finland, Sweden, Denmark, Slovakia, Czech Republic, Hungary, Austria and Poland | EpiPen Jr. |
| Belgium, Netherlands | EpiPen Junior |
| Spain | ALTELLUS 0.15 niños |
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|---|---|---|---|
| EPIPEN SENIOR | solution for injection in a syringe |
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| JEXT | solution for injection in a syringe |
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ALK-Abello A/S |
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The original data is available in the language of the country of manufacture.
Data source: Register of Medicinal Products of Poland (URPL)
Data last verified: September 01, 2026