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

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

  • Save 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 you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What EpiPen is and what it is used for 
2. What you need to know before you use EpiPen 
3. How to use EpiPen 
4. Possible side effects 
5. How to store EpiPen 
6. Contents of the packaging and other information 

1. What EpiPen is and what it is used for

EpiPen contains sterile solution in a pre-filled pen for injection into a muscle ( intramuscularly ) in an emergency.

EpiPen ( adrenaline ) autoinjectors are used for emergency treatment of severe allergic reactions ( anaphylaxis ) caused by allergens in e.g. foods, medicines, insect bites, or bites. As well as severe reactions that have been triggered by physical exertion or for unknown reasons.

EpiPen auto-injectors are intended for an immediate injection of adrenaline into patients who are considered to be at increased risk of anaphylaxis. This also includes patients who have previously had anaphylactic reactions.

Symptoms of a severe allergic (anaphylactic) reaction are itchy skin, raised rash (such as hives ), redness, swelling of the lips, throat, tongue, hands, and feet, wheezing, hoarseness, nausea, vomiting, stomach cramps, and in some cases unconsciousness.

The drug in the autoinjector (pen) is adrenaline, which is an adrenergic drug.

Adrenaline has a direct effect on the heart, circulation,n, and airways. It counteracts the possible life-threatening consequences of severe allergic (anaphylactic) reactions by rapidly constricting the blood vessels, acting as a muscle relaxant in the trachea so that breathing improves, reducing swelling,g and stimulating the heart.

2. What you need to know before using EpiPen

Do not use EpiPen

There are no known reasons why EpiPen should not be used in an acute allergic reaction.

Warnings and cautions

If you have asthma, you may have an increased risk of a severe allergic reaction.

Anyone who has suffered from anaphylactic shock should contact their doctor to test which substances they may be allergic t so that these can be completely avoided in the future. It is important to be aware that allergies to one substance can lead to allergies to other related substances.

If you have a food allergy, you must control the ingredients in everything you eat (including medicines), as even small amounts can cause severe reactions.

Tell your doctor if you have:

  • heart disease
  • overactive thyroid gland
  • high blood pressure
  • diabetes
  • elevated pressure in the eye ( glaucoma )
  • severe kidney problems
  • a tumor in your prostate
  • high calcium levels or low potassium levels in the blood
  • Parkinson’s disease

Despite the above conditions, adrenaline is necessary for the treatment of severe allergic reactions. Patients with these conditions or people who may be giving EpiPen to a person who has had an allergic reaction should be given clear instructions on the situations in which EpiPen should be given.

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

EpiPen should only be given on the outside of the thigh. It should not be given into the buttocks due to the risk of accidentally injecting into a vein.

Warning: Accidental injection into hands or fingers may lead to reduced blood flow to affected areas. Always consult a doctor for treatment if you accidentally inject it into your hands or fingers.

If you have a thick layer of subcutaneous fat, there is a risk that a dose of EpiPen is not sufficient. A second injection may be needed. Carefully follow the instructions for use in section 3.

Children and young people

Children with bodyweight between 15 and 30 kg:

For children with bodyweight between 15 kg and 30 kg, EpiPen Jr. is available. Auto-injector containing 150 micrograms adrenaline per dose available. 

Children with a bodyweight under 15 kg:

The suitability of using EpiPen Jr. (150 micrograms) must be assessed individually by a physician. Use in children weighing less than 7.5 kg is not recommended except in life-threatening situations and after medical assessment.

Other medicines and EpiPen

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

This is especially important if you use any of the following:

  • Antidepressants such as tricyclic antidepressants or monoamine oxidase inhibitors ( MAOIs ) as the effect of adrenaline may be enhanced.
  • Drugs for Parkinson’s disease such as catechol-O-methyltransferase inhibitors (COMT inhibitors) and levodopa as the effect of adrenaline may be enhanced.
  • Drugs that cause the heart to start beating unevenly ( arrhythmias ) such as digitalis and quinidine.
  • Beta-blockers (used to treat heart disease) or medicines to treat diseases of the nervous system as the effect of adrenaline can be reduced.
  • Medicines for thyroid disease.
  • Drugs that make it easier to breathe, used against asthma (theophylline).
  • Medicines used in connection with childbirth ( oxytocin ).
  • Drugs used to treat allergies such as diphenhydramine or chlorpheniramine ( antihistamines ).
  • Drugs that act on the nervous system (parasympatholytics).

Diabetics should carefully monitor their blood sugar levels after using EpiPen as adrenaline can affect the production of insulin in the body and thus raise blood sugar levels.

EpiPen with food, drink, and alcohol

Intake of food and drink does not affect EpiPen.

Tell your doctor if you drink alcohol as the effect of adrenaline may increase.

Pregnancy and breastfeeding

Pregnancy

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

In an emergency, do not hesitate to use EpiPen as your and your child’s lives may be in danger. There is limited experience with the use of adrenaline during pregnancy.

Breast-feeding

EpiPen is not expected to have any effect on the breastfed baby.

Driving and using machines

Driving ability is not affected by injection of adrenaline, but it can be affected by a severe allergic reaction. If your driving ability is affected, do not drive.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

EpiPen contains sodium metabisulfite (E223) and sodium chloride

Sodium metabisulphite may in rare cases cause severe allergic reactions or difficulty breathing ( bronchospasm ).

This medicine contains less than 1 mmol sodium (23 mg) per dose, ie essentially ‘sodium-free’.

3. How to use EpiPen

When you get EpiPen prescribed by your doctor, you need to make sure you understand why you have prescribed it. You need to make sure you know exactly how to use the product. Always use EpiPen exactly as your doctor or pharmacist has told you. If you are not sure how to use EpiPen, talk to your doctor, nurse, or pharmacist.

It is recommended that your family members, guardians, or teachers also receive instructions on the proper use of EpiPen.

If the injection is not given by the patient himself, the patient’s legs should be kept still during injection to minimize the risk of injection injuries.

Never reuse a used EpiPen.

There is an EpiPen practice pen (without medicine, without needle) for training and demonstration purposes. The practice pen and the active EpiPen auto-injector should not be carried together to avoid confusion in an emergency.

EpiPen is intended for people with a bodyweight of over 30 kg.

For children weighing less than 30 kg, see the section above on “Children and adolescents”.

Dosage

Dose one is determined by the doctor who adjusts it individually for you. The usual dose for adults in acute allergy treatment is 300 micrograms of adrenaline intramuscularly.

If you notice any signs of an acute allergic reaction, use EpiPen immediately.

The EpiPen auto-injector provides a single dose of 0.3 ml equivalent to 300 micrograms of adrenaline. After use, there is a small amount of liquid left in the autoinjector. It can not be used again.

Sometimes a dose of adrenaline is not enough to eliminate a severe allergic reaction. This is why your doctor will probably prescribe more than one EpiPen. If the symptoms have not improved or worsened within 5-15 minutes after the first injection, either you or the person you are with should give a second injection. For this reason, you should always carry more than one EpiPen with you.

How Epipen is given

EpiPen is designed to be easily used by people without medical training. The EpiPen should be pushed against the outside of the thigh at a distance of about 10 cm. It does not matter where on the outside of the thigh. When you push the pen against the thigh, a spring-triggered piston is activated which pushes the hidden needle into the thigh muscle and administers a dose of adrenaline. If you are wearing clothing, EpiPen can be injected through the clothing.

The operating instructions for the EpiPen must be followed carefully.

EpiPen should only be injected into the outside of the thigh. Never inject into the buttocks.

Instructions for use

Familiarize yourself with EpiPen and how it is used.

Epipen

Follow these instructions only when it’s time to use EpiPen.

Hold in the middle of the pen, never at the ends. For the correct procedure for use, see the pictures and follow these instructions:

  • Never place your thumb, fingers, or hand over the orange end of the EpiPen. Never press the orange end with your thumb, fingers, or hand.
  • The needle comes out of the orange end.
  • DO NOT remove the blue safety sleeve until it is time to use the pen

1. Grasp the EpiPen with the hand you normally use (the hand you type with), with your thumb against the blue safety sleeve. Close your hand around the pen and hold a firm grip. The orange end should point downwards.
2. Remove the blue safety sleeve by pulling it straight up with the other hand.
3. Hold the EpiPen about 10 cm from the outside of the thigh. The orange end should point towards the outside of the thigh.
4. Push the pen against the outside of the thigh at a right angle (90 degrees). Listen for a click.
5. Hold the pen firmly in place for 5 seconds. Injection one is now complete and the auto window injector window is dark.
6. Remove the EpiPen (the orange needle cover is extended to cover over the needle) and discard safely.
Massage the injection site gently for 10 seconds.

There may be a small bubble in the EpiPen auto-injector. It does not affect the effectiveness of the medicine.

Although most of the liquid (approximately 90%) remains in the EpiPen after use, it cannot be reused. However, you have been given the right amount of medicine if the orange needle guard is extended and the sight window is dark. After use, the EpiPen should be placed in the storage tube provided. Take it with you when you go to your doctor, hospital or pharmacy for disposal.

EpiPen is intended for emergency treatment. You should always seek medical help immediately after using EpiPen. ask for an ambulance and report anaphylactic shock even if the symptoms seem to be getting better.

You will need to see a hospital for observation and further treatment as needed. This is because the reaction may occur again sometime later.

While waiting for an ambulance, you should lie down with your feet in a high position, unless this makes you breathless, in which case you should sit up. Ask someone to stay with you until the ambulance arrives in case you feel unwell again.

Unconscious patients should be placed in a stable lateral position.

If you take more dose than you should

If you have ingested too much medicine or injected adrenaline by mistake, contact a doctor, hospital or the Poison Information Center immediately for an assessment of the risk and advice.

4. Possible side effects

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

Rare cases of serious infection of the skin and soft tissue ( infection at the injection site) have been reported. In case of signs of infection at the injection site, such as swelling, redness, heat, or pain, always consult a doctor.

Accidental injection into the hands or feet has been reported and may lead to decreased blood flow to affected areas. Always consult a doctor if you accidentally inject.

Allergic reactions may occur in patients who are hypersensitive to sodium metabisulphite.

Treatment with adrenaline can in rare cases (may occur in up to 1 in 1000 users) cause stress- induced cardiomyopathy (temporary cardiac muscle weakness).

Not known (can not be calculated from the available data): Rapid or irregular heartbeat, sometimes severe, severe chest pain, high blood pressure, difficulty breathing, paleness, sweating, nausea, vomiting, headache, dizziness, weakness, tremors and worry or anxiety, injection sites damage such as bruising, bleeding and redness.

5. How to store EpiPen

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 carton and label after EXP.

The expiration date is the last day of the specified month.

Do not store above 25 ° C. Store in a cold place. Do not freeze.

Store EpiPen in the outer carton. Sensitive to light. When adrenaline is exposed to air or light, it breaks down quickly and then gets a pink or brownish color. Be sure to check the contents of the glass ampoule from time to time to see that the liquid is still clear and colorless. Replace the auto-injector no later than the expiry date or earlier if the liquid is discolored or contains particles.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

The active substance is adrenaline . Each dose contains 300 micrograms of adrenaline.

The other ingredients are sodium chloride, sodium metabisulfite (E223), hydrochloric acid , water for injections.

What the medicine looks like and contents of the pack

Clear and colorless solution in a pre-filled pen (auto-injector).

The auto-injector contains a 2 ml solution for injection. Each auto-injector provides a single dose (0.3 ml) of 0.3 mg adrenaline.

The length of the exposed and protected needle is about 16 mm.

Pack sizes:

1 autoinjector.

2 x 1 car injector.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Meda AB

Box 906

170 09 Solna

tel: 08-630 1900

fax: 08-630 1950

e-mail: info@meda.se

Manufacturer

Meda Pharma GmbH & Co. KG

Benzstrasse 1

61352 Bad Homburg

Germany

This medicinal product is authorized under the European Economic Area under the names:

Name of Member State Name of the medicine
The Netherlands, Belgium, Iceland, Norway, Finland, Denmark, Austria, Slovakia, the Czech Republic, and Hungary EpiPen
Poland EpiPen Senior
Spain ALTELLUS 0.3 adults.

Muhammad Nadeem

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