Anapen 0.30 mg/0.3 ml solution for injection in pre-filled syringe

Spain
Brand name Anapen 0.30 mg/0.3 ml solution for injection in pre-filled syringe
Form solution for injection
Active substance / Dosage
EPINEPHRINE · 0,30 mg
Prescription type Prescription Only Medicine
ATC code
C01C C01CA C01CA24
Registration number 75409
Manufacturer Bioprojet Pharma
Anapen 0.30 mg/0.3 ml solution for injection in pre-filled syringe solution for injection

Table of Contents

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Anapen 0.30 mg/0.3 ml solution for injection in pre-filled syringe

Adrenaline (epinephrine)

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

  • Keep this leaflet as you may need to read it again.
  • If you have any questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it may harm them.
  • If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

  1. What Anapen is and what it is used for
  2. What you need to know before using Anapen
  3. How to use Anapen
  4. Possible side effects
  5. How to store Anapen
  6. Contents of the pack and other information
A hand firmly grasps a small cylindrical white tube between the fingers, held securely against a neutral background

1. What Anapen is and what it is used for

  • Anapen is supplied as a pre-filled adrenaline syringe in an automatic injection system (Auto-injector). This system delivers a single dose of adrenaline into the muscle.
  • This medicine is for emergency use only, and you must seek immediate medical attention from your doctor after using your Auto-injector.
  • Adrenaline is a hormone naturally secreted in response to stress. In acute allergic reactions, it acts by improving blood pressure, heart function, and breathing, and by reducing swelling. Adrenaline is also known as epinephrine.
  • Anapen is used for the emergency treatment of severe allergic reactions (anaphylaxis) caused by peanuts or other foods, medications, insect bites or stings, and other allergens, as well as by exercise or an unknown cause.

2. What you need to know before using Anapen

Do not use Anapen

There is no known reason why Anapen should not be used in an allergic emergency situation.

Warnings and precautions

Talk to your doctor or pharmacist before using Anapen.

  • Your doctor must provide you with detailed instructions on when and how to correctly use the Anapen auto-injector.
  • You must inform your doctor if you have any heart condition, including angina pectoris, hyperthyroidism, high blood pressure, low potassium levels, elevated calcium levels in the blood, circulatory disorders, pheochromocytoma (a type of tumor of the adrenal gland), increased eye pressure (glaucoma), kidney or prostate disease, diabetes, or any other illness.
  • If you have asthma, you may be at increased risk of a severe allergic reaction.
  • Anyone who has experienced an anaphylactic episode should consult their doctor to identify which substances they may be allergic to, in order to strictly avoid them in the future. It is important to note that an allergy to one substance may lead to allergies to a wide range of related substances.
  • If you have food allergies, it is important to check the ingredients of everything you are about to ingest (including medicines), as even small amounts can cause severe reactions.
  • Repeated local injections may cause skin damage at the injection site. Accidental intravascular injection may cause a sudden increase in blood pressure. Accidental injection into the hands or feet may cause loss of blood flow to the affected area. Seek immediate medical attention at the nearest emergency department.

Using Anapen with other medicines

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines, including:

  • Medicines for heart conditions, such as digitalis (digoxin), β-blockers, quinidine,
  • Medicines for depression, such as tricyclic antidepressants, monoamine oxidase inhibitors (MAOIs), serotonin-norepinephrine reuptake inhibitors (SNRIs),
  • Medicines for diabetes; your doctor may need to adjust your medication dose after using Anapen,
  • Medicines for Parkinson’s disease,
  • Medicines for thyroid disorders,
  • Other medicines: antihistamines such as diphenhydramine or chlorpheniramine, theophylline, ipratropium and oxitropium (used to treat respiratory diseases such as asthma), oxytocin (used to induce contractions in pregnant women), inhaled anesthetics, α-adrenergic blockers (used to treat high blood pressure), sympathomimetics (used in the treatment of asthma, other airway diseases, and nasal congestion).

Using Anapen with alcohol

Alcohol may negatively affect this medicine by increasing its effects.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

  • It is unclear whether adrenaline administration during pregnancy poses a risk to the fetus. However, this should not deter you from using Anapen in an emergency if you are pregnant, as your life may be in danger. Consult your doctor before an emergency occurs.
  • Adrenaline is not expected to have any effect on the breastfed infant.

Driving and using machines

You should not drive or operate machinery after injecting this medicine, as you may still be experiencing the effects of anaphylactic shock.

Anapen contains sodium metabisulfite (E223)

This medicine may cause severe allergic reactions and bronchospasm (sudden feeling of suffocation) because it contains sodium metabisulfite (E223).

Inform your doctor or pharmacist if you know you are allergic to sodium metabisulfite.

Anapen contains a small amount of sodium chloride (salt)

This medicine contains less than 23 mg (1 mmol) of sodium per dose and is therefore considered essentially “sodium-free”.

3. How to use Anapen

Always carry two autoinjectors with you in case the first administration fails or a single dose is not sufficient.

  • Follow exactly the administration instructions for this medicine as given by your doctor.
  • If in doubt, consult your doctor or pharmacist again.
  • It is injected only into the thigh.
  • For single use only; please ensure you dispose of it safely immediately after use. Anapen delivers a single dose of 0.3 ml of liquid equivalent to 0.3 mg (300 micrograms) of adrenaline. After use, a residual volume of 0.75 ml remains in the autoinjector, which must not be reused.

The allergic reaction typically begins minutes after exposure to the allergen, and the person may experience:

  • Itching of the skin, hives, redness, and swelling of the eyes, lips, or tongue.
  • Breathing difficulties due to throat swelling. Wheezing, shortness of breath, and coughing caused by tightening of the lung muscles.
  • Other symptoms of anaphylaxis such as headaches, vomiting, and diarrhea.
  • Collapse and loss of consciousness due to a sudden drop in blood pressure.

If you experience these signs and symptoms, use the Anapen autoinjector immediately. You must inject this medicine only into the outer part of the thigh—never into the buttock.

Sometimes, a single dose of adrenaline may not be sufficient to completely reverse the effects of a severe allergic reaction. For this reason, your doctor may prescribe more than one Anapen unit. If your symptoms have not improved or have worsened within 5–15 minutes after the first injection, you or the person with you must administer a second injection. Therefore, you should always carry more than one Anapen unit with you.

Use in adults

  • The recommended dose is 0.30 mg for individuals weighing less than 60 kg.
  • The recommended dose is 0.30 mg to 0.50 mg for individuals weighing 60 kg or more, according to clinical judgment.
  • Adults weighing over 60 kg may require more than one injection to reverse the effects of an allergic reaction, based on clinical assessment.

Use in children and adolescents

  • The appropriate dose is 0.15 mg or 0.30 mg,
  • This depends on the child's body weight and the physician's clinical judgment.
  • Children and adolescents weighing more than 30 kg should use Anapen 0.30 mg.
  • Autoinjectors delivering 0.15 mg of adrenaline are also available. A dose lower than 0.15 mg cannot be accurately administered in children weighing less than 15 kg; therefore, its use is not recommended unless the situation poses a health risk and under medical discretion.

Children between 15 kg and 30 kg

The usual dose is 0.15 mg.

Children over 30 kg

The usual dose is 0.30 mg.

Anapen is designed as an emergency treatment. You must always seek medical help immediately after using Anapen. Call 112, request an ambulance, and state “anaphylaxis,” even if symptoms appear to improve. You will need to go to a hospital for monitoring and further treatment as required. This is because the reaction may recur later.

While waiting for the ambulance, lie down with your legs raised, unless this makes breathing difficult—in which case, remain seated. Ask someone to stay with you until the ambulance arrives, in case your condition worsens again.

Unconscious patients should be placed on their side in the recovery position.

Instructions for use

It is recommended that family members, caregivers, or teachers also be trained in the correct use of the Anapen autoinjector.

  • Parts of the Anapen Autoinjector

Before using the Anapen Autoinjector, you should become familiar with all its parts. These are shown in the illustration.

Black needle cover (reversible)

Rotating cap of solution window

Injection indicator

Gray safety cap

Technical diagram of an injection pen with arrows indicating the adjustment knob, central body, viewing window, and red tip

End of autoinjector needle

Solution window

Safety lock

Red injection button

  • Solution window rotating cover: Rotate the cover over the solution window to align the lens with the solution window of the Autoinjector.

  • Solution window: Look through the lens of this window before injection to check that the solution is clear and ready for use.

  • Injection indicator: Before injection, you can see a white plastic plunger through the window. This indicates that the Anapen Autoinjector has not been accidentally activated or tampered with. After injection, the injection indicator turns red, indicating that the Autoinjector has been correctly activated.

  • Black needle shield (reversible): Protects the needle when the Anapen Autoinjector is not in use. Pull off the needle shield before injection. After injection, the patient should rotate the black needle shield and replace it back onto the same end of the Anapen Autoinjector to cover the needle.

  • Grey safety cap: This covers the red injector button. It prevents accidental activation of the button.

Do not remove the black needle shield or the grey safety cap until the Anapen Autoinjector is to be used.

  • Checking the Anapen Autoinjector

Before using your Anapen Autoinjector, you should carry out the following checks:

Diagram with number 1 in a black circle showing a black curved arrow indicating the rotation of a white elongated medical device

  1. Turn the cap protecting the solution window fully in the direction indicated by the arrows to align the lens with the solution window of the Auto-injector.

Technical diagram of an elongated medical device with a black arrow pointing to a central rectangular section on a light green background

  1. Look through the lens of the solution window and check that the solution is clear and colorless.

Discard the Anapen Auto-injector if the solution is cloudy, discolored, or contains particles.

A black arrow points to a small rectangular window located on the top of a white cylindrical medical device

  1. Ensure that the injection indicator is not red. If it is red, this means the Anapen Auto-injector has already been activated and must be discarded.

Illustration numbered 4 showing a black curved arrow indicating the rotational movement of a white rectangular medical device

  1. Turn the cap over the solution window fully in the direction indicated by the arrows, to ensure the solution window is covered. Return the Anapen Auto-injector to its container until it is needed.
  • Use of the Anapen Auto-injector

If the black needle cap has been removed, do not place your thumb, fingers, or hand over the open end (needle end) of the Anapen Auto-injector.

You should follow these steps for using the Anapen Auto-injector:

A hand grasps the dark base of a medical device while an arrow indicates the insertion movement toward the

  1. Remove the black needle cap by pulling firmly in the direction of the arrow. This also removes the grey needle safety shield.

A hand holds a gray medical device and moves it toward the

  1. Remove the grey safety cap from the red injector button by pulling as indicated by the arrow.

A hand holds a syringe with the

  1. Place the open end (needle end) of Anapen against the outer thigh. If necessary, Anapen can be used through lightweight clothing such as jeans, cotton, or polyester.

A hand firmly holds an injection pen with the thumb pressing the top section next to the number 4 and a time symbol

  1. Press the red injector button until a click is heard. Keep the Anapen auto-injector pressed against the thigh for 10 seconds. Slowly remove Anapen from the thigh. Gently massage the injection site.

A black arrow points to a red strip on a white medical device with the number 5 in a black circle in the upper left corner

  1. The injection indicator will have turned red. This indicates that the injection has been completed.

If it is not red, repeat the injection using a new Anapen.

A hand holds a dark medical device and moves it toward the

  1. After injection, the needle will be exposed. To cover it, turn the black needle cap around and, using the wide end, press the needle into the open end (needle end) of the Anapen auto-injector (as indicated by the arrow).

Return your used Anapen to the hospital or pharmacy for proper disposal.

If you use more Anapen than you should

  • If you inject too much adrenaline or accidentally inject into a blood vessel or finger, seek immediate medical help at the nearest hospital.
  • In case of overdose or accidental injection, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20.
  • If you have any further questions about the use of this product, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.

  • Anapen contains sodium metabisulphite (E223), which may cause allergic reactions and breathing difficulties, especially in individuals with a history of asthma. You should seek medical help immediately if you experience these adverse effects.
  • Frequent adverse effects of adrenaline include a sensation of strong heartbeats (palpitations), rapid or irregular heartbeat, sweating, nausea, vomiting, difficulty breathing, dizziness, weakness, pallor, tremors, headache, apprehension, nervousness, anxiety, and coldness in the extremities.
  • Other less common adverse effects include: hallucinations, fainting, dilated pupils, difficulty urinating, muscle tremors, increased blood pressure, and blood changes such as elevated blood sugar levels, low potassium levels, and high acid content.
  • Occasionally, at high doses or in susceptible patients, a sudden increase in blood pressure may occur, which could lead to cerebral haemorrhage, irregular heartbeats or heart attack, and reduced blood flow to the skin, mucous membranes, and kidneys.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Anapen

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton and auto-injector. The expiry date refers to the last day of the month indicated.

Do not store above 25°C.

Do not use this medicine if you notice that the solution is cloudy, has changed colour, or contains particles. See the instructions for use to learn how to check the medicine.

Keep the auto-injector in its outer packaging to protect it from light.

Medicines must not be disposed of via wastewater or household waste. Return any unused medicines and their packaging to the SIGRE point at your pharmacy. If in doubt, ask your pharmacist how to dispose of unwanted medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Anapen

  • The active substance is adrenaline (epinephrine) 0.30 mg in 0.3 ml.
  • The other components are: sodium metabisulfite (E223), sodium chloride, hydrochloric acid, water for injections.

Appearance of the product and contents of the pack

Anapen is supplied as a pre-filled syringe containing an adrenaline solution for injection in an automatic injection system (Auto-injector).

Packs containing 1 or 2 auto-injector units with a thermoformed protective tray are available in a cardboard carton. Only certain pack sizes may be marketed.

Length of exposed needle: 10 mm ± 1.5 mm.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Bioprojet Pharma,

9 rue Rameau, 75002 Paris, France

Manufacturer:

Owen Mumford Limited

Primsdown Industrial Estate,

Worcester Road, Chipping Norton,

Oxfordshire OX7 5XP,

UK

LYOFAL - SALON DE PROVENCE, ZA La Gandonne,

452 rue du Rémoulaire, SALON DE PROVENCE,

13300, France

This medicinal product is authorized in the European Economic Area member states under the following names:

Austria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Latvia, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovenia, Spain, Sweden and the Netherlands: Anapen

Belgium, Italy: Chenpen

Date of the most recent review of this leaflet: 04/2024

Anapen is a registered trademark.

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/