Anapen 0.15 mg/0.3 ml solution for injection in pre-filled syringe

Spain
Brand name Anapen 0.15 mg/0.3 ml solution for injection in pre-filled syringe
Form solution for injection in a pre-filled syringe
Active substance / Dosage
EPINEPHRINE · 0,15 mg
Prescription type Prescription Only Medicine
ATC code
C01C C01CA C01CA24
Registration number 75408
Manufacturer Bioprojet Pharma
Anapen 0.15 mg/0.3 ml solution for injection in pre-filled syringe solution for injection in a pre-filled syringe

Table of Contents

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Anapen 0.15 mg/0.3 ml solution for injection in a 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 could harm them.

  • If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects 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 thin, white cylindrical container positioned vertically against a person's side

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 after using your Auto-injector.
  • Adrenaline is a hormone naturally secreted in response to stress. In acute allergic reactions, it works 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 or 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 starting to use Anapen.

  • Your doctor must provide you with detailed instructions on when and how to correctly use your Anapen auto-injector.
  • You must inform your doctor if you have any heart condition, including angina, hyperthyroidism, high blood pressure, low potassium levels, elevated calcium levels in the blood, circulatory disorders, phaeochromocytoma (a type of tumour 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 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 intend to consume (including medicines), as even small amounts may 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 lead to loss of blood flow in the affected area. In such cases, you must go immediately to the nearest emergency department.

Use of Anapen with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take 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-noradrenaline 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 conditions such as asthma), oxytocin (used to induce contractions in pregnant women), inhaled anaesthetics, α-adrenergic blockers (used to treat high blood pressure), sympathomimetics (used in the treatment of asthma, other airway diseases, and nasal congestion).

Use of 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 administration of adrenaline 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 at risk. Consult your doctor before an emergency occurs.
  • Adrenaline is not expected to have any effect on the breastfed infant.

Driving and use of 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 metabisulphite (E223)

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

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

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 auto-injectors 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 0.15 mg (150 micrograms) of adrenaline. After use, a volume of 0.75 ml remains in the auto-injector, which must not be reused.

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

  • Skin itching, 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 auto-injector immediately. You must inject this medicine only into the outer 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. For this reason, you should always carry more than one Anapen unit with you.

Use in adults

  • The normal dose is 0.30 mg.
  • Overweight individuals may require more than one injection to reverse the effects of an allergic reaction.

Use in children and adolescents

  • The appropriate dose is 0.15 mg or 0.30 mg,
  • Depending on the child's body weight and the doctor's judgment.
  • Children and adolescents weighing over 30 kg should use Anapen 0.30 mg.
  • Auto-injectors delivering 0.30 mg of adrenaline are also available.
  • A dose below 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 judgment.

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 immediate medical help 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 observation and further treatment as appropriate. This is because the reaction may recur later.

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

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

Instructions for use

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

  • Parts of the Anapen Auto-injector

Before using the Anapen auto-injector, you should be familiar with all its parts. These are shown in the diagram.

Black needle cover (reversible)

Rotating cap of the solution window

Injection indicator

Grey safety cap

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

End of the autoinjector needle

Solution window

Safety lock

Red injection button

  • Rotating cap of the solution window: Rotate the cap 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 turn the black needle shield around and replace it onto the same end of the Anapen Autoinjector to cover the needle.

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

The black needle shield and the grey safety cap must not be removed until the Anapen Autoinjector is ready to be used.

  • Checking the Anapen Autoinjector

Before using your Anapen Autoinjector, you must perform the following checks:

Technical drawing of a white medical device with a black curved arrow indicating rotational movement toward the

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

Technical diagram of a white rectangular medical device with a black arrow pointing to a central gray 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 indicates 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.

Diagram with number 4 and a black curved arrow indicating the rotation of a white rectangular medical device on a light green background

  1. Turn the cap over the solution window completely in the direction of the arrows to ensure the solution window is covered. Place the Anapen Auto-injector back into its carrier until 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.

Follow these steps for using the Anapen Auto-injector:

A hand grasps the dark base of a medical device while an arrow indicates the movement of insertion or sliding to the left

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

A hand holds a gray medical device to apply it onto the red tip of a white cylinder following the direction of a black arrow

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

A hand holds a white injection pen on a green background with the number 3 in a black circle at the bottom left

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

A hand firmly holds a cylindrical medical device with a circular indicator showing a highlighted black section and the number 4

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

Diagram with number 5 and a black arrow indicating a red strip on a white medical device with diagonal stripes

  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 black and white medical device while a black arrow indicates the movement of removing the upper cap

  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 it into a blood vessel or finger, seek immediate medical attention 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, consult 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, paleness, 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 increased 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, 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, discoloured, or contains particles. See the instructions for use to learn how to check the medicine.

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

Medicines should not be disposed of via wastewater or household waste. Unused containers and medicines should be taken to a pharmacy’s SIGRE collection point. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Anapen

  • The active substance is adrenaline (epinephrine) 0,15 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 presented 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 in a cardboard box are available. 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, France, Germany, Greece, Hungary, Iceland, Ireland, Luxembourg, Malta, Poland, Portugal, Romania, Sweden and the Netherlands: Anapen junior.

Norway: Anapen (junior)

Estonia, Finland, Latvia, Lithuania, Luxembourg and Spain: 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/