Leaflet: information for the user

Anapen 0.50 mg/0.3 ml injectable solution in pre-filled syringe

Adrenaline (epinephrine)

Read this leaflet carefully before starting to use this medicine, as it contains important information for you.

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

1. What Anapen is and for what it is used

2. What you need to know before starting to use Anapen

3. How to use Anapen

4. Possible side effects

5. Storage of Anapen

6. Contents of the pack and additional information

• Anapen is presented in the form of a preloaded adrenaline syringe in an automatic injection system (Autoinjector). This system injects a single dose of adrenaline into the muscle
• This medication is only for emergency situations and you should visit your doctor

immediately after using your Autoinjector.

• Adrenaline is a hormone secreted naturally in response to stress. In acute allergic reactions, it acts by improving blood pressure, heart function, and respiratory function, and 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 exercise or an unknown cause.

No use Anapen

No known reason exists for not using Anapen in an allergic emergency situation.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Anapen.

• Your doctor must instruct you thoroughly on when and how to correctly use Anapen Autoinjector.
• Inform your doctor if you have a heart condition, including angina pectoris, hyperthyroidism, high blood pressure, low potassium levels, and increased calcium in the blood, circulatory disorders, phaeochromocytoma (a type of adrenal gland tumor), increased eye pressure (glaucoma), kidney or prostate disease, diabetes, or any other condition.
• If you have asthma, you may have an increased risk of severe allergic reaction.
• Anyone who has had an anaphylactic episode should consult their doctor to analyze what substances they may be allergic to, in order to avoid them strictly in the future. It is essential to note that an allergy to a substance can lead to allergies to a large number of related substances.
• If you have food allergies, it is essential to review the ingredients of everything you are going to ingest (including medications) as even small amounts can cause severe reactions.
• Repeated local injections can cause skin damage in the injection area. Accidental intravascular injection can cause a sudden increase in blood pressure. Accidental injection in hands or feet can cause loss of blood flow to the affected area. Seek immediate attention at the nearest emergency service.

If you have a thick layer of subcutaneous fat, there is a risk that adrenaline may not reach the muscle tissue, resulting in suboptimal effect.

Other medications and Anapen

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

• Heart disease medications, such as digoxin (digitalis), beta-blockers, quinidine,
• Depression medications, such as tricyclic antidepressants, monoamine oxidase inhibitors (MAOIs), serotonin and noradrenaline reuptake inhibitors (SNRIs),
• Diabetes medications, your doctor may modify your medication dose after using Anapen,
• Parkinson's disease medications,
• Thyroid disorder medications,
• Other medications: antihistamines such as diphenhydramine or chlorpheniramine, theophylline, ipratropium, and oxitropium (used to treat respiratory diseases such as asthma), oxytocin (used in labor contractions), inhalational anesthetics, alpha-adrenergic blockers (used to treat high blood pressure), sympathomimetics (used in the treatment of asthma, other respiratory diseases, and nasal congestion).

Use of Anapen with alcohol

Alcohol can negatively affect this medication by increasing its effects.

Pregnancy and breastfeeding

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

• It is unclear if administering adrenaline during pregnancy poses a risk to the fetus. This should not deter you from using Anapen in an emergency situation as your life may be at risk. Consult your doctor before an emergency occurs.
• No expected effect of adrenaline on the infant is expected.

Driving and operating machinery

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

Anapen contains sodium metabisulfite (E223)(E223)

This medication can cause severe allergic reactions and bronchospasm (sudden sensation of choking) 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 medication contains less than 23 mg (1 mmol) of sodium per dose, making it essentially "sodium-free".

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

• Follow exactly the administration instructions of this medication as indicated by your doctor.
• If in doubt, consult again with your doctor or pharmacist.
• It is only injected into the thigh.
• For single use, please ensure it is disposed of safely immediately after use. Anapen releases a single dose of 0.3 ml of liquid equivalent to 0.5 mg (500 micrograms) of adrenaline. After use, 0.75 ml remains in the autoinjector, which should not be reused.

The reaction usually begins within minutes of exposure to the allergen, and the person may experience:

• Itching of the skin, urticaria, redness and swelling of the eyes, lips, or tongue.
• Difficulty breathing due to swelling of the throat. Wheezing, shortness of breath, and coughing due to stiffening of the lung muscles.
• Other anaphylaxis symptoms such as headaches, vomiting, and diarrhea.
• Coma and loss of consciousness due to a sudden drop in blood pressure.

If you experience these signs and symptoms, use the Anapen autoinjector immediately.Only inject this medication into the outer part of the thigh, never into the buttock.

At times, 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 unit of Anapen. If your symptoms have not improved or have worsened within 5-15 minutes after the first injection, either you or the person with you should administer a second injection. For this reason, you must always carry more than one unit of Anapen with you.

If a second injection is necessary, it is recommended to administer it in the opposite thigh.

Use in adults

• The recommended dose is 0.30 mg for individuals weighing less than 60 kg.
• For adults weighing more than 60 kg, the dose of 300 micrograms may not be sufficient, and these patients may need Anapen 500 micrograms to reverse the effect of an allergic reaction.

Use in children:the use of Anapen 500 micrograms is not recommended in children.

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 doctor's criteria.
• Children and adolescents weighing more than 30 kg should use Anapen 0.30 mg.
• Autoinjectors that release 0.15 mg of adrenaline are also available.

A dose below 0.15 mg cannot be administered with sufficient accuracy in children weighing less than 15 kg, so its use is not recommended unless the situation poses a risk to their health and under medical criteria.

Children between 15 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 indicate "anaphylaxis," even if it seems that the symptoms have improved. You will need to go to a hospital for observation and subsequent treatment, as needed. This is because the reaction can recur later.

While waiting for the ambulance, lie down with your legs elevated unless this makes it difficult to breathe, in which case you should remain seated. 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 recovery position.

Instructions for use

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

A. Parts of the Anapen Autoinjector

Before using the Anapen Autoinjector, you need to know all the parts of the Anapen Autoinjector. These are shown in the diagram.

• Rotary cover of the solution window:Turn the cover over the solution window to align the lens with the solution window of the Anapen 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 piston through the window. This indicates that the Anapen Autoinjector has not been activated by mistake or manipulated. After injection, the injection indicator turns red, indicating that the Anapen Autoinjector has been activated correctly.

• Black needle shield (reversible):Protects the needle when you are not using the Anapen Autoinjector. Pull the needle shield before injection. After injection, the patient must turn the needle shield back and put it back in the same end of the Anapen Autoinjector to cover the needle.

• Gray safety cap:This covers the red injector button. Prevents the button from being pressed by mistake.

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

B. Checking the Anapen Autoinjector

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

C. Using the Anapen Autoinjector

If the needle shield has been removed, do not place your finger, fingers, or hand on the open end (needle end) of the Anapen Autoinjector.

You must follow these steps to use the Anapen Autoinjector:

Dispose of your used Anapen in the hospital or pharmacy for proper disposal.

If you use more Anapen than you should

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

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

The following adverse effects are based on experience with the use of adrenaline, but the frequency of adverse effects cannot be estimated:

• blood changes such as high glucose levels, low potassium levels, and high acid content
• anxiety, hallucinations
• headache, dizziness, tremor, fainting
• dilated pupils
• rapid or irregular heartbeat, irregular heartbeats, or heart attack, sensation of strong heartbeats (palpitations)
• increase in blood pressure, a sudden increase in blood pressure may cause cerebral hemorrhage, decreased blood flow to the skin, mucous membranes, and kidneys, coldness in extremities
• difficulty breathing
• nausea, vomiting
• difficulty urinating
• sweating, pallor, weakness, apprehension, nervousness, muscle tremors

Anapen contains sodium metabisulfite (E223) which may cause allergic reactions and difficulty breathing, especially in cases where there is a history of asthma. You must seek immediate medical attention if you experience these adverse effects.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

Do not store at a temperature above 25°C.

Do not use this medication after the expiration date that appears on the box and the auto-injector. The expiration date is the last day of the month indicated.

After the expiration date, discard the auto-injector and replace it with another. Check the solution periodically through the inspection window to ensure that the solution is clear and colorless. Discard and replace Anapen if the solution is cloudy, changes color, or contains particles.

You should regularly inspect your syringe, as shown in section 3 of this leaflet under the heading “Instructions for use”. This is to ensure that your Anapen can be used in an emergency.

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

Store Anapen in a horizontal position.

Medicines should not be disposed of through the drains or in the trash. Deposit the containers and medicines that you no longer need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines that you no longer need. By doing so, you will help protect the environment.

Composition of Anapen

Appearance of the product and contents of the packaging

Anapen is presented in the form of a pre-loaded syringe with a solution of adrenaline for injection in an automatic injection system (Autoinjector). A dose of 0.3 ml contains 500 micrograms of adrenaline (epinephrine). Anapen is a clear, practically particle-free solution.

Packaging is available with 1 or 2 units of autoinjectors with a thermoformed protective tray in a cardboard box.Only some packaging sizes may be commercially available.

*Exposed length of the needle: 10 mm ± 1.5 mm.

Holder of the marketing authorization and responsible for manufacturing

Holder of marketing authorization:

Bioprojet Pharma

9 rue Rameau

75002 Paris

France.

Responsible for manufacturing:

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 medicine is authorized in the member states of the European Economic Area with the following names:

Anapen:Austria, Cyprus, Czech Republic, France, Germany, Greece, Hungary, Ireland, Poland, Portugal, Slovenia, Spain.

Chenpen:Belgium, Italy.

Date of the last review of this prospectus:April 2024

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/