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

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Anapen 0.50 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 could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

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 a doctor after using your Auto-injector.
• Adrenaline is a hormone naturally released in response to stress. In acute allergic reactions, it helps improve blood pressure, heart function, and breathing, and reduces 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 stings or bites, 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 medical condition.
• If you have asthma, you may be at increased risk of a severe allergic reaction.
• Any person 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 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 result in loss of blood flow to the affected area. You must seek immediate medical attention at the nearest emergency department.

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

Other medicines and Anapen

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

• Medications for heart conditions, such as digitalis (digoxin), β-blockers, quinidine,
• Medications for depression, such as tricyclic antidepressants, monoamine oxidase inhibitors (MAOIs), serotonin and noradrenaline reuptake inhibitors (SNRIs),
• Medications for diabetes; your doctor may need to adjust your medication dose after using Anapen,
• Medications for Parkinson’s disease,
• Medications for thyroid disorders,
• Other medications: 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).

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 your life is 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 sensation 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 0.5 mg (500 micrograms) of adrenaline. After use, a volume of 0.75 ml remains in the autoinjector, which must not be reused.

The 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 due to 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 should administer a second injection. For this reason, you should always carry more than one Anapen unit with you.

If a second injection is required, it is recommended to administer it into the opposite thigh.

Use in adults

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

Use in children: Anapen 500 micrograms is not recommended for use 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 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 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 risk to health and under medical judgment.

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 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 raised, unless this makes breathing difficult, in which case you should remain sitting. 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 coworkers also be trained in the correct use of the Anapen autoinjector.

• Parts of the Anapen autoinjector

Before using the Anapen autoinjector, you need to know all its parts. These are shown in the illustration.

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

• 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 Auto-injector has not been accidentally activated or tampered with. After injection, the injection indicator turns red, indicating that the Anapen Auto-injector has been correctly activated.

• Black needle shield (reversible): Protects the needle when you are not using the Anapen Auto-injector. 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 Auto-injector to cover the needle.

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

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

• Checking the Anapen Auto-injector

Before using your Anapen Auto-injector, and on a regular basis, you should perform the following checks:

• 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:

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 your 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 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.

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

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

Anapen contains sodium metabisulfite (E223), which may cause allergic reactions and breathing difficulties, especially in individuals with a history of asthma. You should seek immediate medical help if you experience these adverse effects.

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 Medicines: 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 store above 25°C.

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.

After the expiry date, dispose of the auto-injector and replace it with a new one. Regularly inspect the solution through the viewing window to ensure that it is clear and colourless. Discard and replace Anapen if the solution becomes cloudy, changes colour, or contains particles.

You should regularly check your auto-injector as shown in section 3 of this leaflet under the heading “Instructions for use”. This ensures that your Anapen will be ready for use in an emergency.

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

Store Anapen in a horizontal position.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers 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) 0.50 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 prefilled* syringe containing an adrenaline solution for injection in an automatic injection system (auto-injector). One dose of 0.3 ml contains 500 micrograms of adrenaline (epinephrine). Anapen is a clear, colourless solution practically free from particles.

Packs containing 1 or 2 units of auto-injectors are available, with a thermoformed protective tray inside a cardboard box. Only certain pack sizes may be marketed.

*Length of exposed needle: 10 mm ± 1.5 mm.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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 authorised in the Member States of the European Economic Area under the following names:

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

Chenpen: Belgium, Italy.

Date of the most recent review of this leaflet: April 2024

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/